更新于：2024-12-07
Celiprolol Hydrochloride
盐酸塞利洛尔
更新于：2024-12-07
概要
基本信息
药物类型 小分子化药 |
别名 Celiprolol、Celiprolol hydrochloride (JAN/USAN)、EDSIVO + [10] |
作用机制 β1-adrenergic receptor拮抗剂(β1-肾上腺素能受体拮抗剂) |
非在研适应症- |
原研机构- |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 奥地利 (1983-01-17) |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、孤儿药 (美国) |
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结构
分子式C20H34ClN3O4 |
InChIKeyVKJHTUVLJYWAEY-UHFFFAOYSA-N |
CAS号57470-78-7 |
关联
7
项与 盐酸塞利洛尔 相关的临床试验A Phase 3 Randomized, Double-Blind, Decentralized Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in the Treatment of Patients With COL3A1-Positive Vascular Ehlers-Danlos Syndrome
This is a prospective, Phase 3, randomized, double-blind, placebo-controlled efficacy study to evaluate celiprolol in patients genetically confirmed as COL3A1-positive vEDS using a decentralized clinical trial design.
开始日期2022-11-07 |
申办/合作机构 |
Prevention of Postoperative Cardiac Arrythmias in Thoracic Surgery : Celiprolol Versus Diltiazem
Cardiac arrythmias are the most common cardiac complications after thoracic surgery. They are made primarily of postoperative atrial fibrillation (POAF).
They are associated with an increased risk of stroke, increased length of hospital stay and cost of care, and increased long-term mortality.
Randomized , single-blind prospective study in the anesthesia and intensive care department of Abderrahmen Mami hospital Ariana Tunisia comparing the efficacy of Diltiazem versus Celiprolol in the prevention of postoperative cardiac arrythmias in patients proposed for pneumonectomy and bilobectomy.
They are associated with an increased risk of stroke, increased length of hospital stay and cost of care, and increased long-term mortality.
Randomized , single-blind prospective study in the anesthesia and intensive care department of Abderrahmen Mami hospital Ariana Tunisia comparing the efficacy of Diltiazem versus Celiprolol in the prevention of postoperative cardiac arrythmias in patients proposed for pneumonectomy and bilobectomy.
开始日期2018-12-01 |
申办/合作机构- |
Proof of Concept Study to Assess the Differential Effects of Chronic Beta-blockade (Celiprolol Versus Bisoprolol) on Cardiopulmonary Outcomes at Rest and During Exercise in Chronic Obstructive Pulmonary Disease
What are the differential effects of beta-blockers on lung and heart function during exercise in chronic obstructive pulmonary disease (COPD)? COPD is a major cause of illness and death. Not only do these individuals suffer from lung disease, but COPD often leads to other illnesses, particularly heart disease. Beta-blockers very successfully treat heart disease. It is therefore logical that one would want to use this treatment in COPD patients with heart disease too. However, there has always been concern that beta-blockers could cause significant problems in COPD by worsening lung function, as these can have the opposite effect to inhalers used to treat COPD that open up airways. Pointedly, there is increasing evidence that despite this problem, COPD patients who have been prescribed beta-blockers have been shown to gain benefit particularly in terms of preventing death.
In this study, the investigators therefore want to examine which beta-blocker might be the safest for COPD patients, as each work slightly differently. Some beta-blockers may have a more beneficial effect on airways than others, whilst still benefitting the heart. The investigators will study two different beta-blockers; one that potentially narrows airways and one that potentially opens airways. The investigators will be using cardiopulmonary exercise testing (an exercise bike that measures both heart and lung function during exercise) to look for differences between both beta-blockers primarily in terms of lung function but also with information about the heart. The investigators will recruit people with moderate to severe COPD who are able to complete a cycle exercise test through their respiratory research department. The study will last for 10-12 weeks with 5 main visits to the department for serial exercise tests, breathing tests, simple heart function tests and simple blood tests that will tell the investigators what other effects these beta-blockers are having on the heart and lungs.
In this study, the investigators therefore want to examine which beta-blocker might be the safest for COPD patients, as each work slightly differently. Some beta-blockers may have a more beneficial effect on airways than others, whilst still benefitting the heart. The investigators will study two different beta-blockers; one that potentially narrows airways and one that potentially opens airways. The investigators will be using cardiopulmonary exercise testing (an exercise bike that measures both heart and lung function during exercise) to look for differences between both beta-blockers primarily in terms of lung function but also with information about the heart. The investigators will recruit people with moderate to severe COPD who are able to complete a cycle exercise test through their respiratory research department. The study will last for 10-12 weeks with 5 main visits to the department for serial exercise tests, breathing tests, simple heart function tests and simple blood tests that will tell the investigators what other effects these beta-blockers are having on the heart and lungs.
开始日期2016-06-07 |
申办/合作机构 |
100 项与 盐酸塞利洛尔 相关的临床结果
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100 项与 盐酸塞利洛尔 相关的转化医学
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100 项与 盐酸塞利洛尔 相关的专利（医药）
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520
项与 盐酸塞利洛尔 相关的文献（医药）2024-06-01·Vascular medicine (London, England)
Despite celiprolol therapy, patients with vascular Ehlers–Danlos syndrome remain at risk of vascular events: A 12-year experience in an Italian referral center
Article
作者: Stassaldi, Deborah ; Buso, Giacomo ; De Ciuceis, Carolina ; Muiesan, Maria Lorenza ; Venturini, Marina ; Ritelli, Marco ; Colombi, Marina ; Paini, Anna ; Salvetti, Massimo ; Bertacchini, Fabio ; Agabiti-Rosei, Claudia
Background::
Vascular Ehlers–Danlos syndrome (vEDS) is an inherited connective tissue disorder characterized by arterial fragility. Celiprolol has been suggested to significantly reduce rates of vascular events in this setting, though real-world evidence is limited. The aim of this study was to report our experience with celiprolol therapy in vEDS management.
Methods::
Patients with a genetically confirmed diagnosis of vEDS who were referred for outpatient consultation at the Brescia University Hospital between January 2011 and July 2023 were included. At each visit, patients’ medical history, results of vascular imaging, and office blood pressure measurements were recorded. Celiprolol therapy was progressively titrated to the maximum tolerated dose of up to 400 mg daily, according to the patients’ tolerance.
Results::
Overall, 26 patients were included. Female sex was prevalent (62%). Mean (SD) age was 37 (16) years. Follow-up duration was 72 (41) months. At the last follow-up visit, all patients were on celiprolol therapy, 80% of whom were taking the maximum recommended dose. The yearly risk of symptomatic vascular events was 8.8%, the majority of which occurred after reaching the maximum recommended dose of celiprolol. No significant predictor of symptomatic vascular events was identified among patients’ clinical characteristics.
Conclusion::
In our cohort, rates of celiprolol use were high and the drug was well tolerated overall. Nonetheless, the risk of symptomatic vascular events remained nonnegligible. Future studies should identify reliable predictors of major adverse events and explore additional therapeutic strategies that could further lower the risk of life-threatening events in this population.
2024-05-01·Nefrologia
Comparison of efficacy and safety of the new generation helixone dialyzers
Article
作者: Gómez, Miquel ; Fontseré, Néstor ; Rodríguez-Espinosa, Diana ; Maduell, Francisco ; Broseta, José Jesús ; Ramos, Rosa ; Rodas, Lida María ; Rico, Nayra ; Vera, Manel ; Salgado, Maria Del Carmen ; Arias-Guillén, Marta
INTRODUCTION:
New generation helixone dialyzers has recently been developed as part of the ongoing effort to improve dialyzer hemocompatibility and avoid adverse reactions to synthetic dialyzers. This study aimed to assess the performance and albumin loss of this new dialyzer series in hemodiafiltration and compare it with the previous generation helixone series.
MATERIAL AND METHODS:
A prospective study was conducted in 19 patients. Each patient underwent eight dialysis sessions with the same routine dialysis parameters; only the dialyzer varied: FX60 CorDiax, FX CorAL 60, FX600 CorDiax, FX CorAL 600, FX80 CorDiax, FX CorAL 80, FX800 CorDiax, and FX CorAL 800. The reduction ratios (RR) of urea, creatinine, ß2-microglobulin, myoglobin, kappa-free immunoglobulin light chains (κFLC), prolactin, α1-microglobulin, α1-acid glycoprotein, lambda immunoglobulin light chains (λFLC), and albumin were compared intra-individually. Dialysate albumin loss was also measured.
RESULTS:
All treatments were well tolerated. The mean amount of replacement fluid ranged from 31 to 34 L. Comparison of dialysis treatments showed no differences between small molecules and even up to those the size of β2-microglobulins. Little differences were found between myoglobin, κFLC, prolactin, α1-microglobulin, and λFLC RRs, and only FX80 CorDiax was slightly superior to the others. Mean dialysate albumin losses were similar, with less than 2.5 g lost in each dialyzer. The FX80 CorDiax showed slightly higher global removal scores than the other dialyzers evaluated, except for FX CorAL 800.
CONCLUSION:
The new generation helixone dialyzers series has been updated to minimise the risk of adverse reactions, while maintaining the effectiveness and albumin loss achieved by the previous most advanced helixone generation.
2023-12-30·Cureus
Sneezing-Induced Subclavian Arterial Rupture: A Case of Vascular Ehlers-Danlos Syndrome in a Child
作者: Ito, Yusuke ; Yoshizawa, Kosuke ; Yamagami, Yuji ; Hanada, Tomoya ; Kanno, Koji
Vascular Ehlers-Danlos syndrome is a fatal disease caused by a type III collagen mutation that can result in the rupture of blood vessels, the intestinal tract, and/or the uterus. Despite being the most severe form of Ehlers-Danlos syndrome, it is not well known in the pediatric context because it rarely presents serious complications in childhood. In this case, the patient experienced a subclavian artery rupture triggered by sneezing, which was initially managed with an endovascular stent. However, the descending aorta subsequently ruptured, and the patient died. Traditionally, surgical or endovascular treatments have been avoided due to the inherent fragility of blood vessels. Nevertheless, favorable outcomes have been documented with a wait-and-see surgical approach or endovascular treatment, especially when the diagnosis precedes the onset of vascular complications. Notably, celiprolol, a partial β2-agonist and β1-blocker, has demonstrated efficacy in preventing vascular complications. Therefore, early diagnosis plays a pivotal role. Raising awareness about this syndrome, along with its management and prophylaxis, holds the potential to enhance the survival rate.
71
项与 盐酸塞利洛尔 相关的新闻（医药）2024-11-12
FDA approval of MIPLYFFA™ and product launch cap third quarter filled with multiple commercial and clinical development milestones
Zevra received rare pediatric disease Priority Review Voucher
Company ends quarter with cash, cash equivalents and investments of $95.5 million
Company to host conference call and webcast today, Nov. 12, 2024, 4:30 p.m. ET
CELEBRATION, Fla., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on addressing unmet needs for the treatment of rare diseases, today reported its financial results for the third quarter ended Sept. 30, 2024, and provided corporate updates.
“The third quarter was one of the most exciting and transformational periods in Zevra’s journey,” said Neil F. McFarlane, Zevra’s President and Chief Executive Officer. “After years of tireless effort, our team has achieved a major milestone with FDA approval of MIPLYFFA™ (arimoclomol), and we’re celebrating with the Niemann-Pick disease type C (NPC) community. We intend to achieve our goals with a high-performing team committed to execute, focus and innovate to drive our continued growth and long-term transformation.”
Program Highlights
On Sept. 20, the U.S. Food and Drug Administration (FDA) approved MIPLYFFA capsules as an orally delivered treatment for NPC. MIPLYFFA, the first NPC drug approved by the FDA, is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older. With the approval of MIPLYFFA, Zevra received a rare pediatric disease Priority Review Voucher (PRV) which the Company could monetize to help fund its growth.
As of Oct. 31, Zevra has received 90 prescription enrollment forms for MIPLYFFA of which 30% are approved for reimbursement and are ready for fulfillment upon drug availability, consistent with the Company’s prior guidance of eight to 12 weeks post launch.
Zevra has launched AmplifyAssist™, a comprehensive support program for caregivers and those eligible living with NPC or UCDs.
OLPRUVA® had three new patient enrollments in the third quarter, and reimbursement coverage is at approximately 76% of covered lives. Improving OLPRUVA’s formulary position is a primary objective to make it the preferred treatment for UCDs.
Zevra is refining its commercial strategy for OLPRUVA to focus on specific patient segments where there are fewer access barriers, and, together with The National Urea Cycle Disorders Foundation, launched a targeted patient education campaign highlighting the importance of prompt and accurate testing of blood ammonia levels, which, when elevated, may be a sign of a UCD. Campaign materials are available at www.checkammonia.com.
The Company recently completed an End-of-Phase 2 meeting with the FDA for KP1077. The Agency indicated that a single pivotal study with appropriate confirmatory evidence will be sufficient to submit a new drug application (NDA). Zevra is evaluating strategic alternatives to advance clinical development and later, commercialization.
The Phase 3 DiSCOVER trial of celiprolol for the treatment of Vascular Ehler-Danlos Syndrome (VEDS) is underway, and the Company has achieved its objective to restart enrollment and to begin dosing new patients, reporting that a total of 19 patients are now in the trial as of the end of the third quarter. Zevra is continuing its efforts to expand its partnerships with patient advocacy groups, treatment centers of excellence, and medical key opinion leaders.
Corporate Highlights and Upcoming Milestones
In August, Zevra completed an underwritten public offering of 10,615,385 shares of its common stock at an offering price of $6.50 per share for total net proceeds of approximately $64.5 million, after deducting underwriting discounts and commissions and offering expenses. Cantor and William Blair were joint book-running managers for the offering. Citizens JMP and H.C. Wainwright & Co. were co-managers.
The Company completed a thorough portfolio assessment and developed a strategic plan for 2025 that builds from its 2024 accomplishments and furthers Zevra’s transformation towards becoming a leading rare disease company with a five-year vision to create value for patients and shareholders by organizing our priorities on four key pillars: Commercial Excellence, Pipeline and Innovation, Talent and Culture, and Corporate Foundation.
Now focused on late-stage clinical development and commercial opportunities, Zevra has discontinued its in-house drug discovery activities and is closing its laboratory facilities in Iowa and Virginia. Future early research and development activities will be outsourced.
Q3 2024 Financial Highlights
Revenue, Net: $3.7 million, comprised of $2.6 million in net reimbursements from the French expanded access program (EAP) for arimoclomol, $1.1 million of royalties and other reimbursements under the AZSTARYS® license agreement, and de minimis OLPRUVA revenue.
Cost of Goods Sold: $2.3 million, which includes recognition of $2.0 million in inventory obsolescence reserve expense related to OLPRUVA inventory that is nearing expiration.
R&D Expenses: $10.9 million, which represents a decrease of $1.4 million compared to Q3 2023 due to the completion of the KP1077 phase 2 trial.
SG&A Expenses: $16.2 million for Q3 2024, compared to $5.8 million in Q3 2023, which reflects the commercial team fully in place and actively engaged in commercial launch activities and patient services initiatives. This includes non-cash stock compensation of $6.1 million during the quarter, of which $2.5 million was performance-based upon the approval of MIPLYFFA.
Net Loss: ($33.2) million, or ($0.69) per basic and diluted share for Q3 2024, compared to a net loss of ($10.4) million, or ($0.30) per basic and diluted share in Q3 2023.
Cash Position: Cash, cash equivalents and investments were $95.5 million as of Sept. 30, 2024.
Cash Runway Forecast: Based on the Company’s current operating plan, available cash, cash equivalents and investments are expected to extend Zevra’s cash runway into 2027, subject to continuing compliance with debt covenants. Cash runway forecast includes anticipated revenue from MIPLYFFA sales, reimbursements from the French EAP for arimoclomol, royalties under the AZSTARYS license agreement, and continued investments into our development pipeline programs. It does not include potential proceeds from a PRV sale.
Common and Fully Diluted Shares O/S: As of Sept. 30, 2024, total shares of common stock outstanding were 53,227,364, and fully diluted common shares were 67,698,898, which included 5,483,537 shares issuable upon exercise of warrants.
Upcoming Events
Guggenheim Securities Healthcare Innovation Conference, with fireside chat on Wednesday, Nov. 13, 2024, at 4:00 p.m. ET. Management will be available for one-on-one meetings with registered attendees.
Conference Call Information - UPDATED
Zevra will host a conference call and audio webcast today at 4:30 p.m. ET to discuss its corporate update and financial results for the third quarter of 2024.
The audio webcast will be accessible via the Investor Relations section of the Company’s website, http://investors.zevra.com/. An archive of the audio webcast will be available for ninety (90) days beginning at approximately 5:30 p.m. ET on Nov. 12, 2024.
Additionally, interested participants and investors may access the conference call by dialing either:
(785) 838-9345 (United States) -- updated dial-in +1 (203) 518-9814 (International)Conference ID: ZVRAQ324
About MIPLYFFA
MIPLYFFA (arimoclomol) increases the activation of the transcription factors EB (TFEB) and E3 (TFE3) resulting in the upregulation of coordinated lysosomal expression and regulation (CLEAR) genes. MIPLYFFA has also been shown to reduce unesterified cholesterol in the lysosomes of human NPC fibroblasts. The clinical significance of these findings is not fully understood. MIPLYFFA was granted Breakthrough Therapy designation, Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track designation by the FDA for the treatment of NPC. MIPLYFFA was further granted Orphan Medicinal Product designation by the European Medicines Agency (EMA) for the treatment of NPC.
INDICATIONS AND USAGE
MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older.
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions:
Hypersensitivity reactions such as urticaria and angioedema have been reported in patients treated with MIPLYFFA during Trial 1: two patients reported both urticaria and angioedema (6%) and one patient (3%) experienced urticaria alone within the first two months of treatment. Discontinue MIPLYFFA in patients who develop severe hypersensitivity reactions. If a mild or moderate hypersensitivity reaction occurs, stop MIPLYFFA and treat promptly. Monitor the patient until signs and symptoms resolve.
Embryofetal Toxicity:
MIPLYFFA may cause embryofetal harm when administered during pregnancy based on findings from animal reproduction studies. Advise pregnant females of the potential risk to the fetus and consider pregnancy planning and prevention for females of reproductive potential.
Increased Creatinine without Affecting Glomerular Function:
Across clinical trials of MIPLYFFA, mean increases in serum creatinine of 10% to 20% compared to baseline were reported. These increases occurred mostly in the first month of MIPLYFFA treatment and were not associated with changes in glomerular function.
During MIPLYFFA treatment, use alternative measures that are not based on creatinine to assess renal function. Increases in creatinine reversed upon MIPLYFFA discontinuation.
The most common adverse reactions in Trial 1 (≥15%) in MIPLYFFA-treated patients who also received miglustat were upper respiratory tract infection, diarrhea, and decreased weight.
Three (6%) of the MIPLYFFA-treated patients had the following adverse reactions that led to withdrawal from Trial 1: increased serum creatinine (one patient), and progressive urticaria and angioedema (two patients). Serious adverse reactions reported in MIPLYFFA-treated patients were hypersensitivity reactions including urticaria and angioedema.
To report SUSPECTED ADVERSE REACTIONS, contact Zevra Therapeutics, Inc. at toll-free phone 1-844-600-2237 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.
Before prescribing MIPLYFFA, please read the full Prescribing Information, including Instructions for Use.
Drug Interaction(s):
Arimoclomol is an inhibitor of the organic cationic transporter 2 (OCT2) transporter and may increase the exposure of drugs that are OCT2 substrates. When MIPLYFFA is used concomitantly with OCT2 substrates, monitor for adverse reactions and reduce the dosage of the OCT2 substrate.
Use in Females and Males of Reproductive Potential:
Based on animal findings, MIPLYFFA may impair fertility and may increase post-implantation loss and reduce maternal, placental, and fetal weights.
Renal Impairment:
The recommended dosage of MIPLYFFA, in combination with miglustat, in patients with an eGFR ≥15 mL/minute to <50 mL/minute is lower than the recommended dosage (less frequent dosing) in patients with normal renal function.
MIPLYFFA capsules for oral use are available in the following strengths: 47 mg, 62 mg, 93 mg, and 124 mg.
About OLPRUVA
OLPRUVA (sodium phenylbutyrate) was approved for the treatment of certain UCDs in December 2022 and has recently been marketed under the brand name, OLPRUVA. OLPRUVA (sodium phenylbutyrate) for oral suspension is a prescription medicine used along with certain therapies, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with UCDs, involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). OLPRUVA is not used to treat rapid increase of ammonia in the blood (acute hyperammonemia), which can be life-threatening and requires emergency medical treatment. For more information, please visit www.OLPRUVA.com.
Important Safety Information
Certain medicines may increase the level of ammonia in your blood or cause serious side effects when taken during treatment with OLPRUVA. Tell your doctor about all the medicines you or your child take, especially if you or your child take corticosteroids, valproic acid, haloperidol, and/or probenecid.
OLPRUVA can cause serious side effects, including: 1) nervous system problems (neurotoxicity). Symptoms include sleepiness, tiredness, lightheadedness, vomiting, nausea, headache, confusion, 2) low potassium levels in your blood (hypokalemia) and 3) conditions related to swelling (edema). OLPRUVA contains salt (sodium), which can cause swelling from salt and water retention. Tell your doctor right away if you or your child get any of these symptoms. Your doctor may do certain blood tests to check for side effects during treatment with OLPRUVA. If you have certain medical conditions such as heart, liver or kidney problems, are pregnant/planning to get pregnant or breast-feeding, your doctor will decide if OLPRUVA is right for you.
The most common side effects of OLPRUVA include absent or irregular menstrual periods, decreased appetite, body odor, bad taste or avoiding foods you ate prior to getting sick (taste aversion). These are not all of the possible side effects of OLPRUVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
About KP1077
Serdexmethylphenidate (SDX) is Zevra’s proprietary prodrug of d-methylphenidate (d-MPH) and is the sole active pharmaceutical ingredient (API) of KP1077. KP1077 has been granted Orphan Drug designation by the FDA, and by the European Commission, for the treatment of Idiopathic Hypersomnia, or IH. The U.S. Drug Enforcement Agency (DEA) has classified SDX as a Schedule IV controlled substance based on evidence suggesting SDX has a lower potential for abuse when compared to d-MPH, a Schedule II controlled substance. In addition, KP1077 has intellectual property protection through 2037.
About Celiprolol
Celiprolol is an investigational clinical candidate for the treatment of Vascular Ehlers-Danlos Syndrome (VEDS). Celiprolol has been granted Orphan Drug and Breakthrough Therapy designations by the FDA. Zevra recently restarted enrollment in the Phase 3 trial, known as the DiSCOVER trial being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Celiprolol’s mechanism of action is designed to reduce the mechanical stress on collagen fibers within the arterial wall through vascular dilation and smooth muscle relaxation.
About Zevra Therapeutics, Inc.
Zevra Therapeutics, Inc. is a commercial-stage rare disease company combining science, data, and patient needs to create transformational therapies for diseases with limited or no treatment options. Our mission is to bring life-changing therapeutics to people living with rare diseases. With unique, data-driven development and commercialization strategies, the Company is overcoming complex drug development challenges to make new therapies available to the rare disease community.
Expanded access programs are made available by Zevra Therapeutics, Inc. and its affiliates and are subject to the Company's Expanded Access Program (EAP) policy, as published on its website. Participation in these programs is subject to the laws and regulations of each jurisdiction under which each respective program is operated. Eligibility for participation in any such program is at the treating physician's discretion.
For more information, please visit www.zevra.com or follow us on X and LinkedIn.
Cautionary Note Concerning Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding the promise and potential impact of our preclinical or clinical trial data; the initiation, timing and results of any clinical trials or readouts, the content, information used for, timing or results of any NDA submissions or resubmissions for any products or product candidates for any specific disease indication or at any dosage; the potential benefits of any of our products or product candidates for any specific disease or at any dosage; the impact of meetings or communications with the FDA or any advisory committee; statements or decisions by the FDA or any other entity for any products or product candidates; our ability to monetize any PRV; future research and development activities; our strategic and product development objectives, including with respect to becoming a leading, commercially focused rare disease company; the potential benefits of our debt facility; our financial position, including our cash balance; our corporate governance objectives; potential revenues from our arimoclomol expanded access program in France; the potential for royalty and milestone contributions, the presentation of data at conferences; and the timing of any of the foregoing. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s Annual Report on Form 10-K for the year ended Dec. 31, 2023, Zevra’s Quarterly Report on Form 10-Q for the three months ended Sept. 30, 2024, and Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.
Zevra Contact
Nichol Ochsner+1 (732) 754-2545nochsner@zevra.com
Russo Partners Contact
David Schull+1 (858) 717-2310david.schull@russopartnersllc.com
ZEVRA THERAPEUTICS, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except share and per share amounts) Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Revenue, net $3,695 $2,895 $11,569 $14,541 Cost of product revenue (excluding $1,545 and $4,619 in intangible asset amortization for the three and nine months ended September 30, 2024, respectively shown separately below) 2,303 144 6,051 946 Intangible asset amortization 1,545 — 4,619 — Operating expenses:
Research and development 10,945 12,297 33,743 28,385 Selling, general and administrative 16,208 5,818 38,743 19,657 Total operating expenses 27,153 18,115 72,486 48,042 Loss from operations (27,306) (15,364) (71,587) (34,447)Other (expense) income:
Interest expense (2,312) (366) (5,157) (745)Fair value adjustment related to warrant and CVR liability (4,746) 3,678 4,660 4,253 Fair value adjustment related to investments 90 124 64 451 Interest and other income (expense), net 1,049 1,738 2,248 4,331 Total other (expense) income (5,919) 5,174 1,815 8,290 Loss before income taxes (33,225) (10,190) (69,772) (26,157)Income tax expense — (177) — — Net loss $(33,225) $(10,367) $(69,772) $(26,157)
Basic and diluted net loss per share of common stock:
Net loss $(0.69) $(0.30) $(1.59) $(0.76)
Weighted average number of shares of common stock outstanding:
Basic and diluted 47,808,817 34,724,614 43,843,851 34,364,075
ZEVRA THERAPEUTICS, INC. UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and par value amounts) September 30, December 31, 2024 2023 Assets
Current assets:
Cash and cash equivalents $54,039 $43,049 Securities at fair value, current 35,337 24,688 Accounts and other receivables 7,790 17,377 Prepaid expenses and other current assets 2,276 1,824 Total current assets 99,442 86,938 Inventories 8,756 9,841 Securities at fair value, long-term 6,105 — Property and equipment, net 607 736 Operating lease right-of-use assets 820 790 Goodwill 4,701 4,701 Intangible assets, net 70,608 69,227 Other long-term assets 512 94 Total assets $191,551 $172,327
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses $24,464 $28,403 Line of credit payable — 37,700 Current portion of operating lease liabilities 540 543 Current portion of discount and rebate liabilities 8,547 4,550 Other current liabilities 930 2,524 Total current liabilities 34,481 73,720 Long-term debt 58,904 5,066 Warrant liability 13,902 16,100 Operating lease liabilities, less current portion 483 456 Discount and rebate liabilities, less current portion 8,490 7,663 Other long-term liabilities 5,521 7,458 Total liabilities 121,781 110,463
Commitments and contingencies
Stockholders’ equity:
Preferred stock:
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of September 30, 2024, or December 31, 2023 — — Common stock, $0.0001 par value, 250,000,000 shares authorized, 54,803,056 shares issued and 53,227,364 shares outstanding as of September 30, 2024; 43,110,360 shares issued and 41,534,668 shares outstanding as of December 31, 2023 5 4 Additional paid-in capital 550,413 472,664 Treasury stock, at cost (10,983) (10,983)Accumulated deficit (469,550) (399,778)Accumulated other comprehensive income (loss) (115) (43)Total stockholders' equity 69,770 61,864 Total liabilities and stockholders' equity $191,551 $172,327
临床3期上市批准突破性疗法孤儿药
2024-09-20
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前九批国家组织药品集中采购品种可替代药品参考监测范围
第一批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿托伐他汀钙口服常释剂型
★辛伐他汀、★匹伐他汀、
普伐他汀、氟伐他汀、洛伐他汀
★瑞舒伐他汀
2
瑞舒伐他汀钙口服常释剂型
★辛伐他汀、★匹伐他汀、
普伐他汀、氟伐他汀、洛伐他汀
★阿托伐他汀
3
氯吡格雷口服常释剂型
噻氯匹定
★替格瑞洛
4
厄贝沙坦口服常释剂型
★奥美沙坦酯、★坎地沙坦酯、★缬沙坦、★替米沙坦、
★氯沙坦、阿利沙坦酯、
阿齐沙坦、美阿沙坦
★赖诺普利、★贝那普利、★依那普利、
★培哚普利、雷米普利、喹那普利、
咪达普利
5
氨氯地平口服常释剂型
★左氨氯地平
★硝苯地平、★非洛地平、拉西地平、
尼群地平、贝尼地平、西尼地平、
马尼地平、尼卡地平、★乐卡地平
6
恩替卡韦口服常释剂型
拉米夫定、★阿德福韦酯、替比夫定
★替诺福韦二吡呋酯、★丙酚替诺福韦、艾米替诺福韦
7
艾司西酞普兰口服常释剂型
★西酞普兰
多塞平、氯米帕明、噻奈普汀、吗氯贝胺、马普替林、
米安色林、瑞波西汀
★氟西汀、★帕罗西汀、伏硫西汀、
★度洛西汀、★舍曲林、氟伏沙明、
安非他酮、曲唑酮、★文拉法辛、
米那普仑、★米氮平、阿戈美拉汀、
阿米替林、圣约翰草提取物
8
帕罗西汀口服常释剂型
多塞平、氯米帕明、噻奈普汀、吗氯贝胺、马普替林、
米安色林、瑞波西汀
★西酞普兰、★艾司西酞普兰、
★氟西汀、伏硫西汀、★度洛西汀、
★舍曲林、氟伏沙明、安非他酮、
曲唑酮、★文拉法辛、米那普仑、
★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
9
奥氮平口服常释剂型
三氟拉嗪、三氟哌多、
五氟利多、洛沙平、硫利达嗪、哌泊塞嗪、氟哌利多
★氨磺必利、★阿立哌唑、★利培酮、
帕利哌酮、★氯氮平、★喹硫平、
布南色林、★鲁拉西酮、齐拉西酮、
舒必利、氯丙嗪、氟哌啶醇、
氟奋乃静、奋乃静、癸氟奋乃静、
硫必利、氯普噻吨
10
头孢呋辛酯口服常释剂型
★头孢克洛、★头孢丙烯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢克肟、★头孢地尼、头孢他美酯、
头孢妥仑匹酯、头孢泊肟酯
11
利培酮口服常释剂型
三氟拉嗪、三氟哌多、
五氟利多、洛沙平、硫利达嗪、
哌泊塞嗪、氟哌利多
★氨磺必利、★阿立哌唑、★奥氮平、
帕利哌酮、★氯氮平、★喹硫平、
布南色林、★鲁拉西酮、齐拉西酮、
舒必利、氯丙嗪、氟哌啶醇、
氟奋乃静、奋乃静、癸氟奋乃静、
硫必利、氯普噻吨
12
吉非替尼口服常释剂型
埃克替尼、★厄洛替尼
★阿法替尼、达可替尼、奥希替尼、
伏美替尼、阿美替尼
13
福辛普利口服常释剂型
★赖诺普利、★贝那普利、
★依那普利、★培哚普利、
雷米普利、喹那普利、咪达普利
★奥美沙坦酯、★坎地沙坦酯、
★缬沙坦、★替米沙坦、★氯沙坦、
阿利沙坦酯、阿齐沙坦、美阿沙坦
14
厄贝沙坦氢氯噻嗪口服常释剂型
奥美沙坦酯氢氯噻嗪、
★氯沙坦氢氯噻嗪、
替米沙坦氢氯噻嗪、
★缬沙坦氢氯噻嗪、坎地氢噻
15
赖诺普利口服常释剂型
★贝那普利、★依那普利、
★培哚普利、雷米普利、
喹那普利、咪达普利
★福辛普利
16
替诺福韦二吡呋酯口服常释剂型
拉米夫定、★阿德福韦酯、替比夫定
★丙酚替诺福韦、艾米替诺福韦
★恩替卡韦
17
氯沙坦口服常释剂型
阿齐沙坦、美阿沙坦、
★奥美沙坦酯、★坎地沙坦酯、
★缬沙坦、★替米沙坦、
★厄贝沙坦、阿利沙坦酯
★赖诺普利、★贝那普利、★依那普利、
★培哚普利、雷米普利、喹那普利、
咪达普利
18
依那普利口服常释剂型
★贝那普利、★赖诺普利、
★培哚普利、雷米普利、
喹那普利、咪达普利
★福辛普利、★奥美沙坦酯、★缬沙坦、
★坎地沙坦酯、★替米沙坦、★氯沙坦、
阿利沙坦酯、阿齐沙坦、美阿沙坦
19
左乙拉西坦口服常释剂型
奥卡西平、丙戊酸镁、丙戊酸钠、
卡马西平、拉莫三嗪、托吡酯
20
伊马替尼口服常释剂型
氟马替尼
尼洛替尼、达沙替尼
21
孟鲁司特口服常释剂型
普仑司特、扎鲁司特
22
蒙脱石口服散剂
23
培美曲塞注射剂
24
氟比洛芬酯注射剂
双氯芬酸、★布洛芬、★帕瑞昔布、
吡罗昔康、★酮咯酸氨丁三醇
25
右美托咪定注射剂
第二批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿比特龙口服常释剂型
氟他胺、★比卡鲁胺、恩扎卢胺
2
阿德福韦酯口服常释剂型
拉米夫定、替比夫定
★替诺福韦二吡呋酯、★丙酚替诺福韦、艾米替诺福韦、★恩替卡韦
3
阿卡波糖口服常释剂型
伏格列波糖、★米格列醇
4
阿莫西林口服常释剂型
青霉素V、氨苄西林、
苯唑西林、氯唑西林
5
阿奇霉素口服常释剂型
红霉素、琥乙红霉素、
环酯红霉素、★罗红霉素
地红霉素、泰利霉素、依托红霉、
★克拉霉素
6
安立生坦片
波生坦
马昔腾坦、利奥西呱
7
奥美沙坦酯口服常释剂型
★氯沙坦、阿利沙坦酯
★坎地沙坦酯、★缬沙坦、★替米沙坦、★厄贝沙坦、阿齐沙坦、美阿沙坦
★福辛普利、★贝那普利、★赖诺普利、
★培哚普利、雷米普利、喹那普利、
咪达普利
8
比索洛尔口服常释剂型
★美托洛尔、卡维地洛、
贝凡洛尔、阿罗洛尔、
塞利洛尔
阿替洛尔、★普萘洛尔、尼群洛尔
9
对乙酰氨基酚口服常释剂型
★布洛芬、萘普生
双氯芬酸、★洛索洛芬、★美洛昔康、
★依托考昔、★塞来昔布、艾瑞昔布
10
多奈哌齐口服常释剂型
加兰他敏、卡巴拉汀、★美金刚
11
氟康唑口服常释剂型
★伏立康唑、伊曲康唑、泊沙康唑、
艾沙康唑
12
福多司坦口服常释剂型
羧甲司坦、乙酰半胱氨酸
厄多司坦、美司坦、★氨溴索、
★溴己新、桉柠蒎
13
格列美脲口服常释剂型
格列本脲
★格列齐特
格列喹酮、★格列吡嗪
14
甲硝唑口服常释剂型
★替硝唑、★奥硝唑、
塞克硝唑
左奥硝唑
15
聚乙二醇口服散剂
复方聚乙二醇电解质Ⅰ、
复方聚乙二醇电解质Ⅱ、
复方聚乙二醇电解质Ⅲ、
复方聚乙二醇电解质Ⅳ、硫酸镁、乳果糖
16
坎地沙坦酯口服常释剂型
★氯沙坦、阿利沙坦酯
阿齐沙坦、美阿沙坦、
★奥美沙坦酯、★缬沙坦、
★替米沙坦、
★厄贝沙坦、阿齐沙坦酯
★福辛普利、★贝那普利、★赖诺普利、
★培哚普利、雷米普利、喹那普利、
咪达普利
17
克林霉素口服常释剂型
克林霉素棕榈酸酯、
克林霉素磷酸酯、林可霉素
18
铝碳酸镁咀嚼片
铝镁加
磷酸铝凝胶、复方氢氧化铝
19
美洛昔康口服常释剂型
吡罗昔康
氯诺昔康、★塞来昔布、★依托考昔、
艾瑞昔布、双氯芬酸、★洛索洛芬
20
莫西沙星口服常释剂型
吡哌酸、氧氟沙星、
★诺氟沙星
★左氧氟沙星、
★环丙沙星、洛美沙星、
氟罗沙星、司帕沙星
吉米沙星、奈诺沙星、加诺沙星、安妥沙星
21
曲美他嗪缓释控释剂型
22
索利那新口服常释剂型
托特罗定、奥昔布宁
23
他达拉非片
★西地那非、伐地那非
24
特拉唑嗪口服常释剂型
阿夫唑嗪、多沙唑嗪
★坦索罗辛、赛洛多辛
25
替吉奥口服常释剂型
氟尿嘧啶
替加氟、★卡培他滨、曲氟尿苷替匹嘧啶
26
头孢氨苄口服常释剂型
★头孢拉定、头孢羟氨苄
★头孢呋辛酯、★头孢克洛、★头孢丙烯、★头孢克肟、★头孢地尼、头孢妥仑匹酯、头孢泊肟酯、头孢他美酯
27
头孢拉定口服常释剂型
★头孢氨苄、头孢羟氨苄
★头孢呋辛酯、★头孢克洛、★头孢丙烯、★头孢地尼、头孢妥仑匹酯、★头孢克肟、头孢泊肟酯、头孢他美酯
28
辛伐他汀口服常释剂型
★匹伐他汀、普伐他汀、
氟伐他汀、洛伐他汀
★瑞舒伐他汀、★阿托伐他汀
29
异烟肼口服常释剂型
30
吲达帕胺口服常释剂型
氢氯噻嗪、★呋塞米、
★托拉塞米
美托拉宗、螺内酯、阿米洛利、布美他尼
31
注射用紫杉醇（白蛋白结合型）
紫杉醇脂质体、
★紫杉醇
★多西他赛
32
左西替利嗪口服常释剂型
赛庚啶、氯苯那敏、
★西替利嗪
苯海拉明、★异丙嗪、★氯雷他定、
★地氯雷他定、卢帕他定、★奥洛他定、
非索非那定、阿伐斯汀、咪唑斯汀、
★依巴斯汀、★贝他斯汀、依美斯汀
第三批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿那曲唑口服常释剂型
★来曲唑、依西美坦
2
阿哌沙班口服常释剂型
华法林
★利伐沙班、艾多沙班、★达比加群酯
3
阿扎胞苷注射剂
4
氨基葡萄糖口服常释剂型
5
氨溴索口服常释剂型
羧甲司坦、乙酰半胱氨酸
★福多司坦、厄多司坦、美司坦 、
★溴己新、桉柠蒎
6
奥氮平口腔崩解片
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★阿立哌唑、★利培酮、
帕利哌酮、★氯氮平、★喹硫平、布南色林、
★鲁拉西酮、齐拉西酮、舒必利、氯丙嗪、
氟哌啶醇、氟奋乃静、奋乃静、癸氟奋乃静、
硫必利、氯普噻吨
7
奥美拉唑口服常释剂型
★艾司奥美拉唑
★泮托拉唑、兰索拉唑、雷贝拉唑、艾普拉唑
8
布洛芬缓释控释剂型
右布洛芬、萘普生
★对乙酰氨基酚、★美洛昔康、双氯芬酸、
★塞来昔布、★依托考昔、芬布芬、洛索洛芬
9
布洛芬颗粒剂
右布洛芬、萘普生
★对乙酰氨基酚、★美洛昔康、双氯芬酸、
★塞来昔布、★依托考昔、芬布芬、洛索洛芬
10
地氯雷他定口服常释剂型
赛庚啶、
氯苯那敏、
★氯雷他定
★异丙嗪、苯海拉明、非索非那定、
卢帕他定、★奥洛他定、★西替利嗪、
★左西替利嗪、阿伐斯汀、咪唑斯汀、
★依巴斯汀、★贝他斯汀、依美斯汀
11
多潘立酮口服常释剂型
★莫沙必利、氯波必利、伊托必利
12
二甲双胍缓释控释剂型
苯乙双胍
二甲双胍常释制剂
13
二甲双胍口服常释剂型
苯乙双胍
二甲双胍缓释控释剂型
14
非布司他口服常释剂型
别嘌醇、苯溴马隆
15
非那雄胺口服常释剂型（5mg）
爱普列特
★度他雄胺
16
非那雄胺口服常释剂型（1mg）
17
氟西汀口服常释剂型
多塞平、氯米帕明、噻奈普汀、
吗氯贝胺、马普替林、米安色林、
瑞波西汀
★西酞普兰、★艾司西酞普兰、★帕罗西汀、
伏硫西汀、★度洛西汀、★舍曲林、
氟伏沙明、安非他酮、曲唑酮、★文拉法辛、
米那普仑、★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
18
枸橼酸西地那非片
★他达拉非、伐地那非
19
甲钴胺口服常释剂型
维生素B12、腺苷钴胺
20
卡培他滨口服常释剂型
氟尿嘧啶
替加氟、★替吉奥、曲氟尿苷替匹嘧啶
21
卡托普利口服常释剂型
★福辛普利、★赖诺普利、★培哚普利、
★依那普利、雷米普利、喹那普利、
★贝那普利、咪达普利
22
喹硫平口服常释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★奥氮平、★利培酮、帕利哌酮、★阿立哌唑、★氨磺必利、布南色林、★鲁拉西酮、齐拉西酮、舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、癸氟奋乃静、硫必利、氯普噻吨
23
来曲唑口服常释剂型
★阿那曲唑、依西美坦
24
氯氮平口服常释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★奥氮平、★利培酮、帕利哌酮、
★阿立哌唑、★氨磺必利、★喹硫平、
布南色林、★鲁拉西酮、齐拉西酮、舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、
癸氟奋乃静、硫必利、氯普噻吨
25
美金刚口服常释剂型
★多奈哌齐、利斯的明、加兰他敏、
卡巴拉汀、丁苯酞、甘露特钠
26
孟鲁司特咀嚼片
普仑司特、扎鲁司特
27
孟鲁司特颗粒剂
普仑司特、扎鲁司特
28
匹伐他汀口服常释剂型
★辛伐他汀
普伐他汀、氟伐他汀、洛伐他汀、
★阿托伐他汀、★瑞舒伐他汀
29
普芦卡必利口服常释剂型
30
曲美他嗪口服常释剂型
31
塞来昔布口服常释剂型
艾瑞昔布
★依托考昔、芬布芬、右布洛芬、★布洛芬、洛索洛芬
32
舍曲林口服常释剂型
多塞平、氯米帕明、噻奈普汀、
吗氯贝胺、马普替林、米安色林、
瑞波西汀
★西酞普兰、★艾司西酞普兰、★氟西汀、
★帕罗西汀、伏硫西汀、★度洛西汀、
氟伏沙明、安非他酮、曲唑酮、★文拉法辛、
米那普仑、★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
33
坦洛新（坦索罗辛） 缓释控释剂型
★特拉唑嗪、阿夫唑嗪、多沙唑嗪、赛洛多辛
34
碳酸氢钠口服常释剂型
35
替格瑞洛口服常释剂型
噻氯匹啶
★氯吡格雷
36
托法替布口服常释剂型
巴瑞替尼、乌帕替尼
37
维格列汀口服常释剂型
★沙格列汀、西格列汀、阿格列汀、利格列汀
38
维生素B6口服常释剂型
39
西酞普兰口服常释剂型
★艾司西酞普兰、多塞平、
氯米帕明、噻奈普汀、吗氯贝胺、
马普替林、米安色林、瑞波西汀
★氟西汀、★帕罗西汀、伏硫西汀、
★度洛西汀、★舍曲林、氟伏沙明、
安非他酮、曲唑酮、★文拉法辛、米那普仑、★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
40
西替利嗪口服常释剂型
赛庚啶、氯苯那敏
★左西替利嗪
苯海拉明、★异丙嗪、★氯雷他定、
★地氯雷他定、非索非那定、卢帕他定、
★奥洛他定、阿伐斯汀、咪唑斯汀、
★依巴斯汀、★贝他斯汀、依美斯汀
41
缬沙坦口服常释剂型
★氯沙坦、
阿利沙坦酯
坎地沙坦、依普沙坦、★厄贝沙坦
★奥美沙坦、★替米沙坦、阿齐沙坦、
美阿沙坦
42
盐酸达泊西汀片
43
依托考昔口服常释剂型
艾瑞昔布
★塞来昔布、芬布芬、右布洛芬
44
乙胺丁醇口服常释剂型
氨硫脲、对氨基水杨酸
45
右佐匹克隆口服常释剂型
佐匹克隆
唑吡坦、扎来普隆、艾司唑仑
46
左乙拉西坦口服液体剂
奥卡西平、丙戊酸镁、丙戊酸钠、卡马西平、拉莫三嗪、托吡酯
47
左乙拉西坦注射用浓溶液
苯巴比妥、丙戊酸钠
48
阿莫西林颗粒剂
青霉素V、氨苄西林
苯唑西林、氯唑西林
49
利奈唑胺口服常释剂型
康替唑胺
50
莫西沙星氯化钠注射剂
氧氟沙星、
诺氟沙星
环丙沙星、★左氧氟沙星、
洛美沙星、帕珠沙星、依诺沙星、
培氟沙星、氟罗沙星、加替沙星
奈诺沙星
51
左氧氟沙星滴眼剂
诺氟沙星滴眼液、氧氟沙星滴眼液、洛美沙星滴眼液、环丙沙星滴眼液
★莫西沙星滴眼液、加替沙星滴眼液
52
环丙沙星口服常释剂型
吡哌酸、
★诺氟沙星
★莫西沙星、奈诺沙星、加诺沙星、
西他沙星、依诺沙星、培氟沙星、氟罗沙星、
氧氟沙星、★左氧氟沙星、洛美沙星、
司帕沙星、加替沙星、吉米沙星、安妥沙星
53
头孢地尼口服常释剂型
★头孢克肟、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
★头孢呋辛酯、★头孢克洛、★头孢丙烯
54
头孢克洛口服常释剂型
★头孢呋辛酯、★头孢丙烯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢克肟、★头孢地尼、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
55
克拉霉素口服常释剂型
红霉素、琥乙红霉素、环酯红霉素、依托红霉素、★罗红霉素
★阿奇霉素、地红霉素、泰利霉素
第四批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
恩曲他滨替诺福韦口服常释剂型
齐多夫定、司他夫定、阿巴卡韦、
替诺福韦、奈韦拉平、依非韦伦、
茚地那韦、利托那韦、
洛匹那韦利托那韦、达芦那韦考比司他、
拉替拉韦、多替拉韦
2
多索茶碱注射剂
氨茶碱
二羟丙茶碱
3
氨溴索注射剂
乙酰半胱氨酸、★溴己新
4
沙丁胺醇吸入剂
左沙丁胺醇、★特布他林
5
氨磺必利口服常释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★奥氮平、★利培酮、帕利哌酮、
★氯氮平、★阿立哌唑、★喹硫平、
布南色林、★鲁拉西酮、齐拉西酮、
舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、
奋乃静、癸氟奋乃静、硫必利、氯普噻吨
6
度洛西汀口服常释剂型
多塞平、氯米帕明、噻奈普汀、
吗氯贝胺、马普替林、米安色林、
瑞波西汀
★西酞普兰、★艾司西酞普兰、
★氟西汀、★帕罗西汀、伏硫西汀、
★舍曲林、氟伏沙明、安非他酮、
曲唑酮、★文拉法辛、米那普仑、
★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
7
喹硫平缓释控释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★奥氮平、★利培酮、
帕利哌酮、★阿立哌唑、布南色林、
★鲁拉西酮、齐拉西酮、舒必利、
氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、
癸氟奋乃静、硫必利、氯普噻吨
8
吡嗪酰胺口服常释剂型
9
诺氟沙星口服常释剂型
部分喹诺酮、小檗碱
10
头孢丙烯口服常释剂型
★头孢呋辛酯、★头孢克洛
★头孢拉定、★头孢氨苄、头孢羟氨苄、★头孢地尼、★头孢克肟、
头孢妥仑匹酯、头孢泊肟酯、头孢他美酯
11
左氧氟沙星口服常释剂型
吡哌酸、氧氟沙星、
★诺氟沙星
★环丙沙星、洛美沙星、
依诺沙星、培氟沙星、氟罗沙星、
司帕沙星、加替沙星、吉米沙星、
安妥沙星
★莫西沙星、奈诺沙星、加诺沙星、
西他沙星
12
伏立康唑口服常释剂型
★氟康唑、伊曲康唑、泊沙康唑、
艾沙康唑
13
特比萘芬口服常释剂型
14
丙泊酚中/长链脂肪乳注射剂
丙泊酚
美索比妥、羟丁酸钠、
氯胺酮、依托咪酯、咪达唑仑、
艾司氯胺酮
15
氯雷他定口服常释剂型
赛庚啶、氯苯那敏
苯海拉明、★异丙嗪、★地氯雷他定、
★奥洛他定、卢帕他定、非索非那定、
★左西替利嗪、★西替利嗪、阿伐斯汀、
咪唑斯汀、★依巴斯汀、★贝他斯汀、
比拉斯汀
16
恩格列净口服常释剂型
达格列净、★卡格列净、
艾托格列净
17
卡格列净口服常释剂型
达格列净、★恩格列净、
艾托格列净
18
格列齐特缓释控释剂型
★格列美脲、格列本脲、消渴丸
格列喹酮、★格列吡嗪
19
那格列奈口服常释剂型
米格列奈、★瑞格列奈
20
瑞格列奈口服常释剂型
米格列奈、★那格列奈
21
羟苯磺酸钙口服常释剂型
22
普拉克索缓释控释剂型
苯海索、金刚烷胺、多巴丝肼、
左旋多巴、卡左双多巴、司来吉兰、
恩他卡朋、雷沙吉兰
23
普拉克索口服常释剂型
苯海索、金刚烷胺、多巴丝肼、
左旋多巴、卡左双多巴、司来吉兰、
恩他卡朋、雷沙吉兰
24
加巴喷丁口服常释剂型
★普瑞巴林、卡马西平
25
布洛芬口服常释剂型
右布洛芬、芬布芬
萘普生、★美洛昔康、双氯芬酸、★塞来昔布、★依托考昔、
★洛索洛芬、氟比洛芬、艾瑞昔布
★对乙酰氨基酚
26
布洛芬注射剂
★帕瑞昔布、★氟比洛芬酯
27
洛索洛芬口服常释剂型
★布洛芬
萘普生、★美洛昔康、双氯芬酸、★塞来昔布、★依托考昔、
氟比洛芬、艾瑞昔布
★对乙酰氨基酚
28
帕瑞昔布注射剂
★布洛芬、★氟比洛芬酯
29
普瑞巴林口服常释剂型
★加巴喷丁、卡马西平
30
艾司奥美拉唑口服常释剂型
★奥美拉唑
兰索拉唑、艾普拉唑
★泮托拉唑、雷贝拉唑
31
莫沙必利口服常释剂型
氯波必利、伊托必利、★多潘立酮、
甲氧氯普胺
32
泮托拉唑口服常释剂型
★奥美拉唑、★艾司奥美拉唑、
兰索拉唑、雷贝拉唑、艾普拉唑
33
泮托拉唑注射剂
★奥美拉唑、★艾司奥美拉唑、
★兰索拉唑、雷贝拉唑、艾普拉唑
34
替格瑞洛口服常释剂型
噻氯匹啶
★氯吡格雷
35
比伐芦定注射剂
36
培哚普利口服常释剂型
★福辛普利、★赖诺普利、
雷米普利、喹那普利、
★贝那普利、咪达普利、
★依那普利
37
替米沙坦口服常释剂型
★氯沙坦、阿利沙坦酯
★缬沙坦、★坎地沙坦酯、
★厄贝沙坦、阿齐沙坦、
美阿沙坦、★奥美沙坦酯
38
缬沙坦氨氯地平口服常释剂型
奥美沙坦酯氨氯地平
39
缬沙坦氢氯噻嗪口服常释剂型
★氯沙坦氢氯噻嗪
★厄贝沙坦氢氯噻嗪、坎地氢噻、替米沙坦氢氯噻嗪
奥美沙坦酯氢氯噻嗪
40
奥洛他定滴眼剂
吡嘧司特滴眼液、萘非滴眼液、
色甘酸钠滴眼液
41
玻璃酸钠滴眼剂（0.1%）
聚乙二醇滴眼液、
羧甲基纤维素钠滴眼液（0.5%）
42
玻璃酸钠滴眼剂（0.3%）
聚乙二醇滴眼液、
羧甲基纤维素钠滴眼液（1%）
43
替莫唑胺口服常释剂型
44
硼替佐米注射剂
卡非佐米
45
索拉非尼口服常释剂型
瑞戈非尼、仑伐替尼、培唑帕尼、
依维莫司、去甲斑蝥素、斑蝥酸钠
第五批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
ω-3鱼油中/长链脂肪乳注射液
多种油脂肪乳(C6-24)
结构脂肪乳(C6-24)、脂肪乳(C14-24)、
中/长链脂肪乳（C6-24）、
中/长链脂肪乳（C8-24）、
中/长链脂肪乳(C8-24Ve)、长链脂肪乳(OO)
2
阿法骨化醇口服常释剂型
★骨化三醇、维生素D
艾地骨化醇
3
阿立哌唑口服常释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★奥氮平、★利培酮、
帕利哌酮、★喹硫平、布南色林、
★鲁拉西酮、齐拉西酮、舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、癸氟奋乃静、
硫必利、氯普噻吨
4
阿昔洛韦口服常释剂型
泛昔洛韦、伐昔洛韦
5
艾司奥美拉唑注射剂
★奥美拉唑
★兰索拉唑、艾普拉唑
★泮托拉唑、雷贝拉唑
6
奥洛他定口服常释剂型
赛庚啶、氯苯那敏
苯海拉明、★异丙嗪、★氯雷他定、
★地氯雷他定、卢帕他定、非索非那定、
★左西替利嗪、★西替利嗪、阿伐斯汀、
咪唑斯汀、★依巴斯汀、依美斯汀、
★贝他斯汀
7
奥沙利铂注射剂
顺铂、卡铂、洛铂、奈达铂
8
贝那普利口服常释剂型
★赖诺普利、★培哚普利、
★依那普利、雷米普利、
喹那普利、咪达普利
★福辛普利
9
贝他斯汀口服常释剂型
赛庚啶、氯苯那敏
阿伐斯汀、咪唑斯汀、
★依巴斯汀、依美斯汀
苯海拉明、★异丙嗪、★氯雷他定、
★地氯雷他定、卢帕他定、★奥洛他定、
非索非那定、★左西替利嗪、★西替利嗪
10
苯磺顺阿曲库铵注射剂
阿曲库铵
★罗库溴铵、维库溴铵
11
比卡鲁胺口服常释剂型
氟他胺
恩扎鲁胺
12
达比加群酯口服常释剂型
★阿哌沙班
★利伐沙班、艾多沙班、华法林
13
单硝酸异山梨酯缓释控释剂型
硝酸异山梨酯
14
地西他滨注射剂
15
碘海醇注射剂
碘比醇、碘佛醇、碘普罗胺、
★碘克沙醇、★碘帕醇、
碘美普尔、复方泛影葡胺
16
碘克沙醇注射剂
碘比醇、碘佛醇、碘普罗胺、
★碘海醇、★碘帕醇、碘美普尔、复方泛影葡胺
17
度他雄胺软胶囊
爱普列特、★非那雄胺
18
多西他赛注射剂
★紫杉醇、紫杉醇脂质体
★紫杉醇（白蛋白结合型）
19
法舒地尔注射剂
尼莫地平
20
复方异丙托溴铵吸入剂
★异丙托溴铵、噻托溴铵、格隆溴铵
21
格列吡嗪缓释控释剂型
★格列美脲、格列本脲、
★格列齐特、消渴丸
格列喹酮、★格列吡嗪（常释剂型）
22
格列吡嗪口服常释剂型
格列喹酮
★格列美脲、格列本脲、★格列齐特、
消渴丸、★格列吡嗪（控释剂型）
23
格隆溴铵注射液
阿托品、东莨菪碱
24
更昔洛韦注射剂
膦甲酸、缬★更昔洛韦
25
枸橼酸氢钾钠颗粒
26
吉西他滨注射剂
27
兰索拉唑注射剂
★泮托拉唑、雷贝拉唑、★奥美拉唑、
艾普拉唑、★艾司奥美拉唑
28
乐卡地平口服常释剂型
★硝苯地平、拉西地平、尼群地平、
贝尼地平、西尼地平、马尼地平、尼卡地平、
★氨氯地平、★左氨氯地平、★非洛地平
29
利伐沙班口服常释剂型
★阿哌沙班
艾多沙班、★达比加群酯、华法林
30
硫辛酸注射剂
31
罗哌卡因注射剂
布比卡因、★左布比卡因、★利多卡因、
丁卡因、普鲁卡因、氯普鲁卡因
32
氯化钾缓释控释剂型
枸橼酸钾
33
美托洛尔口服常释剂型
贝凡洛尔、塞利洛尔、尼群洛尔
阿替洛尔、★普萘洛尔、★比索洛尔
34
米格列醇口服常释剂型
★阿卡波糖、伏格列波糖
35
米索前列醇口服常释剂型
36
帕洛诺司琼注射剂
托烷司琼、★昂丹司琼、格拉司琼、阿扎司琼、多拉司琼、雷莫司琼
37
沙格列汀口服常释剂型
★维格列汀、西格列汀、阿格列汀
利格列汀
38
文拉法辛缓释控释剂型
多塞平、氯米帕明、噻奈普汀、
吗氯贝胺、马普替林、米安色林、
瑞波西汀
★西酞普兰、★艾司西酞普兰、★氟西汀、
★帕罗西汀、伏硫西汀、★度洛西汀、
★舍曲林、氟伏沙明、安非他酮、曲唑酮、
米那普仑、★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
39
西那卡塞口服常释剂型
40
胸腺法新注射剂
胸腺肽、胸腺五肽
41
异丙嗪口服常释剂型
苯海拉明、赛庚啶、氯苯那敏
42
异丙托溴铵吸入剂
★复方异丙托溴铵、噻托溴铵
43
脂肪乳氨基酸葡萄糖注射剂
中长链脂肪乳/氨基酸(16)/葡萄糖(16％)
脂肪乳氨基酸(17)葡萄糖(19%)
10%脂肪乳(OO)/5.5%氨基酸(15)/葡萄糖(20%)、脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)
44
中/长链脂肪乳（C8~24 Ve）注射剂
中/长链脂肪乳（C8～24）、中/长链脂肪乳（C6~24）
★ω-3鱼油中/长链脂肪乳、
多种油脂肪乳(C6~24)、结构脂肪乳(C6-24)、
长链脂肪乳(OO)、脂肪乳(C14-24)
45
注射用盐酸苯达莫司汀
卡莫司汀
46
紫杉醇注射剂
★多西他赛、紫杉醇脂质体
★紫杉醇（白蛋白结合型）
47
阿奇霉素注射剂
红霉素
★克拉霉素
48
布地奈德吸入剂
氟替卡松、倍氯米松
49
氟康唑注射剂
★伏立康唑、泊沙康唑、伊曲康唑、艾沙康唑
50
利奈唑胺葡萄糖注射剂
替考拉宁、万古霉素
51
莫西沙星滴眼剂
★左氧氟沙星滴眼液、
诺氟沙星滴眼液、
氧氟沙星滴眼液、
洛美沙星滴眼液、
环丙沙星滴眼液、
加替沙星滴眼液
52
替硝唑口服常释剂型
★甲硝唑
★奥硝唑、塞克硝唑、左奥硝唑
53
头孢呋辛注射剂
头孢替安、头孢孟多、头孢尼西
★头孢唑林、头孢拉定、头孢硫脒、
头孢噻吩、★头孢曲松、★头孢他啶、
头孢噻肟、头孢哌酮、头孢匹胺、头孢甲肟、
头孢唑肟、★头孢地嗪
54
头孢曲松注射剂
头孢噻肟、头孢匹胺、头孢甲肟、
头孢唑肟、★头孢地嗪
★头孢呋辛、头孢替安、头孢孟多、
头孢尼西、★头孢吡肟、头孢匹罗、
头孢噻利、头孢哌酮、★头孢他啶
55
头孢他啶注射剂
★头孢曲松、头孢噻肟、
头孢哌酮、头孢匹胺、头孢甲肟、
头孢唑肟、★头孢地嗪
★头孢吡肟、头孢匹罗、头孢噻利
56
头孢唑林注射剂
头孢拉定、头孢硫脒、头孢噻吩
头孢替安、头孢孟多、★头孢呋辛、头孢尼西
57
左氧氟沙星注射剂
氧氟沙星、诺氟沙星
洛美沙星、依诺沙星、培氟沙星、
氟罗沙星、加替沙星
★莫西沙星、奈诺沙星、帕珠沙星、环丙沙星
第七批国家组织药品集中采购品种可替代药品参考监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿法替尼口服常释剂型
★厄洛替尼、埃克替尼、
★吉非替尼、达可替尼
奥希替尼、伏美替尼、阿美替尼
2
阿立哌唑口腔崩解片
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★奥氮平、★利培酮、帕利哌酮、
★喹硫平、布南色林、★鲁拉西酮、齐拉西酮、
舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、
癸氟奋乃静、硫必利、氯普噻吨
3
昂丹司琼注射剂
托烷司琼、格拉司琼、阿扎司琼、多拉司琼、雷莫司琼
★帕洛诺司琼
4
奥美拉唑注射剂
★艾司奥美拉唑
★兰索拉唑、艾普拉唑、★泮托拉唑、雷贝拉唑
5
奥曲肽注射剂
★生长抑素
兰瑞肽
6
奥司他韦口服常释剂型
阿比多尔、
法维拉韦、玛巴洛沙韦
7
奥硝唑口服常释剂型
★甲硝唑
★替硝唑、塞克硝唑、左奥硝唑
8
吡格列酮口服常释剂型
罗格列酮
9
丙酚替诺福韦口服常释剂型
★阿德福韦酯、
拉米夫定、
替比夫定
★替诺福韦二吡呋酯、艾米替诺福韦
10
醋酸钙口服常释剂型
碳酸钙
司维拉姆、碳酸镧
11
单硝酸异山梨酯口服常释剂型
硝酸异山梨酯
12
碘帕醇注射剂
★碘海醇、碘比醇、碘佛醇、
碘普罗胺、复方泛影葡胺
碘克沙醇
13
厄洛替尼口服常释剂型
★吉非替尼、埃克替尼
★阿法替尼、达可替尼、奥希替尼、伏美替尼、
阿美替尼
14
二甲双胍维格列汀口服常释剂型
西格列汀二甲双胍、沙格列汀二甲双胍
15
氟桂利嗪口服常释剂型
桂利嗪
16
氟哌噻吨美利曲辛口服常释剂型
多塞平、马普替林、氯米帕明、噻奈普汀、
吗氯贝胺、瑞波西汀、阿米替林
17
磺达肝癸钠注射剂
18
甲磺酸仑伐替尼胶囊
★索拉非尼、瑞戈非尼
19
甲泼尼龙口服常释剂型
20
甲泼尼龙注射剂
21
咖啡因注射剂
22
克林霉素磷酸酯注射剂
★克林霉素、林可霉素
23
拉考沙胺口服常释剂型
奥卡西平、卡马西平
24
来氟米特口服常释剂型
25
利多卡因注射剂
布比卡因、★左布比卡因、丁卡因、普鲁卡因、
氯普鲁卡因
26
罗红霉素口服常释剂型
红霉素、琥乙红霉素、
环酯红霉素、依托红霉素
地红霉素、★克拉霉素、★阿奇霉素
27
罗库溴铵注射剂
维库溴铵
★顺阿曲库铵、阿曲库铵
28
吗替麦考酚酯口服常释剂型
麦考酚钠
29
美罗培南注射剂
★比阿培南
厄他培南、亚胺培南西司他丁
30
美托洛尔缓释剂型
贝凡洛尔、塞利洛尔、尼群洛尔
阿替洛尔、★普萘洛尔、★比索洛尔
31
米卡芬净注射剂
卡泊芬净
32
米力农注射剂
氨力农
33
帕立骨化醇注射剂
34
帕洛诺司琼注射剂
托烷司琼、
★昂丹司琼、
格拉司琼、
阿扎司琼、
多拉司琼、
雷莫司琼
35
普萘洛尔口服常释剂型
★美托洛尔、阿替洛尔、贝凡洛尔、塞利洛尔、
尼群洛尔
36
舒尼替尼口服常释剂型
培唑帕尼
索凡替尼、★索拉非尼、瑞戈非尼、★伊马替尼
37
特布他林吸入剂
★沙丁胺醇、左沙丁胺醇
38
替加环素注射剂
无
无
奥马环素、依拉环素
39
替罗非班注射剂型
★依替巴肽
40
头孢吡肟注射剂型
头孢匹罗
★头孢曲松、★头孢他啶、头孢噻肟、头孢哌酮、
头孢甲肟、头孢唑肟、头孢匹胺、★头孢地嗪
41
头孢克洛口服液体剂
★头孢呋辛酯、★头孢丙烯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢地尼、★头孢克肟、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
42
头孢克肟颗粒剂
★头孢地尼、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢呋辛酯、★头孢丙烯
43
头孢克肟口服常释剂型
★头孢地尼、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢呋辛酯、★头孢丙烯
44
头孢美唑注射剂型
★头孢西丁、★头孢米诺
45
头孢米诺注射剂型
★头孢西丁、★头孢美唑
46
硝苯地平缓释剂型
★硝苯地平控释剂型
拉西地平、尼群地平、贝尼地平、西尼地平、
马尼地平、尼卡地平、★乐卡地平
47
硝苯地平控释剂型
★硝苯地平缓释剂型
拉西地平、尼群地平、贝尼地平、西尼地平、
马尼地平、尼卡地平、★乐卡地平
48
溴己新注射剂
乙酰半胱氨酸、★氨溴索
49
盐酸鲁拉西酮片
三氟拉嗪、三氟哌多、五氟利多、洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★奥氮平、★阿立哌唑、★利培酮、
帕利哌酮、★喹硫平、布南色林、齐拉西酮、
舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、
癸氟奋乃静、硫必利、氯普噻吨
50
盐酸美金刚缓释胶囊
51
伊班膦酸注射剂
帕米膦酸二钠、氯膦酸二钠、
因卡膦酸二钠
★唑来膦酸
52
伊立替康注射剂
无
无
无
53
依巴斯汀口服常释剂型
赛庚啶、氯苯那敏
苯海拉明、★异丙嗪、阿伐斯汀、依美斯汀、
★氯雷他定、★地氯雷他定、卢帕他定、
★奥洛他定、★左西替利嗪、★西替利嗪、
非索非那定、★贝他斯汀
54
依达拉奉注射剂型
无
无
桂哌齐特
55
依替巴肽注射剂
★替罗非班
56
依折麦布口服常释剂型
海博麦布
57
注射用替莫唑胺
无
无
无
58
唑来膦酸注射剂
氯膦酸二钠、帕米膦酸二钠、
★伊班膦酸、因卡膦酸二钠
第八批国家组织药品集中采购品种可替代药品参考监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿加曲班注射剂
无
无
无
2
阿托西班注射剂
无
无
无
3
氨甲环酸注射剂型
氨基己酸
氨甲苯酸
4
氨氯地平阿托伐他汀口服常释剂型
无
无
无
5
丙氨酰谷氨酰胺注射剂
无
无
无
6
丙戊酸钠注射剂
无
无
7
非洛地平缓释控释剂型
★硝苯地平、拉西地平、尼群地平、贝尼地平、尼卡地平、★氨氯地平、★左氨氯地平、★乐卡地平、西尼地平、马尼地平
8
呋塞米注射剂
★托拉塞米、布美他尼
9
骨化三醇口服常释剂型
★阿法骨化醇、维生素D
艾地骨化醇
10
甲钴胺注射剂
维生素B12、腺苷钴胺
11
奥司他韦干混悬剂
阿比多尔、
帕拉米韦、扎那米韦、法维拉韦、玛巴洛沙韦
12
氯沙坦钾氢氯噻嗪口服常释剂型
★厄贝沙坦氢氯噻嗪、奥美沙坦酯氢氯噻嗪、替米沙坦氢氯噻嗪、★缬沙坦氢氯噻嗪、坎地氢噻
13
米氮平口服常释剂型
氯米帕明、噻奈普汀、吗氯贝胺、马普替林、米安色林、瑞波西汀、圣约翰草提取物
多塞平、★西酞普兰、★艾司西酞普兰、★氟西汀、★帕罗西汀、伏硫西汀、★度洛西汀、★文拉法辛、★舍曲林、氟伏沙明、安非他酮、曲唑酮、米那普仑、阿戈美拉汀、阿米替林
14
那屈肝素（那曲肝素）注射剂
★依诺肝素、达肝素、贝米肝素
15
生长抑素注射剂
★奥曲肽
16
酮咯酸氨丁三醇注射剂
★帕瑞昔布、★氟比洛芬酯
17
托拉塞米注射剂
★呋塞米、布美他尼
18
熊去氧胆酸口服常释剂型
牛磺熊去氧胆酸
19
盐酸奥普力农注射剂
氨力农
★米力农
20
依诺肝素注射剂
★那曲肝素、达肝素、贝米肝素
21
左氨氯地平（左旋氨氯地平）口服常释剂型
★氨氯地平
★硝苯地平、★非洛地平、拉西地平、 尼群地平、贝尼地平、西尼地平、马尼地平、尼卡地平、★乐卡地平
22
左布比卡因注射剂
布比卡因
★罗哌卡因、★利多卡因、丁卡因
23
左卡尼汀注射剂
无
无
无
24
阿莫西林克拉维酸钾口服常释剂型
无
无
无
25
阿莫西林钠克拉维酸钾注射剂
哌拉西林钠舒巴坦钠、★哌拉西林钠他唑巴坦钠、阿莫西林钠舒巴坦钠、氨苄西林钠舒巴坦钠、美洛西林钠舒巴坦钠、替卡西林钠克拉维酸钾
26
氨曲南注射剂
无
无
无
27
奥硝唑注射剂型
★甲硝唑
替硝唑、左奥硝唑
28
复方磺胺甲噁唑口服常释剂型
联磺甲氧苄啶
29
甲硝唑注射剂型
替硝唑、奥硝唑
左奥硝唑
30
利福平口服常释剂型
利福喷丁、利福布汀
31
头孢地尼颗粒剂
★头孢克肟、头孢妥仑匹酯、头孢泊肟酯、头孢他美酯
★头孢呋辛酯、★头孢丙烯、★头孢克洛
32
头孢西丁注射剂型
★头孢美唑、★头孢米诺
33
头孢地嗪注射剂
头孢噻肟、头孢甲肟、头孢唑肟、头孢匹胺
★头孢曲松、★头孢他啶、头孢哌酮、 ★头孢呋辛、头孢孟多酯、头孢尼西、头孢替安、 头孢匹罗、★头孢吡肟、头孢噻利
34
比阿培南注射剂
★美罗培南、厄他培南、亚胺培南西司他丁
35
达托霉素注射剂
无
无
无
36
伏立康唑注射剂
★氟康唑、泊沙康唑、艾沙康唑、伊曲康唑
37
哌拉西林钠他唑巴坦注射剂
哌拉西林钠舒巴坦钠、美洛西林钠舒巴坦钠
★阿莫西林钠克拉维酸钾、替卡西林钠克拉维酸钾、阿莫西林钠舒巴坦钠、氨苄西林钠舒巴坦钠、
38
头孢哌酮钠舒巴坦钠注射剂
头孢曲松钠舒巴坦
头孢噻肟钠舒巴坦
头孢哌酮他唑巴坦、头孢噻肟钠他唑巴坦、头孢他啶阿维巴坦、头孢他啶他唑巴坦
39
头孢噻肟注射剂
头孢甲肟、头孢唑肟、头孢匹胺、
★头孢地嗪
★头孢呋辛、头孢孟多酯、头孢尼西、头孢替安、 ★头孢曲松、★头孢他啶、头孢哌酮、 头孢匹罗、★头孢吡肟、头孢噻利
【监测范围说明】
1.完全可替代指的是带量采购药品可以完全替代右侧所列的药品，其他类推，给药途径不同的药品不属于监测范围。
2.清单所列化学药品为中文通用名称中主要化学成分部分，不区分酸根盐基和具体剂型；凡主要化学成分与替代清单中的名称一致且给药途径与中选药品相同的化学药品均在监测替代范围（与中选药品适应症完全不同的除外）。
3.清单中未完全列出的与中选药品主要化学成分相同且给药途径相同的其他药品也属于监测范围（与中选药品适应症完全不同的除外），如盐酸左西替利嗪片为盐酸左西替利嗪胶囊\颗粒的完全可替代药品，苯磺酸氨氯地平为马来酸氨氯地平、门冬氨酸氨氯地平的完全可替代药品，阿卡波糖口服常释剂型为阿卡波糖咀嚼片的完全可替代药品，奥氮平口服常释剂型为奥氮平口崩片的完全可替代药品，帕罗西汀口服常释剂型是帕罗西汀缓控释剂型的完全可替代药品，利培酮口服常释剂型是利培酮口服液的完全可替代药品、阿莫西林口服常释剂型是阿莫西林颗粒的完全可替代药品等。
4.品种具体剂型包括：
（1）口服常释剂型：普通片剂（片、素片、肠溶片、包衣片、薄膜衣片、糖衣片、浸膏片、分散片、划痕片）、硬胶囊、软胶囊（胶丸）、肠溶胶囊；不包括口腔崩解片（口崩片）；
（2）缓释剂型：缓释片、缓释包衣片、缓释胶囊；
（3）控释剂型：控释片、控释胶囊；
（4）吸入剂：气雾剂、粉雾剂、吸入剂、吸入粉雾剂、干粉吸入剂、粉吸入剂、雾化溶液剂、吸入气雾剂、吸入（用）溶液、吸入（用）混悬液、（鼻用）喷雾剂、鼻吸入气雾剂、雾化吸入用混悬液、吸入（用）气雾剂、雾化液；
（5）颗粒剂：颗粒剂、肠溶颗粒剂；
（6）口服液体剂：口服溶液剂、口服混悬剂、干混悬剂、口服乳剂、胶浆剂、口服液、乳液、乳剂、胶体溶液、合剂、酊剂、滴剂、混悬滴剂、糖浆剂（含干糖浆剂）；
（7）注射剂：注射剂、注射液、注射用溶液剂、静脉滴注用注射液、注射用混悬液、注射液无菌粉末、静脉注射针剂、水针、注射用乳剂、粉针剂、针剂、无菌粉针、冻干粉针。
5. 清单所列化学药品已在国家组织药品集中采购范围内的，标注“★”。
(来源:兴平市医疗保障局）
有需要《前九批国家组织药品集中采购品种可替代药品参考监测范围》（Excel版），请扫描下方二维码添加客服微信咨询，申请加入药闻康策高端会员群获取。
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带量采购
2024-08-13
FDA advisory committee voted favorably that the data support arimoclomol as effective treatment for patients with NPC; PDUFA date of September 21, 2024 Pro forma June 30, 2024, cash, cash equivalents, investments and net proceeds from underwritten public offering total $113.8 million following the closing on August 12, 2024 Conference call scheduled for today, August 13, 2024, at 4:30 p.m. ET
CELEBRATION, Fla., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the second quarter ended June 30, 2024. “During the second quarter, we made steady progress executing on our strategic objectives,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra. “We are encouraged by favorable vote from the FDA’s Genetic Metabolic Diseases Advisory Committee, that data presented support that arimoclomol is effective in the treatment in patients with Niemann Pick disease type C. While the vote is non-binding, we believe it is an important factor as the FDA completes its consideration for approval. Additionally, we continue the launch of OLPRUVA with a keen focus on driving patient awareness and intend to use the same commercial team to launch arimoclomol, if approved. Additionally, we expect to meet with the FDA to discuss the design of a pivotal Phase 3 trial to study KP1077 in idiopathic hypersomnia at the end of third quarter.” “We continue to be prudent in our capital allocation as we focus on creating long-term value for stockholders,” said R. LaDuane Clifton, Zevra’s Chief Financial Officer and Treasurer. “Our recent underwritten offering provided net proceeds to the Company of $64.5 million, along with attracting a cadre of institutional investors well known as long term supporters of innovation and building momentum as we lean into our near-term catalysts while also extending our cash runway.” Q2 2024 Corporate Highlights: Arimoclomol On August 2, 2024, the U.S. Food and Drug Administration’s (FDA) newly formed Genetic Metabolic Diseases Advisory Committee (the “GeMDAC”) convened for the first time and discussed the benefits and risks of arimoclomol.The GeMDAC reviewed comments received from independent experts, NPC patients, and patient advocacy group representatives, and voted favorably that arimoclomol is effective in the treatment of NPC.On Friday, August 9, 2024, the Company received the first round of labeling comments, and is working closely with the FDA. OLPRUVA On June 18, 2024, announced transition of specialty pharmacy partner to Orsini.Increased OLPRUVA reimbursement coverage to 75% of covered lives and improved preferred status on formulary plans. Added nine (9) new patient enrollments during Q2 2024, which is defined as a prescription for a patient on the Quick Start program or receiving a paid dispense of OLPRUVA. KP1077 On June 3, 2024, presented positive topline data from its Phase 2 study in patients with idiopathic hypersomnia (IH) at the SLEEP 2024 Annual Meeting. The Company submitted a briefing book to the FDA for an end-of-Phase 2 meeting to be held at the end of Q3 2024. Celiprolol Restarted recruitment for the Phase 3 DiSCOVER trial of celiprolol in patients with Vascular Ehler-Danlos Syndrome (VEDS).
Corporate On April 5, 2024, the Company entered into a $100 million credit facility with leading biotech investors, Perceptive Advisors and Healthcare Royalty Partners.On June 25, 2024, the Company announced the appointment of Rahsaan Thompson as Chief Legal Officer, Secretary and Compliance Officer, and Alison Peters as Chief People Officer, bringing expertise that will support the next phase of the Company’s growth. Overview of Q2 2024 Financial Results: Net revenue for Q2 2024 was $4.4 million, compared to net revenue of $8.5 million in Q2 2023. The components of revenue during the second quarter included $3.1 million in net reimbursements from the French EAP for arimoclomol, $1.3 million of royalties and other reimbursements under the AZSTARYS® License Agreement, and de minimis OLPRUVA revenue via sales to the new specialty pharmacy, Orsini, were offset by returns from the prior pharmacy in Q2 2024. In addition, cost of goods sold was inflated during the quarter due to recognition of a $3.2 million obsolescence reserve against OLPRUVA inventory which is nearing expiration. This excess inventory was ordered prior to our acquisition of Acer, and the delayed launch impacted the rate of usage, leading to the need for this reserve to be recognized in the quarter. Research and development (R&D) expenses were $10.5 million for Q2 2024, compared to $7.4 million in Q2 2023. The increase in R&D expenses was primarily driven by an increase in spending for the KP1077 Phase 2 clinical trial and an increase in personnel-related costs, partially offset by a decrease in third-party costs related to arimoclomol. Selling, general and administrative (SG&A) expenses were $12.6 million for Q2 2024, compared to $6.6 million in Q2 2023. The period-over-period increase reflects the commercial team in place for the entire quarter and actively engaged in activities to build awareness and provide patient services related to OLPRUVA, leading to an increase in personnel costs due to the additional headcount and an increase in other expenses related primarily to the launch of OLPRUVA. Net loss for Q2 2024 was ($19.9) million, or ($0.48) per basic and diluted share, compared to a net loss of ($2.6) million, or ($0.08) per basic and diluted share for Q2 2023.
As of June 30, 2024, total cash, cash equivalents, and investments were $49.3 million, a decrease of $3.4 million compared to $52.7 million as of March 31, 2024. The decrease was driven, in part, by increased third-party R&D costs related to the KP1077 clinical development program and increased SG&A expenses during the period as the Company invested in its commercial infrastructure. As of June 30, 2024, total shares of common stock outstanding were 41,991,464, and fully diluted common shares were 57,324,496, which included 5,483,537 shares issuable upon exercise of warrants. On April 5, 2024, the Company announced the refinancing of its existing debt with up to $100 million in committed capital, which strengthened its balance sheet, simplified its debt structure, and provided non-dilutive capital flexibility. The refinancing was led by Perceptive Advisors and HealthCare Royalty Partners, premier biotech investors. From the initial draw of $60 million at closing, the Company refinanced its existing debt of $43 million and added an incremental $14 million in net cash proceeds to the cash balance after fees and discounts. A second tranche of up to $20 million is available at the Company’s discretion until October 5, 2025, and a third tranche of up to $20 million will become available upon approval of arimoclomol, in each case subject to certain terms and conditions. On August 12, 2024, the Company completed an underwritten public offering, further strengthening its balance sheet. The underwriters fully exercised their overallotment option, resulting in the issuance of approximately 10.6 million shares at a price of $6.50 per share, raising net proceeds of $64.5 million after fees and expenses. Combining the net proceeds from this offering with our existing resources, pro forma June 30, 2024 total cash, cash equivalents and investments was $113.8 million. Following the closing of the underwritten public offering on August 12, 2024, pro forma June 30, 2024, common shares and fully diluted shares outstanding were 52,606,849 and 67,939,881, respectively. No warrants were issued as part of the underwritten public offering. Based on our current operating plan, available cash, cash equivalents, and investments, including proceeds from the underwritten offering closed in August, are expected to extend our cash runway into the first quarter of 2027, subject to continuing compliance with our debt covenants. Cash runway forecast includes: revenue from the expected sales of OLPRUVA, ongoing reimbursements from the French EAP for arimoclomol, ongoing royalties under the AZSTARYS license agreement, and investments into the incremental commercial activities needed to support the launch of arimoclomol, if approved. Cash runway forecast does not include commercial revenue from arimoclomol which could follow a potential FDA approval or the potential sale of the Priority Review Voucher which would be received upon approval. Conference Call Information Zevra will host a conference call and audio webcast today at 4:30 p.m. ET, to discuss its corporate and financial results for Q2 2024. The audio webcast will be accessible via the Investor Relations section of the Company’s website, http://investors.zevra.com/. An archive of the audio webcast will be available for ninety (90) days beginning at approximately 5:30 p.m. ET, on August 13, 2024. Additionally, interested participants and investors may access the conference call by dialing either: (800) 225-9448 (United States)+1 (203) 518- 9708 (International)Conference ID: ZVRAQ224 About Urea Cycle Disorders UCDs are a group of rare, genetic disorders that can cause harmful ammonia to build up in the blood, potentially resulting in brain damage and neurocognitive impairments if ammonia levels are not controlled.i Any increase in ammonia over time is serious. Therefore, it is important to adhere to any dietary protein restrictions and have alternative medication options to help control ammonia levels. About OLPRUVA® OLPRUVA (sodium phenylbutyrate) was approved for the treatment of certain UCDs in December 2022 and has recently been marketed under the brand name, OLPRUVA®. OLPRUVA (sodium phenylbutyrate) for oral suspension is a prescription medicine used along with certain therapies, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with UCDs, involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). OLPRUVA is not used to treat rapid increase of ammonia in the blood (acute hyperammonemia), which can be life-threatening and requires emergency medical treatment. For more information, please visit www.OLPRUVA.com. Important Safety Information Certain medicines may increase the level of ammonia in your blood or cause serious side effects when taken during treatment with OLPRUVA. Tell your doctor about all the medicines you or your child take, especially if you or your child take corticosteroids, valproic acid, haloperidol, and/or probenecid. OLPRUVA can cause serious side effects, including: 1) nervous system problems (neurotoxicity). Symptoms include sleepiness, tiredness, lightheadedness, vomiting, nausea, headache, confusion, 2) low potassium levels in your blood (hypokalemia) and 3) conditions related to swelling (edema). OLPRUVA contains salt (sodium), which can cause swelling from salt and water retention. Tell your doctor right away if you or your child get any of these symptoms. Your doctor may do certain blood tests to check for side effects during treatment with OLPRUVA. If you have certain medical conditions such as heart, liver or kidney problems, are pregnant/planning to get pregnant or breast-feeding, your doctor will decide if OLPRUVA is right for you. The most common side effects of OLPRUVA include absent or irregular menstrual periods, decreased appetite, body odor, bad taste or avoiding foods you ate prior to getting sick (taste aversion). These are not all of the possible side effects of OLPRUVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. About Niemann-Pick Disease Type C (NPC) Niemann-Pick disease type C (NPC) is an ultra-rare, progressive, and neurodegenerative lysosomal storage disorder characterized by an inability of the body to transport cholesterol and other lipids within the cell, leading to an accumulation of these substances in various tissue areas, including brain tissue. The disease is caused by mutations in the NPC1 or NPC2 genes, which are responsible for making lysosomal proteins. Both children and adults can be affected by NPC with varying clinical presentations. Those living with NPC lose independence due to physical and cognitive limitations, with key neurological impairments presenting in speech, cognition, swallowing, ambulation, and fine motor skills. Disease progression is irreversible and can be fatal within months or take years to be diagnosed and advance in severity. About Arimoclomol Arimoclomol, Zevra’s orally-delivered, investigational drug product candidate for the treatment of NPC, has been granted Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, and Rare Pediatric Disease designation by the FDA, and Orphan Medicinal Product designation for the treatment of NPC by the European Medicines Agency (EMA). The FDA has accepted the resubmission of the NDA for arimoclomol and has set a user fee action date (PDUFA date) of September 21, 2024. About Idiopathic Hypersomnia (IH) Idiopathic hypersomnia (IH) is a rare sleep disorder characterized by excessive daytime sleepiness (EDS). Patients with IH experience daytime lapses into sleep, or an irrepressible need to sleep that persists even with adequate or prolonged nighttime sleep. Additionally, those with IH have extreme difficulty waking, otherwise known as sleep inertia, severe brain fog, and often fall asleep unintentionally or at inappropriate times. These symptoms of IH often lead to further, even more debilitating problems such as memory lapses, difficulty maintaining focus, and depression. It is estimated, based on claims data, that approximately 37,000 patients in the United States are currently diagnosed with IH, although the total patient population may be much larger due to some patients who have not yet been diagnosed, have been misdiagnosed, or are not currently seeking treatment. About KP1077 KP1077 (serdexmethylphenidate, or SDX) is Zevra’s proprietary prodrug of d-methylphenidate (d-MPH) and its sole active pharmaceutical ingredient (API). KP1077 has been granted Orphan Drug Designation by the FDA, and by the European Commission, for the treatment of IH. The U.S. Drug Enforcement Agency (DEA) has classified SDX, the sole API in KP1077, as a Schedule IV controlled substance based on evidence suggesting SDX has a lower potential for abuse when compared to d-MPH, a Schedule II controlled substance. In addition, KP1077 has intellectual property protection though 2037 and potentially beyond. About Celiprolol Celiprolol is an investigational clinical candidate for the treatment of Vascular Ehlers-Danlos Syndrome (VEDS). Celiprolol has been granted Orphan Drug and Breakthrough Therapy Designations by the FDA. Zevra recently restarted enrollment in the Phase 3 trial, known as the DiSCOVER trial being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Celiprolol’s mechanism of action is designed to reduce the mechanical stress on collagen fibers within the arterial wall through vascular dilation and smooth muscle relaxation. About Vascular Ehlers-Danlos Syndrome Vascular Ehlers-Danlos syndrome is a rare genetic cardiovascular disorder which impairs collagen 3 rich connective tissue and leads to vascular and hollow organ ruptures. It is estimated that approximately 7,500 patients in the United States are currently diagnosed patients with VEDS. There remains an unmet need with no approved treatment in the United States. Celiprolol is currently the standard of care in Europe. About Zevra Therapeutics Zevra Therapeutics is a rare disease company combining science, data, and patient needs to create transformational therapies for diseases with limited or no treatment options. Our mission is to bring life-changing therapeutics to people living with rare diseases. With unique, data-driven development and commercialization strategies, the Company is overcoming complex drug development challenges to make new therapies available to the rare disease community. For more information, please visit www.zevra.com or follow us on X and LinkedIn. Cautionary Note Concerning Forward-Looking Statements This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding the promise and potential impact of our preclinical or clinical trial data; the initiation, timing and results of any clinical trials or readouts, the content, information used for, timing or results of any NDA submissions or resubmissions for arimoclomol or any other product candidates for any specific disease indication or at any dosage; the potential benefits of any of our products or product candidates for any specific disease or at any dosage; the impact of meetings or communications with the FDA or any advisory committee; decisions by the FDA or any other entity for arimoclomol or any other product candidates; our strategic and product development objectives, including with respect to becoming a leading, commercially focused rare disease company; the potential benefits of our debt facility;, our our financial position, including our cash balance: our corporate governance objectives; potential revenues from our arimoclomol expanded access program; the potential for royalty and milestone contributions, the presentation of data at conferences; and the timing of any of the foregoing. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2023, Zevra’s Quarterly Report on Form 10-Q for the three months ended June 30, 2024, and Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release. ________________________i Ah Mew N, et al. Urea cycle disorders overview [updated June 22, 2017]. In: Adam MP, Ardinger HH, Pagon RA, et al, eds. GeneReviews® [Internet]. University of Washington; 1993-2022. Accessed March 20, 2022. Zevra Contact Nichol Ochsner+1 (732) 754-2545nochsner@zevra.com Russo Partners Contacts Adanna G. Alexander, Ph.D.+1 (646) 942-5603adanna.alexander@russopartnersllc.com
ZEVRA THERAPEUTICS, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) Three months endedJune 30, Six months endedJune 30, 2024 2023 2024 2023Revenue, net $4,449 $8,470 $7,874 $11,646 Cost of product revenue (excluding $1,546 and $3,074 in intangible asset amortization for the three and six months ended June 30, 2024, respectively shown separately below) 3,573 677 3,748 802 Intangible asset amortization 1,546 — 3,074 — Operating expenses:
Research and development 10,521 7,433 22,798 16,088 Selling, general and administrative 12,604 6,612 22,535 13,839 Total operating expenses 23,125 14,045 45,333 29,927 Loss from operations (23,795) (6,252) (44,281) (19,083)Other income (expense):
Interest expense (2,110) (197) (2,845) (379)Fair value adjustment related to warrant and CVR liability 5,779 2,118 9,406 575 Fair value adjustment related to investments 1 131 (26) 327 Interest and other income (expense), net 270 1,553 1,199 2,593 Total other income 3,940 3,605 7,734 3,116 Loss before income taxes (19,855) (2,647) (36,547) (15,967)Income tax benefit (70) 74 — 177 Net loss $(19,925) $(2,573) $(36,547) $(15,790)
Basic and diluted net loss per share of common stock:
Net loss $(0.48) $(0.08) $(0.87) $(0.46)Weighted average number of shares of common stock outstanding:
Basic and diluted 41,899,087 33,898,233 41,839,582 34,180,818 ZEVRA THERAPEUTICS, INC. UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and par value amounts) June 30, December 31, 2024 2023Assets
Current assets:
Cash and cash equivalents $39,260 $43,049 Securities at fair value 9,998 24,688 Accounts and other receivables 8,947 17,377 Prepaid expenses and other current assets 2,686 1,824 Total current assets 60,891 86,938 Inventories 10,198 9,841 Property and equipment, net 678 736 Operating lease right-of-use assets 911 790 Goodwill 4,701 4,701 Intangible assets, net 66,154 69,227 Other long-term assets 875 94 Total assets $144,408 $172,327
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses $20,452 $28,403 Line of credit payable — 37,700 Current portion of operating lease liabilities 596 543 Current portion of discount and rebate liabilities 6,768 4,550 Other current liabilities 2,633 2,524 Total current liabilities 30,449 73,720 Long-term debt 58,328 5,066 Warrant liability 7,856 16,100 Operating lease liabilities, less current portion 544 456 Discount and rebate liabilities, less current portion 8,115 7,663 Other long-term liabilities 6,638 7,458 Total liabilities 111,930 110,463
Commitments and contingencies
Stockholders’ equity:
Preferred stock:
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of June 30, 2024, or December 31, 2023 — — Common stock, $0.0001 par value, 250,000,000 shares authorized, 43,567,156 shares issued and 41,991,464 shares outstanding as of June 30, 2024; 43,110,360 shares issued and 41,534,668 shares outstanding as of December 31, 2023 4 4 Additional paid-in capital 479,361 472,664 Treasury stock, at cost (10,983) (10,983)Accumulated deficit (436,325) (399,778)Accumulated other comprehensive income (loss) 421 (43)Total stockholders' equity 32,478 61,864 Total liabilities and stockholders' equity $144,408 $172,327
临床3期突破性疗法临床结果临床2期孤儿药
100 项与 盐酸塞利洛尔 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 心绞痛 | 日本 | 1992-09-01 | |
| 高血压 | 日本 | 1992-09-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| Ehlers-Danlos综合征 | 临床3期 | 美国 | - |
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临床结果
临床结果
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分期
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床4期 | 53 | 獵鑰遞構簾鏇糧襯蓋獵(淵鏇構齋餘鬱繭顧範繭): P-Value = 0·040 更多 | 积极 | 2010-10-30 | |||
(Control) |
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