The study aimed to conduct a randomized, non-inferiority controlled trial to compare the short- and medium-term efficacy and safety of two antibiotic dosage regimens in cardiac implantable electronic devices (CIED) infections with multidrug-resistant Gram-positive cocci: 1) single-dose therapy with a long-half-life antibiotic (oritavancin) vs. standard 7-14 days of therapy with a short-half-life antibiotic (vancomycin) for CIED surgical incision site or pocket infection; and 2) fractionated therapy with a long-half-life antibiotic (oritavancin) at seven-day intervals compared to standard therapy with a short-half-life antibiotic (vancomycin) fractionated in 2-3 daily doses in cases of lead-related infectious endocarditis.

开始日期2025-06-01

申办/合作机构

Medical University of Silesia

[+1]

NCT05521880

/ Terminated临床4期IIT

Anchoring Intermittent Long Acting Antimicrobials to Medication for Opioid Use Disorder Treatment to Facilitate Structured Transitions of Care for People Who Use Drugs Admitted to the Hospital With Invasive Infections

Standard of care for patients with opioid use disorder and complicated infections is discharge to subacute nursing facilities on IV antibiotics until completion of treatment course. We aim to determine the efficacy of an alternative strategy using intermittent outpatient oritavancin therapy dosed weekly combined with initiation and continuation of medication assisted treatment for opioid use disorder for completion of antimicrobial therapy in a 12 week prospective, open-label study. Patients hospitalized for a drug use related infection and thought to need prolonged parenteral antimicrobial therapy will be assessed by a substance use consultant and Infectious Diseases service. If they are not on Medication for Opioid Use Disorder (MOUD), they will be assessed for initiation of MOUD. A collaborative multidisciplinary discharge planning process will be initiated and will involve linkage to care. If they have an infection with a gram positive organism, and are thought to be clinically stable for hospital discharge, they will be assessed for appropriateness for oritavancin and first dose will be administered prior to discharge. They will have an intake into an opioid treatment program where they can access collocated services and will be discharged with linkage to care through a peer recovery coach. They will be assessed in this collocated clinic post discharge for optimization of MOUD and progress of infection and subsequent dose/s of oritavancin will be administered. Patients will be followed for 12 weeks for cure/completion of therapy and MOUD outcomes.

开始日期2024-07-15

申办/合作机构

University of Maryland Baltimore

NCT05599295

/ Recruiting临床2期

A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous Oritavancin for the Treatment of Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric participants with acute bacterial skin and skin structure infections (ABSSSIs).
This study involves 2 oritavancin products, Orbactiv and Kimyrsa. Oritavancin is the active drug substance in both Orbactiv and Kimyrsa. This study protocol distinguishes the differences between Orbactiv and Kimyrsa by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data and information and guidance that is not specific to Orbactiv or Kimyrsa (that is, applies to both).
The study involves pharmacokinetic sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to participants and their caregivers.

开始日期2023-06-15

申办/合作机构

Melinta Therapeutics, Inc.

100 项与奥利万星磷酸盐相关的临床结果

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100 项与奥利万星磷酸盐相关的转化医学

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100 项与奥利万星磷酸盐相关的专利（医药）

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380

项与奥利万星磷酸盐相关的文献（医药）

2025-11-01·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Long-acting lipoglycopeptides compared to standard-of-care for the treatment of complicated gram-positive infections: A systematic review and meta-analysis

Review

作者: Steuber, Taylor D ; Salvatore, Dominick ; Moore, Jaci

OBJECTIVES:

Long-acting lipoglycopeptides (LA-LGPs) are being used more frequently for the treatment of complicated Gram-positive infections, including osteomyelitis, prosthetic joint infections, bloodstream infections, and endocarditis. This systematic review and meta-analysis compared the efficacy and safety of LA-LGP to the standard of care (SOC) antibiotics for the treatment of these infections.

METHODS:

A systematic literature search was conducted using PubMed, Medline, Embase, Cochrane, and Clinicaltrials.gov through November 2024. Prospective and retrospective comparative studies evaluating patients being treated for complicated Gram-positive infections were included. Interventions included multi-dose LA-LGP, including dalbavancin and oritavancin, vs. SOC antibiotics. Risk of bias was assessed using Cochrane RoB 2 and ROBINS-I tools. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using a random effects model. The primary outcome was clinical success.

RESULTS:

Fourteen studies (n = 1582 patients) were included. Studies included a wide array of indications and dosing schemes. LA-LGP was associated with significantly higher clinical success rates compared to SOC (RR = 1.14, 95% CI = 1.05-1.23, P < 0.01). No significant differences were observed for infection recurrence, mortality, adverse events (AEs), or serious adverse events (SAEs). LA-LGP was associated with fewer hospital readmissions. A subgroup analysis of bone and joint infections showed no significant difference in clinical success between LA-LGP and SOC.

CONCLUSIONS:

LA-LGP for the treatment of complicated Gram-positive infections resulted in similar efficacy and safety to SOC antibiotics and may be a reasonable alternative for such infections. Results should be interpreted with caution given the risk of bias and heterogeneity (PROSPERO Registration ID: CRD42024532465).

2025-10-03·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Oritavancin in a patient with recurrent endocarditis by Enterococcus faecalis: a new therapeutic option?

Article

作者: Bongiovanni, Marco ; Turicchi, Giulia

2025-10-01·Infectious Diseases and Therapy

A Comparative Review of the Pharmacology of Dalbavancin and Oritavancin for Gram-Positive Infections: Birds of a Feather or Apples and Oranges?

Review

作者: Blaskovich, Mark A T ; Velkov, Tony ; Hussein, Maytham ; Thombare, Varsha J ; Patil, Nitin ; Rao, Gauri G ; Murthy, Ananya B ; Li, Jian ; Wu, Yuezhou ; Sharma, Rajnikant ; Barclay, James ; Baker, Mark

The clinical landscape of Gram-positive infections has been reshaped with the introduction of long-acting lipoglycopeptides, particularly dalbavancin and oritavancin. Both agents share broad-spectrum activity against multidrug-resistant pathogens, including methicillin-resistant Staphylococcus aureus and vancomycin-resistant strains, yet differ markedly in pharmacokinetics, pharmacodynamics, resistance profiles, and clinical adoption. This review presents a comprehensive comparative analysis of their structural innovations, distinct pharmacokinetic and pharmacodynamic characteristics, and dual mechanisms of action, supported by minimum inhibitory concentration data across key pathogens. Despite belonging to the same antimicrobial class, these agents exhibit important differences in real-world applications and clinical integration. We highlight real-world evidence supporting off-label use in osteomyelitis, endocarditis, and bloodstream infections, where traditional therapies fall short. Furthermore, we explore resistance development, drug-drug interaction profiles, and outpatient utility, providing actionable insights for optimizing treatment strategies. These findings underscore the need for tailored clinical integration of dalbavancin and oritavancin and spotlight their potential roles in future antimicrobial stewardship frameworks.

项与奥利万星磷酸盐相关的新闻（医药）

2025-09-29

·GlobeNewswire-Health Care

CorMedix Announces Completion of Enrollment in Phase III ReSPECT Clinical Trial for REZZAYO

- Enrollment Completed in Ongoing Phase III ReSPECT Study in Prophylaxis of Fungal Infections in Adult Patients Undergoing Allogeneic Blood and Marrow Transplant - - Topline Results from ReSPECT Study Expected in 2Q 2026 - BERKELEY HEIGHTS, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced completion of enrollment for the ongoing, global Phase III ReSPECT trial evaluating the efficacy of REZZAYO® (rezafungin), a single-agent echinocandin in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). This clinical trial has been sponsored by Mundipharma, located in the United Kingdom. The US distribution rights for REZZAYO were licensed under a strategic collaboration agreement with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix. “Completing enrollment for the Phase III ReSPECT study represents an important step toward our goal of seeking FDA approval for REZZAYO in the prophylaxis of invasive fungal disease in adult patients receiving BMT,” said Joseph Todisco, CEO of CorMedix. Mr. Todisco continued, “While we have just recently closed our acquisition of Melinta Therapeutics, we believe that a prophylaxis indication for REZZAYO represents a significant growth opportunity for CorMedix, given the critical unmet need in this high-risk patient population. We look forward to sharing topline results from this study next year.” The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of once-weekly rezafungin (REZZAYO) versus a standard antimicrobial regimen (SAR) for the prevention of invasive fungal diseases (IFDs) in adults undergoing allogeneic BMT. Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebos matching the SAR components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to toxicity, and mortality adjusted for comorbidities. About REZZAYO® REZZAYO (rezafungin for injection) is a next generation echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. There are an estimated 50,000 cases of candidemia and invasive candidiasis each year in the U.S. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic BMT. CorMedix estimates that there are an approximately 130,000 patients that could constitute the addressable market for antifungal prophylaxis in the U.S. and estimates an implied total addressable market (“TAM”) of over $2B in this market segment. REZZAYO has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline), REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Most common adverse reactions (incidence ≥5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com (617) 430-7576

临床3期上市批准并购引进/卖出孤儿药

2025-09-29

·cormedix.com

CORMEDIX ANNOUNCES COMPLETION OF ENROLLMENT IN PHASE III RESPECT CLINICAL TRIAL FOR REZZAYO

– Enrollment Completed in Ongoing Phase III ReSPECT Study in Prophylaxis of Fungal Infections in Adult Patients Undergoing Allogeneic Blood and Marrow Transplant – – Topline Results from ReSPECT Study Expected in 2Q 2026 – Berkeley Heights, NJ – September 29, 2025 – CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced completion of enrollment for the ongoing, global Phase III ReSPECT trial evaluating the efficacy of REZZAYO® (rezafungin), a single-agent echinocandin in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). This clinical trial has been sponsored by Mundipharma, located in the United Kingdom. The US distribution rights for REZZAYO were licensed under a strategic collaboration agreement with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix. “Completing enrollment for the Phase III ReSPECT study represents an important step toward our goal of seeking FDA approval for REZZAYO in the prophylaxis of invasive fungal disease in adult patients receiving BMT,” said Joseph Todisco, CEO of CorMedix. Mr. Todisco continued, “While we have just recently closed our acquisition of Melinta Therapeutics, we believe that a prophylaxis indication for REZZAYO represents a significant growth opportunity for CorMedix, given the critical unmet need in this high-risk patient population. We look forward to sharing topline results from this study next year.” The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of once-weekly rezafungin (REZZAYO) versus a standard antimicrobial regimen (SAR) for the prevention of invasive fungal diseases (IFDs) in adults undergoing allogeneic BMT. Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebos matching the SAR components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to toxicity, and mortality adjusted for comorbidities. About REZZAYO® REZZAYO (rezafungin for injection) is a next generation echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. There are an estimated 50,000 cases of candidemia and invasive candidiasis each year in the U.S. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic BMT. CorMedix estimates that there are an approximately 130,000 patients that could constitute the addressable market for antifungal prophylaxis in the U.S. and estimates an implied total addressable market (“TAM”) of over $2B in this market segment. REZZAYO has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline), REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Most common adverse reactions (incidence ≥5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

临床3期并购上市批准孤儿药临床结果

2025-09-09

·GlobeNewswire-Health Care

CorMedix Announces Strategic Minority Investment in Talphera

Sept. 08, 2025 -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that it has made a $5 million strategic minority equity investment in Talphera, Inc. (Nasdaq: TLPH), acquiring 9,090,909 shares at an at-market price of $0.55 per share as part of Talphera’s concurrently announced private placement financing. Talphera expects to use the proceeds of the equity financing to fund the completion of its ongoing Phase 3 registrational study for Niyad™ and for pre-launch preparations. Talphera is a specialty pharmaceutical company developing Niyad, a lyophilized formulation of nafamostat which is currently being studied as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (“FDA”). Talphera’s randomized, double-blind, registrational study of Niyad, NEPHRO CRRT, aims to enroll and evaluate 70 adult patients undergoing continuous renal replacement therapy (“CRRT”), who cannot tolerate heparin or are at risk for bleeding. An estimated 165,000 acute kidney injury patients receive an average 5 to 7 day course of CRRT in the hospital ICU setting in a given year. In connection with the equity investment, Talphera has granted CorMedix (1) the exclusive right of first negotiation for a potential acquisition of the company with a 60 day exclusive negotiation period following completion and announcement of its Phase 3 study results for Niyad, and (2) the right to nominate one member to Talphera’s Board of Directors. “We are excited to announce this strategic investment and agreement with Talphera, as we see Niyad as a potential significant improvement above the current standard of care in CRRT,” said Joseph Todisco, CEO of CorMedix. “The investment in Talphera is consistent with our business development strategy to invest in highly synergistic and undervalued assets. We look forward to building a relationship with Talphera as it advances Niyad toward a potential approval in 2026.” Vince Angotti, Talphera CEO, stated. “We appreciate the interest CorMedix has in Talphera and the support from a company that has quickly established itself as a leader in acute care specialty products. The completion of this financing with CorMedix as well as other high quality institutional investors further validates the potential value of Niyad to become a new standard of care in the hospital acute care market. If approved, Niyad would become the first available FDA-approved regional anticoagulant for CRRT.” CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter related bloodstream infections in patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products including MINOCIN® (minocycline), REZZAYO™ (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath® in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath® as a catheter lock solution for use in other patient populations. REZZAYO™ is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. The completion of the Phase III study for REZZAYO™ is expected in 1H 2026. The content above comes from the network. if any infringement, please contact us to modify.

上市批准并购突破性疗法

100 项与奥利万星磷酸盐相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05271	奥利万星磷酸盐	J01XA05	DB04911

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
皮肤和皮肤结构感染	美国	Melinta Therapeutics, Inc.	2014-08-06

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
细菌感染	申请上市	加拿大	Xediton Pharmaceuticals, Inc.	2024-08-01
脓肿	临床3期	美国	Melinta Therapeutics, Inc.	2010-12-01
蜂窝织炎	临床3期	美国	Melinta Therapeutics, Inc.	2010-12-01
伤口感染	临床3期	美国	Melinta Therapeutics, Inc.	2010-12-01
丹毒	临床2期	美国	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	保加利亚	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	希腊	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	拉脱维亚	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	立陶宛	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	波兰	Melinta Therapeutics, Inc.	2023-06-15

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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


NCT02925416 (CTgov)	临床4期	细菌性皮肤疾病 \| 丹毒	22	Oritavancin (Oritavancin/Oritavancin)	襯積衊鬱窪遞襯襯簾繭 = 蓋鏇製鏇醖構壓顧餘艱醖觸窪積襯鹽廠蓋顧膚 (鬱簾築餘鹽憲鏇簾範糧, 鏇齋齋願膚餘鹹廠鹹鑰 ~ 簾糧齋艱壓憲鹹簾蓋鹽) 更多	-	2024-02-01
				Placebo (D5W)+Oritavancin (Oritavancin/Placebo)	襯積衊鬱窪遞襯襯簾繭 = 鬱構艱齋簾壓壓醖簾膚醖觸窪積襯鹽廠蓋顧膚 (鬱簾築餘鹽憲鏇簾範糧, 鹽獵願鹹築鑰窪獵範衊 ~ 簾憲蓋衊範築鏇範顧襯) 更多
NCT02452918 (CTgov)	临床4期	皮肤和皮肤结构感染 \| 丹毒 \| 蜂窝织炎	17	Oritavancin (Oritavancin 1200 mg Without Concomitant Warfarin Therapy)	餘觸鑰壓襯鹹繭壓廠鹽 = 窪顧廠淵顧廠襯廠鏇鹽繭醖獵觸鬱顧遞齋鑰鏇 (遞膚觸蓋鬱簾鹽夢鏇鑰, 鏇廠糧蓋餘鏇顧窪蓋窪 ~ 淵簾築積淵壓範蓋遞繭) 更多	-	2023-12-20
				Warfarin+Oritavancin (Oritavancin 1200 mg With Concomitant Warfarin Therapy)	餘觸鑰壓襯鹹繭壓廠鹽 = 獵觸餘築糧蓋築憲繭鬱繭醖獵觸鬱顧遞齋鑰鏇 (遞膚觸蓋鬱簾鹽夢鏇鑰, 觸鹽獵顧餘衊艱鬱鹽夢 ~ 醖鬱廠窪鏇願鑰積齋網) 更多
NCT01252719 (SOLO I, CTgov)	临床3期	脓肿 \| 蜂窝织炎 \| 伤口感染	968	Oritavancin (Single-Dose 1200 mg Oritavancin)	觸選願廠鏇壓齋壓淵築 = 構廠糧壓願願淵鹹淵願顧範廠衊襯製糧構鑰顧 (鬱餘獵鏇壓觸廠廠膚窪, 簾壓網齋範膚糧製餘襯 ~ 網糧構壓積廠壓壓齋淵) 更多	-	2022-08-01
				Vancomycin (Vancomycin)	觸選願廠鏇壓齋壓淵築 = 鬱蓋願築願夢積窪壓廠顧範廠衊襯製糧構鑰顧 (鬱餘獵鏇壓觸廠廠膚窪, 醖壓範壓壓艱膚衊製窪 ~ 憲網醖網憲窪齋淵範遞) 更多
NCT01252732 (SOLO II, CTgov)	临床3期	脓肿 \| 蜂窝织炎 \| 伤口感染	1,019	Oritavancin (Single-Dose 1200 mg Oritavancin)	範願鹽衊構憲夢齋壓淵 = 製醖壓獵淵鑰醖艱遞醖遞獵簾衊製衊簾繭鹹廠 (獵簾網築鏇廠遞餘淵膚, 範選簾遞獵蓋顧廠餘襯 ~ 襯鹹餘觸鏇鹽構醖遞繭) 更多	-	2021-04-13
				Vancomycin (Vancomycin)	範願鹽衊構憲夢齋壓淵 = 鏇壓構鬱觸願簾鹽鏇獵遞獵簾衊製衊簾繭鹹廠 (獵簾網築鏇廠遞餘淵膚, 餘糧繭繭鏇獵蓋鬱鏇獵 ~ 鹹膚壓壓窪顧憲鏇顧膚) 更多
NCT03873987 (CTgov)	临床1期	皮肤和皮肤结构感染 \| 丹毒 \| 蜂窝织炎	102	Kimyrsa	遞鹽膚鏇積構獵蓋網網 = 構廠構積網選願蓋簾顧鑰鹹鹽顧憲鹹鏇淵窪淵 (夢艱遞遞夢齋積鏇蓋糧, 簾遞構鬱廠餘壓艱築窪 ~ 壓遞鹽製衊製淵淵範繭)	-	2021-04-13
NCT01252719 \| NCT01252732 (SOLO II \| SOLO I, Pubmed) 人工标引	临床3期	皮肤和皮肤结构感染	792	Oritavancin	範簾繭艱選鹹鏇餘觸築(範齋繭衊衊願衊夢夢醖) = 餘鑰壓鑰範繭餘鹹襯網製積憲範齋繭憲鹹選鏇 (積鏇淵築膚齋蓋衊範選 ) 更多	积极	2017-01-19
				Vancomycin	範簾繭艱選鹹鏇餘觸築(範齋繭衊衊願衊夢夢醖) = 鬱齋憲衊鏇鏇願衊遞齋製積憲範齋繭憲鹹選鏇 (積鏇淵築膚齋蓋衊範選 ) 更多
NCT01252732 (SOLO II, Pubmed \| Clin Infect Dis) 人工标引	临床3期	革兰氏阳性细菌感染	1,005	oritavancin	製壓築醖製觸夢齋製範(糧壓顧築艱壓獵範積廠) = 簾鬱齋鑰顧製壓簾齋鑰鏇餘築夢醖艱鬱範醖窪 (襯鬱繭膚醖廠膚艱遞築 ) 更多	非劣	2015-01-15
				vancomycin	製壓築醖製觸夢齋製範(糧壓顧築艱壓獵範積廠) = 選襯壓製糧鏇構淵願繭鏇餘築夢醖艱鬱範醖窪 (襯鬱繭膚醖廠膚艱遞築 ) 更多
NCT01252719 (SOLO I, Pubmed \| N Engl J Med)	临床3期	细菌性皮肤疾病	475	Oritavancin 1200 mg	繭淵艱簾糧鏇蓋廠蓋鹹(範製鏇範壓網淵壓膚繭) = nausea was more common among those treated with oritavancin 餘製觸選餘襯鬱糧範夢 (積獵糧衊鏇製簾鏇選夢 )	积极	2014-06-05
				Vancomycin
NCT00514527 (SIMPLIFI, Pubmed \| Antimicrob Agents Chemother)	临床2期	脓肿 \| 链球菌感染 \| 皮肤和皮肤结构感染 ... 更多	302	Daily-dose group	齋繭獵顧網膚遞鹽膚艱(範積製簾網簾淵夢夢窪) = 窪窪範醖遞簾繭網襯網選蓋膚築蓋鹽襯餘築窪 (觸簾蓋選蓋鹹鹹鑰淵醖 ) 更多	积极	2011-07-01
				1,200-mg-single-dose group	齋繭獵顧網膚遞鹽膚艱(範積製簾網簾淵夢夢窪) = 鹹觸構憲遞蓋獵鏇遞鹽選蓋膚築蓋鹽襯餘築窪 (觸簾蓋選蓋鹹鹹鑰淵醖 ) 更多