更新于：2024-11-08

Metoclopramide Hydrochloride

盐酸甲氧氯普胺

更新于：2024-11-08

概要

概要

基本信息

简介甲氧氯普胺是一种多巴胺-2（D2）拮抗剂的小分子药物。用于治疗胃食管反流病（GERD）和急性或复发性糖尿病胃轻瘫（胃淤滞）等疾病，该药最初由赛诺菲开发，于1967年3月首次在日本批准使用。是一种可用于口服和注射的药物。

药物类型

小分子化药

别名

2-methoxy-4-amino-5-chloro-N,N-(dimethylaminoethyl)benzamide、2-methoxy-5-chloroprocainamide、4-amino-5-chloro-2-methoxy-N-(β-diethylaminoethyl)benzamide

+ [30]

靶点

DRDs

作用机制

DRDs拮抗剂(多巴胺受体家族拮抗剂)

治疗领域

神经系统疾病消化系统疾病内分泌与代谢疾病+ [3]

在研适应症

药物引起的恶心和呕吐放疗引起的恶心和呕吐呕吐+ [4]

非在研适应症

化疗引起的恶心和呕吐危重病胃轻瘫+ [1]

原研机构

Sanofi

在研机构

Sanofi

Evoke Pharma, Inc.Bridgewest Perth Pharma Pty Ltd.

+ [3]

非在研机构

Hikma Pharmaceuticals USA, Inc.

Millennium Pharmaceuticals, Inc.

Meda Pharmaceuticals, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

日本 (1967-03-25),

食欲减退恶心和呕吐

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C14H25Cl2N3O3

InChIKeyKJBLQGHJOCAOJP-UHFFFAOYSA-N

CAS号54143-57-6

关联

216

项与盐酸甲氧氯普胺相关的临床试验

CTRI/2024/08/072429 / Not yet recruiting临床3期

An open-label phase III randomized controlled trial comparing metoclopramide, thalidomide, prochlorperazine, and lorazepam for treating breakthrough chemotherapy-induced nausea and vomiting in patients receiving olanzapine as part of antiemetic prophylaxis for highly emetogenic chemotherapy. - Nil

开始日期2024-09-01

申办/合作机构-

CTR20242625 / CompletedN/A

甲氧氯普胺片（10mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择ANI PHARMACEUTICALS INC为持证商的甲氧氯普胺片（商品名：REGLAN，规格：10mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂甲氧氯普胺片（规格：10mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂甲氧氯普胺片（规格：10mg）和参比制剂甲氧氯普胺片（商品名：REGLAN，规格：10mg）的安全性。

开始日期2024-08-16

申办/合作机构

石家庄四药有限公司

CTR20242411 / CompletedN/A

甲氧氯普胺片人体生物等效性试验

主要目的：采用单中心、随机、开放、两制剂、双周期交叉、单剂量、空腹及餐后给药设计，比较空腹及餐后给药条件下，杭州沐源生物医药科技有限公司提供的甲氧氯普胺片（规格：10 mg）与ANI PHARMACEUTICALS INC持证的甲氧氯普胺片（商品名：Reglan®，规格：10 mg）在中国健康人群中吸收程度和吸收速度的差异，评价生物等效性。次要目的：评价空腹及餐后条件下，杭州沐源生物医药科技有限公司提供的甲氧氯普胺片（规格：10 mg）与ANI PHARMACEUTICALS INC持证的甲氧氯普胺片（商品名：Reglan®，规格：10 mg）的安全性。

开始日期2024-07-31

申办/合作机构

杭州沐源生物医药科技有限公司

100 项与盐酸甲氧氯普胺相关的临床结果

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100 项与盐酸甲氧氯普胺相关的转化医学

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100 项与盐酸甲氧氯普胺相关的专利（医药）

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6,177

项与盐酸甲氧氯普胺相关的文献（医药）

2024-10-16·BIOLOGICAL & PHARMACEUTICAL BULLETIN

Involvement of Proton-Coupled Organic Cation Antiporter in Human Blood–Brain Barrier Transport of Mesoridazine and Metoclopramide

Article

作者: Kubo, Yoshiyuki ; Debori, Yasuyuki ; Deguchi, Yoshiharu ; Nakakariya, Masanori ; Kurosawa, Toshiki ; Aoyama, Kazunobu ; Hirabayashi, Hideki ; Amano, Nobuyuki ; Igari, Tomoko

Mesoridazine and metoclopramide are cationic drugs that are distributed in the human brain despite being substrates of multidrug resistance protein 1 (MDR1), an efflux transporter expressed at the blood-brain barrier (BBB). We investigated their transport mechanisms at the BBB using hCMEC/D3, a human cerebral microvascular endothelial cell line often used as an in vitro BBB model. The cells exhibited time- and concentration-dependent uptake of mesoridazine and metoclopramide, with K_m values of 34 and 277 µM, respectively. The uptake of both drugs significantly decreased in the presence of typical inhibitors and/or substrates of the H⁺-coupled organic cation (H⁺/OC) antiporter but not in the presence of inhibitors or substrates of organic cation transporters (OCTs), OCTN2, OATPs, SLC35F2, or the plasma membrane monoamine transporter (PMAT). Furthermore, metoclopramide uptake by hCMEC/D3 cells was pH- and energy-dependent, whereas mesoridazine uptake was unaffected by intracellular acidification and treatment with metabolic inhibitors. These results suggest that the H⁺/OC antiporter is involved in the influx of mesoridazine and metoclopramide into the brain across the BBB.

2024-10-01·STROKE

Metoclopramide to Prevent Pneumonia in Patients With Stroke and a Nasogastric Tube: Data From the PRECIOUS Trial

Article

作者: de Jonge, Jeroen C. ; van de Beek, Diederik ; Bath, Philip M. ; van der Worp, H. Bart ; Westendorp, Willeke F. ; Woodhouse, Lisa J. ; Reinink, Hendrik ; Sluis, Wouter M.

BACKGROUND::

A randomized trial suggested that treatment with metoclopramide reduces the risk of pneumonia in patients with acute stroke and a nasogastric tube. We assessed whether this finding could be replicated in a post hoc analysis of the randomized PRECIOUS trial (Prevention of Complications to Improve Outcome in Elderly Patients With Acute Stroke).

METHODS::

PRECIOUS was an international, 3×2 partial-factorial, randomized controlled, open-label clinical trial with blinded outcome assessment assessing preventive treatment with metoclopramide, paracetamol, and ceftriaxone in patients aged ≥66 years with acute ischemic stroke or intracerebral hemorrhage and a National Institutes of Health Stroke Scale score ≥6. In the present study, we analyzed patients who had a nasogastric tube within 24 hours after randomization. Patients who were allocated to metoclopramide (10 mg TID) were compared with patients who were not. Treatment was started within 24 hours after symptom onset and continued for 4 days or until discharge if earlier. The primary outcome was pneumonia in the first week after stroke. The score on the modified Rankin Scale after 90 days was a secondary outcome and analyzed with ordinal logistic regression.

RESULTS::

From April 2016 through June 2022, a total of 1493 patients were enrolled with 1376 included in this analysis, of whom 1185 (86%) had ischemic stroke and 191 (14%) had intracerebral hemorrhage. The first day after randomization, 329 (23.9%) patients had a nasogastric tube, of whom 156 were allocated to metoclopramide and 173 to standard care. Metoclopramide was not associated with a reduction of pneumonia (41.0% versus 35.8%; adjusted odds ratio, 1.35 [95% CI, 0.79–2.30]) or with poor functional outcome (adjusted odds ratio, 1.07 [95% CI, 0.71–1.61]).

CONCLUSIONS::

In patients with stroke who had a nasogastric tube shortly after stroke onset, metoclopramide for 4 days did not reduce pneumonia or have an effect on the functional outcome.

2024-10-01·JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH

Prevention of postoperative nausea and vomiting after cesarean delivery under neuraxial anesthesia and postpartum analgesia in Japan: A cross‐sectional study

Article

作者: Ikeda, Yusuke ; Watanabe, Kaede ; Noguchi, Shohei ; Mazda, Yusuke ; Sakamaki, Daisuke ; Shiko, Yuki ; Kawasaki, Yohei

Abstract:

Aims:

This study aims to investigate the clinical practice of physicians working in obstetric setting toward postoperative nausea and vomiting (PONV) in parturients undergoing cesarean delivery (CD) with neuraxial anesthesia.

Methods:

We conducted this online survey to all active members of the Japan Society of Obstetric Anesthesiology and Perinatology (JSOAP), where leads academic society in obstetric anesthesia in Japan. The questionnaire was developed using the Delphi method. The survey included questions about routine practices for PONV prevention, the use of neuraxial opioids, optimal practices, and perceived obstacles. The email sent three times every 2 weeks as a reminder.

Results:

A total of 1046 e‐mails were sent, and 307 JSOAP members responded to the survey (29.3%). More than half of responders (62.7%) used neuraxial opioids with intrathecal morphine being the most frequent. They had a higher rate of multimodal PONV prophylaxis compared with who did not use neuraxial opioids for postoperative analgesia (19.9% vs 6.7%). Metoclopramide was the commonest medication for PONV prevention, and there was a significant difference in the use of 5‐hydroxytryptamine receptor antagonists (19.9% vs. 8.6%, p = 0.012). We observed that 80% of physicians reported the routine administration of prophylaxis for PONV for CD. Among these, 20% indicated the use of two or more agents. Conversely, in the cohort not administering neuraxial opioids, only 6.7% reported the use of two or more agents.

Conclusion:

The online survey showed that the physicians using neuraxial opioids for CD had a higher proportion of multimodal PONV management involving two or more agents.

130

项与盐酸甲氧氯普胺相关的新闻（医药）

2024-11-07

·GlobeNewswire-Health Care

Evoke Pharma, Inc. Reports Third Quarter 2024 Financial Results

GIMOTI third quarter net product sales of $2.7 million, highest quarterly revenue ever with a 70% increase year-over-year Strong cumulative prescriber growth, 45% year-over-year increase 52% year-over-year prescription fill increase; 39% increase since Q1 2024 Real-world data presented at ACG 2024 demonstrates that GIMOTI significantly enhanced outcomes for patients on GLP-1 therapy, marking it as a promising supportive care option compared to oral metoclopramide. SOLANA BEACH, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced its financial results for the third quarter ended September 30, 2024, and recent corporate developments. “We are encouraged by the strong year-over-year growth metrics we continue to see for GIMOTI, including a 70% year-over-year increase in net product sales and significant gains in prescriber and prescription fill rates. We continue to grow revenue with this being the highest quarter of revenue on record,” said Matt D’Onofrio, CEO of Evoke Pharma. “The strong response to GIMOTI among healthcare providers and patients underscores its growing value as an innovative non-oral treatment option for diabetic gastroparesis. With award-winning real-world data presented at ACG 2024, GIMOTI has demonstrated its potential to treat diabetic gastroparesis even with those undergoing GLP-1 therapy.” “The recent data presented at ACG 2024 highlights GIMOTI’s ability to significantly reduce healthcare visits, including hospitalizations, underscoring the need for better alternatives to traditional oral treatments. Coupled with our strategic initiatives to expand access and engage more prescribers, we are well-positioned to increase GIMOTI’s reach and help more patients find meaningful relief. The positive feedback from both patients and providers strengthens our resolve to reshape the care paradigm and ensure that people with gastroparesis have access to an effective and innovative option like GIMOTI,” said Chris Quesenberry, Chief Commercial Officer of GIMOTI. “Our dedicated mission is to challenge the notion that gastroparesis 'patients are doing fine' with current treatment options, as we know firsthand that many individuals with diabetic gastroparesis continue to struggle despite existing therapies. According to a survey from IFFGD (gastroenterology patient support organization), 65% of patients with Diabetic Gastroparesis are dissatisfied with current therapies. Based on these data and the efficacy of GIMOTI, we believe patients may benefit by switching from oral to nasally-administered GIMOTI. It is directly absorbed into the bloodstream and does not rely on a dysfunctional stomach to work. In GIMOTI, providers have an alternative to help patients they did not previously think they could help as well as an option to re-challenge patients who did not have optimal efficacy using oral medications,” Chris added. Third Quarter 2024 and Year-to-Date Developments and Recent Highlights: Continued Commercial Progress with GIMOTI Strengthened patient access and streamlined prescription processing with the addition of multiple pharmacy partners, expanding GIMOTI’s reimbursement coverage and availability across key geographic areas.Improved insurance reimbursement rates, reducing patient reliance on savings programs due to increased prescription coverage; Medicare and Medicaid programs accounted for approximately 34% of filled GIMOTI prescriptions in the first nine months of 2024, supporting accessibility for a broader patient demographic. Compelling Data Unveiled at American College of Gastroenterology 2024 Meeting in October Presented posters with data showing statistically significant improvement in patient outcomes for GLP-1 users with diabetic gastroparesis while taking GIMOTI.Poster won the Presidential Poster Award as one of the top 5% of data accepted by the conference and also selected as the Outstanding Research Award in the Stomach Category. Robust Balance Sheet with Extended Runway As of September 30, the Company had cash and cash equivalents of approximately $11.3 million which includes approximately $10.8 million from warrant exercise financing activities through 3Q 2024.In October 2024, the Company also raised approximately $3.5 million through the exercise of warrants by existing investors.The Company anticipates its current cash on hand will fund its operations into the fourth quarter of 2025. Board of Directors Expansion In October 2024, the Company announced the appointment of Ben Smeal to its Board of Directors fulfilling a condition set by Evoke’s existing investor, Nantahala Capital Management in connection with the warrant financing that occurred in September. Third Quarter 2024 Financial Review and Outlook For the third quarter of 2024, net product sales were approximately $2.7 million compared to $1.6 million during the third quarter of 2023, and the net loss was approximately $1.3 million, or $0.94 per share compared with $1.7 million, or $6.08 per share, for the third quarter of 2023. For the third quarter of 2024, selling, general and administrative expenses were approximately $3.8 million compared to $3.1 million for the third quarter of 2023. The $0.7 million increase was due to higher professional fees and reimbursement for expanded marketing efforts and profit-sharing activity with EVERSANA. Total operating expenses for the third quarter of 2024 were approximately $3.9 million compared to $3.2 million for the same period in 2023. Based on net sales generated in the first three quarters of 2024, Evoke is revising its 2024 guidance to $9.5-10.0 million from a range of $11- 12 million, still reflecting almost a doubling from the previous year, if achieved. Evoke’s 2024 guidance is dependent on its current business and expectations, including recent growth rates in net sales, assumptions regarding reimbursements and prescription fills, as well as factors that are outside of our control, such as the global macroeconomic and geopolitical environment, continued supply chain constraints and inflationary pressures. About Evoke Pharma, Inc. Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information. Follow GIMOTI on Facebook Follow Evoke Pharma on LinkedIn Follow Evoke Pharma on Twitter About Gimoti® (metoclopramide) nasal spray GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use. GIMOTI is not recommended for use in: Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. GIMOTI is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm. Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Safe Harbor Statement Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, including the potential that GIMOTI could become the standard of care for gastroparesis; the potential for additional funds from the exercise of outstanding warrants and Evoke’s expected cash runway. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke may not be able to achieve its guidance for 2024 including as a result of decreased demand for GIMOTI; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor & Media Contact: Daniel Kontoh-Boateng DKB Partners Tel: 862-213-1398 dboateng@dkbpartners.net Evoke Pharma, Inc. Condensed Balance Sheets September 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $11,339,032 $4,739,426 Accounts receivable, net of allowance for credit losses of $0 2,022,518 673,071 Prepaid expenses 146,704 885,040 Inventories 493,408 481,840 Other current assets 36,421 47,532 Total current assets 14,038,083 6,826,909 Deferred offering costs 115,488 241,637 Total assets $14,153,571 $7,068,546 Liabilities and stockholders' equity (deficit) Current liabilities: Accounts payable and accrued expenses $2,188,164 $1,711,778 Accrued compensation 590,634 1,324,010 Note payable 5,000,000 5,000,000 Accrued interest payable 1,987,637 1,612,295 Total current liabilities 9,766,435 9,648,083 Total liabilities 9,766,435 9,648,083 Commitments and contingencies Stockholdersʼ equity (deficit): Preferred stock, $0.0001 par value; authorized shares — 5,000,000 as of September 30, 2024 and December 31, 2023; issued and outstanding shares — zero as of September 30, 2024 and December 31, 2023 — — Common stock, $0.0001 par value; authorized shares — 100,000,000 and 50,000,000 as of September 30, 2024 and December 31, 2023, respectively; issued and outstanding shares — 894,843 and 278,558 as of September 30, 2024 and December 31, 2023, respectively 89 28 Additional paid-in capital 131,985,913 120,859,873 Accumulated deficit (127,598,866) (123,439,438)Total stockholdersʼ equity (deficit) 4,387,136 (2,579,537)Total liabilities and stockholders' equity (deficit) $14,153,571 $7,068,546 Evoke Pharma, Inc. Condensed Statement of Operations (unaudited) Three Months Ended September 30, 2024 2023 Net product sales $2,654,186 $1,562,860 Operating expenses: Cost of goods sold 104,024 34,908 Research and development 11,677 — Selling, general and administrative 3,824,142 3,131,389 Total operating expenses 3,939,843 3,166,297 Loss from operations (1,285,657) (1,603,437)Other income (expense): Interest income 99,294 35,558 Interest expense (126,027) (126,028)Total other expense (26,733) (90,470)Net loss $(1,312,390) $(1,693,907)Net loss per share of common stock, basic and diluted $(0.94) $(6.08)Weighted-average shares used to compute basic and diluted net loss per share 1,399,882 278,558

财报上市批准高管变更

2024-11-03

·信狐药迅

科伦博泰ADC新药芦康沙妥珠第三项适应症非小细胞肺癌提交上市申请|新受理（10.28-11.3）

本周药品注册受理数据，分门别类呈现，一目了然。(10.28-11.3）新药上市申请药品名称企业注册分类受理号马来酸噻吗洛尔凝胶上海奥全生物医药科技有限公司2.4CXHS2400111注射用芦康沙妥珠单抗四川科伦博泰生物医药股份有限公司1CXSS2400117 新药临床申请药品名称企业注册分类受理号SYHX1901片石药集团欧意药业有限公司1CXHL2401160SYHX1901片石药集团欧意药业有限公司1CXHL2401158SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401166SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401165SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401164注射用MB0151主流源生物科技(上海)有限公司1CXHL2401162苯磺酸CG-0255胶囊上海柯君医药科技有限公司1CXHL2401153苯磺酸CG-0255胶囊上海柯君医药科技有限公司1CXHL2401152HY-072808软膏合肥恩瑞特药业有限公司1CXHL2401156HY-072808软膏合肥恩瑞特药业有限公司1CXHL2401155HRN01片北京华睿鼎信科技有限公司1CXHL2401144HRN01片北京华睿鼎信科技有限公司1CXHL2401143XY0507注射液南京相元生物医药科技有限公司1CXHL24011391D228片广州中科莱恩药物研究有限公司1CXHL2401138伊匹乌肽雾化吸入溶液益承康泰(厦门)生物科技有限公司1CXHL2401136SYH2051片石药集团中奇制药技术(石家庄)有限公司1CXHL2401135SYH2051片石药集团中奇制药技术(石家庄)有限公司1CXHL2401134盐酸(R)-氯胺酮注射液江苏豪森药业集团有限公司2.1CXHL2401161盐酸(R)-氯胺酮注射液江苏豪森药业集团有限公司2.1CXHL2401159BN020827H山东百诺医药股份有限公司2.2CXHL2401157HQ2216注射液百诚医药(珠海横琴)有限公司2.2CXHL2401154HB018口溶膜合肥华方医药科技有限公司2.2CXHL2401151HB018口溶膜合肥华方医药科技有限公司2.2CXHL2401150HB018口溶膜合肥华方医药科技有限公司2.2CXHL2401149司美格鲁肽注射液中山万汉制药有限公司2.2CXHL2401148司美格鲁肽注射液中山万汉制药有限公司2.2CXHL2401147HXASP028广西善合百升科技有限公司2.2CXHL2401146HXASP028广西善合百升科技有限公司2.2CXHL2401145硫酸阿托品滴眼液山东威智百科药业有限公司2.2CXHL2401142CB275舌下膜杭州成邦医药科技有限公司2.2CXHL2401141CB275舌下膜杭州成邦医药科技有限公司2.2CXHL2401140HQ2303百诚医药(珠海横琴)有限公司2.3CXHL2401163SMF-213江西施美药业股份有限公司2.3CXHL2401137注射用HLX43上海复宏汉霖生物技术股份有限公司1CXSL2400747SYS6041石药集团巨石生物制药有限公司1CXSL2400746PJ008注射液重庆派金生物科技有限公司1CXSL2400745HM2002注射液上海环码生物医药有限公司1CXSL2400740BAT1308注射液百奥泰生物制药股份有限公司1CXSL2400739注射用BAT8007百奥泰生物制药股份有限公司1CXSL2400738RC148注射液荣昌生物制药(烟台)股份有限公司1CXSL2400737OCUL101注射液深圳欧科健生物医药科技有限公司1CXSL2400744OCUL101注射液深圳欧科健生物医药科技有限公司1CXSL2400743OCUL101注射液深圳欧科健生物医药科技有限公司1CXSL2400742注射用ALK201上海安领科生物医药有限公司1CXSL2400734SYS6045石药集团巨石生物制药有限公司1CXSL2400733恩朗苏拜单抗注射液石药集团巨石生物制药有限公司2.2CXSL2400741 仿制药申请药品名称企业注册分类受理号间苯三酚口崩片南京海纳制药有限公司3CYHS2403744恩格列净二甲双胍缓释片南京易亨制药有限公司3CYHS2403743多索茶碱片浙江花园药业有限公司3CYHS2403742多索茶碱片浙江花园药业有限公司3CYHS2403741盐酸甲氧氯普胺注射液平光制药股份有限公司3CYHS2403734盐酸溴己新口服溶液江苏开元药业有限公司3CYHS2403730盐酸纳美芬注射液甘肃农垦药物碱厂有限公司3CYHS2403723劳拉西泮片北京益民药业有限公司3CYHS2403722黄体酮注射液重庆万霖生物医药科技有限公司3CYHS2403721艾司奥美拉唑镁肠溶胶囊寿光富康制药有限公司3CYHS2403718艾司奥美拉唑镁肠溶胶囊寿光富康制药有限公司3CYHS2403717艾司奥美拉唑镁肠溶干混悬剂山东达因海洋生物制药股份有限公司3CYHS2403716盐酸纳美芬注射液舒美奇成都生物科技有限公司3CYHS2403715拉米夫定替诺福韦片石家庄龙泽制药股份有限公司3CYHS2403711重酒石酸去甲肾上腺素注射液江西人可医药科技有限公司3CYHS2403710重酒石酸去甲肾上腺素注射液江西人可医药科技有限公司3CYHS2403709托吡酯口服溶液海南斯达制药有限公司3CYHS2403708复方葡萄糖/电解质颅脑手术冲洗液昆明南疆制药有限公司3CYHS2403702钠钾镁钙注射用浓溶液河南上恒医药科技有限公司3CYHS2403726己酮可可碱缓释片广州仁恒医药科技股份有限公司3CYHS2403696磷酸奥司他韦干混悬剂广州白云山医药集团股份有限公司白云山制药总厂3CYHS2403695磷酸奥司他韦干混悬剂广州白云山医药集团股份有限公司白云山制药总厂3CYHS2403694磷酸奥司他韦干混悬剂山东百诺医药股份有限公司3CYHS2403691硝酸甘油注射液海南未见药业有限公司3CYHS2403689盐酸溴己新注射液中玉制药(海口)有限公司3CYHS2403688多索茶碱片重庆士立德医药科技有限公司3CYHS2403684多索茶碱片重庆士立德医药科技有限公司3CYHS2403683复方聚乙二醇电解质散(儿童型)重庆药谷制药有限公司3CYHS2403697琥珀酸美托洛尔缓释胶囊上海惠永制药有限公司3CYHS2403679醋酸钙口服溶液合肥恩瑞特药业有限公司3CYHS2403678奥贝胆酸片泰州复旦张江药业有限公司3CYHS2403677奥贝胆酸片泰州复旦张江药业有限公司3CYHS2403676复合磷酸氢钾注射液广东迈德珐医药科技有限公司3CYHS2403682硝普钠注射液山东齐都药业有限公司3CYHS2403660西吡氯铵含片广东万泰科创药业有限公司3CYHS2403659小儿复方氨基酸注射液(19AA-I)湖北长联杜勒制药有限公司3CYHS2403657盐酸甲氧氯普胺注射液河南利恒医药科技有限公司3CYHS2403665乳酸钠林格冲洗液石家庄四药有限公司3CYHS2403652己酮可可碱注射液国药集团容生制药有限公司3CYHS2403651盐酸阿莫罗芬乳膏苏州高迈药业有限公司4CYHS2403740熊去氧胆酸口服混悬液安士制药(中山)有限公司4CYHS2403739熊去氧胆酸口服混悬液安士制药(中山)有限公司4CYHS2403738沙库巴曲缬沙坦钠片常州四药制药有限公司4CYHS2403736沙库巴曲缬沙坦钠片常州四药制药有限公司4CYHS2403735依折麦布阿托伐他汀钙片湖北民康药业集团有限公司4CYHS2403733依折麦布阿托伐他汀钙片湖北民康药业集团有限公司4CYHS2403732地夸磷索钠滴眼液广东南国药业有限公司4CYHS2403731利格列汀二甲双胍片(II)安徽佳和药业有限公司4CYHS2403729门冬氨酸钾镁注射液湖南赛隆药业(长沙)有限公司4CYHS2403737丙戊酸钠口服溶液湖南省湘中制药有限公司4CYHS2403701枸橼酸钠血滤置换液宁波泰瑞斯科技有限公司4CYHS2403725替米沙坦氨氯地平片长春海悦药业股份有限公司4CYHS2403720替米沙坦氨氯地平片(II)北京百奥药业有限责任公司4CYHS2403719丙酸氟替卡松乳膏河北新张药股份有限公司4CYHS2403714富马酸伏诺拉生片山东诺明康药物研究院有限公司4CYHS2403713富马酸伏诺拉生片山东诺明康药物研究院有限公司4CYHS2403712二甲硅油乳剂南京海纳制药有限公司4CYHS2403707注射用氨苄西林钠舒巴坦钠圣嘉(滨海)生物医药科技有限公司4CYHS2403706注射用氨苄西林钠舒巴坦钠圣嘉(滨海)生物医药科技有限公司4CYHS2403705注射用氨苄西林钠舒巴坦钠圣嘉(滨海)生物医药科技有限公司4CYHS2403704左氧氟沙星滴眼液润尔眼科药物(广州)有限公司4CYHS2403700磷酸西格列汀片湖南迪诺制药股份有限公司4CYHS2403699吸入用乙酰半胱氨酸溶液远大医药(中国)有限公司4CYHS2403698阿法骨化醇软胶囊人福普克药业(武汉)有限公司4CYHS2403728阿法骨化醇软胶囊人福普克药业(武汉)有限公司4CYHS2403727门冬氨酸钾镁注射液山东齐都药业有限公司4CYHS2403703富马酸福莫特罗吸入溶液南京思聆医药科技有限公司4CYHS2403690注射用氯诺昔康江西科为制药有限公司4CYHS2403687头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2403686米库氯铵注射液舒美奇成都生物科技有限公司4CYHS2403685富马酸伏诺拉生片安徽宏业药业有限公司4CYHS2403693富马酸伏诺拉生片安徽宏业药业有限公司4CYHS2403692地夸磷索钠滴眼液江苏广承药业有限公司4CYHS2403680卡前列素氨丁三醇注射液(预充式)湖州亚瑟制药有限公司4CYHS2403675卡维地洛片重庆士立德医药科技有限公司4CYHS2403674非奈利酮片山东朗诺制药有限公司4CYHS2403673非奈利酮片山东朗诺制药有限公司4CYHS2403672维生素B12滴眼液浙江莎普爱思药业股份有限公司4CYHS2403671布洛芬缓释胶囊国大(吉林)制药集团有限公司4CYHS2403670非布司他片辽宁新高制药有限公司4CYHS2403669布瑞哌唑片昆山龙灯瑞迪制药有限公司4CYHS2403668注射用盐酸美法仑兆科(广州)肿瘤药物有限公司4CYHS2403667洛索洛芬钠凝胶贴膏广东恒健制药有限公司4CYHS2403666复方托吡卡胺滴眼液深圳市瑞霖医药有限公司4CYHS2403681培哚普利氨氯地平片(III)浙江美迪深生物医药有限公司4CYHS2403664培哚普利氨氯地平片(I)浙江美迪深生物医药有限公司4CYHS2403663妥洛特罗贴剂北京泰德制药股份有限公司4CYHS2403662妥洛特罗贴剂北京泰德制药股份有限公司4CYHS2403661达格列净片石家庄市华新药业有限责任公司4CYHS2403658艾拉莫德片长春海悦药业股份有限公司4CYHS2403656富马酸伏诺拉生片山东诚创蓝海医药科技有限公司4CYHS2403655富马酸伏诺拉生片山东诚创蓝海医药科技有限公司4CYHS2403654地夸磷索钠滴眼液武汉先路医药科技股份有限公司4CYHS2403653流感病毒裂解疫苗安徽智飞龙科马生物制药有限公司3.3CXSS2400118帕妥珠单抗注射液杭州博之锐生物制药有限公司3.3CXSS2400116利多卡因丙胺卡因气雾剂江苏润邦药业有限公司3CYHL2400213布洛芬注射液华中药业股份有限公司3CYHL2400212布洛芬注射液华中药业股份有限公司3CYHL2400211重组人促卵泡激素-CTP融合蛋白注射液苏州景泽生物医药有限公司3.2CXSL2400736重组人促卵泡激素-CTP融合蛋白注射液苏州景泽生物医药有限公司3.2CXSL2400735 进口申请药品名称企业注册分类受理号沙美特罗替卡松吸入粉雾剂Celon Pharma S.A.5.2JYHS2400054沙美特罗替卡松吸入粉雾剂Celon Pharma S.A.5.2JYHS2400053MRG-001注射液MEDREGEN, LLC2.3;2.4JXHL2400259BMS-986165片Bristol-Myers Squibb Company2.4JXHL2400262BMS-986165片Bristol-Myers Squibb Company2.4JXHL2400261BMS-986165片Bristol-Myers Squibb Company2.4JXHL240026013价肺炎球菌多糖结合疫苗Pfizer Europe MA EEIG3.1JXSL2400209PIT565Novartis Pharma AG1JXSL2400210注射用德曲妥珠单抗Daiichi Sankyo, Inc.2.2JXSL2400211TarlatamabAmgen Inc.2.2JXSL2400208TarlatamabAmgen Inc.2.2JXSL2400207TarlatamabAmgen Inc.2.2JXSL2400206 中药相关申请药品名称企业注册分类受理号HC009合剂北京厚成医药科技有限公司1.1CXZL2400074仙茜颗粒苏州玉森新药开发有限公司1.1CXZL2400073BYS30颗粒广州白云山医药集团股份有限公司白云山制药总厂1.1CXZL2400072LBZ-18口服乳广州白云山汉方现代药业有限公司1.2CXZL2400071LBZ-18广州白云山汉方现代药业有限公司1.2CXZL2400070 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市抗体药物偶联物

2024-10-28

·GlobeNewswire-Health Care

Evoke Pharma & EVERSANA Announce Statistically Significant Improvement in Patient Outcomes for GLP-1 users with Diabetic Gastroparesis using GIMOTI®

Analysis of real-world data compared patients on GIMOTI (n=51) to Oral Metoclopramide (n=41), both taking GLP-1s, showing significant statistical improvement for GIMOTI over Oral Metoclopramide in All Cause Emergency Department Visits (-91%, p=0.001), All Cause Office Visits (-41%, p=0.027) and All Cause Hospital Outpatient Visits (-89%, p=0.032) within 6-month index period Data presented at American College of Gastroenterology (ACG) 2024; the submission garnered both the Presidential Poster Award as one of the top 5% of data accepted to the conference and selected as the Outstanding Research Award in the Stomach Category First study to show Gimoti’s potential as supportive care for GLP-1 therapy SOLANA BEACH, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on developing treatments for gastrointestinal (GI) diseases, with a particular emphasis on GIMOTI® (metoclopramide) nasal spray, together with EVERSANA, a leading provider of global commercial services to the life sciences industry, today announced the presentation of data for GLP-1 users with diabetic gastroparesis using GIMOTI at the American College of Gastroenterology (ACG) 2024 Annual Meeting. The real-world retrospective study evaluated the impact of GIMOTI (metoclopramide nasal spray) in patients with diabetic gastroparesis (DGP) who were concurrently using GLP-1 receptor agonists. GLP-1 drugs are commonly prescribed for type 2 diabetes, and with the approval of GLP-1 medications, there have been increasing reports of these drugs exacerbating GI symptoms, specifically gastroparesis. GLP-1 medications function, in part, by causing delayed gastric emptying. Delayed gastric emptying, in the absence of mechanical obstruction, is the definition of gastroparesis. In a recent National Institute of Health (NIH) study (https://pubmed.ncbi.nlm.nih.gov/38399414/), an estimated 5.1% of patients in their study (n=10,328) on GLP-1 medications had gastroparesis. The GIMOTI study compared healthcare resource utilization (HRU) between patients using GIMOTI nasal metoclopramide (NMCP) and those on oral metoclopramide (OMCP), specifically focusing on individuals with a prior GLP-1 prescription. Significant reductions across a collection of outcomes were observed in patients treated with GIMOTI versus oral metoclopramide. Key Study Findings Presented at ACG 2024: Patients with prior GLP-1 history had reduced HRU after taking NMCP In NMCP patients, all-cause emergency department (ED) visits decreased by 55% (mean [SD]: 0.25 [1.13] post-index vs. 0.55 [1.30] pre-index; p=0.063); andDGP-related ED visits decreased by 28% (mean [SD]: 0.18 [0.99] post-index vs. 0.25 [1.28] pre-index; p=0.203). In patients taking GLP-1, those that took NMCP had fewer healthcare visits compared to those taking OMCP All-cause and DGP-related ED visits were 91% lower (cIRR: 0.09, 95% CI: 0.01, 0.42; p=0.001) and 89% lower (cIRR: 0.11, 95% CI: 0, 0.93; p=0.046) for NMCP vs. OMCP; andAll-cause Hospital Outpatient visits were 89% lower (cIRR = 0.11, 95% CI: 0.01, 0.73; p = 0.032)All-cause and DGP-related office visits were 41% lower (cIRR: 0.59, 95% CI: 0.37, 0.94; p=0.027) and 66% lower (cIRR: 0.34, 95% CI: 0.017, 0.65; p=0.001) for NMCP vs. OMCP. NMCP can be used to effectively treat patients with gastroparesis taking GLP-1 treatment and avoid costly healthcare visits All-cause clinic, outpatient, and inpatient visits showed similar trends favoring NMCP vs. OMCP.In DGP patients with a prior claim for GLP-1, NMCP use was associated with numerically and significantly reduced all-cause and DGP-related HRU compared to pre-treatment utilization and OMCP-treated controls. "This data is particularly encouraging given the rising number of patients using GLP-1 agonists for diabetes, many of whom also suffer from gastroparesis," said Matt D’Onofrio, CEO of Evoke Pharma. "Our goal is to provide data regarding Gimoti as supportive care for diabetic gastroparesis for those also on GLP-1 agonists. This study, combined with the earlier real-world data presented at key conferences, reinforces GIMOTI's potential to improve outcomes for patients and reduce the overall financial burden on the healthcare system." The study's specific cohort consisted of 92 total patients between the nasal metoclopramide (NMCP, N=51) and oral metoclopramide (OMCP, N=41) groups. The NMCP group had a slightly older average age (55.1 years) compared to the OMCP group (53.1 years). A notable portion of the NMCP group (31.4%) had experienced hospitalizations or emergency department visits before treatment, compared to 19.5% in the OMCP group. In a separate study, a post-hoc analysis focused on safety data for a female subgroup from a previous Phase 3 study that included 36 women using GLP-1 drugs during the 28-day study. Among these, 13 were treated with GIMOTI and 23 with placebo. The majority (94%) of the participants completed the study, with no serious adverse events reported in either group. This analysis indicated no series safety issues and a trend toward nausea improvement when GLP-1 drugs were used with NMCP. "Our continued focus is helping patients that have gastroparesis and diabetes. The fact that up to 20 million patients (KFF Health Tracking Poll (April 23-May 1, 2024) (kff.org/KFF Health Tracking Poll)) may have taken or are currently taking GLP-1s for their diabetes, indicates this is an important patient constituency the medical community needs to monitor and address," said Chris Quesenberry, Chief Commercial Officer of Gimoti. "Evoke Pharma, through its clinical development program and real-world evidence studies, is uniquely positioned to provide clinicians with information that may inform treatment decisions. This study provides insight that clinicians who treated their patients with diabetic gastroparesis, who were also taking a GLP-1, benefitted in taking GIMOTI®, an innovative, non-oral therapy that does not rely on a dysfunctional gut to work." The results presented at ACG 2024 build on a growing body of real-world data that underscores GIMOTI's ability to significantly reduce HRU in patients with diabetic gastroparesis. Earlier studies presented at Digestive Disease Week (DDW) 2024 and ACG 2023 demonstrated that patients treated with GIMOTI showed fewer hospitalizations, emergency department visits, and physician office visits compared to those using oral metoclopramide. Also, these studies highlighted that GIMOTI reduced healthcare costs by over $15,000 per patient in a six-month period compared to oral metoclopramide. "These studies further confirm the important role of GIMOTI in managing diabetic gastroparesis and supports its use for patients concurrently on GLP-1 agonists," said Dr. Michael Cline, Medical Director of the Gastroparesis Clinic at Cleveland Clinic, an author of the study. "In my practice, I’ve treated patients arriving with gastroparesis while on a GLP-1. This data demonstrates a significant reduction in emergency room visits, office visits, and overall healthcare resource utilization, which not only improves patient outcomes but also reduces the strain on healthcare systems. The nasal delivery of metoclopramide offers a distinct advantage for patients with delayed gastric emptying, ensuring they receive the relief they need without the complications or unknown absorption associated with oral medications." EVERSANA was named Evoke’s commercialization partner to support commercialization efforts of GIMOTI, first in 2020 and then an extended partnership was announced in February 2022. Slides referencing data to the studies can be found under news and presentations of the Evoke Pharma investor relations website. About Evoke Pharma, Inc. Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information. Follow Evoke Pharma on LinkedInFollow Evoke Pharma on Twitter About Gimoti® (metoclopramide) nasal spray GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information: WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use. GIMOTI is not recommended for use in: Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. GIMOTI is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm. Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Safe Harbor Statement Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: GIMOTI’s potential to reduce HRU by diabetic gastroparesis patents taking GLP-1 therapies; the possibility that increased use of GLP-1 agonists could increase the need for treatment of gastroparesis or increase the patient base for GIMOTI; and Evoke’s belief that GIMOTI can improve treatment of gastroparesis in patients taking GLP-1 agonists. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke and EVERSANA may not be able to successfully drive market demand for GIMOTI; the results of market research studies may not predict acceptance by patients, healthcare providers or payors; GLP-1 agonists may not increase the number of patients diagnosed with gastroparesis, which remains speculative; alternative treatments for gastroparesis may be developed or approved and may be shown to be superior to GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; Evoke’s ability to maintain compliance with Nasdaq’s stockholder’s equity requirements; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. About EVERSANA EVERSANA® is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X. Investor & Media Contact: Daniel Kontoh-Boateng DKB Partners Tel: 862-213-1398 dboateng@dkbpartners.net A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cfc46127-a976-498b-8e19-d5c879171b81

临床结果上市批准临床3期

100 项与盐酸甲氧氯普胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05008	盐酸甲氧氯普胺	A03FA01	DB01233

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
药物引起的恶心和呕吐	澳大利亚	Bridgewest Perth Pharma Pty Ltd.	1991-08-13
放疗引起的恶心和呕吐	澳大利亚	Bridgewest Perth Pharma Pty Ltd.	1991-08-13
呕吐	澳大利亚	Bridgewest Perth Pharma Pty Ltd.	1991-08-13
胃食管反流	美国	ANI Pharmaceuticals, Inc.	1980-12-30
化疗引起的恶心和呕吐	美国	Hikma Pharmaceuticals USA, Inc.	1979-02-07
糖尿病性胃轻瘫	美国	Hikma Pharmaceuticals USA, Inc.	1979-02-07
术后恶心呕吐	美国	Hikma Pharmaceuticals USA, Inc.	1979-02-07
食欲减退	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1967-03-25
恶心和呕吐	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1967-03-25

未上市

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适应症	最高研发状态	国家/地区	公司	日期
危重病	临床2期	美国	Millennium Pharmaceuticals, Inc.	2018-08-25
危重病	临床2期	澳大利亚	Millennium Pharmaceuticals, Inc.	2018-08-25
危重病	临床2期	加拿大	Millennium Pharmaceuticals, Inc.	2018-08-25
危重病	临床2期	英国	Millennium Pharmaceuticals, Inc.	2018-08-25
胃轻瘫	临床2期	美国	Evoke Pharma, Inc.	2009-04-01

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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


GlobeNewswire 人工标引	N/A	糖尿病性胃轻瘫	92	GIMOTI	網鏇廠餘餘選觸簾製範(網糧餘餘醖願選夢糧艱) = 積醖繭積膚襯鹹遞窪鹽鏇遞衊顧夢構積獵餘鬱 (鏇繭構鑰鹹廠範壓衊鏇 ) 更多	积极	2024-10-28
				Oral Metoclopramide	-
ADA2024	N/A	-	-	Metoclopramide (Diabetic controls treated with recurrent saline (STZ+RS))	醖餘鑰鹽積淵壓積窪鑰(觸蓋衊夢蓋醖顧廠艱鬱) = 蓋廠壓齋膚繭鑰選構壓醖餘築鹹獵鹽壓蓋餘簾 (餘願鏇夢遞蓋簾鹽壓構, 0.8)	-	2024-06-14
				Metoclopramide (Diabetic rats preconditioned with recurrent hypoglycemia (STZ+RH))	醖餘鑰鹽積淵壓積窪鑰(觸蓋衊夢蓋醖顧廠艱鬱) = 廠範糧廠築顧蓋構窪構醖餘築鹹獵鹽壓蓋餘簾 (餘願鏇夢遞蓋簾鹽壓構, 0.9)
NCT03435003 (CTgov)	临床4期	术后恶心呕吐 \| 呕吐	83	dexmedetomidine+Compazine+Total intravenous anesthesia+scopolamine transdermal+sugammadex+Reglan+Propofol+Fentanyl+Ondansetron+Aprepitant 80 mg Oral Capsule+Dexamethasone (Intervention Arm)	遞衊積鬱廠構鏇餘餘鹽(觸選製衊繭壓餘觸積範) = 蓋壓蓋淵鑰願餘窪齋鹽鑰衊遞築網糧築鏇糧壓 (鏇醖憲網糧顧鏇餘積衊, 齋夢齋艱積蓋遞襯蓋積 ~ 艱繭襯遞構憲淵範築獵) 更多	-	2024-02-14
				Compazine+sugammadex+Reglan+Sevoflurane+Desflurane+Ondansetron+Dexamethasone (Control Arm)	遞衊積鬱廠構鏇餘餘鹽(觸選製衊繭壓餘觸積範) = 繭壓蓋遞蓋鹹蓋廠壓窪鑰衊遞築網糧築鏇糧壓 (鏇醖憲網糧顧鏇餘積衊, 廠襯構淵襯醖簾鏇醖夢 ~ 鬱鬱鹹鹹鏇積襯廠膚蓋) 更多
NCT05098067 (CTgov)	临床2期	妊娠剧吐 \| 恶心 \| 妊娠呕吐	30	Lactated Ringers, Intravenous+Metoclopramide+Capsaicin Topical Cream+Ondansetron (Intervention Group)	範願鑰餘衊夢獵衊願範(製鑰鏇繭憲獵襯願範構) = 憲簾鑰築構獵鹹憲鏇網壓範鹽憲選簾顧鹹醖鏇 (網艱窪範鹽製鑰獵糧選, 鹹構窪襯窪選淵餘鹽築 ~ 網衊選鬱構遞積遞醖繭) 更多	-	2024-02-07
				Lactated Ringers, Intravenous+Metoclopramide+Ondansetron (Placebo Group)	範願鑰餘衊夢獵衊願範(製鑰鏇繭憲獵襯願範構) = 鏇範獵積襯膚夢鏇簾蓋壓範鹽憲選簾顧鹹醖鏇 (網艱窪範鹽製鑰獵糧選, 壓製鏇網齋餘鏇夢網蓋 ~ 網淵廠觸夢憲範製選醖) 更多
NCT04771481 (Pubmed) 人工标引	临床4期	消化道出血	62	Metoclopramide	願蓋餘鏇簾鹽鏇積範願(構糧構壓繭鹽鏇積鏇繭) = 鑰顧蓋積醖廠築獵選壓遞遞艱網鏇築選鑰製積 (築夢鹽衊壓憲製繭鑰壓 ) 更多	不佳	2024-01-05
				Placebo	願蓋餘鏇簾鹽鏇積範願(構糧構壓繭鹽鏇積鏇繭) = 鑰醖廠醖繭淵鏇顧蓋廠遞遞艱網鏇築選鑰製積 (築夢鹽衊壓憲製繭鑰壓 ) 更多
NCT04027348 (CTgov)	临床2期	恶性肠梗阻	15	Octreotide+Metoclopramide+dexamethasone	構構遞糧齋餘壓顧衊襯(鹽淵簾夢鏇鏇範糧鑰願) = 範廠淵糧窪憲醖膚齋顧膚鹹構鏇膚鹹顧廠淵廠 (淵鹹範夢願觸膚壓鬱簾, 獵遞餘鹹繭選淵鹽壓製 ~ 糧夢獵遞構餘願糧築襯) 更多	-	2022-11-29
ADA2022	N/A	-	-	Vehicle	鏇鹹壓窪淵鏇鹹憲襯壓(遞鑰繭鹹繭壓淵範餘顧) = 醖膚積顧窪窪遞願遞淵鏇糧遞廠顧鏇夢鑰範襯 (網製窪醖糧鏇艱廠獵膚 )	-	2022-06-01
				Metoclopramide	鏇鹹壓窪淵鏇鹹憲襯壓(遞鑰繭鹹繭壓淵範餘顧) = 築醖網構範蓋憲憲壓網鏇糧遞廠顧鏇夢鑰範襯 (網製窪醖糧鏇艱廠獵膚 )
DDW2022	N/A	迟发性运动障碍	-	Metoclopramide-prescribed patients	鹽積製餘築範繭醖憲製(餘膚餘鑰膚鑰遞糧壓廠) = 製鬱獵醖繭遞窪醖鑰醖選觸衊顧淵鏇膚廠夢構 (遞廠遞鬱簾齋憲顧憲齋 )	-	2022-05-21
				Metoclopramide (Gastroparesis patients)	鹽積製餘築範繭醖憲製(餘膚餘鑰膚鑰遞糧壓廠) = 膚網鏇築膚蓋獵鏇壓繭選觸衊顧淵鏇膚廠夢構 (遞廠遞鬱簾齋憲顧憲齋 )
DDW2022	N/A	迟发性运动障碍	-	Metoclopramide-prescribed patients	簾鹹築網構憲獵廠憲鏇(鏇夢鬱構廠廠衊簾願觸) = 憲窪遞鏇築襯餘襯鏇壓膚膚繭製膚襯選衊憲繭 (獵夢獵選夢襯憲願範蓋, 12)	-	2022-05-21
				Metoclopramide (Gastroparesis patients)	簾鹹築網構憲獵廠憲鏇(鏇夢鬱構廠廠衊簾願觸) = 鬱製襯範衊繭選壓鑰糧膚膚繭製膚襯選衊憲繭 (獵夢獵選夢襯憲願範蓋, 40)
DDW2022	N/A	迟发性运动障碍	-	Metoclopramide-prescribed patients	遞衊積獵鬱蓋範繭簾鏇(齋淵獵構壓鹹鹽鑰衊觸) = 製廠範醖簾鏇遞鏇醖淵鑰醖鏇廠鏇襯膚網壓積 (醖襯鬱鑰襯構鏇網獵製, 12)	-	2022-05-21
				Metoclopramide (Gastroparesis patients)	遞衊積獵鬱蓋範繭簾鏇(齋淵獵構壓鹹鹽鑰衊觸) = 積淵衊憲襯顧網觸夢遞鑰醖鏇廠鏇襯膚網壓積 (醖襯鬱鑰襯構鏇網獵製, 40)