更新于：2024-06-23

Zavegepant

更新于：2024-06-23

概要

研发状态

概要

基本信息

药物类型

小分子化药

别名

1-piperidinecarboxamide, 4-(1,2-dihydro-2-oxo-3-quinolinyl)-n-((1r)-1-((7-methyl-1h-indazol-5-yl)methyl)-2-(4-(1-methyl-4-piperidinyl)-1-piperazinyl)-2-oxoethyl)-、Vazegepant、Zavegepant

+ [8]

靶点

CGRP

作用机制

CGRP拮抗剂(降钙素基因相关肽拮抗剂)

治疗领域

神经系统疾病

在研适应症

急性偏头痛偏头痛疼痛

非在研适应症

过敏性哮喘新型冠状病毒感染

原研机构

Bristol Myers Squibb Co.

在研机构

Pfizer Inc.

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2023-03-09),

急性偏头痛

最高研发阶段(中国)临床3期

特殊审评-

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结构

分子式C36H46N8O3

InChIKeyJJVAPHYEOZSKJZ-JGCGQSQUSA-N

CAS号1337918-83-8

关联

项与 Zavegepant 相关的临床试验

NCT06103734 / Not yet recruiting临床3期

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 3-ARM, STUDY TO INVESTIGATE PAIN RESPONSE WITH INTRANASAL ZAVEGEPANT COMPARED WITH PLACEBO IN THE ACUTE TREATMENT OF MULTIPLE MIGRAINE ATTACKS IN ADULT PARTICIPANTS

The purpose of this study to show that zavegepant 10 milligrams given through the nose provides:
freedom from pain, 2 hours after taking the medicine for the first migraine attack.
consistent freedom from pain, 2 hours after taking the medicine across 4 separate migraine attacks.
This study is seeking participants who:
are 18 years of age or older.
have migraine attacks present for at least 1 year with age onset before 50 years old.
have migraine attacks, on average, lasting about 4 to 72 hours if not treated.
have 3 to 8 attacks per month but less than15 headache days per month.
If the participant is fit to take part in the study, the participant will receive either the study medicine zavegepant or placebo. A placebo looks like zavegepant but does not contain active ingredients. The study medicine will be given using nasal spray device containing a single amount of zavegepant or matching placebo.
The participants will be instructed to take the study medicine at home if participants have a migraine headache which reaches moderate or severe pain intensity. The participants are expected to treat up to 4 migraines of moderate to severe intensity.
After taking the study medicine, the participant is not allowed to take any other medications for at least 2 hours after taking the study medicine or placebo. Participant can take other medicines after the 2 hours if the migraine is still present. The participant is expected to record on a paper log all medications taken throughout the study.
The study duration is around 26 weeks. This includes a 28-day screening window, up to 20 weeks of treatment period, and a follow up visit at about 4 weeks after taking the study medicine the last time.
The participant is expected to come into the study center up to 4 times. There will be up to 3 telephone contacts including one after taking the study medicine the first time or Month 1 whichever comes first, at Month 3 if the participant is still in the study, and a safety follow-up.
During the study, the participant is expected to complete two sets of questions in an app on a smartphone. This step is done before and after taking the study medicine. The participants must rate:
Pain
Pain symptoms
How the participants are feeling
General well-being

开始日期2025-03-31

申办/合作机构

Pfizer Inc.

NCT06401642 / Not yet recruiting临床4期

A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.

Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US. The purpose of this study is to investigate the effectiveness and tolerability of zavegepant for the acute treatment of migraine attacks amongst participants who are using calcitonin gene-related peptide (CGRP) migraine preventive treatments.

开始日期2024-07-01

申办/合作机构

Mayo Clinic

NCT06453356 / Not yet recruiting临床1期

A PHASE 1 SINGLE INTRANASAL DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ZAVEGEPANT IN HEALTHY LACTATING WOMEN

The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women. This would allow to see if there are any possible risk to infants from medicines during breast-feeding.
The study is seeking for about 12 healthy breast-feeding females who are:
18 to 55 years of age.
actively breast-feeding or producing breast milk.
at least 2 weeks post-partum and not pregnant at present. Participants will not be allowed to breast-feed their infant from the evening of the day before to the first dose till 48 hours (2 days) after the dose.
Eligible participants will check into the clinical research unit (CRU) on Day -1. Participants will receive the zavegepant dose sprayed into the nose at the CRU on Day 1. The participants will stay at the CRU until the morning of Day 2. There will be collections of breast milk and plasma over 24 hours. Participants will be sent from the CRU on Day 2 and may begin to breastfeed their infant 48 hours (2 days) after the dose. A safety follow-up call will be done at about 28 to 35 days from the day the first dose of study medicine was given.

开始日期2024-06-11

申办/合作机构

Pfizer Inc.

100 项与 Zavegepant 相关的临床结果

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100 项与 Zavegepant 相关的转化医学

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100 项与 Zavegepant 相关的专利（医药）

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项与 Zavegepant 相关的文献（医药）

2024-01-01·Handbook of clinical neurology

CGRP receptor antagonists (gepants)

Review

作者: Latysheva, Nina V ; Younis, Samaira ; Ashina, Messoud ; Danilov, Alexey B

Small molecule calcitonin gene-related peptide (CGRP) receptor antagonists are commonly referred to as gepants. The first generation of gepants provided the first line of evidence of CGRP-mediated antimigraine medication in 2004-2011. However, further development was halted due to either lack of oral availability or concerns of hepatotoxicity. More than 15 years later, the first second generation of gepants, ubrogepant and rimegepant, are now approved for the acute treatment of migraine with or without aura. Furthermore, a novel and promising third-generation gepant, zavegepant, has recently been approved as well. In this chapter, we review the evidence supporting the effectiveness, safety, and tolerability of gepants for the acute treatment of migraine. Furthermore, we discuss the potential limitations and future directions of this class of migraine-specific medication.

2023-12-02·Expert opinion on drug metabolism & toxicology

Metabolic and toxicological considerations regarding CGRP mAbs and CGRP antagonists to treat migraine in COVID-19 patients: a narrative review

Review

作者: Garcia-Azorin, David ; Martelletti, Paolo ; Takizawa, Tsubasa ; Uno, Shunsuke ; Ohtani, Seiya ; Hori, Satoko ; Watanabe, Narumi ; Imai, Noboru ; Ihara, Keiko ; Nakahara, Jin

INTRODUCTION:

Migraine pharmacological therapies targeting calcitonin gene-related peptide (CGRP), including monoclonal antibodies and gepants, have shown clinical effect and optimal tolerability. Interactions between treatments of COVID-19 and CGRP-related drugs have not been reviewed.

AREAS COVERED:

An overview of CGRP, a description of the characteristics of each CGRP-related drug and its response predictors, COVID-19 and its treatment, the interactions between CGRP-related drugs and COVID-19 treatment, COVID-19 and vaccination-induced headache, and the neurological consequences of Covid-19.

EXPERT OPINION:

Clinicians should be careful about using gepants for COVID-19 patients, due to the potential drug interactions with drugs metabolized via CYP3A4 cytochrome. In particular, COVID-19 treatment (especially nirmatrelvir packaged with ritonavir, as Paxlovid) should be considered cautiously. It is advisable to stop or adjust the dose (10 mg atogepant when used for episodic migraine) of gepants when using Paxlovid (except for zavegepant). CGRP moncolconal antibodies (CGRP-mAbs) do not have drug - drug interactions, but a few days' interval between a COVID-19 vaccination and the use of CGRP mAbs is recommended to allow the accurate identification of the possible adverse effects, such as injection site reaction. Covid-19- and vaccination-related headache are known to occur. Whether CGRP-related drugs would be of benefit in these circumstances is not yet known.

2023-12-01·Journal, genetic engineering & biotechnology

Pangenome diversification and resistance gene characterization in Salmonella Typhi prioritized RfaJ as a significant therapeutic marker

Article

作者: Jalal, Khurshid ; Khan, Kanwal ; Uddin, Reaz

Abstract:

Background:

Salmonella Typhi stands as the etiological agent responsible for the onset of human typhoid fever. The pressing demand for innovative therapeutic targets against S. Typhi is underscored by the escalating prevalence of this pathogen and the severe nature of its infections. Consequently, this study employs pangenome analysis to scrutinize 119 S. Typhi-resistant strains, aiming to identify the most promising therapeutic targets originating from its core genome.

Results:

Subtractive genomics was employed to systematically eliminate non-homologous (n=1147), essential (n=551), drug-like (n=80), and pathogenicity-related (n=18) proteins from the initial pool of 3351 core genome proteins. Consequently, lipopolysaccharide 1,2-glucosyltransferase RfaJ was designated as the optimal pharmacological target due to its potential versatility. Furthermore, a compendium of 9000 FDA-approved compounds was repurposed for evaluation against the RfaJ drug target, with the specific intent of prioritizing novel, high-potency therapeutic candidates for combating S. Typhi. Ultimately, four compounds, namely DB00549 (Zafirlukast), DB15637 (Fluzoparib), DB15688 (Zavegepant), and DB12411 (Bemcentinib), were singled out as potential inhibitors based on the ligand-protein binding affinity (indicated by the lowest anticipated binding energy) and the overall stability of these compounds. Notably, molecular dynamics simulations, conducted over a 50 nanosecond interval, convincingly demonstrated the stability of these compounds in the context of the RfaJ protein.

Conclusion:

In summary, the present findings hold significant promise as an initial stride in the broader drug discovery endeavor against S. Typhi infections. However, the experimental validation of the identified drug target and drug candidate is further required to increase the effectiveness of the applied methodology.

165

项与 Zavegepant 相关的新闻（医药）

2024-06-03

·echemi

Neuroscience Takes Center Stage: MNCs Accelerate Investments in a Promising Field

The biopharmaceutical landscape is quietly undergoing a transformation, with neuroscience emerging as a hotspot amidst the industry's shifting dynamics. While the cancer therapy arena has seen setbacks with dual antibodies and ADCs, the metabolic disease space, led by weight loss treatments, has experienced a surge in popularity. Concurrently, the neuroscience (CNS) field is witnessing a renaissance, marked by clinical breakthroughs and a series of high-profile mergers and acquisitions. The renewed focus on neuroscience is driven by the immense unmet medical needs and recent advancements in fundamental research. According to WHO projections, neurological disorders are poised to become the second leading cause of death within the next 20 years. Alarmingly, the number of individuals diagnosed with Alzheimer's disease (AD) and other forms of dementia continues to rise, with an estimated 50 million people worldwide affected. Additionally, the prevalence of depression and severe mental illnesses is on the rise, with a worrying trend towards younger populations. Despite this growing burden, the efficacy of existing treatment options for neurological disorders remains below 50%, presenting a vast clinical demand and market potential. In this landscape, even minor therapeutic differences can lead to commercial success, as "you don't need a cure to have a blockbuster, just an incremental improvement." Moreover, the rapid advancements in sequencing technologies and the resulting drop in costs have enabled exponential growth in genetic research related to neurodegenerative diseases. By analyzing relevant genes, scientists have been able to identify critical signaling pathways and drug targets. The approval of Biogen's Aduhelm, the first Alzheimer's drug targeting the Aβ cascade, has served as a catalyst for the resurgence of the CNS field. Although Aduhelm faced challenges due to its significant side effects, leading to commercial failure, the recent full approval of Eisai and Biogen's Leqembi (lecanemab) in the United States and China marks a significant milestone. Leqembi is the first drug capable of slowing the progression of early-stage Alzheimer's disease, a landmark achievement in this notoriously difficult-to-treat field. Sensing the renewed promise of neuroscience, multinational corporations (MNCs) have accelerated their efforts to establish a presence in this space. However, the shadows of past failures have made them more cautious, leading them to favor low-risk, late-stage transactions that avoid the risks associated with early and mid-stage clinical trials. In 2022, Pfizer acquired Biohaven for $11.6 billion, gaining access to the migraine drug Nurtec ODT (rimegepant). In 2023, Pfizer's CGRP receptor antagonist nasal spray, Zavzpret, successfully obtained FDA approval. The neuroscience field has witnessed three major acquisition deals in 2023: Bristol Myers Squibb's $14 billion acquisition of Karuna Therapeutics, which provided the company with the schizophrenia drug KarXT; AbbVie's $8.7 billion purchase of Cerevel, securing the Parkinson's disease candidate Tavapadon and the schizophrenia and Alzheimer's psychosis candidate Emraclidine; and Biogen's $7.3 billion acquisition of Reata, gaining access to the Nrf2 activator Omaveloxolone for neurological indications. As the industry navigates the complexities of the neuroscience landscape, the promise of genetic research, advancements in AI-driven precision medicine, and the recent regulatory successes have ignited a renewed sense of optimism. The stage is set for MNCs to continue their aggressive pursuit of promising neuroscience assets, driven by the urgent need to address the growing burden of neurological disorders and the potential for significant commercial rewards.

并购上市批准

2024-05-23

·BioSpace

Pfizer Targets Another $1.5B in Cost Cuts By End of 2027

Pictured: Pfizer's signage outside its office in Canada/iStock, JHVEPhoto Pfizer in an SEC filing on Wednesday revealed its plans to implement a fresh round of cost cuts to generate savings of around $1.5 billion by the end of 2027. According to the SEC document, the $1.5-billion savings scheme is just the “first phase” of a multi-year program designed to “reduce our cost of goods sold.” The program will include structural changes to its network, operational adjustments to boost efficiency and improvements to its product portfolio. Pfizer expects to incur around $1.7 billion in one-time costs—primarily due to severance pay and implementation fees—as part of the first phase. The pharma will reflect these costs in 2024, while savings from the first phase will start being realized in 2025. Wednesday’s announcement adds to Pfizer’s ongoing $3.5 billion cost-cutting initiative unveiled in October 2023 and another $500 million in targeted savings announced in December 2023. The “multi-year, enterprise-wide cost realignment program” is designed to help the pharma weather the sharp drop in COVID-19 demand, which bottomed out its revenues in recent quarters, according to the company. In the third quarter of 2023, Pfizer reported its first quarterly decline since 2019. At the time, the pharma suffered a 42% year-over-year drop to bring in $13.2 billion in revenue. Sales of Paxlovid, its antiviral treatment for, cratered 97%, while its COVID-19 vaccine Comirnaty slipped 70%. Pfizer reported a 42% hit in full-year revenues last year, driven by a 92% and 72% drop in Paxlovid and Comirnaty sales, respectively. Excluding Paxlovid and Comirnaty, Pfizer’s revenue grew 7% operationally last year. The cost-cutting program will also involve layoffs, though the pharma has yet to specify how many employees will be affected. Pfizer expects to absorb a one-time upfront cost of $3 billion, primarily associated with severance and implementation fees. Pfizer also announced in its first-quarter 2024 earnings report that it culled four programs from its pipeline. The pharma will no longer be working on VTX-801, a recombinant gene therapy for Wilson disease. Zavzpret (zavegepant), its migraine nasal spray, will also no longer be developed as an oral preventive therapy. In Wednesday’s SEC filing, Pfizer cautioned that the savings from the first phase of its program are estimates and are “subject to a number of assumptions.” The pharma said its actual results may differ. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

疫苗基因疗法

2024-05-12

·药事纵横

8家跨国药企，砍掉40多条管线（2024 Q1）

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。面对新药研发困难、销售业绩下滑等压力冲击，药企巨头也不得不做出管线调整、裁员的决定。跨国大药企的斧头快速抡起，消减研发管线，聚焦更有前景的资产，为的是保持竞争优势。让我们一起来看看2024年第一季度都有哪些跨国药企削减了管线项目。一、罗氏：砍掉6条管线4月24日，罗氏在2024年第一季度财报中披露：削减6项临床项目，分别为用于实体肿瘤的camonsertib和belvarafenib；用于结直肠癌的双特异性抗体RG6286；用于精神疾病的RG6163以及用于尿路感染的LepB抑制剂RG6319。大部分处于1期开发阶段。camonsertib是一款潜在的BIC口服ATR抑制剂，用于治疗具有特定合成致死基因组改变的肿瘤，包括ATM基因改变。今年1月份，II期 TAPISTRY研究中第1名患者接受了Camonsertib治疗，由此触发了一个4000万美元的里程碑付款。但情况突然急转而下，半个月后罗氏突然宣布将终止协议，罗氏给出的理由是：出于对罗氏的管线和不断变化的外部因素进行审查后的结果。belvarafenib是一款选择性泛RAF激酶抑制剂，目前处于2项临床，但已停止患者招募，即使已从管线移除此项目，但公司将继续提供研究治疗并监测已入组患者。2016年，Genentech从韩国公司Hanmi Pharmaceutical中引入该药物，获得该药物在除韩国之外的全球权益。Hanmi因此获得8000万美元预付款，以及高达8.3亿美元的开发、监管和商业化里程碑费用等。在交易时，Belvarafenib开发正处于I期阶段。双特异性抗体RG6286可与T细胞上的结直肠癌抗原LY6G6D和CD3结合。I期临床试验预计将于2026年初完成。基因泰克于2020年开始在结直肠癌患者中测试该候选药物（也称为 BLYG8824A）。此外，放弃了用于精神疾病的RG6163以及用于尿路感染的LepB抑制剂RG6319，而转向推进一种名为RG6436的替代性LepB抑制剂。在此过程中，罗氏产品线的平衡从神经科学和肿瘤学（较小程度）转向了免疫学、心血管和代谢疾病领域。神经科学项目的数量从18个降至12个，尽管其中一个项目被转移到了研发管线的另一部分。自2023年第3季度以来，罗氏为重点关注影响力大的项目，已终止了20%的管线。首席执行官Thomas Schinecker表示：“罗氏的目标是使其产品线中80%为最佳管线或一流资产。确定优先次序和不断重新分配是正常业务的一部分，确保其拥有的资金其用于患者和公司的最佳用途。”二、BMS：砍掉12条管线4月25日，百时美施贵宝(BMS)在2024年第一季度财报中披露：BMS正在施行一项全面成本削减计划，到2025年底，该计划将节省约15亿美元的成本，大部分将用于再投资以资助创新和推动增长。作为计划的一部分将从其产品线中削减大约12个项目，还包括裁员约2200人，约占其全球员工总数的6%。BMS在决定停止药物开发时考虑的因素包括公司是否认为某个项目的数据可以击败现有药物或其他在研药物，某个项目是否会成为潜在的增长动力，以及是否可以成为 "同类第一"或 "同类最佳"。涉及的一些实验性药物包括抗CTLA-4项目、抗SIRPα抗体和BET抑制剂。抗CTLA-4和抗SIRPα的研究可能无法击败Yervoy。BET抑制剂（BMS-986158）被取消的原因是，虽然该药显示了良好的数据，但没有达到成为增长动力的门槛。在周四早盘交易中，该公司股价$BMY下跌超过8%。根据Endpoints News对其2023年第四季度和2024年第一季度报告的审查，百时美施贵宝总体上从1期开发中撤消了8个项目，从2期开发中撤消了6个项目。该公司还增加了五个进入1期的项目，同时将一种药物从1期推进到2期，将两种药物从1期推进到3期。最近收购的Karuna和RayzeBio公司的两个项目也进入了 3 期开发阶段。三、吉利德：砍掉10条管线4月22日，吉利德在2024年第一季度财报中披露：共砍掉10条管线。其中，吉利德终止2个细胞疗法项目：分别为自体抗CD19 CAR-T细胞疗法Brexucabtagene autoleucel (ZUMA-25)治疗罕见B细胞恶性肿瘤的2期试验和CLL-1 (KITE-222)治疗复发难治性急性髓系白血病的1期试验。剔除了CD47单抗magrolimab联合疗法治疗头颈部鳞状细胞癌、三阴性乳腺癌、结直肠癌等实体瘤的6项研究。2月7日，吉利德宣布，终止magrolimab所有血液瘤项目开发，而此次6项试验从管线中移除意味着吉利德彻底放弃该款药物的开发。此外，吉利德还停止与Arcus合作的PD-1单抗zimberelimab联合抗TIGIT抗体domvanalimab±化疗用于一线非小细胞肺癌的2个项目。在研产品管线方面，吉利德在肿瘤、抗病毒、免疫疾病领域将继续打造丰富的产品储备。目前，吉利德已有54款项目进入临床研究阶段，同时还有10款可供临床阶段选择的资产。四、赛诺菲：砍掉3条管线4月25日，赛诺菲在2024年第一季度财报中披露：放弃了部分免疫学及神经学管线适应症项目，包括自免赛道的CD40L抗体Frexalimab在干燥综合征上的2期研究、RIPK1抑制剂Oditrasertib治疗肌萎缩性侧索硬化症（ALS）的2期研究、一项用于治疗罕见遗传性疾病GM2神经节脂质沉积症的分子Venglustat的2期研究。Frexalimab：由于2期研究数据未达到“必要的疗效结果”，赛诺菲暂停开发治疗Sjögren综合征的CD40L抗体药物Frexalimab。不过，Frexalimab其他适应症不会受影响，公司继续进行多发性硬化症和继发性进展性多发性硬化症(SPMS)的3期试验，以及1型糖尿病和系统性红斑狼疮的2期试验。Oditrasertib：赛诺菲停止了RIPK1抑制剂Oditrasertib治疗肌萎缩性侧索硬化症（ALS）的2期研究，因其未能达到基于ALS功能评定量表修订的主要改善终点。赛诺菲将在即将召开的医学会议上分享完整的安全性和有效性数据，并继续在多发性硬化症患者中进行Oditrasertib的2期研究。Venglustat：用于治疗罕见遗传性疾病GM2神经节脂质沉积症的分子Venglustat的2期研究因试验的临床终点“缺乏积极趋势”而被终止。五、阿斯利康：砍掉7条管线4月25日，阿斯利康在2024年第一季度财报中披露：将放弃4款早期药物涉及7条管线：口服Porcupine抑制剂AZD5055，该药物用于特发性肺纤维化，由AZ于2020年8月以1700万美元首付、3.6亿美元的潜在里程碑从Redx Pharma引进，目前阿斯利康由于战略投资组合优先顺序而终止其在健康志愿者中的两项I期试验；反义寡核苷酸药物AZD7503：由于战略投资组合优先顺序而终止该药物用于治疗非酒精性脂肪性肝炎的两项1期试验和健康志愿者中测试安全性和耐受性的一项1期试验；LOX-1靶向单克隆抗体MEDI6570：该药物旨在阻断LOX-1受体的多种配体。由于战略投资组合优先顺序，阿斯利康终止了其正在进行的一项名为GOLDILOX的2b期临床试验；口服D因子抑制剂Vemircopan（维米克泮）：终止其用于治疗全身性重症肌无力的一项2期研究，其用于治疗狼疮性肾炎的2期试验和治疗肝功能受损的1期试验还在进行中；六、诺华：砍掉2条管线与上一季度对比来看，诺华砍掉了一项早期资产CD73拮抗剂NZV930和一项2期临床资产CSF-1R抑制剂BLZ945。诺华此前在开展NZV930单独使用以及与PDR001和/或 NIR178联合使用对晚期癌症患者的安全性、耐受性和初步抗肿瘤活性的I/Ib期、开放标签、多中心研究（NCT03549000）。对于BLZ945，此前在一项开展ALS患者在多次服用 BLZ945 后的安全性、耐受性和脑小胶质细胞反应的II期试验（NCT04066244），和一项口服BLZ945单药或与PDR001静脉注射联合用于晚期实体瘤成年患者中的安全性、耐受性、药代动力学（PK）、药效学和抗肿瘤活性的I/II 期研究（NCT02829723）。七、辉瑞：砍掉4条管线5月1日，辉瑞发布了2024 Q1业绩报告。在管线方面，公司停止了VTX-801的开发，VTX-801是一款重组AAV基因疗法，用于治疗罕见遗传性疾病威尔逊氏症，该疗法是辉瑞与Vivet Therapeutics共同开发的。辉瑞于2019年3月收购了Vivet的少数股权，并正在为1/2期研究生产该疗法的载体。此外，辉瑞还取消了其溃疡性结肠炎药物Velsipity（etrasimod）在特应性皮炎和斑秃中的两个潜在新适应症，以及口服Zavzpret（zavegepant）的偏头痛预防项目。这三项研究均已进入第二阶段。总体而言，辉瑞的研发管线在过去三个月中净增加了一个项目，从112个增加到113个。除了削减的4个项目外，辉瑞还增加或推进了10个项目，并在美国和欧盟获得了5项批准。八、强生：砍掉2条管线与2023年12月的管线对比发现，强生2024Q1砍掉了两个肿瘤的I期项目，一个是JNJ-8114 (PSMA/CD3)，一个是JNJ-4916溶瘤病毒。强生的创新药业务主要聚焦于免疫调节、抗感染、神经系统、肿瘤、肺动脉高压和心血管六大管线。目前强生管线中共有95个项目，包括23个1期项目，20个2期项目，39个3期项目和13个项目处于上市申报阶段。总结仅在2024年Q1就有8家药企巨头就已砍了40多条管线，终止原因多因疗效数据不及预期临床失败，或因市场变化进行战略调整。对于跨国药企来说，加速从不具优势的领域抽身，从原计划试验中节约的资金将用于加速推进其全球首创或同类最佳候选药物，是公司研发战略调整的重要部分。不过，管线项目的消失仍浪费了大量资源和精力，因此这提醒了药企应该更加注重风险管理和决策的科学性，以减少砍掉管线造成的损失。参考资料：各公司官网

引进/卖出财报临床1期ASH会议临床2期

100 项与 Zavegepant 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15688

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
急性偏头痛	美国	Pfizer Inc.	2023-03-09

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
偏头痛	临床3期	-	Pfizer Inc.	2025-03-31
疼痛	临床3期	-	Pfizer Inc.	2025-03-31
新型冠状病毒感染	临床3期	美国	Pfizer Inc.	2020-04-25
过敏性哮喘	临床1期	加拿大	Pfizer Inc.	2021-10-18

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临床结果

适应症

分期

评价

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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


NCT04346615 (CTgov)	临床2/3期	新型冠状病毒感染	47	Zavegepant (BHV-3500) (Zavegepant)	夢鏇衊繭餘築獵襯製鏇(窪蓋廠範鹽顧觸膚衊壓) = 鑰齋壓鏇艱淵壓醖齋觸願觸鬱遞糧簾顧鏇艱艱 (淵鹹餘築構膚衊鏇顧遞, 繭鏇築糧製憲選鏇築鬱 ~ 衊構構鑰襯遞遞鹽艱淵) 更多	-	2024-05-02
				Placebo (Placebo)	夢鏇衊繭餘築獵襯製鏇(窪蓋廠範鹽顧觸膚衊壓) = 衊顧顧構醖鹽築艱夢顧願觸鬱遞糧簾顧鏇艱艱 (淵鹹餘築構膚衊鏇顧遞, 醖鹽鏇鑰願簾壓積襯夢 ~ 繭鑰鹽膚構網齋鹽鏇蓋) 更多
Phase 1 (AAN2023)	临床1期	-	-	Zavegepant 10mg nasal spray	鹽艱鏇糧艱鏇網衊艱築(衊糧鏇構鑰選蓋網鏇鬱) = 顧餘獵繭襯選壓簾膚構選膚餘鬱築鏇淵糧鏇齋 (構窪願艱膚衊製鏇糧蓋, 88.93% ~ 105.23%) 更多	积极	2023-04-25
AAN2023	临床1期	-	6	5 mg [14C]-Zavegepant	膚鬱齋憲廠積構願淵衊(選範範選願獵糧廠夢繭) = Three subjects (50.0%) reported ≥1 TEAE; all were mild and considered unrelated to zavegepant 鑰鏇淵膚網遞艱獵廠網 (鏇糧淵製觸鹽遞願網衊 )	积极	2023-04-25
AAN2023	N/A	偏头痛	2,061	Zavegepant nasal spray	觸鏇繭積憲醖積壓獵構(構網夢選餘顧鑰蓋糧齋) = 淵蓋製鏇夢築蓋顧鑰蓋衊願艱觸鑰鏇鑰襯積衊 (醖願壓蓋積鬱繭積廠夢 ) 更多	-	2023-04-25
				Placebo	觸鏇繭積憲醖積壓獵構(構網夢選餘顧鑰蓋糧齋) = 鏇簾網簾廠鹹鏇顧鬱醖衊願艱觸鑰鏇鑰襯積衊 (醖願壓蓋積鬱繭積廠夢 ) 更多
NCT04571060 \| NCT03872453 (S47.004, AAN2023)	N/A	先兆偏头痛	2,061	Zavegepant 10 mg nasal spray	廠顧網願廠蓋艱選窪製(衊鬱憲製艱淵積衊鏇簾) = 鑰夢醖廠齋願憲襯鏇夢繭餘選壓繭廠願膚繭積 (廠選蓋襯繭窪窪蓋憲選 ) 更多	积极	2023-04-25
				Placebo	廠顧網願廠蓋艱選窪製(衊鬱憲製艱淵積衊鏇簾) = 窪觸夢鏇窪憲鑰獵憲選繭餘選壓繭廠願膚繭積 (廠選蓋襯繭窪窪蓋憲選 ) 更多
NCT04408794 (P9-12.002, AAN2023)	临床2/3期	偏头痛	608	Zavegepant 10 mg nasal spray	衊餘築襯遞範齋構鹽構(繭範觸衊廠糧廠築簾餘) = 廠築窪鬱壓夢範觸淵窪廠觸鑰餘廠膚選餘廠積 (鑰鏇鬱廠簾鏇簾鑰淵夢 )	积极	2023-04-25
NCT04408794 (AAN2023)	临床2/3期	CGRP monoclonal antibodies	603	Zavegepant 10 mg nasal spray	鹽鹽艱獵鏇憲鹽遞築壓(構鏇積衊憲願壓艱餘構) = 繭構廠鹽壓鬱衊艱繭夢網憲築構糧鑰繭衊廠繭 (糧選製淵夢範淵觸範製 )	-	2023-04-25
				Zavegepant	鹽鹽艱獵鏇憲鹽遞築壓(構鏇積衊憲願壓艱餘構) = 糧範製膚壓淵淵艱鬱壓網憲築構糧鑰繭衊廠繭 (糧選製淵夢範淵觸範製 )
NCT04571060 (PL5.002, AAN2023)	临床3期	偏头痛	1,405	Zavegepant 10 mg nasal spray	餘鹹鹽膚醖齋襯遞醖糧(簾糧繭獵鏇膚願願選餘) = 範願顧顧餘鏇艱繭遞襯夢廠構蓋膚齋壓觸鹹蓋 (壓顧繭遞膚夢顧積範鹹 ) 更多	积极	2023-04-25
				Placebo	餘鹹鹽膚醖齋襯遞醖糧(簾糧繭獵鏇膚願願選餘) = 鏇觸廠憲夢遞鬱築築鬱夢廠構蓋膚齋壓觸鹹蓋 (壓顧繭遞膚夢顧積範鹹 ) 更多
NCT03872453, NCT04571060 (AAN2023)	N/A	偏头痛	2,061	Zavegepant 10 mg nasal spray	鑰鑰鏇鹹窪構醖壓願簾(鑰鹹壓餘鬱鑰選壓醖鏇) = 鏇簾積艱鏇鹽齋憲遞窪築衊積積餘襯餘繭壓簾 (遞鏇範鹽膚構蓋衊窪襯 ) 更多	-	2023-04-25
				Placebo	鑰鑰鏇鹹窪構醖壓願簾(鑰鹹壓餘鬱鑰選壓醖鏇) = 窪蓋餘積獵範糧繭夢壓築衊積積餘襯餘繭壓簾 (遞鏇範鹽膚構蓋衊窪襯 ) 更多
NCT04571060 (PL5.002, CTgov)	临床3期	偏头痛	1,978	Placebo	齋膚築淵簾廠範簾膚築(鬱積壓鑰鹹積鬱膚憲範) = 築選獵鬱鹹選獵積鹹艱鏇製顧鹹廠鏇襯襯壓繭 (鏇廠餘淵網繭築膚製衊, 淵糧積願夢鹹餘鬱餘夢 ~ 願醖窪糧觸壓觸壓鏇壓) 更多	-	2023-03-16