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瑞美吉泮：首次批准

Zavegepant: First Approval.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2023 Jun;83(9):825-831. doi: 10.1007/s40265-023-01885-6.

DOI:10.1007/s40265-023-01885-6
PMID:37227596
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10209931/
Abstract

Zavegepant is a third generation, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist being developed by Pfizer, under a license from Bristol-Myers Squibb, for the prevention and treatment of chronic and episodic migraine. In March 2023, zavegepant nasal spray (ZAVZPRET™) received its first approval in the USA for the acute treatment of migraine with or without aura in adults. Clinical development of an oral formulation of zavegepant is currently underway. This article summarizes the milestones in the development of zavegepant leading to this first approval for the acute treatment of migraine with or without aura in adults.

摘要

依奈徳（zavegepant）是一种第三代、小分子、降钙素基因相关肽（CGRP）受体拮抗剂，由辉瑞公司（Pfizer）开发，由百时美施贵宝公司（Bristol-Myers Squibb）授权，用于预防和治疗慢性和阵发性偏头痛。2023 年 3 月，依奈徳鼻喷剂（ZAVZPRET™）在美国首次获得批准，用于成人有或无先兆偏头痛的急性治疗。依奈徳的口服制剂的临床开发正在进行中。本文总结了依奈徳开发过程中的重要里程碑，这些里程碑导致了其首次获批用于成人有或无先兆偏头痛的急性治疗。

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引用本文的文献

[1]
Gepants: Key Features of A Potent Therapeutic Option and Considerations in The Latin American Context.

Rev Neurol. 2025-6-25

[2]
Gepants in Primary Care: A Targeted Approach to Acute and Preventive Treatment of Migraine.

Pain Ther. 2025-6-27

[3]
Adverse events associated with gepants: a pharmacovigilance analysis based on the FDA adverse event reporting system.

J Headache Pain. 2025-6-23

[4]
Head-to-head relief: ubrogepant, rimegepant, and zavegepant in migraine treatment.

Pain Manag. 2025-5

[5]
Nanoformulation innovations: Revolutionizing precision in migraine therapy.

Iran J Basic Med Sci. 2025

[6]
Effects of multiple-dose administration of zavegepant nasal spray on the single-dose pharmacokinetics of ethinyl estradiol-levonorgestrel.

Headache. 2025-1

[7]
Enhancing Acute Migraine Treatment: Exploring Solid Lipid Nanoparticles and Nanostructured Lipid Carriers for the Nose-to-Brain Route.

Pharmaceutics. 2024-10-4

[8]
The significance of chirality in contemporary drug discovery-a mini review.

RSC Adv. 2024-10-22

[9]
Mass balance and pharmacokinetic characterization of zavegepant in healthy male subjects.

Clin Transl Sci. 2024-10

[10]
Reduced hepatic impairment study to evaluate pharmacokinetics and safety of zavegepant and to inform dosing recommendation for hepatic impairment.

Clin Transl Sci. 2024-7

本文引用的文献

[1]
Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial.

Lancet Neurol. 2023-3

[2]
Zavegepant nasal spray for the acute treatment of migraine: A Phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial.

Headache. 2022-10

[3]
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale.

BioDrugs. 2022-5

[4]
Calcitonin gene-related peptide-targeting drugs for migraine: how pharmacology might inform treatment decisions.

Lancet Neurol. 2022-3

[5]
Discovery of (R)-N-(3-(7-methyl-1H-indazol-5-yl)-1-(4-(1-methylpiperidin-4-yl)-1-oxopropan-2-yl)-4-(2-oxo-1,2-dihydroquinolin-3-yl)piperidine-1-carboxamide (BMS-742413): a potent human CGRP antagonist with superior safety profile for the treatment of migraine through intranasal delivery.

Bioorg Med Chem Lett. 2013-4-12

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