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乌布格列净:首次批准。

Ubrogepant: First Approval.

机构信息

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

出版信息

Drugs. 2020 Feb;80(3):323-328. doi: 10.1007/s40265-020-01264-5.


DOI:10.1007/s40265-020-01264-5
PMID:32020557
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7062659/
Abstract

Ubrogepant (Ubrelvy™) is an orally administered, small molecule, highly-selective, calcitonin gene-related peptide (CGRP) antagonist that was developed by Allergan under license to Merck & Co. as an acute treatment for migraine. In December 2019, ubrogepant received its first global approval in the USA for the acute treatment of migraine (± aura) in adults. This article summarizes the milestones in the development of ubrogepant leading to its first global approval for the acute treatment of migraine (± aura) in adults.

摘要

乌布列泮(Ubrelvy™)是一种经口给予的、小分子的、高选择性的降钙素基因相关肽(CGRP)拮抗剂,由 Allergan 公司授权 Merck & Co. 开发,作为偏头痛的急性治疗药物。2019 年 12 月,乌布列泮在美国首次获得全球批准,用于成人偏头痛(伴或不伴先兆)的急性治疗。本文总结了乌布列泮开发过程中的重要里程碑,最终使其在全球范围内首次获批用于成人偏头痛(伴或不伴先兆)的急性治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29b8/7062659/25deb032cb59/40265_2020_1264_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29b8/7062659/0c085e830b98/40265_2020_1264_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29b8/7062659/25deb032cb59/40265_2020_1264_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29b8/7062659/0c085e830b98/40265_2020_1264_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29b8/7062659/25deb032cb59/40265_2020_1264_Figb_HTML.jpg

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Determinants of Improved CGRP Peptide Binding Kinetics Revealed by Enhanced Molecular Simulations.

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[2]
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[4]
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[5]
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[6]
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[7]
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[8]
A Comprehensive Review of the Mechanism, Efficacy, Safety, and Tolerability of Ubrogepant in the Treatment of Migraine.

Cureus. 2023-11-2

[9]
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Neurol Ther. 2023-12

[10]
Research Progress in Calcitonin Gene-Related Peptide and Bone Repair.

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本文引用的文献

[1]
Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial.

Headache. 2020-1

[2]
Ubrogepant Is Not Associated With Clinically Meaningful Elevations of Alanine Aminotransferase in Healthy Adult Males.

Clin Transl Sci. 2020-5

[3]
Ubrogepant for the Treatment of Migraine.

N Engl J Med. 2019-12-5

[4]
Making Better Dose Decisions: Using Exposure-Response Modeling to Integrate Efficacy Outcome of Two Phase IIb Clinical Trials of Ubrogepant for Migraine Treatment.

Clin Transl Sci. 2020-5

[5]
Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial.

JAMA. 2019-11-19

[6]
Characterisation of the calcitonin gene-related peptide receptor antagonists ubrogepant and atogepant in human isolated coronary, cerebral and middle meningeal arteries.

Cephalalgia. 2020-4

[7]
Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial.

Clin Pharmacol Ther. 2019-12-14

[8]
Recent Advances in Pharmacotherapy for Episodic Migraine.

CNS Drugs. 2019-11

[9]
Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: Randomized, placebo-controlled trial in healthy adults.

Cephalalgia. 2019-9-19

[10]
CGRP as the target of new migraine therapies - successful translation from bench to clinic.

Nat Rev Neurol. 2018-6

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