Pfizer Launches Phase 3 Clinical Trial of CGRP Receptor Antagonist Zavegepant in Asia, Plans to Enroll Nearly 1,000 Participants in China

Intelligent Finance APP learned on August 10 that, according to the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, Pfizer (PFE.US) has initiated a Phase 3 study in Asian adults to evaluate the efficacy and safety of zavegepant nasal spray for the acute treatment of migraine. The trial will be conducted across 64 research institutions globally, with plans to enroll 1,400 participants internationally and 980 participants in China. Public data shows that zavegepant is a CGRP receptor antagonist intranasal spray, which was approved in the United States in March this year for the acute treatment of adult patients with migraine, showing rapid effectiveness within 15 minutes.

Screenshot source: Official website of the China Drug Clinical Trial Registration and Information Disclosure Platform

It is reported that Zavegepant, a third-generation small molecule CGRP receptor antagonist with high affinity and high selectivity, was developed by Biohaven Pharmaceutical. CGRP, fully known as Calcitonin Gene-Related Peptide, is a vasodilatory neuropeptide whose release levels significantly increase during migraine attacks and are positively correlated with the severity of headaches. By reversibly blocking the CGRP receptor and thereby inhibiting the biological activity of the CGRP neuropeptide, it can alleviate and prevent migraine attacks. In October 2022, Pfizer announced the completion of its acquisition of Biohaven, in a deal worth approximately $11.6 billion.

According to the information on the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, Pfizer has launched a Phase 3 international multicenter, randomized, double-blind, placebo-controlled, parallel-group study in China. The purpose of the trial is to evaluate the efficacy and safety of zavegepant compared to placebo for the acute treatment of migraine (with or without aura) in Asian adults, as assessed by the absence of pain and the most bothersome symptom (MBS) at 2 hours post-dose. The primary endpoint of the trial is the percentage of participants with no pain (pain intensity of zero) at 2 hours post-dose, and the percentage of participants who reported a most bothersome symptom (MBS) prior to dosing and were free of this symptom at 2 hours post-dose.