Overview

Zavegepant (BHV-3500) is a calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is released from sensory nerves and acts as a strong vasodilator, and thanks to these properties, it is involved in pain pathways. CGRP receptors are expressed in the central and peripheral nervous system; however, CGRP does not cross the blood-brain barrier, suggesting that it acts on peripheral nerves. In migraine, CGRP innervates pain-producing meningeal blood vessels and is released by trigeminal nerve stimulation. Since they inhibit these mechanisms and desensitize neuronal circuits, the use of CGRP receptor antagonists is beneficial in the treatment of migraine. Small molecule CGRP antagonists are also known as "gepants", and this category includes other drugs such as rimegepant and ubrogepant. Zavegepant is a third-generation CGRP receptor antagonist that is small in size and highly soluble. Due to its pharmacological properties, it can be administered intranasally. In March 2023, the FDA approved the use of zavegepant nasal spray for the acute treatment of migraine with or without aura in adults. A clinical trial (NCT04804033) is currently investigating the efficacy and safety of oral zavegepant in migraine prevention, and another one (NCT04987944) is evaluating the safety and efficacy of oral zavegepant (150 mg bid) in subjects with mild allergic asthma.

Indication

Zavegepant in a nasal spray form is indicated for the acute treatment of migraine with or without aura in adults. It is not indicated for the preventive treatment of migraine.

Associated Conditions

Acute Migraine

Research Report

Published: Sep 8, 2025

Zavegepant (Zavzpret): A Comprehensive Monograph on a Novel Intranasal CGRP Receptor Antagonist for the Acute Treatment of Migraine

1.0 Executive Summary & Introduction to CGRP Antagonism in Migraine Therapy

1.1 Executive Summary

Zavegepant, marketed under the brand name Zavzpret®, is a third-generation, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine with or without aura in adults.[1] Developed by Pfizer following its acquisition of Biohaven Pharmaceuticals, Zavegepant represents a significant innovation in migraine therapeutics as the first and only "gepant" class medication formulated for intranasal administration.[1] This unique delivery system is designed to provide rapid onset of action, with clinical trials demonstrating pain relief as early as 15 minutes post-dose.[6] Its mechanism of action, which targets the well-established CGRP pathway in migraine pathophysiology, offers a valuable alternative to traditional therapies, particularly for patients who experience significant nausea and vomiting or who have contraindications to triptans.[8] With a robust clinical profile demonstrating efficacy and a favorable safety and tolerability record, Zavegepant is positioned to address key unmet needs in the management of acute migraine attacks.[6]

1.2 The Pathophysiological Role of CGRP in Migraine

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine	2025/05/29	NCT06995729	Phase 1	Recruiting	Pfizer
Acute Migraine Treatment in the ED With Gepants	2025/05/22	NCT06985342	Phase 4	Recruiting	Icahn School of Medicine at Mount Sinai
A Study to Learn How the Study Medicine Called Zavegepant is Taken Up Into Blood and Breast Milk of Healthy Breast-Feeding Women	2024/06/11	NCT06453356	Phase 1	Completed	Pfizer
Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications	2024/05/07	NCT06401642	Phase 4	Recruiting	Mayo Clinic
A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers	2023/11/18	NCT06137703	Phase 1	Completed	Pfizer
A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults	2023/08/14	NCT05989048	Phase 3	Completed	Pfizer
A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants	2023/07/25	NCT05960032	Phase 1	Completed	Pfizer
A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling	2023/07/17	NCT05948085	Phase 1	Completed	Pfizer
Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma	2021/08/03	NCT04987944	Phase 1	Terminated	Pfizer
Randomized Trial in Adult Participants With Acute Migraines	2020/09/30	NCT04571060	Phase 3	Completed	Pfizer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ZAVZPRET	U.S. Pharmaceuticals	63539-135	NASAL	10 mg in 0.1 mL	3/9/2023
ZAVZPRET	Pfizer Laboratories Div Pfizer Inc	0069-3500	NASAL	10 mg in 0.1 mL	8/11/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Migraine Treatment Pipeline Shows Robust Activity with 30+ Companies Advancing Novel Therapies Through Clinical Trials

6 months ago

DelveInsight's 2025 pipeline report reveals over 30 companies are actively developing more than 30 pipeline therapies for migraine treatment, indicating a robust therapeutic landscape.

FDA Rejects Satsuma's STS101 Nasal Migraine Treatment Citing Manufacturing Issues

9 months ago

• The FDA issued a complete response letter for Satsuma Pharmaceuticals' STS101, a nasal powder formulation of dihydroergotamine mesylate (DHE), due to chemistry, manufacturing, and controls (CMC) issues. • STS101 aimed to offer a portable, easy-to-use option for acute migraine, potentially improving upon existing DHE nasal sprays like Bausch Health's Migranal. • The rejection positions Satsuma behind competitors like Impel Neuropharma (Trudhesa) and Pfizer (Zavzpret) in the crowded acute migraine treatment market. • Satsuma plans to meet with the FDA to determine the timeline for resubmitting the marketing application, emphasizing that clinical data was not a concern.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access

Zavegepant