Drugs / Zavegepant
Zavegepant
also known as
BHV-3500 · PF-07930207 · BHV-3500 hydrochloride · BMS-742413 · BMS-742413 hydrochloride · BMS-742413-01 · BMS-742413-03 · vazegepant · +2 more
Small molecule targets CALCRL via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed migraine disorder 1 milestone | |||||
| Filed | US (FDA) | — | migraine disorder | — | “The New Drug Application (NDA) was filed for intranasal zavegepant with the U.S. Food and Drug Administration for the acute treatment of migraine in adults.” pfizer.com ↗ “On track for a 2Q2022 acceptance (based on March 2022 submission) in the U.S. as an intranasal spray for the acute treatment of migraine” pfizer.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | ZAVZPRET | — | 2023-03-09 | fda.gov ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 1 missed | ||||||
| Phase 1 | NCT07667621 | Jul 2026 → Jul 2027 expected | migraine with aura, migraine without aura | University of South Florida | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06995729 | May 2025 → Aug 2027 expected | — | Pfizer | Recruiting | No outcome recorded |
| Phase 1 | NCT06453356 | Jun → Sep 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05960032 | Oct → Dec 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05948085 | Jul → Sep 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06137703 | Aug → Dec 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04987944 | Oct 2021 → Mar 2023 | asthma | Pfizer | Terminated | Missed primary Stop: Business |
| Phase 21 trial | ||||||
| Phase 2 | NCT07714369 | Oct 2026 → Apr 2028 expected | cluster headache syndrome | The University of Texas Health Science Center, Houston | Not yet recruiting | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT04408794 | Jun 2020 → Dec 2021 | migraine disorder | Pfizer | Completed | No outcome recorded |
| Phase 2/3 | NCT04346615 | Apr 2020 → Apr 2022 | COVID-19 | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT03872453 | Mar → Oct 2019 | migraine disorder | Pfizer | Completed | Mixed |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT06103734 | Sep 2025 → Aug 2027 | migraine disorder | Pfizer | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT05989048 | Nov 2023 → May 2025 | migraine disorder | Pfizer | Completed | Met primary |
| Phase 3 | NCT04571060 | Oct 2020 → Oct 2021 | migraine disorder | Pfizer | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06985342 | Jun 2025 → Jan 2026 | migraine disorder | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded |
| Phase 4 | NCT06401642 | Mar 2024 → Mar 2027 expected | migraine disorder | Mayo Clinic | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07861412 | Sep 2026 → Dec 2027 expected | migraine disorder | American Center for Psychiatry and Neurology | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT04804033 Comparator | Mar 2021 → Mar 2024 | migraine disorder | Pfizer | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-03-10 | Pfizer | Regulatory Pfizer’s ZAVZPRET™ (zavegepant) Migraine Nasal Spray Receives FDA Approval pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. |
| 2023-02-16 | Pfizer | Results Pfizer Announces The Lancet Neurology Has Published Phase 3 Data for Zavegepant for the Acute Treatment of Migraine in Adults pfizer.com ↗
The study met its co-primary endpoints, showing that a single 10 mg dose of zavegepant was more effective than placebo for both pain freedom and freedom from the most bothersome symptom (MBS) at two hours post-dose. |
All press releases naming this drug 3 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zavegepant | “The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number...” NCT04804033 ↗ |
| Known as | BHV-3500 | “* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant).” NCT04346615 ↗3“Zavegepant (PF-07930207/BHV3500) 100mg non-enteric coated soft gel capsule” NCT06137703 ↗ “BHV-3500, formerly "vazegepant", is now referred to as "zavegepant"” NCT04408794 ↗ |
| Known as | BHV-3500 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL2397415 ↗ |
| Known as | BMS-742413 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2397415 ↗ |
| Known as | BMS-742413 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL2397415 ↗ |
| Known as | BMS-742413-01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2397415 ↗ |
| Known as | BMS-742413-03 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2397415 ↗ |
| Known as | PF-07930207 | “A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine” NCT06995729 ↗1“Zavegepant (PF-07930207/BHV3500) 100mg non-enteric coated soft gel capsule” NCT06137703 ↗ |
| Known as | vazegepant | “* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant).” NCT04346615 ↗ |
| Known as | ZAVEGEPANT HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2397415 ↗ |
| Known as | Zavzpret | “Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US.” NCT06401642 ↗ |
| Action | Inhibit | “Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL2397415 ↗1“CGRP receptor antagonist” NCT04346615 ↗ |
| Modality | Small molecule | “ZAV 10-mg nasal spray is the first intranasal, small-molecule CGRP receptor antagonist approved for the acute treatment of migraine with or without aura in adults.” PMID 40391567 ↗ May 2025 |
| Route | Intranasal | “single intranasal dose of zavegepant 5 mg” NCT03872453 ↗ |
| Target | CALCRL | “Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL2397415 ↗ |