Drugs / Zavegepant

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ZAVZPRET 2023-03-09 fda.gov

Trials 16 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
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 No outcome recorded
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
Phase 2/3 NCT03872453 Mar → Oct 2019 migraine disorder Pfizer Completed No outcome recorded
Phase 33 trials
Phase 3 NCT06103734 Sep 2025 → Aug 2027 migraine disorder Pfizer Withdrawn No outcome recorded
Phase 3 NCT05989048 Nov 2023 → May 2025 migraine disorder Pfizer Completed No outcome recorded
Phase 3 NCT04571060 Oct 2020 → Oct 2021 migraine disorder Pfizer Completed No outcome recorded
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
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/3 NCT04804033 Comparator Mar 2021 → Mar 2024 migraine disorder Pfizer Terminated No outcome recorded

Press releases naming this drug 3 releases

DateIssuerRelease
2023-03-10 Pfizer Pfizer’s ZAVZPRET™ (zavegepant) Migraine Nasal Spray Receives FDA Approval pfizer.com
2023-02-16 Pfizer Pfizer Announces The Lancet Neurology Has Published Phase 3 Data for Zavegepant for the Acute Treatment of Migraine in Adults pfizer.com
2022-01-05 Pfizer Biohaven and Pfizer Complete Collaboration Transaction for Commercialization of Rimegepant and Zavegepant Outside United States pfizer.com

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 19 sources stand behind the page.

FieldValueCited 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
16

NCT07667621

NCT04346615

NCT05948085

NCT05989048

NCT05960032

NCT03872453

NCT06995729

NCT04408794

NCT07714369

NCT04571060

NCT06103734

NCT06137703

NCT06401642

NCT06985342

NCT06453356

NCT04987944

Known as BHV-3500 hydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL2397415
Known as BHV3500 “* 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

NCT04804033

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