Zavzpret

(Zavegepant)

ApprovedSmall molecule

Zavzpret is a small molecule that works as a CGRP Receptor Antagonist.[2] It is being used across 2 indications, with its most advanced program in Approved.[1]

Zavzpret is one of 46 small molecule programs targeting Migraine. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

MigraineRecruiting

Cluster HeadacheNot yet recruiting

MigraineApproved

Recruiting

Cluster HeadachePhase 2

Not yet recruiting

Competition

Competitive Landscape

102 competitors in Migraine

#DrugCompanyPhaseTrials

Zavzpret

Pfizer

Approved

8 2

Zonegran

AAzurity Pharmaceuticals

Phase 3

3 3

Effient

CCosette Pharmaceuticals, Inc.

Phase 3

1 4

Triptans

Pfizer

Phase 3

2 5

Aspirin /d

TThe First Affiliated Hospital with Nanjing Medical University

Phase 3

1 6

Flunarizine

AAspartes Pharmaceuticals, Inc.

Phase 3

9 7

BAT7104

Teva

Phase 3

1 8

Tizanidine Hydrochloride

EElan Pharmaceuticals

Phase 3

1 9

Bayer Aspirin

Bayer

Preclinical

2 10

Cervidil

Pfizer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

ApprovedRecruiting

Migraine

NCT06401642

Q3 2027

Phase 1Recruiting

Migraine

NCT07667621

Phase 1Recruiting

Migraine

NCT06995729

Q2 2028

Phase 2Not yet recruiting

Cluster Headache

NCT07714369

Clinical

Trials by Indication[1]

Migraine8 trials

Acute Treatment Trial in Adult Subjects With Migraines

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT03872453·2,154 enrolled

Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT04408794·974 enrolled

Randomized Trial in Adult Participants With Acute Migraines

Completed· Pfizer logo

Pfizer·Phase 3·NCT04571060·1,978 enrolled

Show 5 more trials

Acute Migraine Treatment in the ED With Gepants

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT06985342·100 enrolled

A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults

Completed· Pfizer logo

Pfizer·Phase 3·NCT05989048·1,414 enrolled

A Prospective, Open-Label Study Evaluating the Effectiveness of Rimegepant ODT or Zavegepant Nasal Spray for Acute Treatment of Migraine in the Emergency Department

Recruiting·UUniversity of South Florida·Phase 1·NCT07667621·100 enrolled

A PHASE 1, MULTICENTER, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ZAVEGEPANT IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH HISTORY OF MIGRAINE

Recruiting· Pfizer logo

Pfizer·Phase 1·NCT06995729·16 enrolled

A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.

Recruiting·MMayo Clinic·Approved·NCT06401642·200 enrolled

Asthma1 trial

Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma

Terminated· Pfizer logo

Pfizer·Phase 1·NCT04987944·45 enrolled

Adult1 trial

A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT05960032·13 enrolled

Breast1 trial

A Study to Learn How the Study Medicine Called Zavegepant is Taken Up Into Blood and Breast Milk of Healthy Breast-Feeding Women

Completed· Pfizer logo

Pfizer·Phase 1·NCT06453356·12 enrolled

Concentration1 trial

A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling

Completed· Pfizer logo

Pfizer·Phase 1·NCT05948085·14 enrolled

3 more indications

COVID-191 trial

Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen

Terminated· Pfizer logo

Pfizer·Phase 2/3·NCT04346615·47 enrolled

Medication1 trial

A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT06137703·52 enrolled

Cluster headache1 trial

Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache: A Prospective, Open-Label, Single-Arm, Interventional Pilot Study

Not yet recruiting·TThe University of Texas Health Science Center, Houston·Phase 2·NCT07714369·40 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 9, 2023

ZAVZPRET

NDA NDA216386

Mar 9, 2023

ZAVZPRET

NDA NDA216386

Mar 21, 2025

ZAVZPRET

NDA NDA216386

Aug 1, 2025

ZAVZPRET

NDA NDA216386

Aug 17, 2026

ZAVZPRET

NDA NDA216386

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Zavegepant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zavegepant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zavegepant. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216386). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Zavzpret. U.S. Food & Drug Administration.
[6]
PubMed — 10 publications indexed for Zavegepant. U.S. National Library of Medicine.
[7]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: CGRP Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[5]

Patent Cliff

Oct 7, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8481546Oct 7, 2031

Key Publications[6]

Performance of artificial intelligence versus clinician left-ventricular segmentation of cardiac MRI for mortality prediction: a retrospective, multicentre, prognostic study.

Lancet Digit HealthJun 16, 2027DOI: 10.1016/j.landig.2026.101042

Propofol in Exhaled Air and Plasma During Paedfusor Target-Controlled Infusion in Children.

Acta Anaesthesiol ScandJan 1, 2027DOI: 10.1111/aas.70368

Two-center comparison of dedicated and general-purpose treatment planning for stereotactic body radiotherapy of spinal metastases with simultaneous integrated boost.

Z Med PhysNov 3, 2026DOI: 10.1016/j.zemedi.2026.10.007

Measurable Residual Disease in IDH-Mutated AML: Identifying a Clinically Relevant Threshold for IDH Mutation Monitoring.

Eur J HaematolNov 2, 2026DOI: 10.1111/ejh.70351

Pharmaceutical Industry Pay-Per-Click Advertising Strategies to Influence Public Opinions on Drug Pricing.

Clin Pharmacol TherNov 2, 2026DOI: 10.1002/cpt.70538

Efficacy and safety of palbociclib in older women with advanced HR-Positive/HER2-negative breast cancer: a systematic review and meta-analysis.

Expert Opin PharmacotherNov 2, 2026DOI: 10.1080/14656566.2026.2706075

Nanobody-Modified Outer Membrane Vesicles Attenuate Alzheimer's Disease-Like Neurodegeneration by Modulating Mitophagy-Associated Phenotypes and cGAS-STING-Related Inflammatory Signaling.

Adv Healthc MaterNov 2, 2026DOI: 10.1002/adhm.71891

Baseline severity and early tacrolimus trough are associated with time to minimal manifestations in steroid-free tacrolimus monotherapy for AChR antibody-positive myasthenia gravis.

Rev Neurol (Paris)Nov 2, 2026DOI: 10.1016/j.neurol.2026.10.008

Corrigendum to "Sculponeatin A promotes the ETS1‑SYVN1 interaction to induce SLC7A11/xCT‑dependent ferroptosis in breast cancer" [Phytomedicine 117(2023) 154921].

PhytomedicineNov 2, 2026DOI: 10.1016/j.phymed.2026.158881

Focused Ultrasound in Parkinson's Disease: From Mechanisms to Precision Therapy.

Ultrasound Med BiolNov 2, 2026DOI: 10.1016/j.ultrasmedbio.2026.10.001

Zavzpret

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q2 2028

Trials by Indication[1]

Migraine8 trials

Asthma1 trial

Adult1 trial

Breast1 trial

Concentration1 trial

COVID-191 trial

Medication1 trial

Cluster headache1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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