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 44 small molecule programs targeting Cluster headache. 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

Cluster HeadacheNot yet recruiting

MigraineRecruiting

Cluster HeadachePhase 2

Not yet recruiting

MigraineApproved

Recruiting

Competition

Competitive Landscape

105 competitors in Migraine

#DrugCompanyPhaseTrials

Zavzpret

Pfizer

Approved

8 2

Zonegran

AAzurity Pharmaceuticals

Phase 3

3 3

Avicel

SSanthera Pharmaceuticals

Phase 3

2 4

Aspirin /d

TThe First Affiliated Hospital with Nanjing Medical University

Phase 3

1 5

BAT7104

Teva

Phase 3

1 6

Flunarizine

AAspartes Pharmaceuticals, Inc.

Phase 3

9 7

Bayer Aspirin

Bayer

Preclinical

2 8

Cymbalta

Jazz Pharmaceuticals

Preclinical

1 9

Adempas

Bayer

Preclinical

1 10

Cervidil

Pfizer

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Migraine

NCT06985342

Q1 2027

ApprovedRecruiting

Migraine

NCT06401642

Q3 2027

Phase 1Not yet recruiting

Migraine

NCT07667621

Phase 1Recruiting

Migraine

NCT06995729

Q2 2028

Phase 2Not yet recruiting

Cluster Headache

NCT07714369

Clinical

Trials by Indication[1]

Migraine8 trials

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

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

Show 5 more trials

Acute Treatment Trial in Adult Subjects With Migraines

Completed· Pfizer logo

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

A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine

Recruiting· Pfizer logo

Pfizer·Phase 1·NCT06995729·16 enrolled

Acute Migraine Treatment in the ED With Gepants

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

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

Not yet recruiting·UUniversity of South Florida·Phase 1·NCT07667621·100 enrolled

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

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

Asthma1 trial

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

Terminated· Pfizer logo

Pfizer·Phase 1·NCT04987944·45 enrolled

3 more indications

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

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

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]
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

Zavzpret

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q2 2028

Trials by Indication[1]

Migraine8 trials

COVID-191 trial

Medication1 trial

Breast1 trial

Asthma1 trial

Concentration1 trial

Adult1 trial

Cluster headache1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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