Zavzpret

(Zavegepant)

ApprovedSmall molecule

Zavzpret is a small molecule that works as a CGRP Receptor Antagonist.[2] It is being used across 3 indications, with its most advanced program in Approved.[1]

Zavzpret is one of 64 small molecule programs targeting Migraine. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

MigraineActive, not recruiting

COVID-19Active, not recruiting

AsthmaActive, not recruiting

MigraineApproved

Active, not recruiting

COVID-19Phase 2/Phase 3

Active, not recruiting

AsthmaPhase 1

Active, not recruiting

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Zavzpret

Pfizer

Approved

1 2

COVID-19 Vaccine

Moderna

Preclinical

27 3

Aldactone

Pfizer

Preclinical

1 4

Nexavar

Bayer

Preclinical

1 5

Benadryl

PParkedale

Preclinical

1 6

SARS-COV-2 VACCINE

Moderna

Preclinical

2 7

Interferon-Gamma

SSPP Pharmaclon Ltd.

Preclinical

1 8

Pfizer-COVID-19 Vaccine

Moderna

Preclinical

1 9

Immunosuppressive

Chiesi Farmaceutici S.p.A.

Preclinical

1 10

Serology

UUniversity Hospital Center of Martinique

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Migraine

NCT06985342

Q1 2027

Post-ApprovalRecruiting

Migraine

NCT06401642

Q3 2027

Phase 1Not yet recruiting

Migraine

NCT07667621

Phase 1Recruiting

Migraine

NCT06995729

Clinical

Trials by Indication[1]

Migraine8 trials

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

Randomized Trial in Adult Participants With Acute Migraines

Completed· Pfizer logo

Pfizer·Phase 3·NCT04571060·1,978 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

Show 5 more 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

Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications

Recruiting·MMayo Clinic·Phase 4·NCT06401642·200 enrolled

Acute Treatment Trial in Adult Subjects With Migraines

Completed· Pfizer logo

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

Acute Migraine Treatment in the ED With Gepants

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

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

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

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

2 more indications

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

Regulatory

FDA Approval Timeline[4]

Mar 9, 2023

ZAVZPRET

NDA NDA216386

Sources

References

[1]
ClinicalTrials.gov — 14 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

Trials by Indication[1]

Migraine8 trials

Concentration1 trial

Medication1 trial

Breast1 trial

COVID-191 trial

Asthma1 trial

Adult1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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