Zavegepant

Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.

• ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine.ICD-10: G43.909

• ZAVZPRET is contraindicated in patients with a history of hypersensitivity reaction to zavegepant or any of the components of ZAVZPRET. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] .contraindicated

• The recommended dose is 10 mg given as a single spray in one nostril, as needed. ( 2.1 ) • The maximum dose in a 24-hour period is 10 mg (one spray). ( 2.1 ) • The safety of treating more than 8 migraines in a 30-day period has not been established. ( 2.1 ) 2.1 Dosing Information The recommended dose of ZAVZPRET is 10 mg given as a single spray in one nostril, as needed. The maximum dose that may be given in a 24-hour period is 10 mg (one spray). The safety of treating more than 8 migraines in a 30-day period has not been established.

• Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy. Hypersensitivity reactions including anaphylaxis, facial swelling, and urticaria, have occurred with ZAVZPRET. ( 5.1 ) • Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) • Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, facial swelling, and urticaria, have occurred in patients treated with ZAVZPRET. If a hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy [see Contraindications (4) and Adverse Reactions (6.1 , 6.2) ]. 5.2 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists in the postmarketing setting. Some of the patients receiving a CGRP antagonist who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Hypertension [see Warnings and Precautions (5.2) ] • Raynaud’s Phenomenon [see Warnings and Precautions (5.3) ] Most common adverse reactions (at least 2% of patients treated with ZAVZPRET and greater than placebo) were taste disorders, nausea, nasal discomfort, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ZAVZPRET for the acute treatment of migraine in adults has been evaluated in two randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) in patients with migraine who received one 10 mg dose of ZAVZPRET nasal spray (N=1023) or placebo (N=1056) [see Clinical Studies (14) ] . Approximately 83% were female, 81% were White, 20% were Hispanic or Latino, and 15% were Black. The mean age at study entry was 41 years (range 18-79 years of age). Adverse reactions in Study 1 and 2 are shown in Table 1.

• Avoid use in patients with severe hepatic impairment. ( 8.6 ) • Avoid use in patients with CLcr < 30 mL/min. ( 8.7 ) 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ZAVZPRET in pregnant women. No adverse developmental effects were observed following subcutaneous administration of zavegepant to pregnant animals at doses associated with plasma exposures higher than those used clinically (see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated rate of major birth defects (2.2 to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data Subcutaneous administration of zavegepant to pregnant rats (0, 10, 20, or 40 mg/kg/day) or rabbits (0, 20, 40, or 60 mg/kg/day) during the period of organogenesis resulted in no adverse effects on embryofetal development.

Metabolism

Absorption Peak plasma concentration of zavegepant was observed at approximately 30 minutes after a single 10 mg dose of the nasal spray. After nasal spray administration of zavegepant, the absolute bioavailability is approximately 5%.

• Mar 9, 2023NDANDA216386Pfizer

1. 1Dysgeusia23229%
2. 2Drug Ineffective13917%
3. 3Nasal Discomfort8210%
4. 4Nausea759.4%
5. 5Throat Irritation678.4%
6. 6Vomiting637.9%
7. 7Therapeutic Product Effect Incomplete435.4%
8. 8Migraine425.2%
9. 9Headache364.5%
10. 10Taste Disorder354.4%
11. 11Off Label Use344.2%
12. 12Burning Sensation283.5%
13. 13Oropharyngeal Pain202.5%
14. 14Dizziness192.4%
15. 15Fatigue182.2%

The 10 most recently updated of 15 ClinicalTrials.gov registrations naming Zavegepant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults
  Completed · Phase 3 · Interventional · 1,414 enrolled · Pfizer
  NCT05989048updated 2026-05-22
• Acute Migraine Treatment in the ED With Gepants
  Terminated · Phase 4 · Interventional · 9 enrolled · Icahn School of Medicine at Mount Sinai
  NCT06985342updated 2026-04-29
• A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
  Recruiting · Phase 1 · Interventional · 16 enrolled · Pfizer
  NCT06995729updated 2026-03-18
• A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling
  Completed · Phase 1 · Interventional · 14 enrolled · Pfizer
  NCT05948085updated 2026-01-29
• A Study to Learn About Zavegepant as a Treatment for Multiple Migraine Attacks in Adult Participants
  Withdrawn · Phase 3 · Interventional · 0 enrolled · Pfizer
  NCT06103734updated 2026-01-13
• Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
  Recruiting · Phase 4 · Interventional · 200 enrolled · Mayo Clinic
  NCT06401642updated 2025-09-09
• A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
  Terminated · Phase 2 · Phase 3 · Interventional · 1,753 enrolled · Pfizer
  NCT04804033updated 2025-03-27
• A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants
  Completed · Phase 1 · Interventional · 13 enrolled · Pfizer
  NCT05960032updated 2025-01-06
• A Study to Learn How the Study Medicine Called Zavegepant is Taken Up Into Blood and Breast Milk of Healthy Breast-Feeding Women
  Completed · Phase 1 · Interventional · 12 enrolled · Pfizer
  NCT06453356updated 2024-10-08
• A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers
  Completed · Phase 1 · Interventional · 52 enrolled · Pfizer
  NCT06137703updated 2024-10-01

Frequently asked questions

How does Zavegepant work?

Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.

What is Zavegepant used for?

According to FDA labeling, Zavegepant carries indications including: ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Zavegepant?

Zavegepant is classified as Calcitonin gene-related peptide (CGRP) antagonists, Calcitonin Gene-related Peptide Receptor Antagonist, Calcitonin Gene-related Peptide Receptor Antagonists.

What are the brand names for Zavegepant?

Zavegepant is marketed under brand names including Zavzpret.

What are the contraindications for Zavegepant?

Zavegepant labeling lists contraindications including: ZAVZPRET is contraindicated in patients with a history of hypersensitivity reaction to zavegepant or any of the components of ZAVZPRET. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] .. Always consult the full prescribing information and a clinician.