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Drug

Fremanezumab

Approved medicine
ClassCalcitonin gene-related peptide antagonistResearchActive indication expansion

Also known as Ajovy.

RxNorm2056691ChEMBLCHEMBL4297756ATCN02CD03UNIIPF8K38CG54
2
Protein targets
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Single Center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Fremanezumab (675 mg Quarterly) in Female Patients Aged 18-45 With Menstrual Migraine

Clinical trial2026-08-26Status changed to Completed · ClinicalTrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age

Clinical trial2026-06-22Results posted · ClinicalTrials.gov

Label change: FREMANEZUMAB-VFRM (BLA761089)

Regulatory2026-06-05FDA

A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

Clinical trial2025-12-22Completed · ClinicalTrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

Clinical trial2025-12-19Results posted · ClinicalTrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study With an Open-Label Treatment Period of Fremanezumab Administered Subcutaneously Monthly or Quarterly for the Preventive Treatment of Migraine in Adult Chinese Patients

Clinical trial2025-11-26Results posted · ClinicalTrials.gov

Indication expansion: FREMANEZUMAB-VFRM (BLA761089)

Regulatory2025-08-05FDA

Label change: FREMANEZUMAB-VFRM (BLA761089)

Regulatory2025-03-21FDA

A Phase II Double-Blinded Placebo Controlled Individual Subject Stepped Wedge Clinical Trial Evaluating the Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

Clinical trial2024-12-01Withdrawn · ClinicalTrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

Clinical trial2023-10-02Results posted · ClinicalTrials.gov

An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States

Clinical trial2023-04-14Terminated · ClinicalTrials.gov

Label change: FREMANEZUMAB-VFRM (BLA761089)

Regulatory2021-09-24FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fremanezumab
Aliases & brands
Ajovy
RxNorm CUI
2056691
ChEMBL ID
CHEMBL4297756
ATC codes
N02CD03
UNII
PF8K38CG54
Primary mechanism
Calcitonin gene-related peptide antagonist
Regulatory jurisdictions
emafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Calcitonin gene-related peptide 1
CALCA · P06881
ANTAGONISTCalcitonin gene-related peptide antagonist
Calcitonin gene-related peptide 2
CALCB · P10092
ANTAGONISTCalcitonin gene-related peptide antagonist

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2018-09-14 → 2020-01-27)
Earliest approval
2018-09-14
Latest approval
2025-08-05
Authorities
FDA · EMA
Total events
7
fdaU.S. Food and Drug Administration· 6 events
2026-06-05Label change
Label change: FREMANEZUMAB-VFRM (BLA761089)
Evidence ↗
2025-08-05Indication expansion
Indication expansion: FREMANEZUMAB-VFRM (BLA761089)
Evidence ↗
2025-03-21Label change
Label change: FREMANEZUMAB-VFRM (BLA761089)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2019-03-28ApprovalMulti-authority
Approval: Ajovy (EMA)

Indication: Ajovy is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

18 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
18
registered trials across all phases
LATEST COMPLETION 2026
14
Late-stage (III+)
11
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 18
Phase 24Phase 311Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Single Center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Fremanezumab (675 mg Quarterly) in Female Patients Aged 18-45 With Menstrual Migraine

CompletedPH IVBrigham and Women's Hospitaln=152026

An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States

TerminatedPH IVH. Lundbeck A/Sn=322023

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

CompletedPH IVTeva Branded Pharmaceutical Products R&D, Inc.n=3532022

A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

CompletedPH IIITeva Branded Pharmaceutical Products R&D LLCn=5062025

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

CompletedPH IIITeva Branded Pharmaceutical Products R&D, Inc.n=2922024

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Single Center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Fremanezumab (675 mg Quarterly) in Female Patients Aged 18-45 With Menstrual Migraine

CompletedPH IVBrigham and Women's Hospitaln=152026

A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

CompletedPH IIITeva Branded Pharmaceutical Products R&D LLCn=5062025

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

CompletedPH IIITeva Branded Pharmaceutical Products R&D, Inc.n=2922024

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study With an Open-Label Treatment Period of Fremanezumab Administered Subcutaneously Monthly or Quarterly for the Preventive Treatment of Migraine in Adult Chinese Patients

CompletedPH IIITeva Branded Pharmaceutical Products R&D, Inc.n=3652024

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age

CompletedPH IIITeva Branded Pharmaceutical Products R&D, Inc.n=2352024

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

CompletedPH IVTeva Branded Pharmaceutical Products R&D, Inc.n=3532022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.