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Drug

Atogepant

Approved medicine
ClassCalcitonin gene-related peptide type 1 receptor antagonistResearchOngoing clinical research

Also known as Qulipta.

RxNorm2571813ChEMBLCHEMBL3991065ATCN02CD07UNII7CRV8RR151
7
Active clinical trials
CALCRL
Primary target
1
Regulatory events
Latest activity
beta

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

[Articles] Tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine (TEMPLE): a randomised, head-to-head, phase 3b trial

Clinical trial2026-07-23Trial news · The Lancet Neurology

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.

Clinical trial2026-07-14Results expected Q1 2028 · ClinicalTrials.gov

A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study

Clinical trial2026-06-29Results expected Q1 2029 · ClinicalTrials.gov

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Clinical trial2026-06-17Results expected Q3 2031 · ClinicalTrials.gov

A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for the Preventive Treatment of Chronic Migraine

Clinical trial2026-06-16Results posted · ClinicalTrials.gov

A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With An Active Treatment Extension to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Subjects With Episodic Migraine

Clinical trial2026-06-11Results posted · ClinicalTrials.gov

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age

Clinical trial2026-06-04Results expected Q1 2031 · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine

Clinical trial2026-05-11Results expected Q1 2027 · ClinicalTrials.gov

A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine

Clinical trial2025-10-20Completed · ClinicalTrials.gov

A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Migraine

Clinical trial2025-08-11Results expected Q2 2032 · ClinicalTrials.gov

Approval: Aquipta (EMA)

Regulatory2023-08-11EMA

Profile

Identifiers & mechanism

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

Canonical name
Atogepant
Aliases & brands
Qulipta
RxNorm CUI
2571813
ChEMBL ID
CHEMBL3991065
ATC codes
N02CD07
UNII
7CRV8RR151
Primary mechanism
Calcitonin gene-related peptide type 1 receptor antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Calcitonin gene-related peptide type 1 receptor
CALCRL · Q16602
ANTAGONISTCalcitonin gene-related peptide type 1 receptor antagonist

Regulatory timeline

1 event

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.

Earliest approval
2023-08-11
Latest approval
2023-08-11
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-08-11Approval
Approval: Aquipta (EMA)

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

Evidence ↗

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

Clinical trials

22 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
22
registered trials across all phases
LATEST COMPLETION 2026
7
Active studies
5
Recruiting
20
Late-stage (III+)
15
Completed
PHASE DISTRIBUTIONn = 22
Phase 12Phase 2 / 31Phase 316Phase 43

Late-stage studies

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

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Not yet recruitingPH IVStanford Universityn=1202031

A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study

RecruitingPH IVKey trialMayo Clinicn=1,3352029

A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of the Concomitant Use of Ubrogepant for the Acute Treatment of Migraine in Subjects Taking Atogepant for the Preventive Treatment of Episodic Migraine

CompletedPH IVAbbVien=2632023

A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Migraine

Enrolling by invitationPH IIIAbbVien=6502032

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age

RecruitingPH IIIAbbVien=4202031

Recent completions

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

A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)

CompletedPH IIIAbbVien=5452026

A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine

CompletedPH IIIAbbVien=5962025

A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for the Preventive Treatment of Chronic Migraine

CompletedPH IIIAbbVien=752025

A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With An Active Treatment Extension to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Subjects With Episodic Migraine

CompletedPH IIIAbbVien=5242025

A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

CompletedPH IIIAbbVien=1862024

A Phase 1 Lactation Study in Healthy Adult Lactating Female Subjects One to Six Months Post-Partum to Evaluate the Pharmacokinetics and Safety of Ubrogepant and Atogepant

CompletedPH IAbbVien=242024
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.