Product
Atogepant
Aliases
AGN-241689, Aquipta, Atogepant 60 mg, Placebo for Atogepant (2 other aliases)
Name
Qulipta
INN Name
Atogepant
FDA Approved
Yes
14 clinical trials
1 organization
4 indications
1 document
Indication
MigraineIndication
Healthy Control ParticipantsIndication
Migraine With AuraIndication
Migraine Without AuraClinical trial
Randomized, Double-blind, Placebo-Controlled, Multiple-Attack Study With an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)Status: Recruiting, Estimated PCD: 2025-10-05
Clinical trial
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 AtogepantStatus: Completed, Estimated PCD: 2024-02-22
Clinical trial
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 MigraineStatus: Recruiting, Estimated PCD: 2024-12-27
Clinical trial
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 MigraineStatus: Active (not recruiting), Estimated PCD: 2024-06-14
Clinical trial
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 MigraineStatus: Active (not recruiting), Estimated PCD: 2025-10-08
Clinical trial
A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Episodic MigraineStatus: , Estimated PCD: 2029-11-16
Clinical trial
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.Status: Recruiting, Estimated PCD: 2028-03-30
Clinical trial
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 MigraineStatus: Recruiting, Estimated PCD: 2025-01-24
Clinical trial
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 MigraineStatus: Completed, Estimated PCD: 2023-04-04
Clinical trial
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)Status: Completed, Estimated PCD: 2022-08-04
Clinical trial
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)Status: Completed, Estimated PCD: 2022-01-20
Clinical trial
A Phase 3, Multicenter, Open-Label, 12-Week Study to Evaluate the Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Chinese Participants With Chronic MigraineStatus: Completed, Estimated PCD: 2022-01-20
Clinical trial
STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR)Status: Recruiting, Estimated PCD: 2025-09-01
Clinical trial
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)Status: Recruiting, Estimated PCD: 2026-06-14
Document
DailyMed Label: QuliptaOrganization
AbbVie Inc.