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Qulipta

(Atogepant)

ApprovedSmall molecule

Atogepant is a medication used to help prevent migraine headaches by blocking a natural substance in the body that triggers migraines. It helps reduce how often migraines occur, though it doesn't cure them.[2] Qulipta is currently approved and in use across 3 indications[4].[1]

Qulipta is one of 95 small molecule programs targeting Migraine Disorder. It is currently in Approved.

3

Indications

28

Total Trials

10

Active Trials

94

Competitors

7

FDA Applications

NDA/BLA/ANDA regulatory filings

6

Patents

Pipeline

Status by Indication[4][1]

Indication

Migraine DisorderActive, not recruiting

Chronic MigraineRecruiting

MigraineCompleted

Migraine DisorderApproved

Active, not recruiting

Chronic MigrainePhase 3

Recruiting

MigraineApproved

Completed

Competition

Competitive Landscape

105 competitors in Migraine

#DrugCompanyPhaseTrials

Qulipta

Avicel

SSanthera Pharmaceuticals

Magnesium

SSpherium Biomed

BAT7104

Tizanidine Hydrochloride

EElan Pharmaceuticals

Bayer Aspirin

Adempas

Cervidil

Cymbalta

Jazz Pharmaceuticals

Nitrostat

VViatris Specialty LLC

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

Timeline

Expected Milestones

Q3 2027

Phase 3Active, not recruiting

Migraine

NCT06806293

Q2 2028

Phase 3Recruiting

Episodic Migraine

NCT05711394

Q4 2028

ApprovedNot yet recruiting

Migraine

NCT07826910

Q2 2029

Chronic Migraine

NCT06603558

Clinical

Trials by Indication[1]

Migraine22 trials

Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

Completed· AbbVie logo

AbbVie·Phase 3·NCT05861427·523 enrolled

Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

Completed· AbbVie logo

AbbVie·Phase 4·NCT05264129·263 enrolled

Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine

Enrolling by invitation· AbbVie logo

AbbVie·Phase 3·NCT05707949·650 enrolled

Show 19 more trials

Study to Assess Adverse Events (AEs) When Oral Atogepant Tablet is Given to Adult Chinese Participants Who Completed Study 3101-303-002 to Prevent Chronic Migraine

Completed· AbbVie logo

AbbVie·Phase 3·NCT04829747·3 enrolled

Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

Completed· AbbVie logo

AbbVie·Phase 2/3·NCT02848326·834 enrolled

Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine

Completed· AbbVie logo

AbbVie·Phase 3·NCT05216263·75 enrolled

Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

Completed· AbbVie logo

AbbVie·Phase 3·NCT03939312·685 enrolled

A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

Completed· AbbVie logo

AbbVie·Phase 3·NCT04437433·186 enrolled

Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.

Completed· AbbVie logo

AbbVie·Phase 3·NCT04740827·315 enrolled

Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients

Active, not recruiting·UUniversity of Florence··NCT06414044·500 enrolled

Migraine Medication Effects on Urinary Symptoms

Enrolling by invitation·TThe Cleveland Clinic··NCT06212661·200 enrolled

Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine

Recruiting·IIRCCS National Neurological Institute "C. Mondino" Foundation··NCT06882122·30 enrolled

A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

Completed· AbbVie logo

AbbVie·Phase 3·NCT04686136·596 enrolled

Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

Completed· AbbVie logo

AbbVie·Phase 3·NCT03855137·778 enrolled

12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine

Completed· AbbVie logo

AbbVie·Phase 3·NCT03777059·910 enrolled

Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

Completed· AbbVie logo

AbbVie·Phase 3·NCT03700320·744 enrolled

The Role of CGRP in Human Vestibulo-Ocular Reflex (VOR) - a Randomized, Blinded, Placebo-controlled, Cross-over Trial

Not yet recruiting·KKonrad Peter Weber·Approved·NCT07826910·80 enrolled

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

Recruiting·MMayo Clinic·Approved·NCT06972056·1,335 enrolled

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)

Completed· AbbVie logo

AbbVie·Phase 3·NCT06241313·2,158 enrolled

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

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT06806293·468 enrolled

Long-term Atogepant for Treatment-resistant Migraine in Real-world Clinical Practice: 12-month Result

Completed·FFundación de Investigación Biomédica - Hospital Universitario de La Princesa··NCT07699549·513 enrolled

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)

Completed· AbbVie logo

AbbVie·Phase 3·NCT05748483·545 enrolled

Adverse Events2 trials

Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers

Completed· AbbVie logo

AbbVie·Phase 1·NCT05892757·24 enrolled

Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine

Completed· AbbVie logo

AbbVie·Phase 1·NCT04818515·26 enrolled

Chronic Migraine2 trials

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

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06810505·420 enrolled

Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients

Recruiting· AbbVie logo

AbbVie··NCT06603558·3,000 enrolled

Episodic Migraine1 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.

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT05711394·450 enrolled

Unspecified1 trial

Atogepant in Real Life in Italy (GIANT)

Unknown status·IIRCCS San Raffaele Roma··NCT06136442·500 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 28, 2021

QULIPTA

NDA NDA215206

Sep 28, 2021

QULIPTA

NDA NDA215206

Apr 17, 2023

QULIPTA

NDA NDA215206

Mar 21, 2025

QULIPTA

NDA NDA215206

Jun 10, 2025

QULIPTA

NDA NDA215206

Jun 10, 2025

QULIPTA

NDA NDA215206

Sep 30, 2025

QULIPTA

NDA NDA215206

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Atogepant. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Qulipta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Atogepant compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Atogepant. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215206). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Qulipta. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Atogepant. U.S. National Library of Medicine.
[8]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: CGRP Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[6]

Patent Cliff

Mar 13, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9850246Mar 13, 2033

12383545Jun 6, 2039

12090148Jul 29, 2041

12465598Sep 27, 2042

12622897Sep 27, 2042

1 more patents

12350259Feb 27, 2043

Key Publications[7]

Atogepant for Chronic Migraine Prevention: PROGRESS Phase 3

N Engl J MedNov 30, 2023DOI: 10.1056/NEJMoa2305254

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