QULIPTA (atogepant)
QULIPTA (atogepant) is a medication indicated for the preventive treatment of migraine in adults. It belongs to the pharmacological class of calcitonin gene-related peptide (CGRP) receptor antagonists. This therapy is specifically approved for use in the adult patient population to manage migraine through a preventive approach.
How QULIPTA Works
Atogepant functions as a calcitonin gene-related peptide (CGRP) receptor antagonist. The drug works by targeting and binding to the CGRP receptor, which serves as its primary biological target. By blocking this receptor, atogepant prevents the CGRP protein from interacting with it, thereby producing its therapeutic effect in migraine prevention.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-09-28
- Patent Cliff
- 2043
- Revenue
- $296M (Q1-2026)
- Routes
- ORAL
- Dosage Forms
- TABLET
QULIPTA Approval History
What QULIPTA Treats
1 indicationsQULIPTA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
QULIPTA Target & Pathway
ProTarget
A neuropeptide involved in pain transmission and blood vessel dilation. CGRP levels rise during migraine attacks and contribute to headache pain. Blocking CGRP or its receptor prevents and treats migraines.
QULIPTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to QULIPTA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05711394 | M21-201 2022-501100-94-00 | Ph 3 | recruiting | A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine |
| NCT06810505 | M23-712 2024-513836-28, 2024-513836-28-00 | Ph 3 | recruiting | A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years |
| NCT06241313 ATO ACUTE | M24-305 2023-506029-12-00 | Ph 3 | active not recruiting | Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine |
| NCT06806293 ATO MM | M24-859 2024-512946-41, 2024-512946-41-00 | Ph 3 | active not recruiting | Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine |
| NCT05707949 Kaleidoscope | M21-199 2022-501099-24-00 | Ph 3 | enrolling by invitation | Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine |
| NCT05748483 ATO-TOPIRAMATE | M22-061 2022-501172-25-00 | Ph 3 | active not recruiting | Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine |
| NCT05216263 ATO-BOTOX | M22-418 | Ph 3 | completed | Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine |
| NCT05861427 JPN PIVOTAL | M22-056 | Ph 3 | completed | Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine |
| NCT05264129 TANDEM results posted | M23-072 | Ph 4 | completed | Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine |
| NCT05892757 | M22-394 | Ph 1 | completed | Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers |
| NCT04829747 results posted | 3101-311-002 | Ph 3 | completed | 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 |
| NCT04818515 | 3101-106-002 | Ph 1 | completed | Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine |
| NCT03939312 results posted | 3101-309-002 | Ph 3 | completed | Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine |
| NCT03777059 results posted | 3101-301-002 | Ph 3 | completed | 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine |
| NCT03700320 results posted | 3101-302-002 | Ph 3 | completed | Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine |
| NCT02848326 results posted | CGP-MD-01 | Ph 2, Ph 3 | completed | Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
QULIPTA FDA Label Details
Indications & Usage
FDA Label (PDF)QULIPTA is indicated for the treatment of Migraine.
QULIPTA Patents & Exclusivity
Patents (8 active)
Exclusivity
Pro Intelligence Preview
Deep insights for QULIPTA
Revenue Insights
- • Q1-2026: $296M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 60 active patents
Trial Analysis
- • 16 total trials
- • Stage: Expansion
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment