UBROGEPANT · Aurobindo Pharma
UBROGEPANT is FDA-approved to treat 1 condition (same as UBRELVY).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-12-23
- Routes
- N/A
- Dosage Forms
- TABLET
UBROGEPANT Approval History
What UBROGEPANT Treats
1 indicationsUBROGEPANT is approved for 1 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as UBRELVY (same active ingredient).
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05125302 Ubro Peds | 3110-305-002 | Ph 3 | recruiting | Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17) |
| NCT06417775 UBRO MM | M23-714 | Ph 3 | recruiting | Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine |
| NCT06578585 | 20527A | Ph 1 | completed | A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine |
| NCT05127954 UBRO PEDS OLE | 3110-306-002 | Ph 3 | enrolling by invitation | Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17) |
| 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 |
| 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 |
| NCT04179474 results posted | 3110-108-002 | Ph 1 | completed | Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine |
| NCT02873221 results posted | UBR-MD-04 | Ph 3 | completed | An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine |
| NCT02867709 ACHIEVE II results posted | UBR-MD-02 | Ph 3 | completed | Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine |
| NCT02828020 ACHIEVE I results posted | UBR-MD-01 | Ph 3 | completed | Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine |
| NCT07680686 | M26-480 | Ph 1 | not yet recruiting | Study to Assess How Different Oral Formulations of Ubrogepant Move Through the Body in Healthy Adult Participants |
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.
UBROGEPANT FDA Label Details
Indications & Usage
UBROGEPANT is FDA-approved to treat 1 condition — same approved indications as UBRELVY.
Looking for the branded version?
UBRELVY
Full clinical data, patents, trials, and competitive landscape for ubrogepant.
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