Ubrogepant is evaluated across numerous clinical trials spanning Phase 1 through Phase 4 protocols, focusing primarily on neurovascular conditions such as episodic migraine and migraine with or without aura. Clinical investigations also cover urological disorders—including overactive bladder syndrome and interstitial cystitis—alongside pharmacokinetic, lactation safety, and Phase 2b dose-ranging efficacy evaluations in healthy volunteers. Sponsored by pharmaceutical leaders such as AbbVie and Allergan as well as academic institutions like The Cleveland Clinic, these studies encompass recruitment statuses including completed, recruiting, and terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05127954 | ENROLLING_BY_INVITATION | Migraine |
AbbVie |
2022-01-14 | PHASE3 |
| NCT06417775 | ACTIVE_NOT_RECRUITING | Migraine |
AbbVie |
2024-09-10 | PHASE3 |
| NCT05125302 | RECRUITING | Migraine |
AbbVie |
2022-01-13 | PHASE3 |
| NCT07680686 | RECRUITING | Healthy Volunteer |
AbbVie |
2026-07-14 | PHASE1 |
| NCT06578585 | COMPLETED | Migraine |
H. Lundbeck A/S |
2024-09-13 | PHASE1 |
| NCT05503082 | UNKNOWN | Headache, Migraine |
Chicago Headache Center & Research Institute |
2022-09-06 | PHASE4 |
| NCT05214001 | TERMINATED | Migraine With Aura; Migraine Without Aura |
Messoud Ashina, MD |
2022-06-30 | PHASE4 |
| NCT05892757 | COMPLETED | Healthy Volunteers |
AbbVie |
2023-07-11 | PHASE1 |
| NCT05892757 | Completed | Healthy Volunteers |
AbbVie |
2023-07-11 | Phase 1 |
| NCT05827887 | Recruiting | Migraine |
AbbVie |
2023-06-25 | -- |
| NCT05264129 | COMPLETED | Episodic Migraine |
AbbVie |
2022-03-07 | PHASE4 |
| NCT05654298 | COMPLETED | Migraine |
Universitaire Ziekenhuizen KU Leuven |
2022-03-15 | |
| NCT04492020 | COMPLETED | Migraine |
AbbVie |
2020-08-21 | PHASE3 |
| NCT04818515 | COMPLETED | Migraine |
AbbVie |
2021-03-17 | PHASE1 |
| NCT04818515 | Completed | Migraine |
AbbVie |
2021-03-17 | Phase 1 |
| NCT04179474 | COMPLETED | Migraine |
Allergan |
2019-09-26 | PHASE1 |
| NCT04179474 | Completed | Migraine |
Allergan |
2019-09-26 | Phase 1 |
| NCT02873221 | COMPLETED | Migraine, With or Without Aura |
Allergan |
2016-09-13 | PHASE3 |
| NCT02867709 | COMPLETED | Migraine, With or Without Aura |
Allergan |
2016-08-26 | PHASE3 |
| NCT02828020 | COMPLETED | Migraine, With or Without Aura |
Allergan |
2016-07-22 | PHASE3 |
| NCT01657370 | Completed | Migraine |
Allergan |
2012-08 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2025-07-20)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).