Clinical Trials

Atogepant is evaluated across numerous clinical trials spanning Phase 1 through Phase 4, focusing on migraine spectrum disorders—including episodic, chronic, menstrual, and vestibular migraines—as well as overactive bladder syndrome. Sponsored by industry leaders like AbbVie and Allergan alongside academic centers such as Stanford University and Mayo Clinic, these initiatives range from completed pivotal studies to active, recruiting, and upcoming observational protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05707949 ENROLLING_BY_INVITATION
Migraine Prophylaxis
AbbVie
 2023-06-05 PHASE3
NCT07655440 NOT_YET_RECRUITING
Migraine Associated Vertigo; Tinnitus; Migraine; Vestibular Migraine
Stanford University
 2026-07 PHASE4
NCT06810505 RECRUITING
Chronic Migraine
AbbVie
 2025-02-13 PHASE3
NCT06972056 RECRUITING
Migraine
Mayo Clinic
 2025-07-09 PHASE4
NCT05711394 RECRUITING
Episodic Migraine
AbbVie
 2023-05-01 PHASE3
NCT06806293 ACTIVE_NOT_RECRUITING
Menstrual Migraine (MM)
AbbVie
 2025-02-10 PHASE3
NCT04686136 COMPLETED
Episodic Migraine; Chronic Migraine
AbbVie
 2021-02-19 PHASE3
NCT06241313 ACTIVE_NOT_RECRUITING
Migraine
AbbVie
 2024-03-25 PHASE3
NCT05216263 COMPLETED
Chronic Migraine
AbbVie
 2022-03-22 PHASE3
NCT05748483 COMPLETED
Migraine
AbbVie
 2023-10-07 PHASE3
NCT05861427 COMPLETED
Migraine
AbbVie
 2023-07-12 PHASE3
NCT04437433 COMPLETED
Chronic Migraine; Episodic Migraine
AbbVie
 2020-06-18 PHASE3
NCT05892757 COMPLETED
Healthy Volunteers
AbbVie
 2023-07-11 PHASE1
NCT05264129 COMPLETED
Episodic Migraine
AbbVie
 2022-03-07 PHASE4
NCT04740827 COMPLETED
Episodic Migraine
Allergan
 2021-03-05 PHASE3
NCT04829747 COMPLETED
Chronic Migraine
Allergan
 2021-08-02 PHASE3
NCT03855137 COMPLETED
Chronic Migraine
Allergan
 2019-03-11 PHASE3
NCT04818515 COMPLETED
Migraine
AbbVie
 2021-03-17 PHASE1
NCT03939312 COMPLETED
Episodic Migraine
Allergan
 2019-05-06 PHASE3
NCT03777059 COMPLETED
Episodic Migraine
Allergan
 2018-12-14 PHASE3
NCT03700320 COMPLETED
Episodic Migraine
Allergan
 2018-10-08 PHASE3
NCT02848326 COMPLETED
Migraine, With or Without Aura
Allergan
 2016-09-06 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2025-08-11)

Check the Atogepant product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atogepant functions as a potent, selective antagonist of the calcitonin gene-related peptide receptor, binding the receptor complex to inhibit CGRP-mediated intracellular signaling and downstream neurogenic vasodilatory cascades. By suppressing neurogenic inflammation and cranial vascular dilation, this receptor blockade prevents the activation of trigeminovascular pain pathways in patients suffering from episodic and chronic migraine.

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>).

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Note: Technical data last updated: Sep 1, 2026.