Drugs / Atogepant
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Aquipta | — | 2023-08-11 | europa.eu ↗ |
| Label expansion | US (FDA) | QULIPTA | — | 2023-04-17 | fda.gov ↗ |
| Approved | US (FDA) | QULIPTA | — | 2021-09-28 | fda.gov ↗ |
Trials 19 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05892757 | Jul 2023 → Feb 2024 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT04818515 | Mar → Jun 2021 | migraine disorder | AbbVie | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02848326 | Sep 2016 → Apr 2018 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT06810505 | Feb 2025 → Mar 2031 expected | migraine disorder | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06806293 | Feb 2025 → Aug 2026 overdue | migraine disorder | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06241313 | Mar 2024 → Jul 2025 overdue | migraine disorder | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05748483 | Oct 2023 → Apr 2025 | migraine disorder | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT05861427 | Jul 2023 → Mar 2025 | migraine disorder | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT05707949 | Jun 2023 → Apr 2032 expected | — | AbbVie | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05711394 | May 2023 → Mar 2028 expected | migraine disorder | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT05216263 | Mar 2022 → May 2025 | migraine disorder | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04829747 | Aug 2021 → Jan 2022 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT04686136 | Feb 2021 → Oct 2025 | migraine disorder | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04437433 | Jun 2020 → Jun 2024 | migraine disorder | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03939312 | May 2019 → Mar 2021 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT03777059 | Dec 2018 → Jun 2020 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT03700320 | Oct 2018 → May 2020 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07655440 | Jul 2026 → Jul 2031 expected | migraine disorder, tinnitus, vestibular disorder | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05264129 | Mar 2022 → Apr 2023 | migraine disorder | AbbVie | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT04740827 Comparator | Mar 2021 → Aug 2022 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT03855137 Comparator | Mar 2019 → Jan 2022 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06972056 Comparator | Jul 2025 → Mar 2029 expected | migraine disorder | Mayo Clinic | Recruiting | No outcome recorded |
Press releases naming this drug 16 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | AbbVie | AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults abbvie.com ↗ |
| 2025-12-01 | AbbVie | AbbVie to Present Phase 3 ECLIPSE Data Demonstrating Atogepant (AQUIPTA®) Superiority Over Placebo in Achieving Pain Freedom for the Acute Treatment of Migraine at the 19th European Headache Congress abbvie.com ↗ |
| 2025-06-18 | AbbVie | AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention abbvie.com ↗ |
| 2024-04-12 | AbbVie | AbbVie Announces Late-Breaking Data at AAN Supporting Long-Term Safety and Efficacy of Atogepant (QULIPTA®) for Preventive Treatment of Migraine abbvie.com ↗ |
| 2023-08-17 | AbbVie | AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Preventive Treatment of Migraine in Adults abbvie.com ↗ |
| 2023-06-23 | AbbVie | AbbVie Secures Positive CHMP Opinion for Atogepant for the Preventive Treatment of Adults with Migraine abbvie.com ↗ |
| 2023-04-21 | AbbVie | AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA®) for the Preventive Treatment of Episodic Migraine Among Patients with Prior Treatment Failure at the 2023 AAN Annual Meeting abbvie.com ↗ |
| 2023-04-17 | AbbVie | U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine abbvie.com ↗ |
| 2022-07-18 | AbbVie | AbbVie Submits Marketing Authorization Application to EMA for Atogepant for the Preventive Treatment of Migraine abbvie.com ↗ |
| 2022-06-21 | AbbVie | AbbVie Submits Supplemental New Drug Application to U.S. FDA for Atogepant (QULIPTA™) to Support Label Expansion for the Preventive Treatment of Migraine abbvie.com ↗ |
| 2022-03-10 | AbbVie | AbbVie Announces Positive Phase 3 Atogepant (QULIPTA™) Data for the Preventive Treatment of Chronic Migraine abbvie.com ↗ |
| 2021-09-28 | AbbVie | FDA Approves QULIPTA™ (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine abbvie.com ↗ |
| 2021-08-18 | AbbVie | New England Journal of Medicine Publishes 12-Week Results from Study Evaluating Atogepant for the Preventive Treatment of Migraine abbvie.com ↗ |
| 2021-03-30 | AbbVie | U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine abbvie.com ↗ |
| 2020-07-29 | AbbVie | AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention abbvie.com ↗ |
| 2018-06-11 | AbbVie | Allergan's Oral CGRP Receptor Antagonist Atogepant Demonstrates Robust Efficacy and Safety in Episodic Migraine Prevention in a Phase 2b/3 Clinical Trial abbvie.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Atogepant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03855137 ↗ |
| Known as | AGN-241689 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3991065 ↗ |
| Known as | Aquipta | ChEMBL registry synonym — accepted as the source's own label CHEMBL3991065 ↗ |
| Known as | MK-8031 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3991065 ↗ |
| Known as | Qulipta | ChEMBL registry synonym — accepted as the source's own label CHEMBL3991065 ↗ |
| Action | Inhibit | “Atogepant is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist” PMID 32822633 ↗ Sep 20201“Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL3991065 ↗ |
| Modality | Small molecule | “Atogepant is an orally administered, small-molecule” PMID 32822633 ↗ Sep 2020 |
| Route | Oral | “Atogepant is an orally administered” PMID 32822633 ↗ Sep 2020 |
| Target | CALCRL | “Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL3991065 ↗ |