Drugs / Atogepant
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed migraine disorder 3 milestones | |||||
| Filed | EU (EMA) | — | migraine disorder | 2025-12-01 | “AbbVie has submitted an application to the European Medicines Agency for expanded use of atogepant for the acute treatment of adults with migraine” abbvie.com ↗ “AbbVie announced it submitted an application to the EMA for expanded use of Aquipta (atogepant) for the acute treatment of adults with migraine.” abbvie.com ↗ |
| Filed | EU (EMA) | — | migraine disorder | 2022-12-06 | “AbbVie has submitted a marketing authorization application to the European Medicines Agency for atogepant for the prophylaxis of migraine” abbvie.com ↗ |
| Filed | EU (EMA) | — | migraine disorder | 2022-07-18 | “has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant” abbvie.com ↗ |
| Filed migraine with aura 1 milestone | |||||
| Filed | US (FDA) | — | migraine with aura | 2021-03-30 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant” abbvie.com ↗ |
| Filed migraine without aura 1 milestone | |||||
| Filed | US (FDA) | QULIPTA | migraine without aura | 2022-06-21 | “today announced that it has submitted a supplemental New Drug Application (sNDA) for atogepant (QULIPTA TM ) to the U.S. Food and Drug Administration (FDA)” abbvie.com ↗ “AbbVie announced that it submitted a supplemental NDA to the FDA for Qulipta (atogepant)” abbvie.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 20
| 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 · 1 met primary | ||||||
| Phase 2/3 | NCT02848326 | Sep 2016 → Apr 2018 | migraine disorder | Allergan | Completed | Met primary |
| Phase 314 trials · 4 met primary | ||||||
| Phase 3 | NCT06810505 | Feb 2025 → Mar 2031 expected | migraine disorder | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06806293 | Feb 2025 → Jun 2026 overdue | migraine disorder | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT06241313 | Mar 2024 → Jul 2025 | migraine disorder | AbbVie | Completed | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT03700320 | Oct 2018 → May 2020 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07826910 | Jan 2027 → Dec 2028 expected | migraine disorder | Konrad Peter Weber | Not yet recruiting | No outcome recorded |
| 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 |
| Comparator or background therapy3 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 4 | NCT06972056 Comparator | Jul 2025 → Mar 2029 expected | migraine disorder | Mayo Clinic | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-09-10 | AbbVie | Results AbbVie Extends Migraine Leadership with Positive Phase 3 Atogepant Results in Menstrual Migraine abbvie.com ↗
AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3 LUNA study, which evaluated atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of menstrual migraine in adults. |
| 2026-06-02 | AbbVie | Regulatory AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved AQUIPTA ® (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed (PRN). |
| 2025-12-01 | AbbVie | Results 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 ↗
The study met its primary and key secondary endpoints, with atogepant demonstrating superiority in pain freedom and freedom from most bothersome migraine symptom (MBS) two hours after treatment of the first migraine attack. |
| 2025-06-18 | AbbVie | Results 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 ↗
The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. |
| 2024-04-12 | AbbVie | Results AbbVie Announces Late-Breaking Data at AAN Supporting Long-Term Safety and Efficacy of Atogepant (QULIPTA®) for Preventive Treatment of Migraine abbvie.com ↗
The overall long-term safety results were consistent with the known safety profile of atogepant in chronic and episodic migraine, and no new safety signals were identified. |
| 2023-08-17 | AbbVie | Regulatory AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Preventive Treatment of Migraine in Adults abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Commission has approved AQUIPTA ® (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. |
| 2023-06-23 | AbbVie | Regulatory AbbVie Secures Positive CHMP Opinion for Atogepant for the Preventive Treatment of Adults with Migraine abbvie.com ↗
The positive CHMP opinion is based on results from two pivotal Phase 3 studies evaluating atogepant for the prophylaxis of migraine in adults with episodic or chronic migraine |
| 2023-04-21 | AbbVie | Results 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 ↗
AbbVie (NYSE: ABBV) today announced positive data from its Phase 3 ELEVATE study, evaluating atogepant for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications. |
| 2023-04-17 | AbbVie | Regulatory U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved expanding the indication of QULIPTA ® (atogepant) for the preventive treatment of migraine in adults. |
| 2022-07-18 | AbbVie | Regulatory AbbVie Submits Marketing Authorization Application to EMA for Atogepant for the Preventive Treatment of Migraine abbvie.com ↗
AbbVie (NYSE: ABBV) today announced it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in adult patients who have at least four migraine days per month. |
| 2022-06-21 | AbbVie | Regulatory 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 ↗
AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for atogepant (QULIPTA TM ) to the U.S. Food and Drug Administration (FDA) to support the preventive treatment of chronic migraine in adults. |
| 2022-03-29 | AbbVie | Results AbbVie to Showcase Breadth of Neuroscience Portfolio and Pipeline at American Academy of Neurology (AAN) 2022 Annual Meeting abbvie.com ↗
Atogepant – an orally-administered CGRP antagonist – attenuates activation of meningeal nociceptors by Cortical Spreading Depression (CSD) |
| 2022-03-10 | AbbVie | Results AbbVie Announces Positive Phase 3 Atogepant (QULIPTA™) Data for the Preventive Treatment of Chronic Migraine abbvie.com ↗
The study also demonstrated that treatment with atogepant 60 mg QD and 30 mg BID resulted in statistically significant improvements in all secondary endpoints after adjustment for multiple comparisons. |
| 2021-09-28 | AbbVie | Regulatory FDA Approves QULIPTA™ (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved QULIPTA™ (atogepant) for the preventive treatment of episodic migraine in adults. |
| 2021-08-18 | AbbVie | Results New England Journal of Medicine Publishes 12-Week Results from Study Evaluating Atogepant for the Preventive Treatment of Migraine abbvie.com ↗
The study also found that a greater proportion of atogepant-treated participants achieved at least a 50% reduction in mean monthly migraine days for all doses compared to placebo and met other key secondary endpoints. |
| 2021-05-26 | AbbVie | Results AbbVie to Present Data from its Leading Migraine Portfolio at the 2021 American Headache Society (AHS) Annual Scientific Meeting abbvie.com ↗
Atogepant Significantly Reduces Mean Monthly Migraine Days in the Phase 3 Trial (ADVANCE) for the Prevention of Migraine |
| 2021-03-30 | AbbVie | Regulatory U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine abbvie.com ↗ |
| 2020-07-29 | AbbVie | Results AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the Phase 3 ADVANCE trial evaluating the investigational medicine atogepant, an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days, compared to placebo, for all doses across the 12-week treatment period. |
| 2019-07-09 | AbbVie | Results Allergan Continues to Demonstrate Leadership in Migraine with 29 Presentations at the 2019 American Headache Society Annual Meeting abbvie.com ↗
Absence of Clinically Significant Drug Interactions With Coadministration of Atogepant and an Ethinyl Estradiol/Levonorgestrel Oral Contraceptive in Healthy Female Subjects: A Phase 1 Pharmacokinetic Analysis. |
| 2019-05-02 | AbbVie | Results Allergan Continues to Display Leadership in Neurosciences with 29 Presentations at 2019 American Academy of Neurology Annual Meeting abbvie.com ↗
Orally Administered Atogepant Was Efficacious, Safe, and Tolerable for the Prevention of Migraine: Results from a Phase 2b/3 Study. |
| 2018-06-11 | AbbVie | Results 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 ↗
All active treatment arms of atogepant met the primary endpoint across all doses and dose regimens, with a statistically significant reduction from baseline in monthly migraine/probable migraine (MPM) headache days in patients with episodic migraine treated with atogepant compared with placebo for 12 weeks. |
All press releases naming this drug 21 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 25 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 ↗ |