Overview
Atogepant is an oral antagonist of calcitonin gene-related peptide (CGRP) receptors indicated for the prevention of episodic migraine headaches. It was developed by AbbVie and received FDA approval under the brand name Qulipta in September 2021. While its approval was predated by two other members of the same drug family, namely ubrogepant and rimegepant, these agents are indicated only for abortive migraine therapy - atogepant is novel in that it is the first and only oral CGRP antagonist approved for preventative use in migraine. In December 2022, atogepant received Health Canada approval for the prevention of episodic migraine in adults. It also received approval for preventive treatment of adult migraine by the EMA in August 2023. In patients requiring preventative migraine therapy, current practice guidelines recommend the use of certain anti-epileptic medications (e.g. valproic acid or topiramate) or beta-blockers (e.g. propranolol), all of which can be associated with significant adverse effects. The "gepants" family of drugs, including atogepant, are comparatively well-tolerated and may provide a desirable treatment option for patients struggling with adverse reactions to other preventative therapies.
Indication
Atogepant is indicated for the preventive treatment of migraine in adults by the FDA, EMA, and Health Canada.
Associated Conditions
- Episodic Migraine
- Migraine
Research Report
Atogepant (DB16098): A Comprehensive Monograph on a Novel Oral CGRP Receptor Antagonist for Migraine Prophylaxis
Executive Summary
Atogepant is a second-generation, orally administered, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist, also known as a gepant, specifically developed and approved for the preventive treatment of both episodic and chronic migraine in adults.[1] Marketed under the brand names Qulipta and Aquipta, it represents a significant evolution in migraine prophylaxis, offering a targeted mechanism of action within a convenient once-daily oral formulation.[1]
The primary mechanism of action of Atogepant involves its function as a highly potent and selective competitive antagonist of the CGRP receptor. By blocking the binding of the CGRP neuropeptide, Atogepant effectively inhibits the downstream signaling cascades responsible for the neurogenic inflammation, vasodilation, and nociceptive signal transmission that are central to migraine pathophysiology.[6] Its therapeutic activity is believed to be primarily mediated at peripheral sites, with evidence suggesting limited penetration of the blood-brain barrier.[9]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/14 | Phase 4 | Recruiting | |||
2025/03/18 | N/A | Recruiting | |||
2025/02/05 | Phase 3 | Recruiting | |||
2025/02/04 | Phase 3 | Recruiting | |||
2024/09/19 | N/A | Recruiting | |||
2024/05/14 | N/A | Recruiting | |||
2024/02/05 | Phase 3 | Recruiting | |||
2024/01/19 | N/A | ENROLLING_BY_INVITATION | |||
2023/11/18 | N/A | Not yet recruiting | IRCCS San Raffaele Roma | ||
2023/06/07 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AbbVie Inc. | 0074-7095 | ORAL | 10 mg in 1 1 | 2/9/2024 | |
| AbbVie Inc. | 0074-7094 | ORAL | 60 mg in 1 1 | 2/9/2024 | |
| AbbVie Inc. | 0074-7096 | ORAL | 30 mg in 1 1 | 2/9/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/11/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AQUIPTA TABLET 10MG | SIN17145P | TABLET | 10.0mg | 11/29/2024 | |
| AQUIPTA TABLET 60MG | SIN17146P | TABLET | 60.0mg | 11/29/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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