Atogepant
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Atogepant
- Molecular weight
- 603.52
- Structure (SMILES)
- C[C@@H]1[C@H](c2c(F)ccc(F)c2F)C[C@H](NC(=O)c2cnc3c(c2)C[C@@]2(C3)C(=O)Nc3ncccc32)C(=O)N1CC(F)(F)F
- aquipta
- Aquipta
- qulipta
- Qulipta
- agn 241689
- AGN-241689
- atogepant
- Atogepant
- atogepant [INN]
- Atogepant [MI]
- ATOGEPANT [ORANGE BOOK]
- ATOGEPANT [USAN]
- Atogepant [WHO-DD]
- Atogepant 30 mg
- Atogepant 60 mg
- atogepant inn
- atogepant mi
- atogepant orange book
- atogepant usan
- atogepant who dd
- mk 8031
- MK-8031
- ATC classification codes
- N02CD07
Sources for recorded values
- CAS registry numbers
- 1374248-81-3
- ChEMBL ID
- CHEMBL3991065
- InChIKey
- QIVUCLWGARAQIO-OLIXTKCUSA-N
- PubChem compound IDs
- 72163100
- RxNorm IDs (RxCUI)
- 2571813
- FDA ingredient codes (UNII)
- 7CRV8RR151
- Applicant
- ABBVIE
- Approval date
- 28 Sept 2021
- Application number
- NDA215206
- Status
- Authorised
- Status date
- 11 Aug 2023
- Authorisation date
- 11 Aug 2023
- Approved indications
- Aquipta is indicated for: - acute treatment of migraine with or without aura in adults - prophylaxis of migraine in adults who have at least 4 migraine days per month.
- Product number
- EMEA/H/C/005871
- Authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Migraine Disorders
European medicines record
- Patents
- 8
- Designations
- 0
- Earliest recorded loss of exclusivity
- 27 Feb 2043
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- atogepant
- Type
- Synthetic organic
- Drug name stem
- -gepant
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Antagonist
- Action type
- Antagonist
- Target
- CGRP receptor
- Gene symbol
- RAMP1
- Protein identifier
- O60894
- Median affinity
- 10.82
- Affinity units
- pKi
- Action
- Antagonist
- Action type
- Antagonist
- Target
- CGRP receptor
- Gene symbol
- CALCRL
- Protein identifier
- Q16602
- Median affinity
- 10.82
- Affinity units
- pKi
- Mechanism
- Calcitonin gene-related peptide type 1 receptor antagonist
- Action type
- Antagonist
- Target
- Calcitonin gene-related peptide type 1 receptor
- Protein identifier
- Q16602
Open Targets mechanisms
- Mechanism
- Calcitonin gene-related peptide type 1 receptor antagonist
- Action type
- Antagonist
- Target
- Calcitonin gene-related peptide type 1 receptor
Investigated indications
- Condition
- Migraine Disorders
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005277
- Subject identifier
- D008881
- Condition identifier
- EFO_0008008
- Condition identifier
- MONDO_0005277
- Condition identifier
- MONDO_0005277
- Highest recorded phase
- 4
- NCT02848326
- NCT03700320
- NCT03777059
- NCT03855137
- NCT03939312
- NCT04437433
- NCT04686136
- NCT04740827
- NCT04818515
- NCT04829747
- NCT04961671
- NCT05216263
- NCT05264129
- NCT05707949
- NCT05711394
- NCT05748483
- NCT05861427
- NCT06241313
- Dose
- 10 mg, 30 mg, or 60 mg
- Route
- Oral
- How often
- Once daily
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 2
- Polar surface area
- 104.29
- Calculated partition coefficient (ALogP)
- 3.95
- Calculated partition coefficient (XLogP)
- 3.4
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 1
- Rotatable bonds
- 4
- Heavy atoms
- 43
- Molecular formula
- C29H23F6N5O3
- Monoisotopic mass
- 603.17050859
- Natural product
- No
- 0074-7094
- 0074-7095
- 0074-7096
- Recorded assays
- 6
- Active assays
- 4
Active assay types
- Confirmatory
Related records
Trials (28)
- 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
- A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
- A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine
- A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
- A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
- Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
- Atogepant in Real Life in Italy (GIANT)
- Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
- Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
- Comparing Migraine Preventive Therapies vs. Anti-CGRP Therapies for Tinnitus in Patients With Migraine (COMPACT-PM)
- Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
- Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
- Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
- Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients
- Long-term Atogepant in Real-world Practice
- Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
- Migraine Medication Effects on Urinary Symptoms
- Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
- Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine
- Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine
Approved for (1)
Targets (1)
- CALCRL Calcitonin gene-related peptide type 1 receptor antagonist