atogepant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
calcitonin gene-related peptide receptor antagonists	5472	1374248-81-3

Description:

Molecule

Description

Molfile Inchi Smiles

Synonyms:

atogepant
qulipta
AGN-241689
MK-8031

Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.

Molecular weight: 603.53
Formula: C29H23F6N5O3
CLOGP: 3.47
LIPINSKI: 1
HAC: 8
HDO: 2
TPSA: 104.29
ALOGS: -4.36
ROTB: 5

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
60	mg	O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	PDK1,PDK2,PDK4	3
kinase-selectivity-class	PDK1	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	1

Approvals:

Date	Agency	Company	Orphan
Sept. 28, 2021	FDA	ABBVIE INC
Aug. 11, 2023	EMA	AbbVie Deutschland GmbH & Co. KG

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Constipation	127.36	25.83	82	2201	280313	90345851
Nausea	83.14	25.83	119	2164	1110197	89515967
Migraine	47.79	25.83	39	2244	190353	90435811
Product administration interrupted	28.44	25.83	11	2272	12481	90613683
Headache	28.36	25.83	65	2218	862681	89763483
Intentional dose omission	27.93	25.83	12	2271	17771	90608393
Weight decreased	26.98	25.83	40	2243	379870	90246294
Therapy interrupted	25.95	25.83	16	2267	50092	90576072

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Migraine	56.18	27.32	33	1514	171619	110416133
Nausea	49.01	27.32	72	1475	1235618	109352134
Constipation	48.54	27.32	40	1507	357746	110230006

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N02CD07	NERVOUS SYSTEM ANALGESICS ANTIMIGRAINE PREPARATIONS Calcitonin gene-related peptide (CGRP) antagonists
FDA EPC	N0000193917	Calcitonin Gene-related Peptide Receptor Antagonist
FDA MoA	N0000193918	Calcitonin Gene-related Peptide Receptor Antagonists
CHEBI has role	CHEBI:196956	calcitonin gene-related peptide receptor antagonist

Related Drugs by ATC class:

N02CD Calcitonin gene-related peptide (CGRP) antagonists 7 drugs

eptinezumab erenumab fremanezumab galcanezumab rimegepant ubrogepant zavegepant

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Preventive treatment of episodic migraine in adults	indication	408381007

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	9499545	Nov. 10, 2031	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
30MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	9499545	Nov. 10, 2031	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
60MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	9499545	Nov. 10, 2031	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
10MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	8754096	Sept. 28, 2035	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
30MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	8754096	Sept. 28, 2035	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
60MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	8754096	Sept. 28, 2035	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
10MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12383545	June 6, 2039	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
30MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12383545	June 6, 2039	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
60MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12383545	June 6, 2039	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
10MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12090148	July 29, 2041	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
30MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12090148	July 29, 2041	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
60MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12090148	July 29, 2041	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
10MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12465598	Sept. 27, 2042	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS WITH SEVERE RENAL IMPAIRMENT OR END-STAGE RENAL DISEASE
10MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12622897	Sept. 27, 2042	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS UNDERGOING CONCURRENT TREATMENT WITH AN OATP INHIBITOR
30MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12622897	Sept. 27, 2042	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS UNDERGOING CONCURRENT TREATMENT WITH AN OATP INHIBITOR
10MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	12350259	Feb. 27, 2043	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS UNDERGOING CONCURRENT TREATMENT WITH A STRONG CYP3A4 INHIBITOR

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	April 17, 2026	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
30MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	April 17, 2026	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
60MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	April 17, 2026	PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
10MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	Sept. 28, 2026	NEW CHEMICAL ENTITY
30MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	Sept. 28, 2026	NEW CHEMICAL ENTITY
60MG	QULIPTA	ABBVIE	N215206	Sept. 28, 2021	RX	TABLET	ORAL	Sept. 28, 2026	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Calcitonin gene-related peptide type 1 receptor	GPCR	Q16602	CALRL_HUMAN	ANTAGONIST	Ki	10.82		SCIENTIFIC LITERATURE	DRUG LABEL

External reference:

ID	Source
7CRV8RR151	UNII
C5238205	UMLSCUI
CHEBI:196955	CHEBI
CHEMBL3991065	ChEMBL_ID
72163100	PUBCHEM_CID
DB16098	DRUGBANK_ID
D11313	KEGG_DRUG
10510	INN_ID
C000718987	MESH_SUPPLEMENTAL_RECORD_UI
9730	IUPHAR_LIGAND_ID
2054131000122101	SNOMEDCT_US
4040846	VANDF
350582	MMSL
39917	MMSL
d09812	MMSL
018859	NDDF
2571813	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Qulipta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-7094	TABLET	60 mg	ORAL	NDA	31 sections
Qulipta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-7094	TABLET	60 mg	ORAL	NDA	31 sections
Qulipta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-7095	TABLET	10 mg	ORAL	NDA	31 sections
Qulipta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-7095	TABLET	10 mg	ORAL	NDA	31 sections
Qulipta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-7096	TABLET	30 mg	ORAL	NDA	31 sections
Qulipta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-7096	TABLET	30 mg	ORAL	NDA	31 sections