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