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ubrogepant 🐶 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 | 5361 | 1374248-77-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ubrogepant is a calcitonin gene-related peptide receptor antagonist.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
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 |
|---|---|---|---|
| Dec. 23, 2019 | FDA | ALLERGAN |
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 |
|---|---|---|---|---|---|---|
| Migraine | 84.48 | 22.56 | 69 | 3975 | 190323 | 90434080 |
| Pineal gland cyst | 81.09 | 22.56 | 13 | 4031 | 197 | 90624206 |
| Cervicogenic headache | 80.96 | 22.56 | 13 | 4031 | 199 | 90624204 |
| Migraine without aura | 70.47 | 22.56 | 14 | 4030 | 741 | 90623662 |
| COVID-19 | 46.77 | 22.56 | 47 | 3997 | 168796 | 90455607 |
| Product administration interrupted | 45.14 | 22.56 | 18 | 4026 | 12474 | 90611929 |
| Tension headache | 38.61 | 22.56 | 14 | 4030 | 7495 | 90616908 |
| Headache | 36.39 | 22.56 | 102 | 3942 | 862644 | 89761759 |
| Product dose omission issue | 34.63 | 22.56 | 53 | 3991 | 291634 | 90332769 |
| Device difficult to use | 33.11 | 22.56 | 16 | 4028 | 17509 | 90606894 |
| Intentional dose omission | 32.88 | 22.56 | 16 | 4028 | 17767 | 90606636 |
| Nausea | 32.78 | 22.56 | 116 | 3928 | 1110200 | 89514203 |
| Somnolence | 32.17 | 22.56 | 43 | 4001 | 209041 | 90415362 |
| Asthma | 28.72 | 22.56 | 44 | 4000 | 242116 | 90382287 |
| Drug dose omission by device | 27.70 | 22.56 | 12 | 4032 | 10219 | 90614184 |
| Drug ineffective | 27.59 | 22.56 | 128 | 3916 | 1384170 | 89240233 |
| Impaired quality of life | 26.20 | 22.56 | 15 | 4029 | 23129 | 90601274 |
| Suicidal ideation | 25.03 | 22.56 | 23 | 4021 | 73832 | 90550571 |
| Injection site pain | 24.11 | 22.56 | 34 | 4010 | 173665 | 90450738 |
| Pruritus | 23.69 | 22.56 | 65 | 3979 | 541460 | 90082943 |
| Surgery | 23.56 | 22.56 | 18 | 4026 | 44869 | 90579534 |
| Dermatitis atopic | 23.37 | 22.56 | 14 | 4030 | 23458 | 90600945 |
| Drug effect less than expected | 22.71 | 22.56 | 9 | 4035 | 6129 | 90618274 |
FDA Adverse Event Reporting System (Male)
| 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 | 43.89 | 42.00 | 13 | 271 | 25401 | 42595650 |
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 | 95.53 | 25.71 | 60 | 3106 | 171592 | 110414541 |
| Cervicogenic headache | 85.62 | 25.71 | 13 | 3153 | 218 | 110585915 |
| Pineal gland cyst | 84.86 | 25.71 | 13 | 3153 | 232 | 110585901 |
| Migraine without aura | 72.32 | 25.71 | 13 | 3153 | 630 | 110585503 |
| Device difficult to use | 45.76 | 25.71 | 18 | 3148 | 18787 | 110567346 |
| Tension headache | 41.31 | 25.71 | 14 | 3152 | 9604 | 110576529 |
| Headache | 40.33 | 25.71 | 82 | 3084 | 882295 | 109703838 |
| Nausea | 32.80 | 25.71 | 93 | 3073 | 1235597 | 109350536 |
| Drug dose omission by device | 32.20 | 25.71 | 13 | 3153 | 14503 | 110571630 |
| Product administration interrupted | 31.72 | 25.71 | 12 | 3154 | 11280 | 110574853 |
| Surgery | 29.55 | 25.71 | 17 | 3149 | 41266 | 110544867 |
| Suicidal ideation | 29.12 | 25.71 | 23 | 3143 | 93914 | 110492219 |
| Injection site pain | 28.39 | 25.71 | 30 | 3136 | 177892 | 110408241 |
| Asthma | 27.80 | 25.71 | 35 | 3131 | 250256 | 110335877 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N02CD04 | 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 |
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 |
|---|---|---|---|
| Migraine | indication | 37796009 | DOID:6364 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.67 | acidic |
| pKa2 | 11.49 | acidic |
| pKa3 | 2.79 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 9499545 | Nov. 10, 2031 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS |
| 100MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 9833448 | Nov. 10, 2031 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS |
| 50MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 9499545 | Nov. 10, 2031 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS |
| 50MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 9833448 | Nov. 10, 2031 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS |
| 100MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 8754096 | July 19, 2032 | ACUTE TREATMENT OF MIGRAINE WITH HEADACHE, WITH OR WITHOUT AURA IN ADULTS |
| 50MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 8754096 | July 19, 2032 | ACUTE TREATMENT OF MIGRAINE WITH HEADACHE, WITH OR WITHOUT AURA IN ADULTS |
| 100MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 12070450 | Dec. 22, 2041 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT UNDERGOING TREATMENT WITH A WEAK OR MODERATE CYP3A4 INDUCER |
| 50MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 11717515 | Dec. 22, 2041 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT WITH SEVERE HEPATIC IMPAIRMENT |
| 50MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 11857542 | Dec. 22, 2041 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT WITH SEVERE RENAL IMPAIRMENT |
| 50MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 12194030 | Dec. 22, 2041 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT UNDERGOING TREATMENT WITH A MODERATE CYP3A4 INHIBITOR |
| 50MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 12194030 | Dec. 22, 2041 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT UNDERGOING TREATMENT WITH A WEAK CYP3A4 INHIBITOR |
| 50MG | UBRELVY | ABBVIE | N211765 | Dec. 23, 2019 | RX | TABLET | ORAL | 12329750 | Dec. 22, 2041 | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT UNDERGOING TREATMENT WITH A BCRP AND/OR P-GP ONLY INHIBITOR |
Orange Book exclusivity data (new drug applications)
None
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 | 10.20 | IUPHAR | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 4039081 | VANDF |
| CHEMBL2364638 | ChEMBL_ID |
| D10673 | KEGG_DRUG |
| C000615620 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10176 | IUPHAR_LIGAND_ID |
| DB15328 | DRUGBANK_ID |
| 838467004 | SNOMEDCT_US |
| 838488008 | SNOMEDCT_US |
| C4505936 | UMLSCUI |
| CHEBI:234515 | CHEBI |
| 9803 | INN_ID |
| 328458 | MMSL |
| 37856 | MMSL |
| d09467 | MMSL |
| 68748835 | PUBCHEM_CID |
| 018241 | NDDF |
| AD0O8X2QJR | UNII |
| 2268216 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| UBRELVY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-6498 | TABLET | 50 mg | ORAL | NDA | 32 sections |
| UBRELVY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-6501 | TABLET | 100 mg | ORAL | NDA | 32 sections |