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vibegron 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| beta3-adrenoreceptor agonists | 5311 | 1190389-15-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Vibegron is selectively binds to the beta 3 adrenergic receptor (beta3 AR) in bladder smooth muscle, resulting in relaxation of the detrusor muscle.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 75 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.16 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 4 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | EIF2AK3,GRK2,PDK1,PDK2,PDK4,PRKDC | 6 | |||
| kinase-selectivity-class | AXL,GRK2,PDK1 | 3 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 23, 2020 | FDA | UROVANT SCIENCES GMBH | |
| Sept. 21, 2018 | PMDA | Kyorin Pharmaceutical Co., Ltd. |
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 |
|---|---|---|---|---|---|---|
| Urinary retention | 63.02 | 24.96 | 24 | 1565 | 37720 | 90589138 |
| Pruritus | 28.79 | 24.96 | 41 | 1548 | 541484 | 90085374 |
| Dry skin | 27.84 | 24.96 | 18 | 1571 | 88055 | 90538803 |
| Urinary tract infection | 27.23 | 24.96 | 30 | 1559 | 305602 | 90321256 |
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 |
|---|---|---|---|---|---|---|
| Urinary retention | 121.61 | 31.16 | 42 | 859 | 42172 | 42578262 |
| Pleurothotonus | 38.02 | 31.16 | 8 | 893 | 1203 | 42619231 |
| Tendinous contracture | 32.04 | 31.16 | 5 | 896 | 139 | 42620295 |
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 |
|---|---|---|---|---|---|---|
| Urinary retention | 101.55 | 22.20 | 41 | 2055 | 69642 | 110517561 |
| Urinary tract infection | 35.60 | 22.20 | 37 | 2059 | 326245 | 110260958 |
| Pleurothotonus | 33.10 | 22.20 | 8 | 2088 | 2490 | 110584713 |
| Instillation site discharge | 32.68 | 22.20 | 4 | 2092 | 18 | 110587185 |
| Tendinous contracture | 22.25 | 22.20 | 4 | 2092 | 295 | 110586908 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | G04BD15 | GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence |
| FDA MoA | N0000185007 | Adrenergic beta3-Agonists |
| FDA EPC | N0000185008 | beta3-Adrenergic Agonist |
| CHEBI has role | CHEBI:35522 | β-adrenergic agonist |
Related Drugs by ATC class:
G04BD Drugs for urinary frequency and incontinence 13 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Bladder muscle dysfunction - overactive | indication | 236633002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.78 | acidic |
| pKa2 | 8.94 | Basic |
| pKa3 | 2.54 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 75MG | GEMTESA | SUMITOMO PHARMA AM | N213006 | Dec. 23, 2020 | RX | TABLET | ORAL | 8247415 | Dec. 23, 2034 | TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY |
| 75MG | GEMTESA | SUMITOMO PHARMA AM | N213006 | Dec. 23, 2020 | RX | TABLET | ORAL | 8247415 | Dec. 23, 2034 | TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY IN ADULT MALES ON PHARMACOLOGICAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH) |
| 75MG | GEMTESA | SUMITOMO PHARMA AM | N213006 | Dec. 23, 2020 | RX | TABLET | ORAL | 12102638 | March 22, 2040 | TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY |
| 75MG | GEMTESA | SUMITOMO PHARMA AM | N213006 | Dec. 23, 2020 | RX | TABLET | ORAL | 12357636 | July 6, 2042 | TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY IN ADULT MALES ON PHARMACOLOGICAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 75MG | GEMTESA | SUMITOMO PHARMA AM | N213006 | Dec. 23, 2020 | RX | TABLET | ORAL | Dec. 18, 2027 | TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY IN ADULT MALES ON PHARMACOLOGICAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Beta-3 adrenergic receptor | GPCR | AGONIST | EC50 | 8.96 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Beta-3 adrenergic receptor | GPCR | EC50 | 7.07 | CHEMBL | |||||
| Beta-3 adrenergic receptor | GPCR | EC50 | 7.96 | CHEMBL | |||||
| Beta-3 adrenergic receptor | GPCR | EC50 | 9.24 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| M5TSE03W5U | UNII |
| 4039964 | VANDF |
| C4279743 | UMLSCUI |
| CHEBI:142418 | CHEBI |
| CHEMBL2107826 | ChEMBL_ID |
| 44472635 | PUBCHEM_CID |
| DB14895 | DRUGBANK_ID |
| D10433 | KEGG_DRUG |
| 9676 | INN_ID |
| C000608232 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10100 | IUPHAR_LIGAND_ID |
| 1149377005 | SNOMEDCT_US |
| 1149380006 | SNOMEDCT_US |
| 39113 | MMSL |
| d09697 | MMSL |
| 018600 | NDDF |
| 2472254 | RXNORM |
| M5TSE03W5U | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| GEMTESA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73336-075 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 31 sections |