vibegron 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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:
None
ADMET properties:
None
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)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| CHEBI has role | CHEBI:35522 | beta-adrenergic agonists |
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 | UROVANT | N213006 | Dec. 23, 2020 | RX | TABLET | ORAL | 8247415 | Dec. 1, 2030 | TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY |
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 | UROVANT | N213006 | Dec. 23, 2020 | RX | TABLET | ORAL | Dec. 23, 2025 | NEW CHEMICAL ENTITY |
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 |
| C4279743 | UMLSCUI |
| CHEBI:142418 | CHEBI |
| CHEMBL2107826 | ChEMBL_ID |
| 44472635 | PUBCHEM_CID |
| DB14895 | DRUGBANK_ID |
| D10433 | KEGG_DRUG |
| 9676 | INN_ID |
| 10100 | IUPHAR_LIGAND_ID |
| 39113 | MMSL |
| d09697 | MMSL |
| 018600 | NDDF |
| 1149377005 | SNOMEDCT_US |
| 1149380006 | SNOMEDCT_US |
| 4039964 | VANDF |
| C000608232 | MESH_SUPPLEMENTAL_RECORD_UI |
| 2472254 | RXNORM |
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 |