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Vibegron
Gemtesa (vibegron) is a small molecule pharmaceutical. Vibegron was first approved as Gemtesa on 2020-12-23. It is used to treat overactive urinary bladder in the USA. The pharmaceutical is active against beta-3 adrenergic receptor.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Gemtesa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vibegron
Tradename
Company
Number
Date
Products
GEMTESAUrovant SciencesN-213006 RX2020-12-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
gemtesaNew Drug Application2021-01-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
overactive urinary bladderEFO_1000781D053201N32.81
Agency Specific
FDA
EMA
Expiration
Code
VIBEGRON, GEMTESA, UROVANT
2025-12-23NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Vibegron, Gemtesa, Urovant
82474152030-12-01DS, DPU-3045
86532602029-04-02DP
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
13 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Overactive urinary bladderD053201EFO_1000781N32.81314—19
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Irritable bowel syndromeD043183EFO_0000555K58—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I101————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVIBEGRON
INNvibegron
Description
Vibegron is a pyrrolopyrimidine obtained by formal condensation of the carboxy group of (6S)-4-oxo-4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6-carboxylic acid with the amino group of (R)-[(2R,5S)-5-(4-aminobenzyl)pyrrolidin-2-yl](phenyl)methanol. It is a beta3-adrenergic receptor agonist currently in clinical development for the treatment of patients with overactive bladder. It has a role as a beta-adrenergic agonist. It is a secondary alcohol, a member of pyrrolidines, a member of benzenes, a secondary carboxamide, a pyrrolopyrimidine and a secondary amine.
Classification
Small molecule
Drug classbeta3 adrenoreceptor agonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(Nc1ccc(C[C@@H]2CC[C@H]([C@H](O)c3ccccc3)N2)cc1)[C@@H]1CCc2nccc(=O)n21
Identifiers
PDB—
CAS-ID1190389-15-1
RxCUI—
ChEMBL IDCHEMBL2107826
ChEBI ID—
PubChem CID44472635
DrugBankDB14895
UNII IDM5TSE03W5U (ChemIDplus, GSRS)
Target
Agency Approved
ADRB3
ADRB3
Organism
Homo sapiens
Gene name
ADRB3
Gene synonyms
ADRB3R, B3AR
NCBI Gene ID
155
Protein name
beta-3 adrenergic receptor
Protein synonyms
adrenergic, beta-3-, receptor, Beta-3 adrenoceptor, Beta-3 adrenoreceptor
Uniprot ID
Q4JFT4
Mouse ortholog
Adrb3 (11556)
beta-3 adrenergic receptor (Q9QZ98)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 116 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29 adverse events reported
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