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Balovaptan
Balovaptan is a small molecule pharmaceutical. It is currently being investigated in clinical studies. It is known to target 5-hydroxytryptamine receptor 2B, vasopressin V1a receptor, vasopressin V2 receptor, and oxytocin receptor.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
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Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
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Patent Expiration
No data
ATC Codes
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HCPCS
No data
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autism spectrum disorderD000067877F84.0321——6
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Post-traumatic stress disordersD013313EFO_0001358F43.1—1———1
Ischemic strokeD000083242—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—9————9
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBALOVAPTAN
INNbalovaptan
Description
Balovaptan (INN; developmental code name RG7314), is a selective small molecule antagonist of the vasopressin V1A receptor which is under development by Roche for the treatment of post-traumatic stress disorder. It was in a phase III clinical trial for adults and a phase II clinical trial for children for this indication. On 29 January 2018, Roche announced that the US Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation for balovaptan in individuals with autism spectrum disorder (ASD). The FDA granted this based on the results of the adult phase II clinical trial called VANILLA (Vasopressin ANtagonist to Improve sociaL communication in Autism) study. The phase III adult study (March 2020) is called V1aduct and the currently-closed (August 2019) phase II child study is called Av1ation. It was also in phase II studies for the treatment of stroke. However, it has since been discontinued for both of those indications, and is only being developed for post-traumatic stress disorder, with plans to submit regulatory filings in 2025 or later.
Classification
Small molecule
Drug classaptamers, classical and mirror; vasopressin receptor antagonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN1Cc2cc(Cl)ccc2-n2c(nnc2[C@H]2CC[C@H](Oc3ccccn3)CC2)C1
Identifiers
PDB—
CAS-ID1228088-30-9
RxCUI—
ChEMBL IDCHEMBL4297183
ChEBI ID—
PubChem CID46200932
DrugBankDB14823
UNII IDRAX5D5AGV6 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
HTR2B
HTR2B
AVPR1A
AVPR1A
AVPR2
AVPR2
OXTR
OXTR
Organism
Homo sapiens
Gene name
HTR2B
Gene synonyms
NCBI Gene ID
3357
Protein name
5-hydroxytryptamine receptor 2B
Protein synonyms
5-HT 2B receptor, 5-hydroxytryptamine (serotonin) receptor 2B, G protein-coupled, 5-hydroxytryptamine 2B receptor, Serotonin receptor 2B
Uniprot ID
Q6P523
Mouse ortholog
Htr2b (15559)
5-hydroxytryptamine receptor 2B (Q9QWS2)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 35 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1 adverse events reported
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