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Ganaxolone
Ztalmy (ganaxolone) is a small molecule pharmaceutical. Ganaxolone was first approved as Ztalmy on 2022-06-01. It is used to treat seizures in the USA. It is known to target gamma-aminobutyric acid receptor subunit alpha-1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Ztalmy
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ganaxolone
Tradename
Company
Number
Date
Products
ZTALMYMarinus PharmaceuticalsN-215904 RX2022-06-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ztalmyNew Drug Application2022-06-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
seizuresHP_0007359D012640G40.4
Agency Specific
FDA
EMA
Expiration
Code
GANAXOLONE, ZTALMY, MARINUS
2029-06-01ODE-395
2027-06-01NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Ganaxolone, Ztalmy, Marinus
106033082037-08-10U-3374
78586092026-11-28DP
80220542026-11-28DP
83187142026-11-28DP
83676512026-11-28DP
86180872026-11-28U-3374
90293552026-11-28DP
90561162026-11-28U-3374
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AX: Other antiepileptics in atc
— N03AX27: Ganaxolone
HCPCS
No data
Clinical
Clinical Trials
24 clinical trials
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Mock data
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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
Tuberous sclerosisD014402HP_0009720Q85.1—11——2
Status epilepticusD013226EFO_0008526G41—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pregnancy complicationsD011248—2———2
Postpartum depressionD019052EFO_0007453F53.0—2———2
DepressionD003863F33.9—2———2
Mood disordersD019964EFO_0004247F30-F39—2———2
Mental disordersD001523EFO_0000677F91.9—2———2
Depressive disorderD003866EFO_1002014F32.A—2———2
Behavioral symptomsD001526HP_0000708—2———2
EpilepsyD004827EFO_0000474G40.9—2———2
Partial epilepsiesD004828EFO_0004263—2———2
Infantile spasmsD013036EFO_1000643G40.82—2———2
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Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Major depressive disorderD003865EFO_0003761F22————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGANAXOLONE
INNganaxolone
Description
Ganaxolone is a corticosteroid hormone.
Classification
Small molecule
Drug classsteroids (not prednisolone derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(=O)[C@H]1CC[C@H]2[C@@H]3CC[C@H]4C[C@](C)(O)CC[C@]4(C)[C@H]3CC[C@]12C
Identifiers
PDB—
CAS-ID38398-32-2
RxCUI—
ChEMBL IDCHEMBL1568698
ChEBI ID—
PubChem CID6918305
DrugBankDB05087
UNII ID98WI44OHIQ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
GABRA1
GABRA1
Organism
Homo sapiens
Gene name
GABRA1
Gene synonyms
NCBI Gene ID
2554
Protein name
gamma-aminobutyric acid receptor subunit alpha-1
Protein synonyms
GABA(A) receptor subunit alpha-1, GABA(A) receptor, alpha 1, gamma-aminobutyric acid (GABA) A receptor, alpha 1, gamma-aminobutyric acid type A receptor alpha1 subunit
Uniprot ID
Q8N629
Mouse ortholog
Gabra1 (14394)
gamma-aminobutyric acid receptor subunit alpha-1 (P62812)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 613 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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