Ztalmy(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 has been approved in Europe to treat epileptic syndromes and infantile spasms. It is known to target gamma-aminobutyric acid receptor subunit alpha-1.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| signs and symptoms pathological conditions | D013568 |
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 |
|---|---|---|---|---|
| ZTALMY | Marinus Pharmaceuticals | N-215904 RX | 2022-06-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ztalmy | New Drug Application | 2025-08-15 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
GANAXOLONE, ZTALMY, MARINUS | |||
| 2029-06-01 | ODE-395 | ||
| 2027-06-01 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
25 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 |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 6 | 1 | — | — | 7 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 2 | 2 | — | — | 4 |
| Seizures | D012640 | — | G40.4 | — | 2 | 2 | — | — | 4 |
| Tuberous sclerosis | D014402 | — | Q85.1 | — | 1 | 2 | — | — | 3 |
| Sclerosis | D012598 | — | — | — | 1 | 1 | — | — | 2 |
| Drug resistant epilepsy | D000069279 | — | — | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | — | 2 | — | — | 1 | 3 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 2 | — | — | 1 | 3 |
| Pregnancy complications | D011248 | — | — | — | 2 | — | — | — | 2 |
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | 2 | — | — | — | 2 |
| Puerperal disorders | D011644 | EFO_0009683 | O89 | — | 2 | — | — | — | 2 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 2 | — | — | — | 2 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | 2 | — | — | — | 2 |
| Behavioral symptoms | D001526 | — | — | — | 2 | — | — | — | 2 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | 2 | — | — | — | 2 |
| Spasm | D013035 | — | M62.83 | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | — | — | 1 | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ganaxolone |
| INN | ganaxolone |
| Description | Ganaxolone is a corticosteroid hormone. |
| Classification | Small molecule |
| Drug class | steroids (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-ID | 38398-32-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1568698 |
| ChEBI ID | — |
| PubChem CID | 6918305 |
| DrugBank | DB05087 |
| UNII ID | 98WI44OHIQ (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
GABRA1
GABRA1
Organism
Homo sapiens
Gene name
GABRA1
Gene synonyms
NCBI Gene ID
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
Mouse ortholog
Gabra1 (14394)
gamma-aminobutyric acid receptor subunit alpha-1 (P62812)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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492 adverse events reported
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