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ganaxolone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| steroids not used as glucocorticosteroids | 5508 | 38398-32-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
The precise mechanism by which ganaxolone exerts its therapeutic effects in the treatment of seizures associated with CDD is unknown, but its anticonvulsant effects are thought to result from positive allosteric modulation of the gamma-aminobutyric acid type A (GABAA) receptor in the CNS.
|
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 18, 2022 | FDA | MARINUS PHARMA INC | |
| July 26, 2023 | EMA | Marinus Pharmaceuticals Emerald Limited |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Product dose omission issue | 77.12 | 71.57 | 20 | 39 | 291667 | 90336721 |
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 |
|---|---|---|
| ATC | N03AX27 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics |
| MeSH PA | D000081227 | Neurosteroids |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018682 | GABA Agents |
| MeSH PA | D018757 | GABA Modulators |
| FDA MoA | N0000193997 | GABA A Receptor Positive Modulators |
| FDA EPC | N0000194006 | Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator |
| CHEBI has role | CHEBI:35469 | antidepressant |
| CHEBI has role | CHEBI:35623 | anticonvulsant |
| CHEBI has role | CHEBI:53784 | antispasmodic drug |
Related Drugs by ATC class:
N03AX Other antiepileptics 18 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Seizures associated with CDKL5 deficiency disorders | indication | 773230003 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 50MG/ML | ZTALMY | IMMEDICA PHARMA | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | 8618087 | Nov. 28, 2026 | TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER |
| 50MG/ML | ZTALMY | IMMEDICA PHARMA | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | 9056116 | Nov. 28, 2026 | TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER |
| 50MG/ML | ZTALMY | IMMEDICA PHARMA | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | 10603308 | Aug. 10, 2037 | TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER |
| 50MG/ML | ZTALMY | IMMEDICA PHARMA | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | 12144801 | Aug. 10, 2037 | TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE-5 (CDLK5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER |
| 50MG/ML | ZTALMY | IMMEDICA PHARMA | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | 12115169 | Sept. 30, 2042 | TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER |
| 50MG/ML | ZTALMY | IMMEDICA PHARMA | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | 12268696 | Sept. 30, 2042 | TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 50MG/ML | ZTALMY | IMMEDICA PHARMA | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | June 1, 2027 | NEW CHEMICAL ENTITY |
| 50MG/ML | ZTALMY | IMMEDICA PHARMA | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | Oct. 16, 2028 | REVISED DOSING TITRATION REGIMEN |
| 50MG/ML | ZTALMY | IMMEDICA PHARMA | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | June 1, 2029 | TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| GABA A receptor alpha-1/beta-1/gamma-2 | Ion channel | MODULATOR | EC50 | 6.67 | SCIENTIFIC LITERATURE | ||||
| GABA A receptor alpha-3/beta-1/gamma-2 | Ion channel | MODULATOR | EC50 | 6.91 | SCIENTIFIC LITERATURE | ||||
| GABA A receptor alpha-2/beta-1/gamma-2 | Ion channel | MODULATOR | EC50 | 7.03 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| CHEBI:177658 | CHEBI |
| CHEMBL1568698 | ChEMBL_ID |
| C105051 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11942 | IUPHAR_LIGAND_ID |
| DB05087 | DRUGBANK_ID |
| 4041529 | VANDF |
| C0537150 | UMLSCUI |
| D04300 | KEGG_DRUG |
| 7476 | INN_ID |
| 6918305 | PUBCHEM_CID |
| 357899 | MMSL |
| 40556 | MMSL |
| d09866 | MMSL |
| 018994 | NDDF |
| 98WI44OHIQ | UNII |
| 2604689 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ZTALMY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81583-100 | SUSPENSION | 50 mg | ORAL | NDA | 35 sections |
| ZTALMY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81583-100 | SUSPENSION | 50 mg | ORAL | NDA | 35 sections |