Stem definition | Drug id | CAS RN |
---|---|---|
steroids not used as glucocorticosteroids | 5508 | 38398-32-2 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
July 26, 2023 | EMA | Marinus Pharmaceuticals Emerald Limited | |
March 18, 2022 | FDA | MARINUS PHARMA INC |
None
None
None
None
Source | Code | Description |
---|---|---|
ATC | N03AX27 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics |
MeSH PA | D018682 | GABA Agents |
MeSH PA | D018757 | GABA Modulators |
MeSH PA | D000081227 | Neurosteroids |
MeSH PA | D018377 | Neurotransmitter Agents |
FDA MoA | N0000193997 | GABA A Receptor Positive Modulators |
FDA EPC | N0000194006 | Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Seizures associated with CDKL5 deficiency disorders | indication | 773230003 |
None
None
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
50MG/ML | ZTALMY | MARINUS | 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 | MARINUS | 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 | MARINUS | 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 |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
50MG/ML | ZTALMY | MARINUS | N215904 | June 1, 2022 | RX | SUSPENSION | ORAL | June 1, 2027 | NEW CHEMICAL ENTITY |
50MG/ML | ZTALMY | MARINUS | 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 |
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 |
ID | Source |
---|---|
CHEMBL1568698 | ChEMBL_ID |
C105051 | MESH_SUPPLEMENTAL_RECORD_UI |
11942 | IUPHAR_LIGAND_ID |
DB05087 | DRUGBANK_ID |
018994 | NDDF |
4041529 | VANDF |
C0537150 | UMLSCUI |
D04300 | KEGG_DRUG |
7476 | INN_ID |
6918305 | PUBCHEM_CID |
2604689 | RXNORM |
357899 | MMSL |
40556 | MMSL |
d09866 | MMSL |
98WI44OHIQ | UNII |
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 |