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| Stem definition | Drug id | CAS RN |
|---|---|---|
| steroids not used as glucocorticosteroids | 5738 | 1632051-40-1 |
None
None
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | CDK5,EIF2AK3,GRK2,PDK1,PDK2,PDK4,PRKDC | 7 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 4, 2023 | FDA | SAGE THERAP |
| 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 |
|---|---|---|---|---|---|---|
| Somnolence | 584.41 | 78.30 | 183 | 1124 | 208901 | 90418239 |
| Dizziness | 181.60 | 78.30 | 109 | 1198 | 589175 | 90037965 |
| Sedation | 165.45 | 78.30 | 50 | 1257 | 48121 | 90579019 |
| Therapy cessation | 143.28 | 78.30 | 42 | 1265 | 36319 | 90590821 |
| Suicidal ideation | 129.06 | 78.30 | 46 | 1261 | 73809 | 90553331 |
| Feeling drunk | 93.72 | 78.30 | 20 | 1287 | 4738 | 90622402 |
None
| 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 |
|---|---|---|---|---|---|---|
| Somnolence | 342.65 | 85.13 | 114 | 729 | 297335 | 110291121 |
| Therapy cessation | 137.46 | 85.13 | 37 | 806 | 44820 | 110543636 |
| Dizziness | 126.29 | 85.13 | 73 | 770 | 698120 | 109890336 |
None
| Source | Code | Description |
|---|---|---|
| ATC | N06AX31 | NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants |
| MeSH PA | D000928 | Antidepressive Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D011619 | Psychotropic Drugs |
| 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:50268 | GABA modulator |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Postpartum depression | indication | 58703003 | DOID:9478 |
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 20MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | 10172871 | April 17, 2034 | METHOD OF TREATING POSTPARTUM DEPRESSION |
| 20MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | 10342810 | April 17, 2034 | METHOD OF TREATING POSTPARTUM DEPRESSION |
| 25MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | 10172871 | April 17, 2034 | METHOD OF TREATING POSTPARTUM DEPRESSION |
| 25MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | 10342810 | April 17, 2034 | METHOD OF TREATING POSTPARTUM DEPRESSION |
| 30MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | 10172871 | April 17, 2034 | METHOD OF TREATING POSTPARTUM DEPRESSION |
| 30MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | 10342810 | April 17, 2034 | METHOD OF TREATING POSTPARTUM DEPRESSION |
| 20MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | 11884696 | Aug. 23, 2037 | METHOD OF TREATING POSTPARTUM DEPRESSION |
| 25MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | 11884696 | Aug. 23, 2037 | METHOD OF TREATING POSTPARTUM DEPRESSION |
| 30MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | 11884696 | Aug. 23, 2037 | METHOD OF TREATING POSTPARTUM DEPRESSION |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 20MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | Oct. 31, 2028 | NEW CHEMICAL ENTITY |
| 25MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | Oct. 31, 2028 | NEW CHEMICAL ENTITY |
| 30MG | ZURZUVAE | BIOGEN | N217369 | Oct. 31, 2023 | RX | CAPSULE | ORAL | Oct. 31, 2028 | NEW CHEMICAL ENTITY |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| GABA-A receptor alpha-1/beta-2/gamma-2 | Ion channel | ALLOSTERIC MODULATOR | EC50 | 6.37 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| GABA A receptor alpha-4/beta-3/delta | Ion channel | ALLOSTERIC MODULATOR | EC50 | 6.93 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE |
| ID | Source |
|---|---|
| CHEBI:228302 | CHEBI |
| CHEMBL4105630 | ChEMBL_ID |
| C000634505 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12858 | IUPHAR_LIGAND_ID |
| DB15490 | DRUGBANK_ID |
| 4042740 | VANDF |
| C5227595 | UMLSCUI |
| 10896 | INN_ID |
| 86294073 | PUBCHEM_CID |
| 371468 | MMSL |
| 41988 | MMSL |
| d10110 | MMSL |
| 019513 | NDDF |
| D11793 | KEGG_DRUG |
| 7ZW49N180B | UNII |
| 2669905 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ZURZUVAE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-029 | CAPSULE | 20 mg | ORAL | NDA | 35 sections |
| ZURZUVAE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-029 | CAPSULE | 20 mg | ORAL | NDA | 35 sections |
| ZURZUVAE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-030 | CAPSULE | 25 mg | ORAL | NDA | 35 sections |
| ZURZUVAE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-030 | CAPSULE | 25 mg | ORAL | NDA | 35 sections |
| ZURZUVAE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-031 | CAPSULE | 30 mg | ORAL | NDA | 35 sections |
| ZURZUVAE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-031 | CAPSULE | 30 mg | ORAL | NDA | 35 sections |