Zuranolone
Zurzuvae (zuranolone) is a small molecule pharmaceutical. Zuranolone was first approved as Zurzuvae on 2023-10-31. It is used to treat postpartum depression in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Zurzuvae
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zurzuvae | New Drug Application | 2024-11-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| postpartum depression | EFO_0007453 | D019052 | F53.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ZURANOLONE, ZURZUVAE, BIOGEN INC | |||
| 2028-10-31 | NCE | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
16 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 |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | 1 | 2 | 7 | — | 1 | 11 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | 2 | 7 | — | 1 | 11 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 2 | 6 | — | — | 9 |
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | — | 2 | — | 1 | 3 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 1 | — | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | — | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | — | — | 1 |
| Essential tremor | D020329 | EFO_0003108 | G25.0 | — | 1 | — | — | — | 1 |
| Tremor | D014202 | — | R25.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Zuranolone |
| INN | zuranolone |
| Description | Zuranolone is a 3-hydroxy steroid that is 5beta-19-norpregnane substituted by hydroxy, methyl, oxo, and 4-cyano-1H-pyrazol-1-yl groups at positions 3, 3, 20 and 21, respectively. It is a positive allosteric modulator of GABAA receptor developed by Sage Therapeutics and Biogen for the treatment of postpartum depression in adults. It has a role as an antidepressant, a GABA modulator and an anticonvulsant. It is a nitrile, a member of pyrazoles, a 3-hydroxy steroid and a 20-oxo steroid. |
| Classification | Small molecule |
| Drug class | steroids (not prednisolone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12CC[C@@H]3[C@H]4CC[C@@](C)(O)C[C@H]4CC[C@H]3[C@@H]1CC[C@@H]2C(=O)Cn1cc(C#N)cn1 |
Identifiers
| PDB | — |
| CAS-ID | 1632051-40-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4105630 |
| ChEBI ID | — |
| PubChem CID | 86294073 |
| DrugBank | DB15490 |
| UNII ID | 7ZW49N180B (ChemIDplus, GSRS) |
Target
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Zurzuvae – Biogen
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Estimated US medical usage
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PubMed Central
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Additional graphs summarizing 307 documents
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Safety
Black-box Warning
Black-box warning for: Zurzuvae
Adverse Events
Top Adverse Reactions
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672 adverse events reported
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