Brexanolone
Zulresso (brexanolone) is a small molecule pharmaceutical. Brexanolone was first approved as Zulresso on 2019-06-17. It is used to treat postpartum depression in the USA. It is known to target gamma-aminobutyric acid receptor subunit alpha-5, gamma-aminobutyric acid receptor subunit alpha-1, gamma-aminobutyric acid receptor subunit alpha-2, gamma-aminobutyric acid receptor subunit alpha-3, gamma-aminobutyric acid receptor subunit alpha-4, and gamma-aminobutyric acid receptor subunit alpha-6.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Brexanolone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZULRESSO | Sage Therapeutics | N-211371 DISCN | 2019-06-17 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zulresso | New Drug Application | 2024-07-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| postpartum depression | EFO_0007453 | D019052 | F53.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BREXANOLONE, ZULRESSO, SAGE THERAP | |||
| 2025-06-16 | NPP | ||
| 2024-06-17 | NCE | ||
HCPCS
Code | Description |
|---|---|
| J1632 | Injection, brexanolone, 1 mg |
Clinical
Clinical Trials
49 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | 2 | 4 | 2 | 2 | 10 |
| Depression | D003863 | — | F33.9 | 1 | 2 | — | 3 | 3 | 9 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 2 | — | 2 | 2 | 6 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | 3 | — | 1 | — | 5 |
| Premenstrual dysphoric disorder | D065446 | — | F32.81 | — | 1 | — | 1 | — | 2 |
| Traumatic stress disorders | D040921 | — | — | — | 1 | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | 2 | 1 | — | — | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 1 | — | — | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | — | 1 | — | — | 1 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 2 | — | — | 1 | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 2 | 1 | — | — | — | 3 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 2 | 1 | — | — | — | 3 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 3 | — | — | — | 3 |
| Brain injuries | D001930 | — | S06.9 | — | 3 | — | — | — | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 2 | — | — | 1 | 3 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | 1 | 2 | — | — | — | 3 |
| Seizures | D012640 | — | G40.4 | — | 1 | — | — | 1 | 2 |
| Tremor | D014202 | — | R25.1 | — | 2 | — | — | — | 2 |
| Premenstrual syndrome | D011293 | — | N94.3 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dementia | D003704 | EFO_0003862 | F03 | 1 | — | — | — | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | — | — | — | — | 1 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | — | — | — | — | 1 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | — | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
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 |
| Smoking cessation | D016540 | EFO_0004319 | — | — | — | — | — | 1 | 1 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Brexanolone |
| INN | brexanolone |
| Description | Brexanolone is a 3-hydroxy-5alpha-pregnan-20-one in which the hydroxy group at position 3 has alpha-configuration. It is a metabolite of the sex hormone progesterone and used for the treatment of postpartum depression in women. It has a role as a human metabolite, an antidepressant, a GABA modulator, an intravenous anaesthetic and a sedative. |
| 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@H](O)CC[C@]4(C)[C@H]3CC[C@]12C |
Identifiers
| PDB | — |
| CAS-ID | 516-54-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL207538 |
| ChEBI ID | 50169 |
| PubChem CID | 92786 |
| DrugBank | DB11859 |
| UNII ID | S39XZ5QV8Y (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
GABRA5
GABRA5
GABRA1
GABRA1
GABRA2
GABRA2
GABRA3
GABRA3
GABRA4
GABRA4
GABRA6
GABRA6
Organism
Homo sapiens
Gene name
GABRA5
Gene synonyms
NCBI Gene ID
Protein name
gamma-aminobutyric acid receptor subunit alpha-5
Protein synonyms
GABA(A) receptor subunit alpha-5, gamma-aminobutyric acid (GABA) A receptor, alpha 5, gamma-aminobutyric acid type A receptor alpha5 subunit
Uniprot ID
Mouse ortholog
Gabra5 (110886)
gamma-aminobutyric acid receptor subunit alpha-5 (Q8BHJ7)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,290 documents
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Safety
Black-box Warning
Black-box warning for: Zulresso
Adverse Events
Top Adverse Reactions
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264 adverse events reported
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