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AboutPricing
Drug ReportsBrexanolone
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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FDA Novel Drug Approvals 2019
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
mental disordersD001523
Trade Name
FDA
EMA
Zulresso
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
ZULRESSOSage TherapeuticsN-211371 RX2019-06-17
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
zulressoNew Drug Application2022-06-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
postpartum depressionEFO_0007453D019052F53.0
Agency Specific
FDA
EMA
Expiration
Code
BREXANOLONE, ZULRESSO, SAGE THERAP
2025-06-16NPP
2024-06-17NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Brexanolone, Zulresso, Sage Therap
109401562037-03-08U-2552
102518942033-11-27U-2552
103221392033-01-23DP
76357732029-03-13DP
84100772029-03-13DP
92000882029-03-13DP
97508222029-03-13DP
101179512029-03-13DP
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AX: Other antidepressants in atc
— N06AX29: Brexanolone
HCPCS
Code
Description
J1632
Injection, brexanolone, 1 mg
Clinical
Clinical Trials
43 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 depressionD019052EFO_0007453F53.0—23229
DepressionD003863—F33.91——225
Post-traumatic stress disordersD013313EFO_0001358F43.111—1—3
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382—U07.1——1——1
Respiratory distress syndromeD012128EFO_1000637J80——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F0321———3
Traumatic brain injuriesD000070642—S06—3———3
Neurodegenerative diseasesD019636EFO_0005772G31.9—1———1
Premenstrual dysphoric disorderD065446—F32.81—1———1
Essential tremorD020329EFO_0003108G25.0—1———1
Low back painD017116HP_0003419M54.5—1———1
Post-traumatic epilepsyD004834———1———1
Tourette syndromeD005879EFO_0004895F95.2—1———1
TinnitusD014012HP_0000360H93.1—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlcoholismD000437EFO_0003829F10.12————2
Psychotic disordersD011618—F20.811———12
Cognitive dysfunctionD060825HP_0001268G31.841————1
Premenstrual syndromeD011293—N94.31————1
Healthy volunteers/patients———1————1
Parkinson diseaseD010300EFO_0002508G201————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.9————11
Major depressive disorderD003865EFO_0003761F22————11
Smoking cessationD016540EFO_0004319—————11
PhenylketonuriasD010661—E70.0————11
SchizophreniaD012559EFO_0000692F20————11
Bipolar disorderD001714EFO_0000289F30.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBrexanolone
INNbrexanolone
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 classsteroids (not prednisolone derivatives)
Image (chem structure or protein)Loading
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-ID516-54-1
RxCUI—
ChEMBL IDCHEMBL207538
ChEBI ID50169
PubChem CID92786
DrugBankDB11859
UNII IDS39XZ5QV8Y (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
2558
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
Q9NYT5
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 5,351 documents
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Safety
Black-box Warning
Black-box warning for: Zulresso
Adverse Events
Top Adverse Reactions
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128 adverse events reported
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