All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

zuranolone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
steroids not used as glucocorticosteroids	5738	1632051-40-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: zuranolone SAGE-217 SGE-797 S-812217 zurzuvae	The mechanism of action of zuranolone in the treatment of PPD is not fully understood, but is thought to be related to its positive allosteric modulation of GABAA receptors. Molecular weight: 409.57 Formula: C25H35N3O2 CLOGP: 4.34 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 78.91 ALOGS: ROTB: 3 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

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

Approvals:

Date	Agency	Company	Orphan
Aug. 4, 2023	FDA	SAGE THERAP

FDA Adverse Event Reporting System (Female)

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

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

Related Drugs by ATC class:

N06AX Other antidepressants 28 drugs

agomelatinebifemelanebrexanolonebupropiondesvenlafaxinedextromethorphanduloxetineesketaminegepironelevomilnacipranmedifoxaminemianserin show all 28 →

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Postpartum depression	indication	58703003	DOID:9478

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

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

Bioactivity Summary:

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	P14867 P18507 P47870	GBRA1_HUMAN GBRG2_HUMAN GBRB2_HUMAN	ALLOSTERIC MODULATOR	EC50	6.37		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
GABA A receptor alpha-4/beta-3/delta	Ion channel	P48169 P28472 O14764	GBRA4_HUMAN GBRB3_HUMAN GBRD_HUMAN	ALLOSTERIC MODULATOR	EC50	6.93		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

External reference:

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

Pharmaceutical products:

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