Zuranolone API is a synthetic neuroactive steroid and a positive allosteric modulator of the gamma-aminobutyric acid type A (GABA-A) receptor. It is also known by the development codes SAGE-217 and SGE-797.
Zuranolone is a neuroactive steroid structurally related to endogenous neurosteroids and has been developed for its activity on GABA-A receptors. It is used as the active pharmaceutical ingredient in Zurzuvae, an oral medicine approved by the U.S. FDA for the treatment of postpartum depression (PPD) in adults.
Zuranolone has the molecular formula C₂₅H₃₅N₃O₂, a molecular weight of approximately 409.6 g/mol, and CAS Number 1632051-40-1.
SDP provides sourcing and supply support for Zuranolone API, subject to product availability, applicable specifications, regulatory requirements, and customer requirements.
| Parameter | Details |
|---|---|
| Product Name | Zuranolone |
| Synonyms | SAGE-217, SGE-797 |
| CAS Number | 1632051-40-1 |
| Molecular Formula | C₂₅H₃₅N₃O₂ |
| Molecular Weight | 409.6 g/mol |
| PubChem CID | 86294073 |
| ChEMBL ID | CHEMBL4105630 |
| UNII | 7ZW49N180B |
PubChem lists these chemical identifiers and physicochemical properties for Zuranolone.
Zuranolone is a synthetic neuroactive steroid that acts as a positive allosteric modulator of GABA-A receptors. GABA-A receptors are involved in inhibitory neurotransmission within the central nervous system.
Zuranolone has been developed as an oral neuroactive steroid for the treatment of postpartum depression. The FDA approved Zurzuvae (zuranolone) in August 2023 as the first oral medication specifically indicated for postpartum depression in adults.
Zuranolone enhances GABA-A receptor activity through positive allosteric modulation. GABA is the principal inhibitory neurotransmitter in the central nervous system, and GABA-A receptors mediate many of its inhibitory effects.
As a neuroactive steroid, zuranolone interacts with GABA-A receptors and enhances inhibitory signaling. This mechanism differs from that of many conventional antidepressants and forms the basis for its development as a rapidly acting treatment for postpartum depression.
The FDA describes zuranolone as a neuroactive steroid GABA-A receptor positive modulator.
Zuranolone is the active ingredient in Zurzuvae, which the U.S. FDA approved for the treatment of postpartum depression in adults.
The FDA approval was supported by two randomized, double-blind, placebo-controlled clinical studies involving adults with postpartum depression.
Zuranolone is also relevant to research involving:
For your SDP CMS, use the actual approved specification/CoA for numerical limits.
| Parameter | Specification |
|---|---|
| Identification | IR & HPLC compliant |
| Assay | As per approved product specification |
| Related Substances | As per approved product specification |
| Loss on Drying | As per approved product specification |
| Residue on Ignition | As per approved product specification |
| Heavy Metals / Elemental Impurities | Complies with applicable specification |
| Residual Solvents | Complies with applicable specification |
| Water Content | As per approved product specification |
| Particle Size | As per applicable specification |
Don't enter assumed assay or impurity percentages unless they are present in your actual Zuranolone specification/CoA.
Zuranolone API supply may be supported by applicable technical and quality documentation, depending on product availability and customer requirements.
Documentation may include:
Zuranolone API can be supplied in suitable packaging according to the required quantity, product handling requirements and customer specifications.
Storage conditions should be maintained according to the applicable manufacturer's approved specification and stability data.
For commercial enquiries, customers can request information regarding:
Zuranolone is a synthetic neuroactive steroid and positive allosteric modulator of the GABA-A receptor.
The CAS number of Zuranolone is 1632051-40-1.
The molecular formula is C₂₅H₃₅N₃O₂.
The molecular weight is approximately 409.6 g/mol.
Zuranolone has been developed under the codes SAGE-217 and SGE-797.
Zuranolone acts as a positive allosteric modulator of GABA-A receptors.
In the United States, zuranolone is the active ingredient in Zurzuvae, which is approved for the treatment of postpartum depression in adults.
Bulk availability, MOQ, pricing, documentation and lead time depend on current product availability and applicable regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |