Zuranolone

Overview

Zuranolone, sold under the brand name Zurzuvae, is a medication used for the treatment of postpartum depression and major depressive disorder. It is taken orally. Zuranolone is a neuroactive steroid which enhances the activity of the neurotransmitter γ-aminobutyric acid (GABA) and is thought to exert antidepressant effects by enhancing GABAergic inhibition.[1–5] WP

The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.[1][6] WP

Zuranolone was approved for medical use in the United States for the treatment of postpartum depression in August 2023. It was developed by Sage Therapeutics and Biogen.[6][7] WP

Drug class

Neurosteroid GABAA receptor positive allosteric modulator WP

From the Wikipedia article's infobox.

Uses, dosage and effects

Medical uses

Zuranolone is indicated for the treatment of postpartum depression in the United States and for the treatment of major depressive disorder in Japan. It was not approved for major depressive disorder in the United States.[1][2][6][8] WP

The efficacy of zuranolone for the treatment of postpartum depression in adults was demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies. The trial participants were women with postpartum depression who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery. In study 1, participants received 50 mg of zuranolone or placebo once daily in the evening for 14 days. In study 2, participants received another zuranolone product that was approximately equal to 40 mg of zuranolone or placebo, also for 14 days. Participants in both studies were monitored for at least four weeks after the 14-day treatment. The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured at day 15. Participants in the zuranolone groups showed significantly more improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at day 42—four weeks after the last dose of zuranolone.[6] WP

Risks and side effects

Adverse effects

The most common side effects include drowsiness, dizziness, diarrhea, fatigue, and urinary tract infection.[6] WP

The US prescribing information contains a boxed warning noting that zuranolone can impact a person's ability to drive and perform other potentially hazardous activities. The use of zuranolone may cause suicidal thoughts and behavior. Zuranolone may also cause fetal harm.[6] WP

Research

Research

In a randomized, placebo-controlled phase III trial to assess its efficacy and safety for the treatment of major depressive disorder, subjects in the zuranolone group (50 mg oral zuranolone once daily for 14 days) experienced statistically significant and sustained improvements in depressive symptoms (as measured by HAM-D score) throughout the treatment and follow-up periods of the study.[9] WP

Other investigational applications include insomnia, bipolar depression, essential tremor, and Parkinson's disease.[10][11][12] WP

History

History

Zuranolone was developed as an improvement on the intravenously administered neurosteroid brexanolone, with high oral bioavailability and a biological half-life suitable for once-daily administration. Its half-life is around 16 to 23 hours, compared to approximately 9 hours for brexanolone.[4][13][14][15] WP

Zuranolone was approved for the treatment of postpartum depression in the United States in August 2023 and for the treatment of major depressive disorder in Japan in March 2026. It was not approved for major depressive disorder in the United States.[2][8] WP

Legal status

Names

Zuranolone is the International Nonproprietary Name (INN). The drug is sold under the brand name Zurzuvae.[1][16] WP

Legal status

Zuranolone was approved by the U.S. Food and Drug Administration (FDA) for the treatment of postpartum depression in August 2023. The FDA granted the application for zuranolone priority review and fast track designations. Approval of Zurzuvae was granted to Sage Therapeutics, Inc. Zuranolone has also been under development for the treatment of major depressive disorder, but the application for this use was given a Complete Response Letter by the FDA due to insufficient evidence of effectiveness.[6][17][18] WP

In the United States, zuranolone is a Schedule IV controlled substance.[1] WP

In July 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zurzuvae, intended for the treatment of adults with postpartum depression. The applicant for this medicinal product is Biogen Netherlands B.V. Zuranolone was authorized for medical use in the European Union in September 2025.[3][19] WP

Chemistry

Formula

C25H35N3O2 PC

CAS number

1632051-40-1 PC

Molar mass (g/mol)

409.6 PC

IUPAC name (computed by PubChem)

1-[2-[(3R,5R,8R,9R,10S,13S,14S,17S)-3-hydroxy-3,13-dimethyl-2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carbonitrile PC

SMILES

C[C@]1(CC[C@H]2[C@@H](C1)CC[C@@H]3[C@@H]2CC[C@]4([C@H]3CC[C@@H]4C(=O)CN5C=C(C=N5)C#N)C)O PC

InChIKey

HARRKNSQXBRBGZ-GVKWWOCJSA-N PC

PubChem CID

86294073

IUPAC name

1-(2-((3R,5R,8R,9R,10S,13S,14S,17S)-3-Hydroxy-3,13-dimethylhexadecahydro-1H-cyclopenta WP

Harm reduction information

No harm reduction data is on file for this compound yet. That means no dose, timing or combination data from PsychonautWiki or TripSit. Please don't guess a dose from similar compounds. If you have taken it and feel unwell, contact emergency services or a poison control center.

User reports

Pop culture

No references added yet.

Sources

1. Journal / agency Zurzuvae- zuranolone capsule. 5 November 2024
2. Journal / agency Biogen/SAGE Therapeutics. 8 April 2026
3. Journal / agency Zurzuvae EPAR. 25 July 2025
4. Journal / agency Blanco MJ, La D, Coughlin Q, Newman CA, Griffin AM, Harrison BL, Salituro FG. Breakthroughs in neuroactive steroid drug discovery. Bioorganic & Medicinal Chemistry Letters. 2018. doi:10.1016/j.bmcl.2017.11.043 · PMID 29223589
5. Journal / agency Martinez Botella G, Salituro FG, Harrison BL, Beresis RT, Bai Z, Blanco MJ, Belfort GM, Dai J, Loya CM, Ackley MA, Althaus AL, Grossman SJ, Hoffmann E, Doherty JJ, Robichaud AJ. Neuroactive Steroids. 2. 3α-Hydroxy-3β-methyl-21-(4-cyano-1H-pyrazol-1'-yl)-19-nor-5β-pregnan-20-one (SAGE-217): A Clinical Next Generation Neuroactive Steroid Positive Allosteric Modulator of the (γ-Aminobutyric Acid)A Receptor. Journal of Medicinal Chemistry. 2017. doi:10.1021/acs.jmedchem.7b00846 · PMID 28753313
6. Journal / agency FDA Approves First Oral Treatment for Postpartum Depression. 4 August 2023
7. Other Saltzman, Jonathan. FDA approves postpartum depression pill from two Cambridge drug firms. 4 August 2023
8. Journal / agency Cosgrove L, Kostic M, Mintzes B, D'Ambrozio G, Shaughnessy A. Zuranolone: A case study in (regulatory) rush to judgement?. Br J Clin Pharmacol. February 2026. doi:10.1002/bcp.70472 · PMID 41640203
9. Journal / agency Clayton AH, Lasser R, Parikh SV, Iosifescu DV, Jung J, Kotecha M, Forrestal F, Jonas J, Kanes SJ, Doherty J. Zuranolone for the Treatment of Adults With Major Depressive Disorder: A Randomized, Placebo-Controlled Phase 3 Trial. The American Journal of Psychiatry. May 2023. doi:10.1176/appi.ajp.20220459 · PMID 37132201
10. Journal / agency Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021. doi:10.1001/jamapsychiatry.2021.1559 · PMID 34190962 · PMC8246337
11. Journal / agency Bullock A, Kaul I, Li S, Silber C, Doherty J, Kanes SJ. Zuranolone as an oral adjunct to treatment of Parkinsonian tremor: A phase 2, open-label study. Journal of the Neurological Sciences. 2021. doi:10.1016/j.jns.2020.117277 · PMID 33387701
12. Journal / agency Bullock A, Gunduz-Bruce H, Zammit GK, Qin M, Li H, Sankoh AJ, Silber C, Kanes SJ, Jonas J, Doherty J. A phase 1 double-blind, placebo-controlled study of zuranolone (SAGE-217) in a phase advance model of insomnia in healthy adults. Hum Psychopharmacol. January 2022. doi:10.1002/hup.2806 · PMID 34352138 · PMC9286466
13. Journal / agency Althaus AL, Ackley MA, Belfort GM, Gee SM, Dai J, Nguyen DP, Kazdoba TM, Modgil A, Davies PA, Moss SJ, Salituro FG, Hoffmann E, Hammond RS, Robichaud AJ, Quirk MC, Doherty JJ. Preclinical characterization of zuranolone (SAGE-217), a selective neuroactive steroid GABAA receptor positive allosteric modulator. Neuropharmacology. 2020. doi:10.1016/j.neuropharm.2020.108333 · PMID 32976892 · PMC8265595
14. Journal / agency Cerne R, Lippa A, Poe MM, Smith JL, Jin X, Ping X, Golani LK, Cook JM, Witkin JM. GABAkines - Advances in the discovery, development, and commercialization of positive allosteric modulators of GABAA receptors. Pharmacology & Therapeutics. 2022. doi:10.1016/j.pharmthera.2021.108035 · PMID 34793859 · PMC9787737
15. Journal / agency Faden J, Citrome L. Intravenous brexanolone for postpartum depression: what it is, how well does it work, and will it be used?. Therapeutic Advances in Psychopharmacology. 2020. doi:10.1177/2045125320968658 · PMID 33224470 · PMC7656877
16. Journal / agency World Health Organization. International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82. WHO Drug Information. 2019
17. Other FDA Approves Zurzuvae (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder. 4 August 2023
18. Other McKenzie, Heather. Sage Hints at Difficult Decisions After Zuranolone's Rejection in MDD
19. Other Zurzuvae PI. 18 September 2025

Text and values on this page are quoted from Wikipedia (CC BY-SA 4.0), PubChem (public domain). Each value links to the exact revision it came from.