{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:brexanolone", "owner": "maternal", "kind": "drug", "slug": "brexanolone", "name": "Brexanolone", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "The active substance in Zulresso, a medicine given by drip into a vein over about 2.5 days in hospital to treat postpartum depression. It is a neuroactive steroid that acts on GABA-A receptors in the brain, as zuranolone does.", "summary_technical": "Brexanolone injection (formerly SAGE-547) is a positive allosteric modulator of GABA-A receptors (Lancet abstract). RxNorm concept 2121777 (ingredient). The approved product is Zulresso (NDA211371), now listed as discontinued in openFDA. Two phase 3 trials of a 60-hour infusion in moderate and severe postpartum depression are recorded on this atlas (see the claims on this page). The recipient is the adult postpartum woman.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "rxnorm", "value": "2121777", "normalized_value": "2121777", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "maternal": { "life-stage": [ "postpartum" ], "care-area": [ "maternal-mental-health" ] } }, "payload": { "level": "substance", "mechanism": "Positive allosteric modulator of gamma-aminobutyric-acid type A (GABA-A) receptors, as described in the Lancet abstract." }, "content_digest": "a4f14509e2a299b3aa5dc15797b0422fc2c66b1762aca83503ea166da9c5e11b", "review": { "content_digest": "a4f14509e2a299b3aa5dc15797b0422fc2c66b1762aca83503ea166da9c5e11b", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-brexanolone-trials-hamd-60-hours", "owner": "maternal", "subject_entity_id": "maternal:brexanolone", "category": "effect", "statement": "Two double-blind, placebo-controlled phase 3 trials of a single 60-hour intravenous infusion of brexanolone in postpartum depression randomized 138 women in study 1 (brexanolone 90 µg/kg per hour n=45, 60 µg/kg per hour n=47, placebo n=46) and 108 in study 2 (brexanolone 90 µg/kg per hour n=54, placebo n=54). In study 1, severe depression, the average fall in HAM-D total score at 60 hours was 19.5 points with the 60 µg/kg dose, 17.7 with the 90 µg/kg dose and 14.0 with placebo, differences from placebo of -5.5 (95% CI -8.8 to -2.2, p=0.0013) and -3.7 (95% CI -6.9 to -0.5, p=0.0252). In study 2, moderate depression, the fall was 14.6 points with the 90 µg/kg dose and 12.1 with placebo, a difference of -2.5 (95% CI -4.5 to -0.5, p=0.0160).", "context": { "id": "maternal:ctx-brexanolone-trials-ppd-women-18-45", "label": "Women aged 18 to 45 years, up to 6 months post partum, with moderate to severe postpartum depression, 60-hour infusion (2018 trials)", "recipient": "maternal", "population": "Women with postpartum depression and a qualifying 17-item Hamilton Rating Scale for Depression (HAM-D) score: 26 or more in study 1 (severe) and 20 to 25 in study 2 (moderate). They received a single 60-hour intravenous infusion of brexanolone or matching placebo.", "care_setting": "30 clinical research centres and specialised psychiatric units (abstract).", "geography": "United States", "life_stage_note": "Up to 6 months post partum at screening, aged 18 to 45 years.", "life_stage_terms": { "maternal": [ "postpartum" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Followed until day 30; primary endpoint at 60 hours (abstract).", "eligibility": { "inclusion": [ "Aged 18 to 45 years", "6 months post partum or less at screening", "Postpartum depression with a qualifying HAM-D score (26 or more for study 1; 20 to 25 for study 2)" ], "exclusion": [ "Renal failure requiring dialysis", "Anaemia", "Known allergy to allopregnanolone or to progesterone", "Medical history of schizophrenia, bipolar disorder or schizoaffective disorder" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Only the PubMed abstract was read. PubMed lists an erratum (PMID 30303081) that has no abstract and was not read, so these numbers are as printed in the abstract. The trials were funded by Sage Therapeutics (abstract funding line). Follow-up ended at day 30, the primary endpoint was a rating-scale change at the end of the infusion, and the trials excluded women with a history of schizophrenia, bipolar disorder or schizoaffective disorder. Study 2 tested one active dose, and study 1 also tested a lower dose. The abstract does not say which of these doses the marketed product uses; see the FDA label for dosing.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, METHODS, sentence 1", "applicability_note": "Trial design and setting.", "snapshot": { "id": "maternal:pubmed-30177236-2026-10-14", "retrieved_at": "2026-10-14T18:18:20Z", "content_hash": "6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "maternal:pubmed-10-1016-s0140-6736-18-31551-4", "source_type": "publication", "title": "Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials", "canonical_url": "https://doi.org/10.1016/S0140-6736(18)31551-4", "identifiers": [ { "scheme": "doi", "value": "10.1016/S0140-6736(18)31551-4", "normalized_value": "10.1016/s0140-6736(18)31551-4", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30177236", "normalized_value": "30177236", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-09-22", "publisher": "Lancet (London, England)", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 30303081). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). 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