{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:zuranolone", "owner": "maternal", "kind": "drug", "slug": "zuranolone", "name": "Zuranolone", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "The active substance in Zurzuvae, a capsule for postpartum depression. It is a neuroactive steroid that acts on GABA-A receptors in the brain, as brexanolone does.", "summary_technical": "A positive allosteric modulator of synaptic and extrasynaptic GABA-A receptors and a neuroactive steroid (SKYLARK abstract). NIMH says it acts on similar brain receptors to brexanolone. RxNorm concept 2669905 (ingredient); FDA UNII 7ZW49N180B (openFDA drugsfda record). The approved product is Zurzuvae. The SKYLARK trial tested 50 mg a day for 14 days in severe postpartum depression (see the claims on this page). The recipient is the adult postpartum woman. Fetal harm is a labelled concern (FDA press announcement of 2023); no fetal or newborn outcome claim is recorded here.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "rxnorm", "value": "2669905", "normalized_value": "2669905", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "unii", "value": "7ZW49N180B", "normalized_value": "7ZW49N180B", "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 synaptic and extrasynaptic GABA-A receptors (neuroactive steroid), as described in the SKYLARK abstract." }, "content_digest": "208e7c08f7c15177e410e3c32e55ab198d52dd7c7c17cb7a9c065c6a0211d382", "review": { "content_digest": "208e7c08f7c15177e410e3c32e55ab198d52dd7c7c17cb7a9c065c6a0211d382", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-zuranolone-skylark-hamd-day-15", "owner": "maternal", "subject_entity_id": "maternal:zuranolone", "category": "effect", "statement": "In SKYLARK, a double-blind phase 3 trial, 196 women with severe postpartum depression were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days (98 in each group), and 170 (86.7%) completed the 45-day study. At day 15, the primary endpoint, the average change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) total score was -15.6 with zuranolone and -11.6 with placebo, a least-squares mean difference of -4.0 (95% CI -6.3 to -1.7). The authors report significant improvement at days 3, 28 and 45 too.", "context": { "id": "maternal:ctx-skylark-severe-ppd-women-18-45", "label": "Women aged 18 to 45 years with severe postpartum depression, 14-day oral course (SKYLARK, 2023)", "recipient": "maternal", "population": "Women with severe postpartum depression who were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days. The registry gives the age range as 18 to 45 years and the sex as female. The abstract says severe postpartum depression but prints no score cut-off or onset window.", "care_setting": "Not stated in the abstract. The registry lists study sites in the United States, Spain and the United Kingdom.", "geography": "United States, Spain and United Kingdom (registry locations)", "life_stage_note": "Postpartum. The abstract and the registry fields read give no postnatal age limits.", "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": "45-day study: 14 days of treatment, primary endpoint at day 15, secondary endpoints at days 3, 28 and 45 (abstract).", "eligibility": { "inclusion": [ "Women aged 18 to 45 years (registry)", "Severe postpartum depression (abstract)" ], "exclusion": [ "Not stated in the parts of the abstract and registry fields that were read" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Only the PubMed abstract was read, not the full paper. PubMed lists an erratum for the paper (PMID 39659161) that has no abstract and was not read, so these numbers are as printed in the abstract and may have been corrected. The registry names an industry lead sponsor (Biogen). The trial enrolled women with severe postpartum depression, so the result does not apply to milder illness. A rating-scale change at day 15 is not remission or relapse, and follow-up ended at day 45. The registry records 200 enrolled while the abstract prints 196 randomized; both counts are kept on the study page.", "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, fragment 1 of 2", "applicability_note": "Design, randomization and dose.", "snapshot": { "id": "maternal:pubmed-37491938-2026-10-14", "retrieved_at": "2026-10-14T18:18:20Z", "content_hash": "12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785", "source_type": "publication", "title": "Zuranolone for the Treatment of Postpartum Depression", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785", "normalized_value": "10.1176/appi.ajp.20220785", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37491938", "normalized_value": "37491938", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-09-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 39659161). 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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 1", "applicability_note": "Numbers randomized and completing the study.", "snapshot": { "id": "maternal:pubmed-37491938-2026-10-14", "retrieved_at": "2026-10-14T18:18:20Z", "content_hash": "12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785", "source_type": "publication", "title": "Zuranolone for the Treatment of Postpartum Depression", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785", "normalized_value": "10.1176/appi.ajp.20220785", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37491938", "normalized_value": "37491938", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-09-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 39659161). 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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, METHODS, sentence 2, fragment 1 of 3", "applicability_note": "Primary endpoint and its timing.", "snapshot": { "id": "maternal:pubmed-37491938-2026-10-14", "retrieved_at": "2026-10-14T18:18:20Z", "content_hash": "12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785", "source_type": "publication", "title": "Zuranolone for the Treatment of Postpartum Depression", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785", "normalized_value": "10.1176/appi.ajp.20220785", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37491938", "normalized_value": "37491938", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-09-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 39659161). 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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 2, fragment 1 of 3", "applicability_note": "Statistically significant improvement at day 15.", "snapshot": { "id": "maternal:pubmed-37491938-2026-10-14", "retrieved_at": "2026-10-14T18:18:20Z", "content_hash": "12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785", "source_type": "publication", "title": "Zuranolone for the Treatment of Postpartum Depression", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785", "normalized_value": "10.1176/appi.ajp.20220785", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37491938", "normalized_value": "37491938", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-09-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 39659161). 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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 2, fragment 2 of 3", "applicability_note": "Mean changes and the difference with its interval.", "snapshot": { "id": "maternal:pubmed-37491938-2026-10-14", "retrieved_at": "2026-10-14T18:18:20Z", "content_hash": "12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785", "source_type": "publication", "title": "Zuranolone for the Treatment of Postpartum Depression", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785", "normalized_value": "10.1176/appi.ajp.20220785", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37491938", "normalized_value": "37491938", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-09-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 39659161). 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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 2, fragment 3 of 3", "applicability_note": "Improvement also reported at days 3, 28 and 45.", "snapshot": { "id": "maternal:pubmed-37491938-2026-10-14", "retrieved_at": "2026-10-14T18:18:20Z", "content_hash": "12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785", "source_type": "publication", "title": "Zuranolone for the Treatment of Postpartum Depression", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785", "normalized_value": "10.1176/appi.ajp.20220785", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37491938", "normalized_value": "37491938", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-09-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 39659161). 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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name", "applicability_note": "Registry lead sponsor.", "snapshot": { "id": "maternal:ctgov-nct04442503-2026-10-14", "retrieved_at": "2026-10-14T18:18:23Z", "content_hash": "fdd893c7dccd1ed53eea5282f35f5e206c6ec2da60ddc2338db12152aff132dd", "source_effective_date": "2023-11-30", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ctgov-nct04442503", "source_type": "registry", "title": "A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)", "canonical_url": "https://clinicaltrials.gov/study/NCT04442503", "identifiers": [ { "scheme": "nct", "value": "NCT04442503", "normalized_value": "NCT04442503", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. National Library of Medicine (ClinicalTrials.gov)", "edition": "ClinicalTrials.gov API v2 record, last update posted 2023-11-30. The record holds a results section; the atlas does not copy registry result tables.", "reuse_basis": "Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/mj-ctgov-NCT04442503.json.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "PublicationType", "applicability_note": "PubMed lists a published erratum for this paper (PMID 39659161). It has no abstract and was not read.", "snapshot": { "id": "maternal:pubmed-39659161-2026-10-14", "retrieved_at": "2026-10-14T18:19:05Z", "content_hash": "7f4a25189d34399d741dc149248c7d6967002b6a87356a099568b41ae8b38ad0", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785correction", "source_type": "publication", "title": "Correction to Deligiannidis et al", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785correction", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785correction", "normalized_value": "10.1176/appi.ajp.20220785correction", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "39659161", "normalized_value": "39659161", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2025-03-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. This is a published erratum (a correction notice). PubMed holds no abstract for it; only its bibliographic record was read.", "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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } } ], "review": { "content_digest": "7c4bdd502460c64df5361c332826b5b2b9755fbd21dfd93ab87ddb63352f2ef9", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-zuranolone-skylark-hamd-day-15.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-zuranolone-skylark-safety", "owner": "maternal", "subject_entity_id": "maternal:zuranolone", "category": "safety", "statement": "In SKYLARK the most common adverse events (10% or more) with zuranolone were somnolence, dizziness and sedation. The abstract reports no loss of consciousness, no withdrawal symptoms and no increased suicidal ideation or behavior in the trial. The US label for Zurzuvae carries a boxed warning that it causes driving impairment, and FDA says it may cause fetal harm.", "context": { "id": "maternal:ctx-skylark-severe-ppd-women-18-45", "label": "Women aged 18 to 45 years with severe postpartum depression, 14-day oral course (SKYLARK, 2023)", "recipient": "maternal", "population": "Women with severe postpartum depression who were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days. The registry gives the age range as 18 to 45 years and the sex as female. The abstract says severe postpartum depression but prints no score cut-off or onset window.", "care_setting": "Not stated in the abstract. The registry lists study sites in the United States, Spain and the United Kingdom.", "geography": "United States, Spain and United Kingdom (registry locations)", "life_stage_note": "Postpartum. The abstract and the registry fields read give no postnatal age limits.", "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": "45-day study: 14 days of treatment, primary endpoint at day 15, secondary endpoints at days 3, 28 and 45 (abstract).", "eligibility": { "inclusion": [ "Women aged 18 to 45 years (registry)", "Severe postpartum depression (abstract)" ], "exclusion": [ "Not stated in the parts of the abstract and registry fields that were read" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The abstract gives no adverse event counts, and the trial was small (196 randomized) and short (45 days), so rare harms cannot be excluded. The label statements come from today's label text in openFDA, not from the trial. Only the abstract was read, and an erratum exists that was not read.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 4", "applicability_note": "Most common adverse events in the trial.", "snapshot": { "id": "maternal:pubmed-37491938-2026-10-14", "retrieved_at": "2026-10-14T18:18:20Z", "content_hash": "12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785", "source_type": "publication", "title": "Zuranolone for the Treatment of Postpartum Depression", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785", "normalized_value": "10.1176/appi.ajp.20220785", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37491938", "normalized_value": "37491938", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-09-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 39659161). 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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 5", "applicability_note": "Events the abstract reports as not observed.", "snapshot": { "id": "maternal:pubmed-37491938-2026-10-14", "retrieved_at": "2026-10-14T18:18:20Z", "content_hash": "12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785", "source_type": "publication", "title": "Zuranolone for the Treatment of Postpartum Depression", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785", "normalized_value": "10.1176/appi.ajp.20220785", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37491938", "normalized_value": "37491938", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-09-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 39659161). 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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "results[0].boxed_warning[0]", "applicability_note": "Boxed warning in the current label.", "snapshot": { "id": "maternal:openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29-2026-10-14", "retrieved_at": "2026-10-14T18:20:51Z", "content_hash": "f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869", "source_effective_date": "2026-06-15", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29", "source_type": "label", "title": "ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)", "canonical_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f18e53b0-d0bb-422d-8de7-ab64b7292b29", "identifiers": [ { "scheme": "spl-set-id", "value": "f18e53b0-d0bb-422d-8de7-ab64b7292b29", "normalized_value": "f18e53b0-d0bb-422d-8de7-ab64b7292b29", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drug label endpoint)", "edition": "openFDA drug label record, label effective 20260615, dataset last updated 2026-10-13.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/mj-openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29.json.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Paragraph 6, sentence 3", "applicability_note": "FDA press statement at approval.", "snapshot": { "id": "maternal:fda-zurzuvae-approval-press-2026-10-14", "retrieved_at": "2026-10-14T18:20:21Z", "content_hash": "ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad", "source_effective_date": "2023-08-22", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zurzuvae-approval-press", "source_type": "regulator", "title": "FDA approves first oral treatment for postpartum depression (FDA press announcement)", "canonical_url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression", "identifiers": [], "publication_date": "2023-08-04", "publisher": "U.S. Food and Drug Administration", "edition": "Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023.", "reuse_basis": "FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "PublicationType", "applicability_note": "PubMed lists a published erratum for the SKYLARK paper (PMID 39659161). It was not read.", "snapshot": { "id": "maternal:pubmed-39659161-2026-10-14", "retrieved_at": "2026-10-14T18:19:05Z", "content_hash": "7f4a25189d34399d741dc149248c7d6967002b6a87356a099568b41ae8b38ad0", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1176-appi-ajp-20220785correction", "source_type": "publication", "title": "Correction to Deligiannidis et al", "canonical_url": "https://doi.org/10.1176/appi.ajp.20220785correction", "identifiers": [ { "scheme": "doi", "value": "10.1176/appi.ajp.20220785correction", "normalized_value": "10.1176/appi.ajp.20220785correction", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "39659161", "normalized_value": "39659161", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2025-03-01", "publisher": "The American journal of psychiatry", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. This is a published erratum (a correction notice). PubMed holds no abstract for it; only its bibliographic record was read.", "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/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } } ], "review": { "content_digest": "eef3876f896cad92b2b85dbe2b316f962e153660a228ab8c6376fe0a2e3274ca", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-zuranolone-skylark-safety.json" } ], "decisions": [], "milestones": [], "relationships": { "outgoing": [ { "predicate": "treats", "label": "SKYLARK: HAM-D change at day 15, zuranolone 50 mg against placebo, severe postpartum depression", "clinical_claim_not_fact": true, "family": "clinical", "other_entity_id": "maternal:postpartum-depression", "other_entity_in_atlas": true, "claim_id": "maternal:claim-zuranolone-skylark-hamd-day-15", "evidence": null, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "part_of", "label": "Filed under this front", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "maternal:front-medicines-and-vaccines", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": true, "role": null, "valid_from": null, "valid_to": null } ], "incoming": [ { "predicate": "contains", "label": "Contained in", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "maternal:zurzuvae", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "maternal:openfda-drugsfda-nda217369-2026-10-14", "locator": "results[0].products[0].active_ingredients[0].name" }, "primary": false, "role": "active", "valid_from": null, "valid_to": null }, { "predicate": "investigates", "label": "Investigated in", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "maternal:skylark-trial", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "maternal:pubmed-38523596-2026-10-14", "locator": "Abstract, MATERIALS AND METHODS, sentence 2, fragment 1 of 2" }, "primary": false, "role": null, "valid_from": null, "valid_to": null } ] }, "page_path": "drugs/zuranolone/", "context_path": "api/v1/context/maternal--zuranolone.md" }