{"id":"brexanolone","rwe":[{"pmid":"41871269","year":"2026","title":"Temporal Dynamics of Antidepressant Response Following Brexanolone Treatment in Postpartum Depression.","finding":"","journal":"The Journal of clinical psychiatry","studyType":"Clinical Study"},{"pmid":"41863265","year":"2026","title":"Neuroactive Steroid Regulation in Premenstrual Dysphoric Disorder: Cross-Integration of Metabolism, Dysfunction, Neurobiology, and Precision Medicine.","finding":"","journal":"Current neuropharmacology","studyType":"Clinical Study"},{"pmid":"41855550","year":"2026","title":"ACOG Clinical Practice Update, Zuranolone and Brexanolone for the Treatment of Postpartum Depression: Correction.","finding":"","journal":"Obstetrics and gynecology","studyType":"Clinical Study"},{"pmid":"41701518","year":"2026","title":"Advances in antidepressant pharmacotherapy: phase 3 evidence and clinical perspectives.","finding":"","journal":"Expert opinion on pharmacotherapy","studyType":"Clinical Study"},{"pmid":"41620811","year":"2026","title":"Intravenous Brexanolone for the Treatment of Posttraumatic Stress Disorder: A Case Report.","finding":"","journal":"The American journal of psychiatry","studyType":"Clinical Study"}],"tags":[{"label":"Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"GABA-A receptor alpha-1/beta-2/gamma-2","category":"target"},{"label":"GABRA1","category":"gene"},{"label":"GABRB2","category":"gene"},{"label":"GABRG2","category":"gene"},{"label":"N06AX29","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Postpartum depression","category":"indication"},{"label":"Sage Therap","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"GABA Agents","category":"pharmacology"},{"label":"GABA Modulators","category":"pharmacology"},{"label":"Neurosteroids","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":91.329,"date":"","count":20,"signal":"Product administration error","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=91)"}],"commonSideEffects":[],"specialPopulations":{"Pregnancy":"May cause fetal harm. There is pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.Risk Summary Based on findings from animal studies of other drugs that enhance GABAergic inhibition, ZULRESSO may cause fetal harm. There are no available data on ZULRESSO use in pregnant women to determine drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, malformations were not seen in rats or rabbits at plasma levels up to and times the maximum recommended human dose (MRHD), respectively. Developmental toxicities were seen in the fetuses of rats and rabbits at and >=3 times the plasma levels at the MRHD, respectively. Reproductive toxicities were seen in rabbits at >=3 times the plasma levels at the MRHD. These effects were not seen in rats and rabbits at and 1.2 times the plasma levels at the MRHD. Brexanolone administered to pregnant rats during pregnancy resulted in developmental toxicities and reproductive toxicities.","Geriatric use":"PPD is condition associated with pregnancy; there is no geriatric experience with ZULRESSO.","Paediatric use":"The safety and effectiveness of ZULRESSO in pediatric patients have not been established.","Renal impairment":"Avoid use in patients with end stage renal disease (ESRD)."}},"trials":[],"aliases":[],"company":"Sage Therap","patents":[{"applNo":"N211371","source":"FDA Orange Book","status":"Active","expires":"Mar 8, 2037","useCode":"U-2552","territory":"US","drugProduct":false,"patentNumber":"10940156","drugSubstance":false},{"applNo":"N211371","source":"FDA Orange Book","status":"Active","expires":"Nov 27, 2033","useCode":"U-2552","territory":"US","drugProduct":false,"patentNumber":"10251894","drugSubstance":false},{"applNo":"N211371","source":"FDA Orange Book","status":"Active","expires":"Mar 13, 2029","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8410077","drugSubstance":false},{"applNo":"N211371","source":"FDA Orange Book","status":"Active","expires":"Mar 13, 2029","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9200088","drugSubstance":false},{"applNo":"N211371","source":"FDA Orange Book","status":"Active","expires":"Mar 13, 2029","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9750822","drugSubstance":false},{"applNo":"N211371","source":"FDA Orange Book","status":"Active","expires":"Mar 13, 2029","useCode":"","territory":"US","drugProduct":true,"patentNumber":"7635773","drugSubstance":false},{"applNo":"N211371","source":"FDA Orange Book","status":"Active","expires":"Jan 23, 2033","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10322139","drugSubstance":false},{"applNo":"N211371","source":"FDA Orange Book","status":"Active","expires":"Mar 13, 2029","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10117951","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BREXANOLONE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:45:50.484483+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:45:46.778655+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Brexanolone","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:45:57.652244+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:45:56.237818+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BREXANOLONE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:45:56.577621+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6068045/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:45:57.296877+00:00"}},"allNames":"zulresso","offLabel":[],"synonyms":["brexanolone","zurlesso","SAGE-547","SGE-102","SGE-00122"],"timeline":[{"date":"2019-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SAGE THERAPEUTICS to Sage Therap"},{"date":"2019-03-19","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sage Therapeutics)"}],"aiSummary":"Zulresso, also known as brexanolone, is a small molecule neuroactive steroid gamma-aminobutyric acid A receptor positive modulator developed by SAGE THERAPEUTICS and currently owned by Sage Therap. It targets the GABA-A receptor alpha-1/beta-2/gamma-2 subunit, modulating the activity of this receptor to treat postpartum depression. Zulresso was FDA approved in 2019 and is a patented medication with no generic manufacturers available. Key safety considerations include its potential effects on blood pressure and electrolyte levels. It is a modulator of the GABA-A receptor, which is a key component of the brain's inhibitory neurotransmission system.","brandName":"Zulresso","ecosystem":[{"indication":"Postpartum depression","otherDrugs":[{"name":"zuranolone","slug":"zuranolone","company":"Sage Therap"}],"globalPrevalence":1360000000}],"mechanism":{"target":"GABA-A receptor alpha-1/beta-2/gamma-2","novelty":"Follow-on","targets":[{"gene":"GABRA1","source":"DrugCentral","target":"GABA-A receptor alpha-1/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit alpha-1"},{"gene":"GABRB2","source":"DrugCentral","target":"GABA-A receptor alpha-1/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit beta-2"},{"gene":"GABRG2","source":"DrugCentral","target":"GABA-A receptor alpha-1/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit gamma-2"},{"gene":"GABRA4","source":"DrugCentral","target":"GABA A receptor alpha-4/beta-3/delta","protein":"Gamma-aminobutyric acid receptor subunit alpha-4"},{"gene":"GABRB3","source":"DrugCentral","target":"GABA A receptor alpha-4/beta-3/delta","protein":"Gamma-aminobutyric acid receptor subunit beta-3"},{"gene":"GABRD","source":"DrugCentral","target":"GABA A receptor alpha-4/beta-3/delta","protein":"Gamma-aminobutyric acid receptor subunit delta"},{"gene":"GABRA6","source":"DrugCentral","target":"GABA-A receptor alpha-6/beta-3/delta","protein":"Gamma-aminobutyric acid receptor subunit alpha-6"},{"gene":"G6PD","source":"DrugCentral","target":"Glucose-6-phosphate 1-dehydrogenase","protein":"Glucose-6-phosphate 1-dehydrogenase"}],"moaClass":"GABA A Receptor Positive Modulators","modality":"Small Molecule","drugClass":"Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator","explanation":"","oneSentence":"","technicalDetail":"Zulresso is a small molecule neuroactive steroid gamma-aminobutyric acid A receptor positive modulator that selectively binds to the GABA-A receptor alpha-1/beta-2/gamma-2 subunit, enhancing the receptor's activity and promoting the effects of the neurotransmitter GABA."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Allopregnanolone","title":"Allopregnanolone","extract":"Allopregnanolone is a naturally occurring neurosteroid which is made in the body from the hormone progesterone. As a medication, allopregnanolone was referred to as brexanolone, sold under the brand name Zulresso, and was used to treat postpartum depression. It was given by injection into a vein.","wiki_history":"==History==\nIn March 2019, brexanolone was approved in the United States for the treatment of postpartum depression (PPD) in adult women,\n\nThe FDA granted the application for brexanolone priority review and breakthrough therapy designations, and granted approval of Zulresso to Sage Therapeutics, Inc. On April 14, 2025, the FDA approval was withdrawn.","wiki_society_and_culture":"==Society and culture==\n\n===Names===\nBrexanolone is both the International Nonproprietary Name and the United States Adopted Name in the context of its use as a medication.\n\nZulresso is a brand name of the medication.\n\n===Legal status===\nIn the United States, brexanolone is a Schedule IV controlled substance.\n\n===Available forms===\nBrexanolone is an aqueous mixture of synthetic allopregnanolone and sulfobutyl ether β-cyclodextrin (betadex sulfobutyl ether sodium), a solubilizing agent. It is provided at an allopregnanolone concentration of 100 mg/20 mL (5 mg/mL) in single-dose vials for use by intravenous infusion. Each mL of brexanolone solution contains 5 mg allopregnanolone, 250 mg sulfobutyl ether β-cyclodextrin, 0.265 mg citric acid monohydrate, 2.57 mg sodium citrate dihydrate, and water for injection. The solution is hypertonic and must be diluted to a target concentration of 1 mg/mL with sterile water and sodium chloride prior to administration. Five infusion bags are generally required for the full infusion. More than five infusion bags are necessary for patients weighing more than 90 kg (200 lbs)."},"commercial":{"launchDate":"2019","_launchSource":"DrugCentral (FDA 2019-03-19, SAGE THERAPEUTICS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5324","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BREXANOLONE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BREXANOLONE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Allopregnanolone","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T09:06:16.746241","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:45:58.868136+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"tryptophan","drugSlug":"tryptophan","fdaApproval":"","relationship":"same-class"},{"drugName":"nomifensine","drugSlug":"nomifensine","fdaApproval":"","relationship":"same-class"},{"drugName":"trazodone","drugSlug":"trazodone","fdaApproval":"1981-12-24","patentExpiry":"Mar 27, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"nefazodone","drugSlug":"nefazodone","fdaApproval":"1994-12-22","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"viloxazine","drugSlug":"viloxazine","fdaApproval":"2021-04-02","patentExpiry":"Sep 4, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"mirtazapine","drugSlug":"mirtazapine","fdaApproval":"1996-06-14","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"bupropion","drugSlug":"bupropion","fdaApproval":"1985-12-30","patentExpiry":"Jun 27, 2026","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"venlafaxine","drugSlug":"venlafaxine","fdaApproval":"1993-12-28","genericCount":41,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"milnacipran","drugSlug":"milnacipran","fdaApproval":"2009-01-14","patentExpiry":"Sep 19, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"duloxetine","drugSlug":"duloxetine","fdaApproval":"2004-08-03","patentExpiry":"Apr 13, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"desvenlafaxine","drugSlug":"desvenlafaxine","fdaApproval":"2008-02-29","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"vilazodone","drugSlug":"vilazodone","fdaApproval":"2011-01-21","genericCount":5,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"vortioxetine","drugSlug":"vortioxetine","fdaApproval":"2013-09-30","patentExpiry":"Sep 21, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"esketamine","drugSlug":"esketamine","fdaApproval":"2019-05-03","patentExpiry":"Sep 10, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"levomilnacipran","drugSlug":"levomilnacipran","fdaApproval":"2013-07-25","patentExpiry":"May 23, 2032","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"brexanolone","indications":{"approved":[{"name":"Postpartum depression","source":"DrugCentral","snomedId":58703003,"regulator":"FDA","globalPrevalence":1360000000,"prevalenceMethod":"ai-extracted","prevalenceSource":"Transl Psychiatry, 2021 (PMID:34671011)"}],"offLabel":[],"pipeline":[]},"currentOwner":"Sage Therap","drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"tryptophan","brandName":"tryptophan","genericName":"tryptophan","approvalYear":"","relationship":"same-class"},{"drugId":"nomifensine","brandName":"nomifensine","genericName":"nomifensine","approvalYear":"","relationship":"same-class"},{"drugId":"trazodone","brandName":"trazodone","genericName":"trazodone","approvalYear":"1981","relationship":"same-class"},{"drugId":"nefazodone","brandName":"nefazodone","genericName":"nefazodone","approvalYear":"1994","relationship":"same-class"},{"drugId":"viloxazine","brandName":"viloxazine","genericName":"viloxazine","approvalYear":"2021","relationship":"same-class"},{"drugId":"mirtazapine","brandName":"mirtazapine","genericName":"mirtazapine","approvalYear":"1996","relationship":"same-class"},{"drugId":"bupropion","brandName":"bupropion","genericName":"bupropion","approvalYear":"1985","relationship":"same-class"},{"drugId":"venlafaxine","brandName":"venlafaxine","genericName":"venlafaxine","approvalYear":"1993","relationship":"same-class"},{"drugId":"milnacipran","brandName":"milnacipran","genericName":"milnacipran","approvalYear":"2009","relationship":"same-class"},{"drugId":"duloxetine","brandName":"duloxetine","genericName":"duloxetine","approvalYear":"2004","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06979544","phase":"PHASE3","title":"A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD","status":"COMPLETED","sponsor":"Lipocine Inc.","startDate":"2025-06-16","conditions":["Depression, Postpartum","Depression, Post-Partum","Postpartum Depression (PPD)","Post-Natal Depression","Peripartum Depression","Postnatal Depression"],"enrollment":90,"completionDate":"2026-02-17"},{"nctId":"NCT05329779","phase":"PHASE4","title":"Study on Allopregnanolone and Depression in Perimenopausal Women","status":"TERMINATED","sponsor":"Brigham and Women's Hospital","startDate":"2022-11-04","conditions":["Depression"],"enrollment":2,"completionDate":"2023-07-18"},{"nctId":"NCT07079761","phase":"PHASE2","title":"Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2025-08-04","conditions":["Post Traumatic Stress Disorder"],"enrollment":96,"completionDate":"2027-04-30"},{"nctId":"NCT01246765","phase":"","title":"National Pregnancy Registry for Psychiatric Medications","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2008-11","conditions":["Pregnant Women","Psychotropic Drugs"],"enrollment":5000,"completionDate":"2033-12"},{"nctId":"NCT02477618","phase":"PHASE3","title":"A Study With SAGE-547 for Super-Refractory Status Epilepticus","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"2015-06","conditions":["Super-Refractory Status Epilepticus"],"enrollment":132,"completionDate":"2017-08-11"},{"nctId":"NCT02942004","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","isPivotal":true,"startDate":"2016-08-01","conditions":["Postpartum Depression"],"enrollment":138,"completionDate":"2017-10-19"},{"nctId":"NCT05223829","phase":"PHASE1","title":"Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yale University","startDate":"2023-08-01","conditions":["PTSD","Alcohol Use Disorder"],"enrollment":25,"completionDate":"2025-12-31"},{"nctId":"NCT03665038","phase":"PHASE3","title":"A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"2018-09-07","conditions":["Post Partum Depression"],"enrollment":28,"completionDate":"2021-01-08"},{"nctId":"NCT02433314","phase":"","title":"An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus","status":"NO_LONGER_AVAILABLE","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"","conditions":["Super-Refractory Status Epilepticus"],"enrollment":0,"completionDate":""},{"nctId":"NCT02285504","phase":"PHASE2","title":"Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"2015-01-07","conditions":["Postpartum Depression"],"enrollment":4,"completionDate":"2015-06-05"},{"nctId":"NCT05645432","phase":"PHASE2","title":"An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"2023-05-10","conditions":["Tinnitus"],"enrollment":10,"completionDate":"2023-11-21"},{"nctId":"NCT02052739","phase":"PHASE1,PHASE2","title":"Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"2014-03-21","conditions":["Super-refractory Status Epilepticus"],"enrollment":25,"completionDate":"2015-05-03"},{"nctId":"NCT02614547","phase":"PHASE2","title":"A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"2015-12-15","conditions":["Severe Postpartum Depression"],"enrollment":21,"completionDate":"2016-06-22"},{"nctId":"NCT05059600","phase":"PHASE4","title":"A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"2021-10-08","conditions":["Postpartum Depression"],"enrollment":52,"completionDate":"2022-07-14"},{"nctId":"NCT02942017","phase":"PHASE3","title":"A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","isPivotal":true,"startDate":"2016-07","conditions":["Postpartum Depression"],"enrollment":108,"completionDate":"2017-10-11"},{"nctId":"NCT03924492","phase":"","title":"Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression","status":"APPROVED_FOR_MARKETING","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"","conditions":["Postpartum Depression"],"enrollment":0,"completionDate":""},{"nctId":"NCT06580444","phase":"PHASE2","title":"Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study","status":"NOT_YET_RECRUITING","sponsor":"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance","startDate":"2025-07-28","conditions":["Alcohol Use Disorder (AUD)","Post Traumatic Stress Disorder (PTSD)"],"enrollment":40,"completionDate":"2027-03-19"},{"nctId":"NCT04468360","phase":"PHASE2","title":"Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD","status":"RECRUITING","sponsor":"Boston University","startDate":"2022-03-04","conditions":["Post Traumatic Stress Disorder"],"enrollment":256,"completionDate":"2026-12"},{"nctId":"NCT05543746","phase":"","title":"Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2022-08-05","conditions":["Postpartum Depression"],"enrollment":10,"completionDate":"2023-11-15"},{"nctId":"NCT05314153","phase":"EARLY_PHASE1","title":"Effects Zulresso on Postpartum Psychosis","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2022-02-23","conditions":["Postpartum Psychosis"],"enrollment":10,"completionDate":"2024-06-01"},{"nctId":"NCT05254405","phase":"PHASE4","title":"An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder","status":"RECRUITING","sponsor":"Donald Jeffrey Newport","startDate":"2023-06-01","conditions":["Post-Traumatic Stress Disorder"],"enrollment":20,"completionDate":"2026-03-01"},{"nctId":"NCT04537806","phase":"PHASE3","title":"A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)","status":"TERMINATED","sponsor":"Sage Therapeutics","startDate":"2020-12-18","conditions":["Acute Respiratory Distress Syndrome","COVID-19"],"enrollment":29,"completionDate":"2021-07-01"},{"nctId":"NCT02277106","phase":"PHASE2","title":"Evaluate SAGE-547 in Participants With Essential Tremor","status":"COMPLETED","sponsor":"Sage Therapeutics","startDate":"2014-09-23","conditions":["Essential Tremor"],"enrollment":25,"completionDate":"2015-08-14"},{"nctId":"NCT04273191","phase":"PHASE4","title":"A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)","status":"WITHDRAWN","sponsor":"Sage Therapeutics","startDate":"2020-02","conditions":["Postpartum Depression"],"enrollment":0,"completionDate":"2021-08"},{"nctId":"NCT02603926","phase":"PHASE2","title":"Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone","status":"COMPLETED","sponsor":"Randi J. Hagerman, MD","startDate":"2015-10","conditions":["Fragile X-associated Tremor/Ataxia Syndrome"],"enrollment":6,"completionDate":"2017-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"pivotalTrials":["NCT02942004","NCT02942017"],"administration":{"route":"Intravenous","formulation":"Injection","formulations":[{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Zulresso"}]},"_patentsChecked":true,"crossReferences":{"MMSL":"36584","NDDF":"017976","UNII":"S39XZ5QV8Y","CHEBI":"CHEBI:50169","VANDF":"4038491","INN_ID":"10446","RXNORM":"2121777","UMLSCUI":"C4548848","chemblId":"CHEMBL6068045","ChEMBL_ID":"CHEMBL207538","KEGG_DRUG":"D11149","DRUGBANK_ID":"DB11859","PUBCHEM_CID":"92786","SNOMEDCT_US":"787054008","MESH_SUPPLEMENTAL_RECORD_UI":"C584548"},"formularyStatus":[],"originalProduct":{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","company":"Sage Therapeutics, Inc.","brandName":"Zulresso","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2019-","companyName":"Sage Therapeutics","relationship":"Original Developer"},{"period":"present","companyName":"Sage Therap","relationship":"Current Owner"}],"publicationCount":199,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N06AX29","allCodes":["N06AX29"]},"biosimilarFilings":[],"originalDeveloper":"Sage Therapeutics","recentPublications":[{"date":"2026 Mar 11","pmid":"41871269","title":"Temporal Dynamics of Antidepressant Response Following Brexanolone Treatment in Postpartum Depression.","journal":"The Journal of clinical psychiatry"},{"date":"2026 Mar 16","pmid":"41863265","title":"Neuroactive Steroid Regulation in Premenstrual Dysphoric Disorder: Cross-Integration of Metabolism, Dysfunction, Neurobiology, and Precision Medicine.","journal":"Current neuropharmacology"},{"date":"2026 Apr 1","pmid":"41855550","title":"ACOG Clinical Practice Update, Zuranolone and Brexanolone for the Treatment of Postpartum Depression: Correction.","journal":"Obstetrics and gynecology"},{"date":"2026 Feb","pmid":"41701518","title":"Advances in antidepressant pharmacotherapy: phase 3 evidence and clinical perspectives.","journal":"Expert opinion on pharmacotherapy"},{"date":"2026 Feb 1","pmid":"41620811","title":"Intravenous Brexanolone for the Treatment of Posttraumatic Stress Disorder: A Case Report.","journal":"The American journal of psychiatry"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Sage Therap","companyId":"sage-therap","modality":"Small molecule","firstApprovalDate":"2019","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":4,"withResults":3},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:45:58.868136+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}