{"id":"ibrexafungerp-citrate","rwe":[{"pmid":"34398948","year":"2021","title":"Ibrexafungerp Citrate.","finding":"","journal":"American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists","studyType":"Clinical Study"}],"tags":[{"label":"Triterpenoid Antifungal","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J02AX07","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Active","category":"status"},{"label":"Candidiasis of vagina","category":"indication"},{"label":"Vulvovaginal candidiasis","category":"indication"},{"label":"Glaxosmithkline","category":"company"},{"label":"Approved 2020s","category":"decade"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antifungal Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[],"contraindications":["Pregnancy, function"],"specialPopulations":{"Lactation":"There are no data on the presence of ibrexafungerp in either human or animal milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for BREXAFEMME and any potential adverse effects on the breastfed child from BREXAFEMME or from the underlying maternal condition.","Pregnancy":"BREXAFEMME use is contraindicated in pregnancy because it may cause fetal harm. In pregnant rabbits, oral ibrexafungerp administered during organogenesis was associated with rare malformations including absent forelimb(s), absent hindpaw, absent ear pinna, and thoracogastroschisis at dose exposures greater or equal to approximately times the human exposure at the RHD.","Geriatric use":"Clinical studies with ibrexafungerp did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. No clinically meaningful differences in the pharmacokinetics of ibrexafungerp were observed in geriatric patients compared to younger adults.","Paediatric use":"The safety and effectiveness of BREXAFEMME for treatment of VVC have been established in post-menarchal pediatric females. Use of BREXAFEMME in post-menarchal pediatric patients is supported by evidence from adequate and well-controlled studies of BREXAFEMME in adult non-pregnant women with additional safety data from post-menarchal pediatric females."}},"trials":[],"aliases":[],"company":"GSK","patents":[{"applNo":"N214900","source":"FDA Orange Book","status":"Active","expires":"Jun 10, 2039","useCode":"U-3159","territory":"US","drugProduct":false,"patentNumber":"11534433","drugSubstance":false},{"applNo":"N214900","source":"FDA Orange Book","status":"Active","expires":"Aug 28, 2030","useCode":"U-3159","territory":"US","drugProduct":true,"patentNumber":"8188085","drugSubstance":true},{"applNo":"N214900","source":"FDA Orange Book","status":"Active","expires":"Jan 19, 2035","useCode":"U-3159","territory":"US","drugProduct":false,"patentNumber":"10370406","drugSubstance":false},{"applNo":"N214900","source":"FDA Orange Book","status":"Active","expires":"Jan 19, 2035","useCode":"","territory":"US","drugProduct":false,"patentNumber":"10927142","drugSubstance":true},{"applNo":"N214900","source":"FDA Orange Book","status":"Active","expires":"Jan 19, 2035","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10174074","drugSubstance":true}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=IBREXAFUNGERP CITRATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:22:44.789163+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:22:41.844542+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ibrexafungerp Citrate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:22:57.929083+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:22:56.575787+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=IBREXAFUNGERP CITRATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:22:57.242588+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: 1,3-beta-glucan synthase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:22:57.928701+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4298168/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:22:57.833346+00:00"}},"allNames":"brexafemme","offLabel":[],"synonyms":["ibrexafungerp","ibrexafungerp citrate","brexafemme","SCY-078","MK-3118"],"timeline":[{"date":"2021-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SCYNEXIS to Glaxosmithkline"},{"date":"2021-06-01","type":"positive","source":"DrugCentral","milestone":"FDA approval (Scynexis)"},{"date":"2026-06-01","type":"negative","source":"FDA Orange Book","milestone":"New Chemical Entity exclusivity expires"},{"date":"2030-08-28","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8188085 expires"},{"date":"2031-06-01","type":"negative","source":"FDA Orange Book","milestone":"GAIN exclusivity expires"},{"date":"2035-01-19","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 10927142 expires"}],"brandName":"Brexafemme","ecosystem":[{"indication":"Candidiasis of vagina","otherDrugs":[{"name":"candicidin","slug":"candicidin","company":"Sanofi Aventis Us"}],"globalPrevalence":null},{"indication":"Vulvovaginal candidiasis","otherDrugs":[],"globalPrevalence":138000000}],"mechanism":{"novelty":"Follow-on","moaClass":"Glucan Synthase Inhibitors","modality":"Small Molecule","drugClass":"Triterpenoid Antifungal","explanation":"","oneSentence":"","technicalDetail":"Ibrexafungerp citrate inhibits the enzyme glucan synthase, which is essential for the synthesis of beta-1,3-glucan, a key component of the fungal cell wall."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ibrexafungerp","title":"Ibrexafungerp","extract":"Ibrexafungerp, sold under the brand name Brexafemme, is an antifungal medication used to treat vulvovaginal candidiasis (VVC). It is taken orally. It is also currently undergoing clinical trials for other indications via an intravenous (IV) formulation. An estimated 75% of women will have at least one episode of VVC and 40 to 45% will have two or more episodes in their lifetime."},"commercial":{"launchDate":"2021","_launchSource":"DrugCentral (FDA 2021-06-01, SCYNEXIS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5462","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=IBREXAFUNGERP CITRATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Ibrexafungerp","fields":["history","overview"],"source":"Wikipedia"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T02:35:04.012855","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:22:59.689917+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"flucytosine","drugSlug":"flucytosine","fdaApproval":"1971-11-26","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"caspofungin","drugSlug":"caspofungin","fdaApproval":"2001-01-26","patentExpiry":"Dec 21, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"micafungin","drugSlug":"micafungin","fdaApproval":"2005-03-16","patentExpiry":"Dec 15, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"anidulafungin","drugSlug":"anidulafungin","fdaApproval":"2006-02-17","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"rezafungin","drugSlug":"rezafungin","fdaApproval":"2023-03-22","patentExpiry":"Mar 2, 2032","patentStatus":"Patent 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