{"changeSha256":"742696ffa066f61ffbda457c7b875ee8514b28ea959804aab294e1aaa0b75455","changedAt":"2026-09-15","changedFields":[{"after":"U.S. accelerated approval for a specified Barth syndrome population","before":"Investigational","field":"Status"},{"after":"approved","before":"investigational","field":"Status classification"},{"after":"FDA granted Forzinity (elamipretide) accelerated approval to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg.","before":"A mitochondria-targeting peptide candidate. This profile cites a recruiting ClinicalTrials.gov study record.","field":"Profile summary"},{"after":"FDA's September 19, 2025 approval letter requires a confirmatory trial to verify clinical benefit. The approval concerns this product and specified use; a recruiting trial record does not describe its full regulatory status.","before":"ClinicalTrials.gov lists the 4TAZPower study as recruiting, updated July 13, 2026.","field":"Evidence note"},{"after":"SS-31, MTP-131, Forzinity","before":"SS-31, MTP-131","field":"Related names"},{"after":"ctg-nct07531251-v4, fda-forzinity-approval-2025","before":"ctg-nct07531251-v4","field":"Cited source records"},{"after":"name: ctg-nct07531251-v4; aliases: ctg-nct07531251-v4, fda-forzinity-approval-2025; category: ctg-nct07531251-v4; status: fda-forzinity-approval-2025; summary: fda-forzinity-approval-2025; evidenceNote: fda-forzinity-approval-2025","before":"name: ctg-nct07531251-v4; aliases: ctg-nct07531251-v4; category: ctg-nct07531251-v4; status: ctg-nct07531251-v4; summary: ctg-nct07531251-v4; evidenceNote: ctg-nct07531251-v4","field":"Claim citations"}],"currentVersion":{"canonicalUrl":"https://peptidescanner.com/peptides/elamipretide/versions/3/","version":3},"id":"profile:elamipretide:v3","interpretationBoundary":"This event describes a PeptideScanner public-version change. It does not by itself establish that the cited source changed, that a scientific conclusion changed, or that source monitoring is continuous.","kind":"corrected","notice":"The previous profile described elamipretide only as investigational. We added FDA's September 19, 2025 accelerated approval of Forzinity for the specified Barth syndrome population. This correction does not extend that approval to other uses or formulations.","peptideSlugs":["elamipretide"],"previousChangeEvent":{"path":"/corrections/v1/profiles/elamipretide/v2.json","sha256":"cd8eefa9e57561829ae5beffce3dc9c0024b84e24b93941c1754255016ed27cc"},"previousVersion":{"canonicalUrl":"https://peptidescanner.com/peptides/elamipretide/versions/2/","version":2},"schemaVersion":"peptidescanner-public-correction-lineage-event/v1","sourceRecords":[{"id":"fda-forzinity-approval-2025","name":"U.S. Food and Drug Administration","sourceClass":"A","title":"Forzinity (elamipretide): NDA 215244 accelerated approval letter, September 19, 2025","url":"https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/215244Orig1s000Approv.pdf","verifiedAt":"2026-09-15"}],"subject":{"slug":"elamipretide","type":"profile"}}