{"slug":"ss-31","seoKey":"ss31","inn":"elamipretide","displayName":"SS-31","codes":["SS-31","MTP-131","RX-31","SBT-131"],"synonyms":["elamipretide","elamipretide hydrochloride","Szeto-Schiller peptide 31","D-Arg-Dmt-Lys-Phe-NH2","Bendavia (historical development name)"],"legalClass":"rx","identifiers":{"cas":"736992-21-5","pubchemCid":11764719,"unii":"87GWG91S09","inchikey":"SFVLTCAESLKEHH-WKAQUBQDSA-N","drugbankId":"DB11981","chemblId":"CHEMBL3833370","wikidataQid":"Q27269822","formula":"C32H49N9O5","molecularWeight":639.8,"sequence":"D-Arg-Dmt-Lys-Phe-NH2"},"approvals":[{"market":"US","status":"approved_rx","date":"2025-09-19","note":"Prescription-only, granted under accelerated approval; indication: improving muscle strength in adult and paediatric patients with Barth syndrome weighing at least 30 kg. A confirmatory trial is required.","source":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215244Orig1s000ltr.pdf"},{"market":"EU","status":"not_approved","note":"No marketing authorisation. Two orphan designations are active (Barth syndrome, 2021; myopathic mtDNA depletion syndrome, 2022); a designation is not an approval.","source":"https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2430"},{"market":"DE","status":"not_approved","note":"No marketing authorisation; an orphan medicine of this kind requires a centralised EU authorisation, which does not exist. No entry found on 2026-09-06.","source":"https://www.ema.europa.eu/en/medicines?search_api_fulltext=elamipretide"},{"market":"UK","status":"not_approved","note":"No marketing authorisation. No entry found in the MHRA product database on 2026-09-06.","source":"https://products.mhra.gov.uk/search/?search=elamipretide"},{"market":"AU","status":"not_approved","note":"No entry in the Australian Register of Therapeutic Goods. No entry found on 2026-09-06.","source":"https://www.tga.gov.au/resources/artg"},{"market":"CA","status":"not_approved","note":"No marketing authorisation and no drug identification number. No entry found on 2026-09-06.","source":"https://health-products.canada.ca/dpd-bdpp/"},{"market":"CH","status":"not_approved","note":"No marketing authorisation. No entry found in the Swiss medicinal product information on 2026-09-06.","source":"https://www.swissmedicinfo.ch/"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"unclear","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT03098797","name":"TAZPOWER (Barth syndrome)","phase":"Phase 2/3","n":12,"status":"COMPLETED"},{"nct":"NCT07531251","name":"4TAZPower (Barth syndrome)","phase":"Phase 4","n":48,"status":"RECRUITING"},{"nct":"NCT03323749","name":"MMPOWER-3 (primary mitochondrial myopathy)","phase":"Phase 3","n":218,"status":"TERMINATED"},{"nct":"NCT02805790","name":"MMPOWER-2 (primary mitochondrial myopathy)","phase":"Phase 2","n":30,"status":"COMPLETED"},{"nct":"NCT02367014","name":"MMPOWER (primary mitochondrial myopathy)","phase":"Phase 1/2","n":36,"status":"COMPLETED"},{"nct":"NCT05162768","name":"NuPOWER (nuclear DNA primary mitochondrial disease)","phase":"Phase 3","n":102,"status":"COMPLETED"},{"nct":"NCT06373731","name":"ReNEW (dry age-related macular degeneration)","phase":"Phase 3","n":313,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT03891875","name":"ReCLAIM-2 (age-related macular degeneration with non-central geographic atrophy)","phase":"Phase 2","n":176,"status":"COMPLETED"},{"nct":"NCT02848313","name":"ReCLAIM (intermediate age-related macular degeneration)","phase":"Phase 1","n":40,"status":"COMPLETED"},{"nct":"NCT01572909","name":"EMBRACE STEMI (reperfusion injury in acute coronary events)","phase":"Phase 2a","n":300,"status":"COMPLETED"},{"nct":"NCT02788747","name":"PROGRESS-HF (heart failure with reduced ejection fraction)","phase":"Phase 2","n":71,"status":"COMPLETED"},{"nct":"NCT02914665","name":"IDDEA-HF (cardiac and renal effects in hospitalised heart failure)","phase":"Phase 2","n":308,"status":"COMPLETED"},{"nct":"NCT02814097","name":"Heart failure with preserved ejection fraction, four weeks subcutaneous treatment","phase":"Phase 2","n":46,"status":"COMPLETED"},{"nct":"NCT02245620","name":"Skeletal muscle function in older adults","phase":"Phase 2","n":41,"status":"COMPLETED"},{"nct":"NCT07275424","name":"Healthy aging and physical function","phase":"Phase 2","n":30,"status":"RECRUITING"}],"sameAs":["https://www.wikidata.org/wiki/Q27269822","https://pubchem.ncbi.nlm.nih.gov/compound/11764719","https://go.drugbank.com/drugs/DB11981","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3833370/"],"lastVerified":"2026-09-06","version":"1.0","published":true,"locale":"en","title":"SS-31 (elamipretide): what the trials show, status and safety","summary":"Elamipretide, known in laboratories as SS-31, is a tiny peptide of four building blocks that attaches to a particular fat inside the mitochondria, the power plants of our cells. In September 2025 it became an approved medicine in the United States for one rare inherited disease, on data from twelve patients. Every larger properly controlled trial of it has failed to show what it set out to show. No other country has approved it for anything.","updated":"2026-09-06","url":"https://mypep.app/peptides/ss-31"}