Drugs / Elamipretide
Elamipretide
also known as
Bendavia · MTP-131 · Elamipretida · ELAMIPRETIDE HYDROCHLORIDE · Elamipretide trihydrochloride · Nh2-d-arg-dmt-lys-phe-nh2 · Ocuvia · RX 31 · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FORZINITY | — | 2025-09-19 | fda.gov ↗ |
Trials 28 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT02848313 | Oct 2016 → Mar 2018 | age-related macular degeneration | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02388529 | May → Sep 2015 | heart failure | Stealth BioTherapeutics Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT02436447 | May → Jul 2015 | impaired renal function disease | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02388464 | Jul 2014 → Apr 2015 | congestive heart failure | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01786915 | Feb → Mar 2013 | — | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01754818 | Nov 2012 → Jan 2013 | — | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01518985 | Jan → Mar 2012 | — | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01513200 | Jan → Feb 2012 | — | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01115920 | May → Sep 2010 | — | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT05168774 | Mar 2022 → Jun 2024 | Friedreich ataxia | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 1/2 | NCT02653391 | Feb 2016 → Mar 2018 | Fuchs' endothelial dystrophy | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02367014 | Feb 2015 → Apr 2016 | pure mitochondrial myopathy | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02314299 | Nov 2014 → May 2015 | age-related macular degeneration, diabetic macular edema | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01755858 | Dec 2012 → Dec 2015 | ischemic disease, renal artery obstruction, renovascular hypertension | Stealth BioTherapeutics Inc. | Terminated | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT07275424 | Nov 2025 → Mar 2026 overdue | — | David Marcinek | Recruiting | No outcome recorded |
| Phase 2 | NCT03891875 | Mar 2019 → Feb 2022 | age-related macular degeneration | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02976038 | Dec 2016 → Mar 2020 | mitochondrial disease | Stealth BioTherapeutics Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02914665 | Oct 2016 → Nov 2017 | heart failure | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02814097 | Sep 2016 → May 2017 | heart failure | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02805790 | Aug 2016 → Mar 2017 | mitochondrial disease | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02788747 | Jun 2016 → Sep 2017 | heart failure | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02693119 | Mar 2016 → Sep 2019 | Leber hereditary optic neuropathy | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02245620 | Jan 2015 → Jul 2016 | pure mitochondrial myopathy | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03098797 | Jul 2017 → Oct 2018 | Barth syndrome | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06373731 | May 2024 → Aug 2027 expected | dry age related macular degeneration | Stealth BioTherapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05162768 | Apr 2022 → Sep 2024 | mitochondrial DNA depletion syndrome, mitochondrial complex I deficiency, nuclear type, pure mitochondrial myopathy | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03323749 | Oct 2017 → Feb 2020 | pure mitochondrial myopathy | Stealth BioTherapeutics Inc. | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04689360 | — | Barth syndrome | Stealth BioTherapeutics Inc. | Available | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01572909 Comparator | Apr 2012 → Nov 2014 | ST-elevation myocardial infarction | Stealth BioTherapeutics Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07531251 Comparator | Jul 2026 → Sep 2029 expected | Barth syndrome | Stealth BioTherapeutics Inc. | Recruiting | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elamipretide | “Phase 2a Clinical Trial of Mitochondrial Protection (Elamipretide) During Stent Revascularization in Patients With Atherosclerotic Renal Artery Stenosis.” PMID 28916603 ↗ Sep 2017 |
| Known as | Bendavia | “A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure” NCT02388529 ↗7“Effects of a Single 4 Hour Intravenous Infusion of Bendavia™ (MTP-131)” NCT02388464 ↗ “This is the first study of MTP-131 (Bendavia™) in humans.” NCT01115920 ↗ |
| Known as | Elamipretida | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833370 ↗ |
| Known as | ELAMIPRETIDE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833370 ↗ |
| Known as | Elamipretide trihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833370 ↗ |
| Known as | MTP-131 | “A Phase 1, Placebo-Controlled Trial to Evaluate the Impact of Intravenous (IV) Bendavia™ (MTP-131) on Endothelial Reactivity Dysfunction Induced by Cigarette Smoking” NCT01518985 ↗6“A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)” NCT01754818 ↗ |
| Known as | Nh2-d-arg-dmt-lys-phe-nh2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833370 ↗ |
| Known as | Ocuvia | “MTP-131 (Ocuvia™) Topical Ophthalmic Solution” NCT02314299 ↗ |
| Known as | RX 31 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833370 ↗ |
| Known as | SS 31 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833370 ↗ |
| Known as | Szeto-schiller peptide | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833370 ↗ |
| Modality | Peptide | “Bendavia, an intravenously administered mitochondrial targeting peptide” PMID 23537966 ↗ Feb 2013 |
| Route | Intravenous | “Single 4 hour intravenous infusion” NCT01115920 ↗ |