synthetic tetrapeptide

SS-31 (elamipretide) updates

Answer

4 changes for SS-31 (elamipretide) in the last 12 months. Latest: 2026-04-16.

DateTypeWhat changedSource
2026-04-16ActionOhio Board of Pharmacy: boardRegulator Ohio Board of Pharmacy
2026-03-12TrialNew trial registered: Clinical Trial in Patients With Barth Syndrome- 4TAZPowerTrial register ClinicalTrials.gov
2025-12-12ResultsResults posted: FRDA Investigator Initiated Study (IIS) With ElamipretideTrial register ClinicalTrials.gov
2025-10-15TrialNew trial registered: Study of Healthy Aging and Physical Function With ElamipretideTrial register ClinicalTrials.gov
2024-04-16ResultsResults posted: A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth SyndromeTrial register ClinicalTrials.gov
2024-04-16TrialNew trial registered: ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular DegenTrial register ClinicalTrials.gov
2023-10-17ResultsResults posted: ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GATrial register ClinicalTrials.gov
2021-12-17ResultsResults posted: Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary MitochondrTrial register ClinicalTrials.gov
2021-12-09TrialNew trial registered: FRDA Investigator Initiated Study (IIS) With ElamipretideTrial register ClinicalTrials.gov
2021-12-08TrialNew trial registered: Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)Trial register ClinicalTrials.gov
2021-10-12ResultsResults posted: A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic NeuropaTrial register ClinicalTrials.gov
2021-09-17ResultsResults posted: A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial DTrial register ClinicalTrials.gov
2021-04-02ResultsResults posted: A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label ExtensionTrial register ClinicalTrials.gov
2020-12-23TrialNew trial registered: An Intermediate Size Expanded Access Protocol of ElamipretideTrial register ClinicalTrials.gov
2020-09-21ResultsResults posted: An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related MaculTrial register ClinicalTrials.gov
2020-08-11ResultsResults posted: Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal ArteryTrial register ClinicalTrials.gov
2020-07-07ResultsResults posted: Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER StudyTrial register ClinicalTrials.gov
2020-06-23ResultsResults posted: A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in ElderlyTrial register ClinicalTrials.gov
2020-06-11ResultsResults posted: Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary EventsTrial register ClinicalTrials.gov
2020-04-22ResultsResults posted: Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection FractionTrial register ClinicalTrials.gov
2019-12-27ResultsResults posted: Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial MyopathyTrial register ClinicalTrials.gov
2019-03-25TrialNew trial registered: ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GATrial register ClinicalTrials.gov
2017-10-12TrialNew trial registered: A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label ExtensionTrial register ClinicalTrials.gov
2017-03-21TrialNew trial registered: A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth SyndromeTrial register ClinicalTrials.gov
2016-11-18TrialNew trial registered: Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary MitoTrial register ClinicalTrials.gov
2016-09-14TrialNew trial registered: A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Trial register ClinicalTrials.gov
2016-07-25TrialNew trial registered: An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-RelatedTrial register ClinicalTrials.gov
2016-06-13TrialNew trial registered: Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER StudyTrial register ClinicalTrials.gov
2016-06-08TrialNew trial registered: A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart FailuTrial register ClinicalTrials.gov
2016-05-27TrialNew trial registered: Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection FractionTrial register ClinicalTrials.gov
2016-02-15TrialNew trial registered: A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic NTrial register ClinicalTrials.gov
2015-12-20TrialNew trial registered: A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal EndotheTrial register ClinicalTrials.gov
2015-04-30TrialNew trial registered: A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal FunctioTrial register ClinicalTrials.gov
2015-03-01TrialNew trial registered: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart FaTrial register ClinicalTrials.gov
2015-03-01TrialNew trial registered: A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart FailureTrial register ClinicalTrials.gov
2015-02-09TrialNew trial registered: Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial MyopathyTrial register ClinicalTrials.gov
2014-12-02TrialNew trial registered: A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular DegeneratiTrial register ClinicalTrials.gov
2014-09-17TrialNew trial registered: A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in ElderlyTrial register ClinicalTrials.gov
2013-02-06TrialNew trial registered: Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 DaysTrial register ClinicalTrials.gov
2012-12-19TrialNew trial registered: Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal ArteryTrial register ClinicalTrials.gov
2012-12-18TrialNew trial registered: A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)Trial register ClinicalTrials.gov
2012-03-28TrialNew trial registered: Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary EventsTrial register ClinicalTrials.gov
2012-01-23TrialNew trial registered: The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette SmokingTrial register ClinicalTrials.gov
2012-01-06TrialNew trial registered: Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without BendaviaTrial register ClinicalTrials.gov
2010-04-30TrialNew trial registered: Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy AdultsTrial register ClinicalTrials.gov

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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