Elamipretide (DrugBank: Elamipretide)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 21 | Mitochondrial disease | 3 |
| 324 | Methylglutaconic aciduria | 1 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02976038 (ClinicalTrials.gov) | December 2016 | 18/11/2016 | Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM) | A Multicenter, Open-Label Phase 2 Extension Trial to Characterize the Long-term Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM) | Primary Mitochondrial Disease | Drug: elamipretide | Stealth BioTherapeutics Inc. | NULL | Terminated | 16 Years | N/A | All | 36 | Phase 2 | United States |
| 2 | NCT02805790 (ClinicalTrials.gov) | August 22, 2016 | 13/6/2016 | Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate Safety, Tolerability, and Efficacy of Subcutaneous Injections of MTP-131 in Subjects With Mitochondrial Myopathy Previously Treated in the SPIMM-201 Study | Primary Mitochondrial Disease | Drug: Elamipretide;Drug: Placebo | Stealth BioTherapeutics Inc. | NULL | Completed | 16 Years | N/A | All | 30 | Phase 2 | United States |
| 3 | NCT02367014 (ClinicalTrials.gov) | February 2015 | 9/2/2015 | Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy | Phase 1/2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Clinical Study for the Safety, Tolerability, and Efficacy of IV MTP-131 for Mitochondrial Myopathy in Genetically Confirmed Mitochondrial Disease | Mitochondrial Myopathy | Drug: elamipretide (low dose);Drug: elamipretide (intermediate dose);Drug: elamipretide (high dose);Drug: Placebo | Stealth BioTherapeutics Inc. | NULL | Completed | 16 Years | 65 Years | All | 36 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03098797 (ClinicalTrials.gov) | May 1, 2017 | 21/3/2017 | A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Injections of Elamipretide (MTP-131) in Subjects With Genetically Confirmed Barth Syndrome Followed by an Open-Label Treatment Extension | Barth Syndrome | Drug: Elamipretide | Stealth BioTherapeutics Inc. | NULL | Active, not recruiting | 12 Years | N/A | Male | 12 | Phase 2;Phase 3 | United States |