{ "generated": "2026-10-17", "method": "Jabbit analysis for /research/ss-31-elamipretide-mitochondria-aging-teardown.html (run 2026-10-17 ~10:15 AM ET).\nInputs:\n - ClinicalTrials.gov API v2: query.intr and query.term for elamipretide / SS-31 / MTP-131 / Bendavia (merged by NCT ID),\n each record's primary outcome and posted results read; hand-review layer HAND below (primary result per placebo-controlled\n efficacy trial, from the publication, CT.gov results or a trial registry; sources named per row).\n - FDA NDC unfinished-products file + establishment registration file dated Oct 16, 2026 (ops/data/ndc/), substance ELAMIPRETIDE.\n - PubMed E-utilities counts.\nOutput: site/research/sources/ss31-elamipretide-trials-listings-2026-10-17.json\n", "ctgov": { "records_giving_drug": 30, "by_status": { "COMPLETED": 22, "TERMINATED": 3, "ACTIVE_NOT_RECRUITING": 1, "AVAILABLE": 1, "RECRUITING": 2, "WITHDRAWN": 1 }, "with_posted_results": [ "NCT01572909", "NCT01755858", "NCT02245620", "NCT02367014", "NCT02653391", "NCT02693119", "NCT02788747", "NCT02805790", "NCT02848313", "NCT02976038", "NCT03098797", "NCT03323749", "NCT03891875", "NCT05168774" ], "sponsors": { "Stealth BioTherapeutics Inc.": 28, "Children's Hospital of Philadelphia": 1, "David Marcinek": 1 }, "records": [ { "nct": "NCT01115920", "title": "Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults", "status": "COMPLETED", "phases": [ "PHASE1" ], "enrollment": 40, "start": "2010-05", "completion": "2010-09", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Healthy" ], "primary_outcomes": [ "Treatment emergent adverse events in treatment group versus placebo group" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT01513200", "title": "Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia", "status": "COMPLETED", "phases": [ "PHASE1" ], "enrollment": 12, "start": "2012-01", "completion": "2012-02", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Healthy Volunteers" ], "primary_outcomes": [ "Mean difference over 24 hours in aPTT (activated partial prothrombin time) in seconds when UFH is administered with and without Bendavia" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT01518985", "title": "The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking", "status": "COMPLETED", "phases": [ "PHASE1" ], "enrollment": 6, "start": "2012-01", "completion": "2012-03", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Healthy Volunteers" ], "primary_outcomes": [ "Analysis of variance (ANOVA) between group mean endothelial function (EndoPAT Index) following smoking a single cigarette with and without Bendavia" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT01572909", "title": "Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events", "status": "COMPLETED", "phases": [ "PHASE2" ], "enrollment": 300, "start": "2012-04", "completion": "2015-02", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Reperfusion Injury", "STEMI" ], "primary_outcomes": [ "Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB)" ], "allocation": "RANDOMIZED", "masking": "TRIPLE" }, { "nct": "NCT01754818", "title": "A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)", "status": "COMPLETED", "phases": [ "PHASE1" ], "enrollment": 30, "start": "2012-11", "completion": "2013-02", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Healthy" ], "primary_outcomes": [ "Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) in each cohort.", "Mean Area Under the Curve (AUC) for Bendavia (hr.ng/ml) in the time from dosing to final plasma sample in each cohort.", "Mean Time post-dose of the peak plasma concentration (Tmax) of Bendavia (hours) in each cohort.", "Mean apparent clearance (CL/F) of Bendavia (ml/hr/kg) in each cohort.", "Mean Volume of Distribution (Vd/F) of Bendavia (ml/kg) in each cohort.", "Mean Half Life(t1/2) of Bendavia (hours) in each cohort." ], "allocation": "RANDOMIZED", "masking": "TRIPLE" }, { "nct": "NCT01755858", "title": "Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery", "status": "TERMINATED", "phases": [ "PHASE1", "PHASE2" ], "enrollment": 16, "start": "2012-12", "completion": "2016-05", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Renal Artery Obstruction", "Hypertension, Renovascular", "Ischemia Reperfusion Injury" ], "primary_outcomes": [ "Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA." ], "allocation": "RANDOMIZED", "masking": "TRIPLE" }, { "nct": "NCT01786915", "title": "Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days", "status": "COMPLETED", "phases": [ "PHASE1" ], "enrollment": 30, "start": "2013-02", "completion": "2013-03", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Healthy Volunteers" ], "primary_outcomes": [ "Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) on Day 1 in each cohort.", "Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) on Day 7 in each cohort.", "Mean time to peak plasma concentration (Tmax) of Bendavia (hr) on Day 1 in each cohort.", "Mean time to peak plasma concentration (Tmax) of Bendavia (hr) on Day 7 in each cohort.", "Mean Area Under the Curve (AUC) from 0-24 hours on Day 1 for Bendavia (hr.ng/ml) in the time from dosing to 24 hours post-dose in each cohort.", "Mean Area Under the Curve (AUC) from 0-24 hours on Day 7 for Bendavia (hr.ng/ml) in the time from dosing to 24 hours post-dose in each cohort.", "Ratio of AUC0-24h calculated on Day 7 to AUC0-24h calculated on Day 1 [AUC0-24h (d7)/AUC0-24h (d1)].", "Number of adverse events observed with and without Bendavia" ], "allocation": "RANDOMIZED", "masking": "TRIPLE" }, { "nct": "NCT02245620", "title": "A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly", "status": "COMPLETED", "phases": [ "PHASE2" ], "enrollment": 41, "start": "2015-01-15", "completion": "2016-07-06", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Skeletal Muscle Mitochondrial Dysfunction in the Elderly" ], "primary_outcomes": [ "Change From Baseline in ATPmax (Maximal ATP Synthetic Rate)" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT02314299", "title": "A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration", "status": "COMPLETED", "phases": [ "PHASE1", "PHASE2" ], "enrollment": 20, "start": "2014-11", "completion": "2015-06", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Diabetic Macular Edema", "Age-related Macular Degeneration" ], "primary_outcomes": [ "Incidence and severity of systemic and ocular adverse events", "Change from Baseline in vital sign measurements", "Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale", "Change from Baseline in slit lamp examinations", "Change from Baseline in intraocular pressure", "Change from Baseline in dilated fundoscopic examinations", "Change from Baseline in central subfield thickness" ], "allocation": "NON_RANDOMIZED", "masking": "NONE" }, { "nct": "NCT02367014", "title": "Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy", "status": "COMPLETED", "phases": [ "PHASE1", "PHASE2" ], "enrollment": 36, "start": "2015-02", "completion": "2016-04", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Mitochondrial Myopathy" ], "primary_outcomes": [ "Change in Distance Walked (Meters) on the 6-minute Walk Test (6MWT)" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT02388464", "title": "A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure", "status": "COMPLETED", "phases": [ "PHASE1" ], "enrollment": 36, "start": "2014-07", "completion": "2015-06", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Congestive Heart Failure" ], "primary_outcomes": [ "Incidence of Adverse Events" ], "allocation": "RANDOMIZED", "masking": "TRIPLE" }, { "nct": "NCT02388529", "title": "A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure", "status": "WITHDRAWN", "phases": [ "PHASE1" ], "enrollment": 0, "start": "2015-05", "completion": "2015-10", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Heart Failure" ], "primary_outcomes": [ "Incidence of Adverse Events", "Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort" ], "allocation": "RANDOMIZED", "masking": "TRIPLE" }, { "nct": "NCT02436447", "title": "A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function", "status": "COMPLETED", "phases": [ "PHASE1" ], "enrollment": 23, "start": "2015-05", "completion": "2015-10", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Normal and Impaired Renal Function" ], "primary_outcomes": [ "Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort" ], "allocation": "NON_RANDOMIZED", "masking": "NONE" }, { "nct": "NCT02653391", "title": "A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)", "status": "COMPLETED", "phases": [ "PHASE1", "PHASE2" ], "enrollment": 22, "start": "2016-02", "completion": "2018-12", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Fuchs' Corneal Endothelial Dystrophy (FCED)" ], "primary_outcomes": [ "Incidence and Severity of Ocular TEAEs.", "The Incidence and Severity of Systemic Adverse Events", "Change From Baseline in Findings From Slit Lamp Examinations (SLE) Part A", "Change From Baseline in Findings From Slit Lamp Examinations (SLE) Part B", "Change From Baseline in Intraocular Pressure (IOP) for Part A", "Change From Baseline in Intraocular Pressure (IOP) for Part B" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT02693119", "title": "A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy", "status": "COMPLETED", "phases": [ "PHASE2" ], "enrollment": 12, "start": "2016-03", "completion": "2019-12", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Leber's Hereditary Optic Neuropathy" ], "primary_outcomes": [ "Double Masked Period: Incidence of Ocular TEAEs", "Open Label Extension: Incidence of Ocular TEAEs", "Double Masked Period: Severity of Ocular TEAEs", "OLE: Severity of Ocular TEAEs", "Double Masked Period: Best Corrected Visual Acuity (BCVA)", "Open Label Extension Period: Best Corrected Visual Acuity (BCVA) Using the Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT02788747", "title": "Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction", "status": "COMPLETED", "phases": [ "PHASE2" ], "enrollment": 71, "start": "2016-06", "completion": "2017-10", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Heart Failure" ], "primary_outcomes": [ "Change in Left Ventricular End Systolic Volume (ml)" ], "allocation": "RANDOMIZED", "masking": "TRIPLE" }, { "nct": "NCT02805790", "title": "Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study", "status": "COMPLETED", "phases": [ "PHASE2" ], "enrollment": 30, "start": "2016-08-22", "completion": "2017-03-23", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Primary Mitochondrial Disease" ], "primary_outcomes": [ "Distance Walked on the 6-minute Walk Test (6MWT) by Visit" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT02814097", "title": "A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction", "status": "COMPLETED", "phases": [ "PHASE2" ], "enrollment": 46, "start": "2016-09-02", "completion": "2017-06-02", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Chronic Heart Failure" ], "primary_outcomes": [ "Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT02848313", "title": "An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration", "status": "COMPLETED", "phases": [ "PHASE1" ], "enrollment": 40, "start": "2016-10-28", "completion": "2018-04-10", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Age-Related Macular Degeneration" ], "primary_outcomes": [ "Change From Baseline in Mean Standard Luminance Best-corrected Visual Acuity (BCVA)" ], "allocation": "NON_RANDOMIZED", "masking": "NONE" }, { "nct": "NCT02914665", "title": "A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure", "status": "COMPLETED", "phases": [ "PHASE2" ], "enrollment": 308, "start": "2016-10-20", "completion": "2017-11-27", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Heart Failure" ], "primary_outcomes": [ "Change in NT-proBNP between Baseline and Day 8/Early Discharge" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT02976038", "title": "Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)", "status": "TERMINATED", "phases": [ "PHASE2" ], "enrollment": 28, "start": "2016-12", "completion": "2020-04-09", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Primary Mitochondrial Disease" ], "primary_outcomes": [ "Distance Walked on Six Minute Walk Test" ], "allocation": "NA", "masking": "NONE" }, { "nct": "NCT03098797", "title": "A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome", "status": "COMPLETED", "phases": [ "PHASE2", "PHASE3" ], "enrollment": 12, "start": "2017-07-05", "completion": "2021-10-11", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Barth Syndrome" ], "primary_outcomes": [ "Part 1: Distance Walked During the 6-Minute Walk Test (6MWT) by Visit", "Part 1: Total Fatigue Score Based on the BTHS-SA by Visit." ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT03323749", "title": "A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension", "status": "TERMINATED", "phases": [ "PHASE3" ], "enrollment": 218, "start": "2017-10-09", "completion": "2020-02-10", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Primary Mitochondrial Myopathy" ], "primary_outcomes": [ "Six-minute Walk Test (6MWT)", "Total Fatigue Score on the on the Primary Mitochondrial Myopathy Symptom Assessment (PMMSA)" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT03891875", "title": "ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA", "status": "COMPLETED", "phases": [ "PHASE2" ], "enrollment": 176, "start": "2019-03-27", "completion": "2022-04-14", "has_results": true, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Age-related Macular Degeneration" ], "primary_outcomes": [ "LL BCVA Score Change From Baseline", "GA Area Change From Baseline by OCT" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT04689360", "title": "An Intermediate Size Expanded Access Protocol of Elamipretide", "status": "AVAILABLE", "phases": null, "enrollment": null, "start": null, "completion": null, "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Mitochondrial Diseases", "Barth Syndrome" ], "primary_outcomes": [], "allocation": null, "masking": null }, { "nct": "NCT05162768", "title": "Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)", "status": "COMPLETED", "phases": [ "PHASE3" ], "enrollment": 102, "start": "2022-04-29", "completion": "2024-12-04", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Mitochondrial Myopathies", "Mitochondrial Pathology", "Mitochondrial DNA Mutation", "Mitochondrial Diseases", "Mitochondrial DNA Deletion", "Mitochondrial DNA Depletion", "Mitochondrial Metabolism Defect", "Mitochondrial Complex I Deficiency" ], "primary_outcomes": [ "Six-minute walk test (6MWT)" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT05168774", "title": "FRDA Investigator Initiated Study (IIS) With Elamipretide", "status": "COMPLETED", "phases": [ "PHASE1", "PHASE2" ], "enrollment": 20, "start": "2022-03-03", "completion": "2024-07-25", "has_results": true, "sponsor": "Children's Hospital of Philadelphia", "conditions": [ "Friedreich Ataxia" ], "primary_outcomes": [ "Change in High Contrast Visual Acuity" ], "allocation": "RANDOMIZED", "masking": "NONE" }, { "nct": "NCT06373731", "title": "ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)", "status": "ACTIVE_NOT_RECRUITING", "phases": [ "PHASE3" ], "enrollment": 313, "start": "2024-05-30", "completion": "2027-09", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Age Related Macular Degeneration (ARMD)" ], "primary_outcomes": [ "Week 48 Rate of change in the macular area of photoreceptor loss" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" }, { "nct": "NCT07275424", "title": "Study of Healthy Aging and Physical Function With Elamipretide", "status": "RECRUITING", "phases": [ "PHASE2" ], "enrollment": 30, "start": "2025-11-26", "completion": "2026-04-15", "has_results": false, "sponsor": "David Marcinek", "conditions": [ "Aging, Healthy" ], "primary_outcomes": [ "To evaluate the safety and tolerability of daily subcutaneous injections of elamipetide: Number of participants with treatment-related adverse events and Number of participants completed 4 weeks of injection" ], "allocation": "NA", "masking": "NONE" }, { "nct": "NCT07531251", "title": "Clinical Trial in Patients With Barth Syndrome- 4TAZPower", "status": "RECRUITING", "phases": [ "PHASE4" ], "enrollment": 48, "start": "2026-07-02", "completion": "2029-11-30", "has_results": false, "sponsor": "Stealth BioTherapeutics Inc.", "conditions": [ "Barth Syndrome" ], "primary_outcomes": [ "Primary Efficacy End Point" ], "allocation": "RANDOMIZED", "masking": "QUADRUPLE" } ] }, "placebo_controlled_efficacy_trials": { "count": 13, "by_result": { "missed": 9, "no results": 2, "borderline": 2 }, "trials": [ { "nct": "NCT01572909", "year_result_public_or_completed": 2016, "condition": "Heart attack (STEMI) during stenting", "n": 297, "dose": "IV 0.05 mg/kg/h for 1 h", "primary_endpoint": "Infarct size (CK-MB AUC 0-72 h)", "result": "missed", "source": "Gibson 2016 Eur Heart J, PMID 26586786: not associated with a significant reduction; CT.gov results" }, { "nct": "NCT01755858", "year_result_public_or_completed": 2017, "condition": "Kidney artery narrowing (stenting)", "n": 14, "dose": "IV 0.05 mg/kg/h during the procedure", "primary_endpoint": "Measured GFR change at 8 weeks (registered)", "result": "missed", "source": "CT.gov posted results: +6.3 vs +12.0 mL/min (placebo higher); Saad 2017 Circ Cardiovasc Interv, PMID 28916603, reports renal blood flow and eGFR gains instead (pilot, 6 vs 8)" }, { "nct": "NCT02914665", "year_result_public_or_completed": 2017, "condition": "Hospitalized heart failure", "n": 308, "dose": "IV 20 mg daily, 7 days", "primary_endpoint": "NT-proBNP change", "result": "no results", "source": "Completed Nov 27, 2017; no results posted on CT.gov; no PubMed record found for the NCT number" }, { "nct": "NCT02814097", "year_result_public_or_completed": 2017, "condition": "Heart failure, preserved EF", "n": 46, "dose": "SC 40 mg daily, 4 weeks", "primary_endpoint": "E/e' (heart filling)", "result": "no results", "source": "Completed Jun 2, 2017; no results posted; no PubMed record found for the NCT number" }, { "nct": "NCT02367014", "year_result_public_or_completed": 2018, "condition": "Mitochondrial myopathy (MMPOWER-1)", "n": 36, "dose": "IV, 5 days, 3 doses", "primary_endpoint": "6-minute walk at day 5", "result": "borderline", "source": "Karaa 2018 Neurology, PMID 29500292: high dose +64.5 vs +20.4 m, P = 0.053; dose trend P = 0.014" }, { "nct": "NCT02788747", "year_result_public_or_completed": 2020, "condition": "Heart failure, reduced EF (PROGRESS-HF)", "n": 71, "dose": "SC 4 or 40 mg daily, 4 weeks", "primary_endpoint": "LV end-systolic volume", "result": "missed", "source": "Butler 2020 J Card Fail, PMID 32068002: P = 0.90 and 0.28" }, { "nct": "NCT02805790", "year_result_public_or_completed": 2020, "condition": "Mitochondrial myopathy (MMPOWER-2)", "n": 30, "dose": "SC 40 mg daily, 4-week crossover", "primary_endpoint": "6-minute walk", "result": "missed", "source": "Karaa 2020 J Cachexia Sarcopenia Muscle, PMID 32096613: +19.8 m, P = 0.0833" }, { "nct": "NCT02245620", "year_result_public_or_completed": 2021, "condition": "Healthy older adults with low muscle ATP", "n": 39, "dose": "One 2-h IV infusion, 0.25 mg/kg/h", "primary_endpoint": "Hand-muscle ATPmax right after infusion", "result": "borderline", "source": "Roshanravan 2021 PLoS One, PMID 34264994: delta P = 0.055, percent change P = 0.045; gone by day 7; no effect on fatigue resistance" }, { "nct": "NCT03098797", "year_result_public_or_completed": 2021, "condition": "Barth syndrome (TAZPOWER, part 1)", "n": 12, "dose": "SC 40 mg daily, 12-week crossover", "primary_endpoint": "6-minute walk and fatigue score", "result": "missed", "source": "FDA complete response letter May 15, 2025: P = 0.97 and P = 0.89; label section 14" }, { "nct": "NCT03323749", "year_result_public_or_completed": 2023, "condition": "Mitochondrial myopathy (MMPOWER-3)", "n": 218, "dose": "SC 40 mg daily, 24 weeks", "primary_endpoint": "6-minute walk and fatigue score", "result": "missed", "source": "Karaa 2023 Neurology, PMID 37268435: -3.2 m, P = 0.69; P = 0.37" }, { "nct": "NCT03891875", "year_result_public_or_completed": 2024, "condition": "Dry AMD with geographic atrophy (ReCLAIM-2)", "n": 176, "dose": "SC 40 mg daily, 48 weeks", "primary_endpoint": "Low-light vision and atrophy growth", "result": "missed", "source": "Ehlers 2024 Ophthalmol Sci, PMID 39605874: did not meet statistical significance on either" }, { "nct": "NCT02693119", "year_result_public_or_completed": 2024, "condition": "Leber optic neuropathy (eye drops)", "n": 12, "dose": "1% eye drops, 52 weeks", "primary_endpoint": "Visual acuity", "result": "missed", "source": "Karanjia 2024 Ophthalmology, PMID 37923251: not significantly different at any time point" }, { "nct": "NCT05162768", "year_result_public_or_completed": 2026, "condition": "Nuclear-DNA mitochondrial disease (NuPower)", "n": 102, "dose": "SC 60 mg daily, 48 weeks", "primary_endpoint": "6-minute walk", "result": "missed", "source": "Dutch trial register results (NL-004124), posted Apr 15, 2026: no more improvement than placebo at week 48" } ] }, "fda_bulk_listings": { "files_dated": "2026-10-16", "count": 6, "started_after_forzinity_approval_2025_09_19": 5, "labeled_for_human_prescription_compounding": 3, 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"aging_terms": 109 }, "x_counts": { "query": "(\"SS-31\" OR SS31 OR elamipretide OR Forzinity) -is:retweet", "utc_days_oct_11_16_all_languages": [ 25, 35, 46, 53, 43, 32 ], "utc_days_oct_11_16_lang_en": [ 24, 24, 43, 31, 36, 35 ], "pulled": "2026-10-17 ~10:05 AM ET" } }