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Elamipretide dosage in clinical trials

What dose levels researchers actually tested, quoted from the trial registry and the published reports — so the numbers circulating online can be checked against their source.

Doses in published trials

Table 1. Dose arms of the principal published Elamipretide trials, as reported in the cited paper.
TrialPopulationDose armsScheduleRef.
TAZPOWER (Barth syndrome)12 randomized (crossover)40 mg/dayDaily subcutaneous, 12 weeks per arm, then open-label1
MMPOWER-3 (primary mitochondrial myopathy)218 adults, 1:140 mg/dayDaily subcutaneous, 24 weeks2
Heart failure (HFrEF), single infusionEF ≤35%; n=24 active, 12 placebo0.005, 0.05, 0.25 mg/kg/h for 4 hoursSingle IV infusion3
Figure 1. Dose levels named in ClinicalTrials.gov arm descriptions that mention Elamipretide, counted once per study (20 interventional studies). Includes titration steps and single-dose pharmacology studies; a level appearing often is not evidence that it is effective or safe.

Arms as registered

Verbatim arm text from ClinicalTrials.gov. Only arms naming Elamipretide and a dose are shown.

  1. NCT06373731 · Phase 3 · Active, not recruiting · n=313

    ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

    • Elamipretide — Subjects will receive once daily subcutaneous doses of 40mg elamipretide for 96 weeks

  2. NCT05162768 · Phase 3 · Completed · n=102

    Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)

    • Elamipretide — 0.75 mL of 80mg/mL solution of elamipretide for a single daily SC dose of 60mg elamipretide

  3. NCT03323749 · Phase 3 · Terminated · n=218

    A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension

    • Part 1: Elamipretide — 40 mg (0.5mL) elamipretide subcutaneous (SC) daily
    • Part 2: Elamipretide open label — Elamepretide 40 mg (0.5 mL) SC daily

  4. NCT03098797 · Phase 2/Phase 3 · Completed · n=12

    A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome

    • Elamipretide, then Placebo — Experimental Part 1: 12 weeks of single daily SC doses of 40 mg elamipretide in Treatment Period 1 followed by 12 weeks of treatment with placebo in Treatment Period 2 (separated by a 4 week washout period). Experimental Open Label Extension Part 2: All subjects will receive Elamipretide 40mg SC daily injections for up to 168 weeks
    • Placebo , then Elamipretide — Placebo Comparator Part 1: 12 weeks of single daily SC doses of placebo in Treatment Period 1 followed by 12 weeks of treatment with 40 mg elamipretide in Treatment Period 2 (separated by a 4 week washout period). Placebo Comparator Open Label Extension Part 2: All subjects will receive Elamipretide 40mg SC daily injections for up to 168 weeks

  5. NCT07531251 · Phase 4 · Recruiting · n=48

    Clinical Trial in Patients With Barth Syndrome- 4TAZPower

    • Elamipretide — Elamipretide - aqueous, sterile 5.0 mL single-patient, ready to use, multi-dose glass vial containing 3.5 mL of elamipretide solution (elamipretide \[80 mg/mL\],

  6. NCT05168774 · Phase 1/Phase 2 · Completed · n=20

    FRDA Investigator Initiated Study (IIS) With Elamipretide

    • Low Dose (20-30mg) — Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
    • High Dose (40-60 mg) — Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks

  7. NCT03891875 · Phase 2 · Completed · n=176

    ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA

    • Elamipretide — Once daily 40 mg subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.

  8. NCT02976038 · Phase 2 · Terminated · n=28

    Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)

    • elamipretide — Open-label once daily subcutaneous injection of 40mg elamipretide

  9. NCT02914665 · Phase 2 · Completed · n=308

    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

    • 20 mg elamipretide — 20 mg elamipretide once daily for 7 consecutive days

  10. NCT02814097 · Phase 2 · Completed · n=46

    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

    • 40 mg elamipretide — 40 mg elamipretide once daily for 28 consecutive days

  11. NCT02805790 · Phase 2 · Completed · n=30

    Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study

    • Elamipretide, Then Placebo — Participants first received 40 mg of elamipretide once daily subcutaneously for 4 weeks. After a washout period of 4 weeks, they then received placebo administered once daily subcutaneously for 4 weeks.
    • Placebo, Then Elamipretide — Participants first received placebo once daily subcutaneously for 4 weeks. After a washout period of 4 weeks, they then received 40 mg of elamipretide once daily subcutaneously for 4 weeks.

  12. NCT02788747 · Phase 2 · Completed · n=71

    Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

    • 4 mg elamipretide — 4 mg elamipretide once daily for 28 consecutive days
    • 40 mg elamipretide — 40 mg elamipretide once daily for 28 consecutive days

  13. NCT02367014 · Phase 1/Phase 2 · Completed · n=36

    Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy

    • Low Dose — elamipretide 0.01 mg/kg/hr infused for 2 hours for 5 days
    • Intermediate dose — elamipretide 0.10 mg/kg/hr infused for 2 hours for 5 days
    • High dose — elamipretide 0.25 mg/kg/hr infused for 2 hours for 5 days

  14. NCT02245620 · Phase 2 · Completed · n=41

    A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly

    • Elamipretide — Elamipretide given as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours.

  15. NCT01755858 · Phase 1/Phase 2 · Terminated · n=16

    Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery

    • Bendavia — Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.

  16. NCT01572909 · Phase 2 · Completed · n=300

    Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events

    • Bendavia™ — Bendavia™ administered intravenously at 0.05 mg/kg/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel.

  17. NCT02848313 · Phase 1 · Completed · n=40

    An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration

    • Intermediate AMD - HRD without GA — Participants had one 1 eye with intermediate age-related macular degeneration with high-risk drusen without geographic atrophy \[GA\]), i.e. the presence of either at least 1 large (≥125 μm) druse or multiple medium-size (63-124 μm) drusen. Participants received 40 mg dose of elamipretide administered once daily as a 1.0mL SC injection.
    • Intermediate AMD with NCGA — Participants had 1 eye with intermediate AMD with noncentral geographic atrophy \[NCGA\]; i.e. evidence of GA with cumulative area ≥1.27 mm2 (approximately 0.5 disc area\[DA\]) by fundus autofluorescence (FAF) that spared the fovea (defined as retinal pigment epithelium (RPE) and outer retina intact by spectral-domain optical coherence tomography \[SD-OCT\]). Participants in this arm also received 40 mg dose of elamipretide administered once daily as a 1.0mL SC injection.

  18. NCT01786915 · Phase 1 · Completed · n=30

    Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days

    • Bendavia 10mg — Bendavia capsule, 10mg, once daily for 7 days
    • Bendavia 50mg — Bendavia capsule, 50mg, once daily for 7 days

  19. NCT01754818 · Phase 1 · Completed · n=30

    A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)

    • Bendavia 10mg — Bendavia, oral capsule, 10mg, single dose
    • Bendavia 50mg — Bendavia, oral capsule, 50mg, single dose
    • Bendavia 100mg — Bendavia, oral capsule, 100mg, single dose

  20. NCT01518985 · Phase 1 · Completed · n=6

    The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking

    • Bendavia — Intravenous infusion of Bendavia (0.25mg/kg/hr) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start

References

Every source below was retrieved from its official API or page and cached on the data-edition date. Numbers match the margin notes.

  1. 1 PubMed Reid Thompson W, Hornby B, Manuel R, et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism. Genet Med 2021. PMID 33077895; doi:10.1038/s41436-020-01006-8.
  2. 2 PubMed Karaa A, Bertini E, Carelli V, et al. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology 2023. PMID 37268435; doi:10.1212/WNL.0000000000207402.
  3. 3 PubMed Daubert MA, Yow E, Dunn G, et al. Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide. Circ Heart Fail 2017. PMID 29217757; doi:10.1161/CIRCHEARTFAILURE.117.004389.

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