Mitochondrial cardiolipin-binding tetrapeptide

Elamipretide (SS-31)

aka SS31 · MTP-131 · Bendavia · Forzinity

Evidence grade
Grade C: Preliminary human data
for mitochondrial support / anti-ageing in people without Barth syndrome
User score everyone · n = 21
US FDA Approved for Barth syndrome only checked 2026-11-13
WADA 2026 Not named no clearance either · checked 2026-11-13
EU EMA orphan designation EU/3/21/2430 for Barth syndrome; marketing authorization not found, and orphan designation is not authorization. · checked 2026-11-13

Grade note: revised from B to C on independent review. The FDA accelerated approval (September 2025) is for Barth syndrome only, an ultra-rare genetic disease that is not what the peptide is marketed for, so the 'narrow approval' route to B does not apply.

User reports

approximate — combined from two independent Reddit reads

Men 45–60

0 men aged 45–60

No reports in this group yet.

All men

1 man

small sample · n = 1

Outcome mixed 1 of 1

Benefits energy 1 of 1

Side effects other 1 of 1

Why stopped side effects 1 of 1

Stopped 1 of 1 Used with other compounds 1 of 1

Everyone

21 people

  • Positive: 11 of 21 (52%)
  • Mixed: 6 of 21 (29%)
  • Negative: 1 of 21 (5%)
  • No effect: 2 of 21 (10%)
  • Unclear: 1 of 21 (5%)
Benefits reported of 21
Benefits reported (n = 21)
ItemReports
Energy11 of 21 (52%)
Endurance4 of 21 (19%)
Focus / cognition4 of 21 (19%)
Recovery2 of 21 (10%)
Mood / anxiety1 of 21 (5%)
Other1 of 21 (5%)
Side effects reported of 21
Side effects reported (n = 21)
ItemReports
Anxiety2 of 21 (10%)
Heart rate up2 of 21 (10%)
Insomnia2 of 21 (10%)
Other2 of 21 (10%)
Blood pressure1 of 21 (5%)
Fatigue1 of 21 (5%)
Flushing1 of 21 (5%)
Why people stopped of 21
Why people stopped (n = 21)
ItemReports
Side effects2 of 21 (10%)

Stopped 2 of 21 (10%) Used with other compounds 7 of 21 (33%)

User reports are anecdata, not evidence: self-selected, unverified, often combined with other compounds.

In their words

  • “Very quickly noticed that it was helping, however it raised my fasting blood sugar 20 to 30 points.”

  • “At 500mcg we both had tons of energy. Couldn’t nap. Had extra endurance for our workouts.”

  • “I ran 2mg a day for 28days. I noticed that about 2 weeks into it my endurnace for physical work was exceptional.”

  • “Why is SS-31 helping me so much?”

  • “SS-31 raised my resting heart rate by 5, and a lot more (translated from a German page view)”

Read summaries and method notes

Read 1. No man aged 45–60; the only explicit man was over 70 (mixed: quick benefit but fasting glucose up 20–30 points, reversed after stopping). Across 19 users in seven threads, energy and endurance were the clearest benefits, with less brain fog and better recovery. Adverse: anxiety, insomnia, dizziness or cardiovascular changes, flushing, fatigue; two noticed nothing. Onset immediate to about two weeks; many stacked with NAD+ or MOTS-c.

Read 2. No stated sex or age. Two users from two accessible threads: one positive ("Why is SS-31 helping me so much?"), one negative (resting heart rate up 5 bpm, among other effects). Four seed threads could not be read. Too small to draw conclusions.

Note 1. No men aged 45-60; the only explicit male was over 70. NAD+/MOTS-c co-use common. Raised fasting glucose counted as 'other'.

Note 2. Four seed threads were unavailable, leaving two threads with minimal detail.

Each read counted people independently. Overlap between the two reads is estimated from shared threads and removed; counts are approximate. How we count.

Summary

Synthetic aromatic-cationic tetrapeptide, D-Arg-dimethylTyr-Lys-Phe, MW ~640. Formerly Bendavia / MTP-131.

Mechanism is well characterised and independently replicated — the sharpest contrast with the Khavinson family. It concentrates in the inner mitochondrial membrane and binds cardiolipin through electrostatic and hydrophobic interaction, preserving cardiolipin's association with cytochrome c and the electron transport chain, stabilising cristae, and cutting ROS at source rather than scavenging downstream (JASN 2013; PNAS 2020 interaction landscape).

Safety

  • Frequent injection-site reactions
  • Serious hypersensitivity contraindication
  • Eosinophil elevations
  • Renal impairment affects dosing
  • Benzyl alcohol formulation must not be used in neonates

From labels, regulators and trials. No signal in small studies ≠ safe.

Evidence C mitochondrial support / anti-ageing in people without Barth syndrome

Changed B to C. The FDA accelerated approval (September 2025) is for Barth syndrome only, an ultra-rare genetic disease that is not what the peptide is marketed for, so the 'narrow approval' route to B does not apply. For the marketed use the only direct evidence is one 39-person RCT in older adults with an acute biomarker signal that was gone by day 7. Every randomized trial in a wider population missed its primary endpoint (primary mitochondrial myopathy phase 3, heart failure, the Barth crossover itself). That is 'small, early, unconfirmed' and sits closer to F than to B. B would be correct only for Barth syndrome.

Human trials · 4

  1. PMID 330778952021Randomized double-blind placebo-controlled crossover plus open-label extension 12 people

    Barth syndrome

    Both randomized primary endpoints failed; eight extension participants improved walking and fatigue at 36 weeks. Source

  2. PMID 372684352023Phase 3 RCT 218 people

    Primary mitochondrial myopathy

    At 24 weeks, walking difference was -3.2 m (95% CI -18.7 to 12.3; p=0.69); fatigue endpoint also failed. Source

  3. PMID 342649942021Double-blind placebo-controlled RCT 39 people

    Adults aged 60-85 selected for low muscle mitochondrial function

    Acute ATP-production biomarker signal; no sustained between-group ATPmax difference at day 7 or significant prespecified fatigue-resistance improvement. Source

  4. PMID 320680022020Phase 2 RCT 71 people

    Stable heart failure with reduced ejection fraction

    Neither 4 mg nor 40 mg daily improved the primary left-ventricular end-systolic-volume endpoint at four weeks. Source

Bar length = trial size on a log scale.

Dose ranges

Reported ranges from labels and studies, with context. Not a recommendation.

  • approved label
    40 mg subcutaneously daily; 20 mg daily in adults with eGFR below 30 mL/min who are not on dialysis Source
  • clinical trial
    4 or 40 mg subcutaneously daily for 28 days in PROGRESS-HF Source
  • clinical trial
    Single IV infusion at 0.25 mg/kg/hour for two hours in the older-adult study Source

Editorial ratings EDITORIAL

Editors’ judgement, 0–5. Opinion, not data; separate from grade and user score.

  • Safety 3 out of 5
  • Sleep 2 out of 5
  • Recovery not rated —
  • Cognitive not rated —

Sources

  1. pubmed.ncbi.nlm.nih.gov/33077895/
  2. pmc.ncbi.nlm.nih.gov/articles/PMC10382259/
  3. pmc.ncbi.nlm.nih.gov/articles/PMC8282018/
  4. pubmed.ncbi.nlm.nih.gov/32068002/
  5. fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-forzinity
  6. wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
  7. ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2430
  8. accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf
  9. fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-c
  10. euclinicaltrials.eu/ctis-public/view/2025-523837-25-00
  11. clinicaltrials.gov/study/NCT07275424

Reddit threads read · 9

2 further sources on commercial or non-primary hosts not listed.

Research checked 2026-11-13.