◇ Compound Reference
Elamipretide · 10mg
Cardiolipin-binding peptide that stabilizes the inner mitochondrial membrane. Standalone 10mg vial; the V-04 longevity protocol uses the 50mg vial.
Elamipretide · 10mg per vial · dispensed after a physician review.
Every 100 units are drawn from one lot and tested once. The certificate below is the one that applies to this batch - when it closes, the next opens with a new lot and a new certificate.
SS-31 (Elamipretide, formerly MTP-131 / Bendavia) is a 4-amino-acid mitochondrially-targeted peptide that selectively accumulates in the inner mitochondrial membrane. FDA-approved September 2025 as Forzinity (Stealth BioTherapeutics) to improve muscle strength in genetically confirmed Barth syndrome at weight ≥30kg - the first FDA-approved mitochondria-targeted therapeutic.
That approval is accelerated, rests on an intermediate endpoint, and requires a confirmatory trial. It covers one ultra-rare genetic disease and no other indication.
Vivre does not dispense Forzinity; use in longevity/mitochondrial-support contexts such as V-04 is off-label and uses a research-grade compound, not the approved product.
Selectively binds cardiolipin in the inner mitochondrial membrane, stabilizing cristae structure and protecting electron transport chain function. Reduces ROS generation and improves ATP synthesis efficiency.
Selectively concentrates in damaged mitochondria.
Cellular / mitochondrial - SS-31, MOTS-c, Epithalon, NAD+, V-04
These protocols target cellular energy, mitochondrial function, and markers of biological aging. Monitoring here is less about week-to-week safety and more about confirming the protocol is moving the deeper markers it is meant to.
Incremental approach. V-04 is introduced in phases (structural support first, then signaling, then a short telomere overlay) at conservative doses. Re-testing at the 6-month mark is how progress is judged.
Educational only - not medical advice or a dosing instruction. Your physician orders the tests, sets your dose, interprets results, and decides if a protocol is right for you. See the Informed Consent & Disclaimer for full terms.
| Class | Mitochondria-targeted tetrapeptide (elamipretide-class) |
| Studied mechanism | Cardiolipin interaction; mitochondrial bioenergetic stabilisation |
| Human pharmacokinetics | Investigated in clinical trials (elamipretide); context-dependent |
| Evidence base | Moderate - clinical trial programmes exist with mixed endpoint results |
| Form | Lyophilized powder, reconstituted under clinical protocol |
| Regulatory status | Investigational; physician-supervised use only |
TAZPOWER was a 28-week randomized, double-blind, placebo-controlled trial in Barth syndrome (a rare genetic mitochondrial disorder), followed by a 168-week open-label extension. Elamipretide (40mg SubQ daily) was well tolerated, with injection-site reactions the most common adverse event; Critically, the randomized phase FAILED its primary endpoints - it did not significantly improve 6-minute walk distance or total fatigue score versus placebo. Knee extensor muscle strength improved during the open-label extension, and it was that intermediate clinical endpoint - not the randomized primary endpoints - on which the FDA granted accelerated approval (September 2025), explicitly accepting more uncertainty than it would for a commoner disease. Continued approval is contingent on a required confirmatory trial (SPIBA-401, NCT07531251). Small population: 12 randomized, 10 entered the extension, 8 reached week 168 - a rare-disease dataset, not a broad-population trial.
View on publisher ↗Pivotal Phase 3 RCT (N=218) of elamipretide 40mg/day SubQ vs placebo over 24 weeks in genetically confirmed primary mitochondrial myopathy. The trial did NOT meet its primary endpoints - no significant difference vs placebo on the 6-minute walk test or total fatigue score. A post-hoc nuclear-DNA-defect subgroup showed 6MWT improvement, described by the authors as hypothesis-generating, not confirmatory. The key honesty point: strong preclinical and rare-disease (Barth) data did not translate to this broader population.
View on publisher ↗KIDNEY - this is the complete human renal dataset, and it is small and old. Phase 2a, 14 patients total (6 elamipretide, 8 placebo), given as an intravenous adjunct before and during stent revascularization for atherosclerotic renal artery stenosis. At 3 months, estimated glomerular filtration rate increased more in the elamipretide arm (P=0.003) and systolic blood pressure fell. A single procedural-adjunct study from 2017 - not a chronic kidney disease trial. There is no ongoing kidney programme: the sponsor's live pipeline is primary mitochondrial myopathy and dry age-related macular degeneration. No renal indication is approved anywhere, and elamipretide cannot be prescribed for kidney protection outside a trial.
View on publisher ↗Foundational mechanistic and preclinical work establishing that SS-31 selectively binds cardiolipin on the inner mitochondrial membrane, stabilizing cristae structure, reducing reactive oxygen species, and restoring electron transport chain function. Preclinical models across muscle aging, ischemia-reperfusion (kidney), and neurodegeneration showed rapid restoration of mitochondrial energetics. These are animal/mechanistic findings - the basis for the human program, not human outcome evidence themselves.
View on publisher ↗SS-31 is verified and lot-tested, dispensed following a Biological Audit. The Audit is complimentary for the Batch 001 cohort.
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