SS-31, Elamipretide

SS-31 is elamipretide. FORZINITY received US accelerated approval in 2025 for muscle strength in Barth syndrome at a weight of at least 30 kg.

Sources for this tile

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

The indication is narrow. A supplier SS-31 vial is not verified as the approved medicine.

Sources for this tile

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Open the pathway notes below. A biological pathway is a possible chain of events in the body. The grade states where it was tested.

Sources for this tile

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Each proposed mechanism

Mitochondrial target

FDA describes binding to cardiolipin in mitochondria.

Evidence note: Official label

Sources

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Go deeper

Mitochondrial target Official label

FDA describes binding to cardiolipin in mitochondria.

Sources

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Open the outcome notes. They show the tested condition and what was measured. A positive marker, a mouse result and a clinical benefit are different things.

Sources for this tile

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Read this before you read a benefit into it

Laboratory and animal results describe what happened in that model. They are not proven healing in a person. Human studies name their own population, outcome and limits. Both are kept apart here on purpose.

Human research found for this product

FDA: FORZINITY trial snapshot A

Proof grade	A
Design	Randomised placebo-controlled crossover with open-label extension
People or model	Male patients with Barth syndrome
Number	12
Outcome measured	Walking, fatigue and muscle strength
Result	The controlled portion did not show superiority on walking or fatigue. Muscle-strength gains appeared in the uncontrolled extension, not the initial controlled period.
Route in the study	Subcutaneous
Duration	28-week crossover; 192-week extension
Risks noted	Injection-site reactions and potentially serious allergic reactions.
Personal regimen	Not set. A study regimen is not a personal instruction.

Source

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Go deeper

Walking, fatigue and muscle strength A

A: Tested in Male patients with Barth syndrome. Read the study result in the human or researcher layer. This is a tested outcome, not a promised benefit.

Sources

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Each claim keeps its own source, evidence grade and limits. This is a scoped first research edition. It is not a full review or a personal treatment plan.

Sources for this tile

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Overall state of the evidence

Status: scoped-human-evidence

This is not evidence of general rejuvenation. Confirmatory benefit and the full current label still need review.

Risk summary

This is not evidence of general rejuvenation. Confirmatory benefit and the full current label still need review.

Unwanted effects reported in the sources

• Injection-site reactions and potentially serious allergic reactions. (FDA: FORZINITY trial snapshot)

What is still open

• Supplier identity and batch match have not been verified
• Full-text systematic review and complete interactions are not finished
• Exact product
• Barth syndrome indication
• Full current label

Checks a reviewer must finish first

• Exact product
• Barth syndrome indication
• Full current label

How to read the proof grades

• A: Controlled human trial. Note whether randomisation and blinding were confirmed.
• B: Small uncontrolled human study or chart review.
• C: Whole-animal intervention.
• D: Cell or other laboratory study.
• E: User reports. Kept separate and never substituted for a measured outcome.
• ungraded: Identity sources, official labels, notices, reviews and unverified claims are not assigned an efficacy grade.

Go deeper

How to read the proof Open the checked detail

A: controlled human trial. State whether it was blinded and randomized. B: small uncontrolled human study or chart review; a weak clinical comparison is marked with its design limits. C: whole-animal work. D: cells or other lab work. E: user reports.

A grade describes the kind of evidence for one claim. It does not grade every claim about a peptide or approve a product. Labels, history and regulatory reviews are named sources, not efficacy grades.

Sources

• Future Health research method (Christopher’s supplied research method; read in full · checked 2026-10-09)

Open questions Open the checked detail

Supplier identity and batch match have not been verified

Full-text systematic review and complete interactions are not finished

Exact product

Barth syndrome indication

Full current label

Open the linked human study records. Each names the tested group, design, result and limits. Related-compound and non-treatment studies are marked so they cannot be used as product treatment proof.

Sources for this tile

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Studies named in this tile

Personal regimen	Not set. A study regimen is not a personal instruction.

What people report

No user reports are recorded for this product. The library keeps human studies and user reports in separate places, so nothing is filled in here.

Each human record

FDA: FORZINITY trial snapshot A

Proof grade	A
Design	Randomised placebo-controlled crossover with open-label extension
People or model	Male patients with Barth syndrome
Number	12
Outcome measured	Walking, fatigue and muscle strength
Result	The controlled portion did not show superiority on walking or fatigue. Muscle-strength gains appeared in the uncontrolled extension, not the initial controlled period.
Route in the study	Subcutaneous
Duration	28-week crossover; 192-week extension
Risks noted	Injection-site reactions and potentially serious allergic reactions.
Personal regimen	Not set. A study regimen is not a personal instruction.

Source

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

This is the shared library. No client has been assessed in this record. This tile will use the person's own words, a named target and checked rule-outs after intake. A catalog entry does not mean it is suitable for someone.

This is not evidence of general rejuvenation. Confirmatory benefit and the full current label still need review.

Sources for this tile

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

The reference medicine is injected under the skin. Supplier equivalence is unverified. Research routes describe what was studied. They are not a client administration guide.

Sources for this tile

• FDA: FORZINITY trial snapshot (FDA · 2025 · Official trial and approval summary · checked 2026-10-08)

Routes seen in the research

• Subcutaneous

Dose and cycle fields in the library

These are blank on purpose. A personal amount, schedule, mixing or storage instruction is only written into an agreed plan after a reviewer checks the exact product.