Peptide Guide + Calculator

Elamipretide Reconstitution Calculator & Guide

SS-31 / Forzinity

Elamipretide, historically known as SS-31, is a mitochondrial cardiolipin-binding peptide. FDA granted accelerated approval in 2025 to Forzinity (elamipretide) for a narrow Barth syndrome indication, which must be kept separate from broader online mitochondrial, anti-aging, exercise, or wellness claims.

Evidence Snapshot

Elamipretide research at a glance

Standardized regulatory and evidence context so research compounds, investigational drugs, and approved medications are not treated as if they have the same level of human evidence.

Reviewed Sep 7, 2026

Regulatory status

FDA-approved

What this status means

Development / evidence stage

Approved clinical use

Human evidence level

Human pharmacology / early clinical

Primary mechanism

Mitochondria-targeted tetrapeptide that binds cardiolipin in the inner mitochondrial membrane.

WADA context

No specific prohibition identified

Primary targets

Cardiolipin / mitochondrial inner membrane

What is a receptor?

Human intervention evidence

FDA accelerated approval of Forzinity for Barth syndrome relied on a small randomized crossover study and long-term extension using knee-extensor strength as an intermediate endpoint.

Human biology evidence

Clinical development in mitochondrial disease established human exposure and measurable effects on muscle-function endpoints.

Variant matters

Forzinity is supplied as an 80 mg/mL solution rather than a lyophilized reconstitution product.

Key takeaway

Elamipretide is an approved rare-disease drug with a narrow evidence base; that status does not validate general wellness, exercise, or anti-aging use.

Evidence labels describe the research base and regulatory context; they are not treatment, dosing, or use recommendations. Review dates describe the last BACToBasics source check for this evidence summary. Anti-doping rules can change and should be verified with the applicable authority.

Elamipretide Reconstitution Calculator

Enter the vial amount, liquid volume, and amount you want to calculate. BACToBasics will automatically calculate concentration, liquid volume, and U-100 syringe-unit equivalents.

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Calculator values are educational math inputs only. They are not recommended preparation amounts, doses, or use protocols.

Elamipretide Reconstitution Math

Reconstitution math starts with the amount contained in the vial and the liquid volume used in the calculation. Dividing the vial amount by the liquid volume gives the resulting concentration.

Example vial amount

10 mg

Liquid VolumeCalculationConcentration
1 mL10 mg ÷ 1 mL10 mg/mL
2 mL10 mg ÷ 2 mL5 mg/mL
3 mL10 mg ÷ 3 mL3.3333 mg/mL

This table demonstrates concentration math only. The liquid volumes shown are examples for comparison and are not preparation recommendations.

More Reconstitution Tools

Need to compare different liquid volumes or convert between mg, mcg, mL, and U-100 units? Use the dedicated BACToBasics calculator tools.

What is Elamipretide / SS-31?

Elamipretide is a mitochondria-targeted tetrapeptide that binds cardiolipin, a phospholipid important to mitochondrial inner-membrane structure and function. SS-31 was an earlier development name; Forzinity is the FDA-approved brand name.

FDA accelerated approval for Barth syndrome

On September 19, 2025, FDA granted accelerated approval to Forzinity to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. Continued approval may depend on verification of clinical benefit in a confirmatory trial.

The approved indication is narrow

Forzinity's approval does not establish elamipretide as a general mitochondrial enhancer, exercise-performance drug, anti-aging therapy, or treatment for unrelated fatigue and metabolic conditions. Evidence from one rare-disease indication should not be generalized automatically.

What evidence supported approval?

FDA's Drug Trials Snapshot describes a randomized double-blind placebo-controlled crossover study with 12 patients and a long-term extension. Accelerated approval was based on improvement in knee-extensor muscle strength as an intermediate clinical endpoint.

Forzinity is not a lyophilized reconstitution product

FDA-approved Forzinity is supplied as an 80 mg/mL solution for subcutaneous injection in single-patient-use vials. The BACToBasics calculator is generic user-entered concentration math and must not be interpreted as Forzinity preparation or prescribing instructions.

Elamipretide concentration math

BACToBasics can calculate concentration from hypothetical or user-entered vial mass and liquid volume. It does not recommend a dose, route, schedule, or use of elamipretide outside a labeled product context.

Explore more about Elamipretide

7 links

Comparisons, research records, development tracking, blends, and related guides are available here when you want to go deeper.

Elamipretide FAQ

Tap a question to expand only the answer you want to read.

Is Elamipretide FDA-approved?

Yes. FDA granted accelerated approval to Forzinity (elamipretide) in 2025 for improving muscle strength in patients with Barth syndrome weighing at least 30 kg.

Is SS-31 the same as Elamipretide?

SS-31 is an earlier development name for elamipretide. Forzinity is the FDA-approved brand name.

Does FDA approval prove general anti-aging or mitochondrial benefits?

No. The approval is for a specific Barth syndrome population and endpoint; it does not validate broader wellness or performance claims.

Is Forzinity reconstituted from powder?

No. FDA labeling describes Forzinity as a ready solution for injection, not a lyophilized vial requiring reconstitution.

Sources & References

4 sources

Open the references when you want to inspect the research and regulatory sources behind this guide.

1
FDA — Accelerated approval of Forzinity for Barth syndrome

Official FDA announcement of the September 2025 accelerated approval.

2
FDA Drug Trials Snapshot — Forzinity

FDA summary of the clinical evidence and trial population supporting approval.

3
FDA Prescribing Information — Forzinity

Official label describing indication, accelerated-approval status, and the 80 mg/mL solution product.

4
FDA Orphan Drug Database — Elamipretide / Forzinity

FDA record showing approved orphan designation and labeled indication.

BACToBasics provides educational information and math tools only. This content is not medical advice, dosing advice, injection instruction, or a recommendation to use any peptide or medication.