SS-31 (Elamipretide) reconstitution calculator

What the FDA-approved product actually is — and why it doesn't need this tool

SS-31 is the research/compounding-market name for elamipretide. Its FDA-approved branded product, Forzinity, received accelerated approval under NDA215244 on September 19, 2025 — read directly off FDA's own Drugs@FDA record — to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg, an ultra-rare mitochondrial genetic disorder. That is a narrow, single-disease approval, not a general mitochondrial-support or longevity product, and this page does not generalize it. Its label, confirmed on DailyMed, describes a 280 mg/3.5 mL (80 mg/mL) ready-to-use aqueous solution in single-patient-use vials. There is no diluent step on Forzinity's own label at all — a patient using the approved product never reconstitutes anything, so this calculator has nothing to check against Forzinity's own instructions or its concentration.

What the calculator above is actually for is the separate compounded/research-market product also called SS-31: sterile lyophilized (freeze-dried) powder sold in a 10mg or 20mg vial — confirmed via a live check of multiple independent vendor listings — which a buyer reconstitutes with bacteriostatic water before drawing up a subcutaneous dose. That is a materially different product, at a materially different concentration, from Forzinity's pre-mixed solution — not a generic copy of the same product. This calculator does the vial-to-syringe arithmetic on whatever numbers you enter for the powder-vial product — it cannot confirm that vial's contents, purity, legal status, or source, and it cannot substitute for Forzinity's own approved dose in its approved indication.

Sources: openFDA Drugs@FDA record for FORZINITY (elamipretide hydrochloride), NDA215244, and the DailyMed structured product label for FORZINITY, both fetched August 2026. View the Drugs@FDA record on openFDA.