FORZINITY Solution for injection Ref.[116071] Active ingredients: Elamipretide

FORZINITY contains elamipretide, a mitochondrial cardiolipin binder. Elamipretide is isolated as a hydrochloride salt that is freely soluble in water. The chemical name for elamipretide hydrochloride is L-Phenylalaninamide, D-arginyl-2,6-dimethyl-L-tyrosyl-L-lysyl-, hydrochloride (1:3). Its molecular formula is C₃₂H₄₉N₉O₅∙3HCl and its molecular weight is 749.2.

The structure of elamipretide hydrochloride is:

All amino acid residues in FORZINITY have the L configuration except for arginine which has the D configuration. The peptide sequence is denoted as D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH₂.

FORZINITY is a ready-to-use sterile, clear, colorless to yellow aqueous solution supplied as single-patient-use vials containing 3.5 mL solution for subcutaneous injection. Each 0.5 mL dose of FORZINITY contains 40 mg of elamipretide (equivalent to 46.8 mg elamipretide hydrochloride), 10 mg benzyl alcohol as a preservative, and 2.07 mg monobasic sodium phosphate (as monohydrate). The product may contain hydrochloric acid or sodium hydroxide to adjust pH. The pH of FORZINITY solution is 4.7 to 6.1.