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Brand Name
Forzinity
Generic Name
Elamipretide
View Brand Information FDA approval date: October 30, 2025
Form: Injection
What is Forzinity (Elamipretide)?
FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. FORZINITY™ is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Approved To Treat
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Related Clinical Trials
Phase 3b/4, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Patients With Genetically Confirmed Barth Syndrome
Summary: Phase 3b/4, randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the efficacy, safety, and pharmacokinetics of a once daily SC injection of elamipretide in subjects with genetically confirmed BTHS for 72 weeks. The primary trial objective is to confirm the efficacy of elamipretide which is approved in the United States(FORZINITY™) under the accelerated approval b...
Open-Label, Single-Arm Phase 2a Pilot Study to Evaluate the Safety and Tolerability of a Daily Subcutaneous Dose of Elamipretide in Older Adults
Summary: This study will utilize a daily dose of elamipetide for 4 weeks and will screen a sufficient number of subjects for 30 subjects to enroll in the study. The planned duration of the study includes baseline measurement, followed by 4 weeks intervention period, a midpoint (2week ±3days) check-in phone interview, and post intervention visits that mirror the baseline visits. After the last injection, su...
Related Latest Advances
Brand Information
FORZINITY (Elamipretide Hydrochloride)
1INDICATIONS AND USAGE
FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.
This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint
2DOSAGE FORMS AND STRENGTHS
Injection: 280 mg/3.5 mL (80 mg/mL), sterile, clear, colorless to yellow aqueous solution for injection supplied as single-patient-use vials.
3CONTRAINDICATIONS
Serious hypersensitivity to elamipretide or any of the excipients in FORZINITY
4OVERDOSAGE
There were no reports of overdose during clinical trials with FORZINITY. Symptoms and signs of overdose are likely to be histamine-related (e.g., decreased blood pressure, presyncope) and should be managed according to standard of care. Interrupt treatment with FORZINITY if there is suspicion of overdose.
5DESCRIPTION
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 C
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-NH
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.
6CLINICAL STUDIES
FORZINITY was evaluated in a randomized, double-blind, placebo-controlled, crossover trial and its 192-week, open-label, single-arm extension period.
The randomized trial evaluated the efficacy and safety of once daily FORZINITY 40 mg injected subcutaneously for 12 weeks in 12 subjects ≥12-years-old and >30 kg with genetically confirmed Barth syndrome. The primary endpoints for the randomized trial were distance walked during 6-minute walk test and Total Fatigue Score on the Barth syndrome Symptom Assessment. FORZINITY was not superior to placebo on these primary endpoints. Ten subjects completed the randomized trial and entered the extension period designed to evaluate long-term safety and tolerability of FORZINITY. Eight of these 10 subjects participated through Week 168 of the extension period.
Knee extensor muscle strength measured by handheld dynamometry was evaluated as one of the secondary endpoints in the randomized trial and in the extension period. Increases in knee extensor muscle strength were not observed during the randomized trial but were observed during the extension period. At the pre-dose baseline visit at the start of the randomized trial, median (min, max) muscle strength was 124 (92, 176) newtons. Table 3 shows descriptive changes from pre-dose baseline for knee extensor muscle strength during the randomized controlled trial and extension period.
7PATIENT COUNSELING INFORMATION
Advise the patient and caregiver to read the FDA-approved patient labeling (Instructions for Use).
Instruct patients and caregivers to discard vials 8 days after first opening.
Instruct patients and caregivers on how to prepare and administer the correct dose of FORZINITY using aseptic technique. Instruct patients and caregivers to administer FORZINITY by subcutaneous injection in the abdomen (at least 2 inches from the navel) or outer thigh and to rotate the injection site daily according to the Instructions for Use. Instruct patients and caregivers not to inject where the skin is tender, bruised, red, or hard and to avoid injecting into scars or stretch marks.
Inform patients and caregivers that injection site reactions such as erythema, pain, induration, pruritus, bruising, or urticaria can be treated with antihistamines or topical corticosteroids.
Advise the patient and caregiver to discontinue FORZINITY and seek immediate medical attention if any signs or symptoms of an immediate hypersensitivity reaction occur
8PRINCIPAL DISPLAY PANEL - 3.5 mL Vial Carton
NDC 72507-800-04
FORZINITY™
280 mg/3.5 mL (80 mg/mL)
For Subcutaneous Use Only
Contains Preservative. Not for use in neonates.
Contains 4 Single-Patient-Use Vials
