Elamipretide: uses, dosing, side effects & brands
Elamipretide is a medicine sold in the U.S. under one brand, for barth syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Barth Syndrome
- Available as
- Injectable
- Sold as
- Forzinity
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How elamipretide is dosed
From the FDA label for Forzinity (application NDA215244). Other elamipretide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For patients weighing 30 kg and greater, the recommended dosage is 40 mg subcutaneously once daily. ( 2.1 ) Reduce the dose in adults with severe renal impairment. ( 2.2 , 8.6 ). 2.1 Recommended Dosage The recommended dosage of FORZINITY in patients weighing at least 30 kg is 40 mg subcutaneously once daily. Patients should receive the dose at the same time each day. Missed Dose If a dose is missed, skip the dose and take the next dose of FORZINITY at the scheduled time. Do not take a double dose of FORZINITY. 2.2 Dosage Modifications For Renal Impairment Refer to Table 1 for dosage modifications in adults with renal impairment. Table 1: Recommended Dosage in Adults with Renal Impairment Estimated Glomerular Filtration Rate (eGFR) (mL/minute) Recommended Dosage Greater than or equal to 30 mL/minute 40 mg subcutaneously once daily Less than 30 mL/minute and NOT on dialysis 20 mg subcutaneously once daily There is insufficient information to recommend a dosage regimen in adults with eGFR less than 30 mL/minute and on dialysis. There is insufficient information to recommend a dosage regimen in pediatric patients weighing 30 kg or greater with renal impairment. 2.3 Important Administration Instructions FORZINITY is a clear, colorless to yellow aqueous solution that contains the preservative, benzyl alcohol. Visually inspect each vial of FORZINITY for particulate matter and…
Elamipretide side effects
Most common adverse reactions are injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Stealth BioTherapeutics Inc. at 1-844-444-6486 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the FORZINITY clinical development program, 12 male patients aged 12 to 35 years with genetically-confirmed Barth syndrome received treatment with daily subcutaneous injections of 40 mg FORZINITY. Eleven of these 12 patients were Caucasian. Patients first participated in a double-blind, placebo-controlled crossover trial where they were randomized to one of two sequences: 12 weeks of FORZINITY in Period 1 then a 4-week washout followed by 12 weeks of placebo in Period 2 or 12 weeks of placebo in Period 1 then a 4-week washout followed by 12 weeks of FORZINITY in Period 2 Ten patients completed the randomized trial and entered the open-label extension period where they received FORZINITY once daily. Eight of these patients received FORZINITY for 168 weeks, three of whom received FORZINITY for a total of 192 weeks. Adverse reactions occurring more commonly on FORZINITY than on…
Who shouldn’t take elamipretide
Serious hypersensitivity to elamipretide or any of the excipients in FORZINITY [see Warnings and Precautions (5.2) ]. Serious hypersensitivity to any of the ingredients ( 4 , 5.2 )
Every elamipretide product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Forzinity.
Related calculators
Frequently asked questions
What is elamipretide?
FORZINITY contains elamipretide, a mitochondrial cardiolipin binder. Elamipretide is isolated as a hydrochloride salt that is freely soluble in water.
Can you take elamipretide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run elamipretide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does elamipretide come in?
Across the brands we track, elamipretide is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic elamipretide?
We do not currently list a generic-labelled elamipretide product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Elamipretide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/elamipretide
- MLA
- “Elamipretide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/elamipretide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for elamipretide on DailyMed (NIH) ↗.