At a glance
Effects
- Improved muscle strength: Approved to improve knee-extensor muscle strength in Barth syndrome; gains were seen in the open-label extension of the TAZPOWER trial.[3][6]
- Mitochondrial energy support: Binds cardiolipin to stabilize mitochondrial structure and enhance ATP production in cells with mitochondrial dysfunction.[1][2]
- Limited effect on walking/fatigue: In primary mitochondrial myopathy (MMPOWER-3) and the randomized Barth phase, it did NOT significantly improve 6-minute walk distance or fatigue scores.[5][6]
Mitochondrial cardiolipin binder (synthetic tetrapeptide)
~3–4 hours (SC)
Subcutaneous injection, once daily
Peak plasma ~0.5–2 hours after SC dose
Renal (≈100% recovered in urine within 48 h)
About Elamipretide
Every point here is drawn from public medical and harm-reduction sources. A bracketed number after a claim — like [1]— is a reference: tap it to open the exact source it's based on (numbered list at the bottom). It is not a rating or score. Educational information, not medical advice.
Product specifics
- Est. delivery
- 3–7 business days · EU tracked
Product details as stated by the vendor (claims, not independently verified). Delivery is our standard EU estimate.
What it is
Elamipretide (also known as SS-31, MTP-131, Bendavia; brand name Forzinity) is a synthetic mitochondria-targeting tetrapeptide classed as a "mitochondrial cardiolipin binder."[1][3] In September 2025 the FDA granted it accelerated approval to improve muscle strength in adult and pediatric Barth syndrome patients weighing at least 30 kg — the first approved treatment for that disease.[3][6]
How it works
Elamipretide is a tetrapeptide (D-Arg-Dmt-Lys-Phe-NH2) whose positively charged residues let it concentrate in the inner mitochondrial membrane, where it binds reversibly to cardiolipin, a key negatively charged phospholipid.[2][5] By stabilizing cardiolipin it helps preserve mitochondrial cristae structure, supports the electron transport chain, reduces oxidative stress, and enhances ATP (cellular energy) production.[1][2] In Barth syndrome — caused by a tafazzin gene mutation that lowers cardiolipin — this is intended to restore mitochondrial function in muscle cells.[4]
Risks & side effects
Most important: The most common adverse effect by far is injection-site reactions — redness, pain, itching, swelling, bruising or hives — which were mild-to-moderate but very frequent (erythema in up to 100% and pain in about 75% of treated Barth patients).[3][7] More seriously, hypersensitivity (allergic) reactions, including serious reactions requiring emergency intervention, have been reported and can appear minutes to months after starting.[6][7]
Common
Serious
Safety & harm reduction
- Watch for signs of hypersensitivity/allergic reaction (rash, dermatitis, respiratory symptoms) at any time during treatment[6][7]
- Renal function (eGFR) — dose is halved in severe renal impairment[7]
- Trial monitoring (ECG, vital signs, serum chemistry) showed no notable cardiovascular signal vs placebo[5]
- No major drug-drug interaction is prominently flagged in the approved labeling; tell your clinician about all prescription, OTC, vitamin and herbal products before starting[7]
- Rotate injection sites (e.g., abdomen, thighs) to reduce injection-site reactions; mild reactions can be managed with antihistamines or topical corticosteroids[7]
- Skip a missed dose and resume at the next scheduled time — do not double up[7]
- Accelerated approval is based on an intermediate endpoint; continued approval depends on confirmatory trials[6]
Dosage context
Commonly-reported, NOT a prescription: in clinical trials and in the approved Forzinity label the dose was 40 mg subcutaneously once daily.[6][9] In adults with severe renal impairment (eGFR <30 mL/min) not on dialysis, the dose was reduced by half to 20 mg once daily.[7] SC exposure increases proportionally over a 2–80 mg range; peak levels occur about 0.5–2 hours after dosing.[10][8] These figures are from clinical/regulatory sources and are not individualized medical advice.
Sources
- 1.Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic Potential (PMC)
- 2.Contemporary insights into elamipretide's mitochondrial mechanism of action (PMC)
- 3.Forzinity (elamipretide) FDA Approval History — Drugs.com
- 4.Forzinity Accelerated Approval for Barth Syndrome — The Cardiology Advisor
- 5.Efficacy and Safety of Elamipretide in PMM: MMPOWER-3 (Neurology / PMC)
- 6.Forzinity: Uses, Dosage, Side Effects, Warnings — Drugs.com
- 7.FORZINITY (Elamipretide): FDA Approval for Barth Syndrome — Laafon
- 8.Phase 1 ophthalmology trial protocol — clinical pharmacology safety summary (ClinicalTrials.gov)
- 9.FDA Cardiovascular & Renal Drugs review — elamipretide PK (link unavailable)
- 10.FORZINITY Prescribing Information (FDA label PDF)
This information is provided for educational and harm-reduction purposes only. It is not medical advice. These substances can carry serious health risks; effects and safe use vary by individual. Consult a qualified healthcare professional before use. Legal status varies by country — it is your responsibility to know your local law. We do not encourage misuse.
Other options for Elamipretide· 3 offers
Same compound from different labs/brands and pack sizes. Tap a row to switch brand — the price and buy button update instantly.
| Brand | Form | Strength | Pack | Price | Per mg |
|---|---|---|---|---|---|
GenericSelected | vial | 10 mg | 10 vial | 209,99 € | — |
Generic | vial | 50 mg | 10 vial | 419,99 € | — |
Generic | vial | 50 mg | 10 vial | 550,00 € | — |