SS-31

Reconstitution Steps

1. Use a sterile syringe to draw the validated diluent volume specified by the selected vial-format table, product label or approved laboratory method.
2. Inject the diluent slowly down the inside wall of the vial; avoid directing the stream onto the material and avoid foaming.
3. Gently swirl or roll until fully dissolved. Do not shake.
4. Label the vial with product, concentration, diluent, preparation date and operator; protect from light and refrigerate at 2–8 °C (35.6–46.4 °F) unless the product-specific method states otherwise.
5. Use within the product-specific validated hold time and no later than 4 weeks after preparation unless published stability data supports a different period.

Injection Technique

Use this technique only when the product-specific approved label or authorized research protocol specifies subcutaneous administration and trained personnel are responsible for the procedure.

• Clean the vial stopper and the selected administration site with alcohol; allow both surfaces to dry completely.
• Pinch a small fold of skin and insert the needle into the subcutaneous tissue at a 45–90° angle.
• Do not aspirate during a subcutaneous injection; deliver the validated volume slowly and steadily.
• If the approved protocol specifies a volume greater than 1.0 mL, divide it between separate sites rather than using one site.
• Rotate sites systematically; commonly referenced subcutaneous sites include the abdomen, thigh and upper arm.
• Wait several seconds after delivery before withdrawing the needle to help ensure the complete validated volume is delivered.
• Discard the used syringe immediately in an approved sharps container; never recap or reuse it.

Supplies Needed

• Product vial (SS-31; use the selected labelled vial strength).
• U-100 insulin syringe (1 mL capacity) or the sterile administration device specified by the approved protocol.
• Validated diluent in the container size specified by the product label or authorized preparation method.
• Alcohol swabs and an approved sharps container—use a fresh swab for the vial stopper and each administration site.

Storage Instructions

Proper storage helps maintain product quality and stability. The supplied label, COA and product-specific validated method take precedence over these general handling rules.

• Unopened: Keep the vial sealed, dry and protected from light at the temperature stated on the supplied label; do not assume a universal shelf life.
• After preparation: Refrigerate at 2–8 °C (35.6–46.4 °F) unless the product-specific method states otherwise, and use only within its validated in-use period.
• Before opening a cold vial, allow the sealed container to equilibrate as required by the method so condensation does not enter the product.
• Long-term storage: Freeze or aliquot only when supported by product-specific stability data; avoid repeated freeze–thaw cycles and discard material with unexpected particles, discoloration or container damage.

How This Works

SS-31 (elamipretide) is a cell-permeable tetrapeptide that concentrates at the inner mitochondrial membrane and binds cardiolipin. Research examines whether this interaction can stabilize mitochondrial structure, reduce pathological oxidative stress and improve energy production.

Chemical identity or a proposed mechanism does not establish an effective amount, treatment indication or safe human-use protocol.

Benefits & Side Effects

Benefits

• Approved Barth-syndrome indication: Elamipretide received FDA accelerated approval in 2025 to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg.
• Mitochondrial mechanism: It binds mitochondrial cardiolipin and is intended to improve mitochondrial structure and function; benefit outside the approved population remains unestablished.

Side Effects & Evidence Limits

• Injection-site reactions: Mild-to-moderate injection-site reactions are the most common adverse effects.
• Serious reactions and approval limits: Hypersensitivity and eosinophilia have been reported; approval is indication- and product-specific and confirmatory clinical benefit remains under study.