SS-31 (Elamipretide)
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Route(s): Subcutaneous
Typical vial sizes: 10, 50 mg
Dosing window: Morning
Receptor / target: Inner mitochondrial membrane (Cardiolipin binding)
Properties: Half-life: ~2 hours
Pre-mixed: No
Unverified protocol notes
Standard Protocol
| Timeframe | Dose | Notes |
|---|---|---|
| Week 1 | 1mg 1x/day, 5 days/week | Initiation phase. |
| Weeks 2-5 | 2mg 1x/day, 5 days/week | Escalation phase. |
| Weeks 6-8 | 3mg 1x/day, 3 days/week | Frequency reduction. |
| Weeks 9-12 | 4mg 1x/day, 3 days/week | Maximum standard dose. |
Unverified protocol note; not label dosing unless graded otherwise on this page.
Alternative Titration 1
| Timeframe | Dose | Notes |
|---|---|---|
| Week 1 | 1.5mg 1x/day, 5 days/week | Initiation phase. |
| Weeks 2-5 | 3mg 1x/day, 5 days/week | Escalation phase. |
| Weeks 6-8 | 4.5mg 1x/day, 3 days/week | Frequency reduction. |
| Weeks 9-12 | 6mg 1x/day, 3 days/week | Maximum alternative dose. |
Unverified alternative protocol; not an approved-label regimen unless graded otherwise on this page.
Alternative Titration 2
| Timeframe | Dose | Notes |
|---|---|---|
| Weeks 1-2 | 5 mg (5000 mcg) 1x Daily | Aggressive loading phase. |
| Weeks 3-8 | 10 mg (10,000 mcg) 1x Daily | High-dose phase. |
Unverified alternative protocol; not an approved-label regimen unless graded otherwise on this page.
Protocol logic check
Independent evidence
Regulatory status: no approved label identified
Storage
No independently verified storage guidance found. Treat any unverified storage claim as unverified, and see the general storage guidance in the FAQ.
Contraindications (limited evidence)
- Active malignancy: SS-31's enhancement of mitochondrial electron transport chain efficiency and ATP production is not cancer-cell-selective; providing superior bioenergetic infrastructure to rapidly dividing tumor cells is a theoretical oncological concern. Limited / unverified
- Known hypersensitivity to SS-31 (elamipretide), D-amino acid peptides, or formulation excipients. Limited / unverified
- Pregnancy: mitochondrial membrane potential regulation is critical in early embryonic development; exogenous cardiolipin-binding peptide safety in pregnancy is not established. Limited / unverified
- Breastfeeding: no safety data. Limited / unverified
- Pediatric use: no data; mitochondrial function in developing tissues may respond differently. Limited / unverified
- Severe cardiovascular instability: while SS-31 is being investigated for cardioprotection, acute cardiac decompensation may not be a stable clinical context for research-grade compound administration. Limited / unverified
- Subjects with primary mitochondrial diseases seeking therapeutic use: SS-31/elamipretide has active clinical trial programs for these conditions; use in these contexts should be through formal clinical trial enrollment rather than research-grade compound protocols. Limited / unverified
Side effects (limited evidence)
- Mild localized injection site irritation: the most commonly and practically consistently reported adverse effect; redness, mild tenderness, minor swelling at the subcutaneous injection site; rated mild in clinical trial data. Limited / unverified
- Injection site bruising: with frequent administration (5x/week protocols); site rotation mitigates accumulation. Limited / unverified
- Mild fatigue during the initiation phase: reported in early weeks; consistent with mitochondrial membrane remodeling; resolves as the cardiolipin stabilization effect establishes. Limited / unverified
- Headache: mild; uncommon. Limited / unverified
- Nausea: rare; mild; self-limiting. Limited / unverified
- No significant systemic adverse effects documented in Phase 2/3 clinical trial data: the clinical trial program for elamipretide (SS-31) in Barth syndrome and primary mitochondrial myopathy has demonstrated a favorable tolerability profile with no dose-limiting toxicities or serious adverse events attributed to the compound in published interim data. Limited / unverified
- No endocrine disruption: SS-31 has no known receptor activity outside the mitochondrial membrane; does not affect the HPA axis, sex hormone pathways, or thyroid function. Limited / unverified
- Potential for pathological energy provision to tumor cells (theoretical): the mechanistic concern for cancer contraindication; not documented as a clinical adverse event. Limited / unverified
Compatibility
The relationships below come from the source site's internal engine and were not verified independently. Treat them as a starting point for a conversation with a clinician. They carry no safety guarantee.
Reported synergistic:
Reported contraindicated combinations:
None listed.