For research and educational purposes only. Not intended for human consumption.
SS-31 (Elamipretide)
Extensively Studied- •🎉 FDA APPROVED Sept 2025 (Forzinity)
- •FIRST mitochondria-targeted therapy ever
- •Approved for Barth syndrome ≥30kg
- •Friedreich's Ataxia trial ongoing
Mitochondrial-Targeted Peptide | Cardiolipin Protector
Overview
What is SS-31 (Elamipretide)?
SS-31, also known as Elamipretide, achieved a major milestone in September 2025 when the FDA granted accelerated approval for Forzinity (elamipretide injection) as the FIRST-EVER mitochondria-targeted therapeutic, approved to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30kg. This represents a breakthrough for all mitochondrial diseases.
Key Benefits
FIRST FDA-approved mitochondria-targeted therapy (September 2025). Directly protects cardiolipin in inner mitochondrial membrane, improves ATP production, enhances electron transport chain function, reduces oxidative stress. High safety profile across multiple clinical trials.
Mechanism of Action
Selectively binds to cardiolipin, a phospholipid essential for mitochondrial structure and function, normalizing the inner mitochondrial membrane structure. This improves ATP production, enhances electron transport chain function, and reduces harmful oxidative stress at the source.
Molecular Information
Pharmacokinetics
Research Indications
Enhanced ATP Production
Improves mitochondrial efficiency and cellular energy generation.
Oxidative Stress Reduction
Protects against reactive oxygen species at the source.
Mitochondrial Disease Support
FDA-approved for Barth syndrome. Shows promise for other mitochondrial disorders.
Research Protocols
Disclaimer: SS-31 (Elamipretide) is FDA-approved as FORZINITY for Barth syndrome. Other uses are investigational. Consult a healthcare provider.
| Goal | Dose | Frequency | Route |
|---|---|---|---|
| General Mitochondrial Support | 5-10mg | Once daily | Subcutaneous |
| Athletic Performance | 10-20mg | Once daily pre-workout | Subcutaneous |
| Clinical Protocols | 40mg | Once daily | Subcutaneous or IV |
| Acute Cardioprotection | 0.25mg/kg/hr | Continuous infusion | Intravenous |
Timing: Morning dosing recommended to align with natural circadian rhythms of mitochondrial function. Pre-workout timing for athletic applications.
Peptide Interactions
How to Reconstitute
Important: Always use bacteriostatic water (BAC). Sterile technique is essential.
Clean vial top with alcohol pad
Add appropriate amount of bacteriostatic water (typically 1-2mL per 10mg)
Gently swirl to dissolve - SS-31 dissolves readily
Solution should be clear and colorless
For IV use, may require sterile filtration
Label with concentration and date
Store in refrigerator immediately
Dosing Calculator
Calculate your injection volume with visual dosing guide
To obtain 250 mcg from this solution:
Draw 0.10 mL=10 units
(1 mL = 100 units on any insulin syringe)
Draw to this mark for 250 mcg
This calculator is for research purposes only. Always verify calculations and consult protocols.
Quality Indicators
Pharmaceutical Grade
SS-31 requires high purity due to clinical use - look for >98% purity.
Clear Solution
Should dissolve completely into clear, colorless solution.
COA Available
Certificate of analysis essential due to clinical applications.
Light Sensitive
Protect from light exposure - use amber vials if available.
pH Considerations
Solution pH should be near physiological (6.5-7.5).
Discoloration
Any yellow or brown color indicates degradation.
What to Expect
- •Day 1-3: Subtle energy improvements, reduced fatigue
- •Week 1-2: Better exercise endurance, faster recovery
- •Week 2-4: Improved stamina, clearer thinking, better sleep quality
- •Week 4-8: Significant improvements in exercise capacity
- •Week 8-12: Sustained energy improvements, potential biomarker changes
Side Effects & Safety
Side Effects
- •Excellent safety profile in clinical trials
- •No significant side effects reported at therapeutic doses
- •May cause mild injection site reactions
- •Monitor for allergic reactions (very rare)
- •Safe for long-term use based on current data
- •No known drug interactions
When to Stop
- •Allergic reactions
- •Severe injection site reactions
- •Unexpected symptoms
- •As directed by physician
- •Before certain medical procedures
References
5 StudiesFDA Accelerated Approval (September 2025)
First-ever mitochondria-targeted therapy | Forzinity approved for Barth syndrome
September 2025: FDA granted accelerated approval as the FIRST mitochondrial-targeted therapeutic approved. Improves muscle strength in Barth syndrome patients ≥30kg. Landmark achievement for all mitochondrial disease research.
Johns Hopkins Barth Syndrome Trial (2021)
Human | Various doses | Energy production | Improved mitochondrial protein complex assembly
Clinical trial showed elamipretide improved energy production and assembly of important protein complexes in mitochondria. Published in Journal of Biological Chemistry.
Renal Artery Stenosis Phase 2a (2017)
Human | 14 patients | Severe atherosclerotic RAS | Increased blood flow and kidney function
Phase 2a trial showed increased blood flow to kidneys and improved kidney function in patients with severe atherosclerotic renal artery stenosis.
Quick Start Guide
Research Disclaimer
SS-31 (Elamipretide) is sold for laboratory research purposes only and is not intended for human or animal consumption. The information provided on this page is compiled from published research, veterinary studies, and anecdotal reports for educational purposes. This content does not constitute medical advice, diagnosis, or treatment recommendations. Any research involving SS-31 (Elamipretide) must comply with all applicable local, state, and federal regulations. BioInfinity Lab makes no claims regarding the safety or efficacy of SS-31 (Elamipretide) for any purpose. Consult qualified professionals for any research applications.