SS-31 (Elamipretide)
A mitochondrial peptide that targets the inner mitochondrial membrane to improve cellular energy production. Has been in serious clinical trials unlike many research peptides — but still not FDA-approved.
This peptide is not FDA-approved for any indication. Human use outside of clinical trials is not recommended.
The basics
- Generic Name
- elamipretide (SS-31 / Bendavia)
- Brand Names
- None (not an approved product)
- Regulatory Status
- Early Research
- Therapeutic Areas
- Metabolic & Weight Management, Cardiovascular
Wellness Goals
Important: This peptide is not yet FDA-approved
SS-31 (Elamipretide) has not been approved by the FDA for any use in humans. That means it hasn't gone through the rigorous testing process that confirms a drug is safe and effective. Products sold online have not been evaluated by any regulatory body.
What it does
SS-31 (Elamipretide) (elamipretide (SS-31 / Bendavia)) is a synthetic peptide that researchers are studying, but it's not yet FDA-approved for any human use. Cell-permeable tetrapeptide that concentrates in the inner mitochondrial membrane, stabilizing cardiolipin and improving electron transport chain efficiency. Reduces oxidative stress at the mitochondrial level.
The research is still early. Most studies so far are in animals or lab settings, so we don't know for sure how well this translates to real-world results in people.
How it's taken
Subcutaneous injection
Nasal spray
How people access it
Currently in clinical trials but not yet FDA-approved. Available through some research vendors and specialty clinics. Has more clinical trial data than most research peptides.
Regulatory Status
Not FDA-approved. Has been in multiple clinical trials for mitochondrial conditions. FDA granted Fast Track designation for Barth syndrome.
Any use in humans outside of an FDA-authorized clinical trial would require an Investigational New Drug (IND) application. Products marketed as “for research use only” are not legally intended for human administration.
What the Evidence Shows
The evidence base for SS-31 (Elamipretide) consists primarily of preclinical studies (animal models and in vitro experiments). There are no completed, large-scale, peer-reviewed clinical trials establishing safety or efficacy in humans. The gap between promising animal data and proven human benefit is substantial — many compounds that show effects in animal studies fail to demonstrate safety or efficacy in human trials.
Marketing claims made by online sellers and “peptide clinics” frequently overstate the evidence and omit critical information about risks and unknowns.
Other options to consider
Depending on what you're hoping to achieve, there may be FDA-approved treatments that have been rigorously tested and proven to work. Discuss evidence-based options with your own healthcare provider to find what fits your specific goals.
Browse our full peptide directory to see FDA-approved options that might work for you.
Common Questions
No. SS-31 (Elamipretide) is not FDA-approved for any indication. It has no approved NDA or BLA and cannot be legally marketed as a drug for human use.
There is insufficient clinical evidence to establish the safety of SS-31 (Elamipretide) in humans. Most available data comes from preclinical studies. Using unapproved substances carries risks including unknown side effects, contamination, and incorrect dosing.
Depending on the condition you are seeking to treat, FDA-approved options may be available. Discuss evidence-based treatments with your own healthcare provider to find options that have undergone rigorous safety and efficacy review.
Curious about what IS approved?
Check out FDA-approved peptides that address similar goals — with established safety profiles and real clinical evidence.
See Approved Options