SS-31 (Elamipretide)
Explore SS-31 (elamipretide), a mitochondria-targeting peptide, including how it works, published research, FDA approval, and patient-specific compounding considerations.
What Is SS-31 (Elamipretide)?
SS-31, also known as elamipretide, is a mitochondria-targeting peptide that interacts with cardiolipin, a phospholipid found primarily in the inner mitochondrial membrane. This interaction has been studied for its potential effects on mitochondrial structure, energy production, and cellular function.
Unlike many peptides discussed primarily in experimental research, elamipretide is also the active ingredient in an FDA-approved prescription drug. Research into SS-31 has examined mitochondrial dysfunction across a variety of conditions, although FDA approval applies only to specific uses of the approved drug product.
Freedom Compounding Pharmacy can work with prescribers to discuss patient-specific elamipretide compounding options when clinically appropriate.
How Does SS-31 Work?
SS-31 is designed to selectively concentrate within mitochondria, the structures responsible for producing much of the energy used by cells. A key target is cardiolipin, a phospholipid that helps organize and stabilize proteins within the inner mitochondrial membrane.
By interacting with cardiolipin, elamipretide has been studied for its ability to support mitochondrial membrane structure, electron transport, and efficient production of cellular energy in the form of ATP. Research has also examined its effects on oxidative stress and mitochondrial function when cells are under metabolic stress.
Because mitochondria are important in tissues with high energy demands, SS-31 has been investigated across a wide range of biological and clinical settings
FDA Approval & SS-31 Research
Elamipretide is the active ingredient in an FDA-approved prescription drug for Barth syndrome, a rare genetic disorder that affects mitochondrial function. FDA approval applies to that specific drug product, indication, strength, and route of administration.
SS-31 has also been investigated in clinical and preclinical research involving other conditions associated with mitochondrial dysfunction. These areas of research should not be interpreted as FDA-approved uses of elamipretide.
Compounded elamipretide preparations are not FDA-approved drug products. When appropriate, patient-specific compounding may provide a prescriber with formulation options that differ from the commercially available drug.
Potential Customized SS-31 Dosage Forms
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Sublingual Liquid
Ask About Sublingual SS-31A customized liquid formulation may provide a needle-free option for sublingual administration when prescribed for an individual patient.
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Dissolving Oral Films
Ask About SS-31 FilmsCustomized dissolving films may provide another convenient, needle-free dosage-form option based on the patient's prescription and formulation requirements.
What Has SS-31 Been Studied For?
Because SS-31 targets mitochondrial biology, researchers have investigated elamipretide in a variety of conditions in which mitochondrial dysfunction may play a role. Published research has included areas such as mitochondrial disease, skeletal muscle function, cardiovascular and kidney function, aging-related mitochondrial changes, and cellular energy metabolism.
The strength of evidence varies substantially by condition. Research into a potential use does not establish that elamipretide is safe or effective for that use, and many investigated applications remain experimental.
The Peptide Library is intended to help patients and healthcare providers understand this research while clearly distinguishing investigational uses from established and FDA-approved uses.
SS-31 (Elamipretide) Frequently Asked Questions
Is SS-31 the same as elamipretide?
Yes. SS-31 is the research name commonly associated with elamipretide.
Is elamipretide FDA approved?
Yes. Elamipretide is the active ingredient in an FDA-approved prescription drug for a specific indication. This approval does not mean that every use or compounded formulation of elamipretide is FDA approved.
How does SS-31 work?
SS-31 targets mitochondria and interacts with cardiolipin in the inner mitochondrial membrane. Research has examined how this interaction may influence mitochondrial structure, energy production, and cellular function.
Does Freedom Compounding Pharmacy offer SS-31?
Freedom Compounding Pharmacy can work with prescribers to evaluate patient-specific elamipretide compounding options when clinically appropriate and permitted under current compounding requirements.
Can SS-31 be compounded without an injection?
Freedom is exploring customized needle-free dosage forms such as sublingual liquids and dissolving oral films. Availability and formulation options should be confirmed with our pharmacists.
Are compounded SS-31 preparations FDA approved?
No. Compounded medications are not FDA-approved drug products and should not be considered equivalent to an FDA-approved elamipretide product.
Can my healthcare provider contact Freedom about SS-31?
Yes. Prescribers are welcome to contact Freedom Compounding Pharmacy to discuss current availability, formulation considerations, and patient-specific prescription options.
Questions About SS-31 (Elamipretide)?
Freedom Compounding Pharmacy works with patients and healthcare providers in Minnesota and Wisconsin to explore patient-specific compounding options for elamipretide.
Interested in SS-31 or a customized dosage form? Contact our pharmacists to discuss current availability and formulation options.