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It actually is an FDA-approved peptide It has an FDA-approved indication, it’s sold under the brand name Forzinity SS-31 is the name that it is sold under on the gray market And it is used for treating a very rare and severe X-linked mitochondrial disease known as Barth syndrome X-linked just means that the gene travels on the X chromosome (it’s a genetic condition) It is a disease that presents in very early life with cardiomyopathy, skeletal muscle weakness, growth delay, chronically low white blood cell counts, that leads to significant infections It’s actually a pretty dramatic disease Historically, Barth syndrome was almost always fatal during childhood And even today with all the medical advances we have, people really struggle with this condition to live beyond their 40s or maybe their 50s Childhood mortality is very substantial with this This is one of those diseases that’s referred to as an orphan disease, meaning it’s very rare, but obviously has significant morbidity and mortality associated with it Back to the mechanism of action SS-31 is kind of interesting ‒ virtually every drug out there, whether it be a small molecule or a peptide, they usually bind to specific receptors That’s actually NOT the case with SS-31—instead, it selectively binds something called cardiolipin Now, this is a phospholipid that’s found in the mitochondria, specifically on the inner mitochondrial membrane And cardiolipin helps maintain the structure of the membrane and support the folds where the electron transport chain is located This in turn, of course, is responsible for producing the vast majority of energy in the cell in the form of ATP Listeners will remember this was discussed in detail in the podcast with Nav Chandel when we talked about mitochondria So, this mechanism makes sense for treating somebody with Barth syndrome, which is caused by defective cardiolipin remodeling—which leads to mitochondrial dysfunction in high energy tissues, like the heart and skeletal muscle This is why they present with cardiomyopathy and profound skeletal muscle weakness But then the question is, so if we just stop there, you might say, “ Well, should we be using this if we don’t have Barth syndrome
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Months 3-6: Approaching the Maintenance Phase What the trials documented: By around month four (week 17), the REDEFINE protocol reached the 2.4 mg maintenance dose, and weight loss continued to accrue beyond that point through the 68-week primary endpoint (Aronne et al., 2025)
