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SS-31, also known by the names Elamipretide, Bendavia, and MTP-131, is a synthetic tetrapeptide. It is a mitochondria-targeted compound that has garnered significant attention in scientific and medical research. Unlike many other peptides, SS-31 is designed to specifically accumulate in the inner mitochondrial membrane, where it interacts with a key phospholipid called cardiolipin.

Mechanism of Action

The primary function of SS-31 is to address mitochondrial dysfunction, a factor implicated in a wide range of diseases and age-related decline. Its mechanism is centered on its interaction with cardiolipin. This interaction helps to:

Stabilize mitochondrial structure: By binding to cardiolipin, which is crucial for maintaining the integrity and shape of mitochondria, SS-31 helps to prevent structural degradation.

Improve energy production (ATP): Cardiolipin is essential for organizing the components of the electron transport chain (ETC) into “supercomplexes,” which allows for more efficient oxidative phosphorylation. SS-31 enhances the efficiency of this process, leading to increased ATP synthesis.

Reduce oxidative stress: SS-31 acts as an antioxidant, reducing the production of reactive oxygen species (ROS) at their source within the mitochondria. This protects cells from damage caused by harmful free radicals.

Prevent mitochondrial permeability transition pore opening: Under cellular stress, the mitochondrial permeability transition pore can open, leading to mitochondrial swelling and cell death (apoptosis). SS-31 helps to inhibit this process.

Research and Potential Applications

SS-31 has been the subject of numerous preclinical and clinical studies for its potential therapeutic effects across various conditions. Research has explored its role in:

Aging and age-related conditions: By improving mitochondrial function, SS-31 has shown potential to counter a fundamental cause of aging. Preclinical studies suggest benefits in muscle aging, exercise tolerance, and age-related cognitive decline.

Neurodegenerative disorders: Due to its ability to cross the blood-brain barrier and its neuroprotective effects, SS-31 has been investigated for conditions like traumatic brain injury, Alzheimer’s, and Parkinson’s disease.

Cardiovascular and kidney diseases: Studies have explored its use in heart failure, chronic kidney disease, and ischemia-reperfusion injury, with some promising results in improving function and reducing damage.

Mitochondrial myopathies: Given its targeted action on mitochondria, it has been studied for its potential in genetic conditions that directly affect mitochondrial function.

Safety and Administration

SS-31 is typically administered via injection, and dosages have varied in scientific studies depending on the research model. While generally reported as well-tolerated, common side effects are mild and may include injection site reactions. It’s important to note that the long-term safety of SS-31 in humans has not been fully established, as clinical trials for extended periods have not been conducted. As a research chemical, SS-31 is not an approved drug for human consumption.

SS-31 (Elamipretide) is a synthetic tetrapeptide that has become a major focus of research for its ability to target and improve mitochondrial function. While the exact, full details of its pharmacological effects are still being explored, the core of its action is its selective binding to cardiolipin, a unique phospholipid found in the inner mitochondrial membrane.

Key Therapeutic Areas of Research

Research into SS-31 has been extensive, with a particular focus on conditions where mitochondrial dysfunction is a central factor. The peptide’s ability to improve energy production, reduce oxidative stress, and protect cellular integrity makes it a candidate for a wide range of applications:

Neurodegenerative Disorders: SS-31 has shown promise in animal models for conditions like Alzheimer’s and Parkinson’s disease, as well as traumatic brain injury. It has demonstrated an ability to cross the blood-brain barrier and protect neurons from damage, improve cognitive function, and reduce neuroinflammation. It’s been shown to restore ATP and mitochondrial membrane potential levels in models of cognitive impairment.

Aging and Age-Related Conditions: Given that mitochondrial dysfunction is a hallmark of aging, SS-31 has been investigated as a potential “anti-aging” therapeutic. Preclinical studies have suggested benefits in muscle aging, exercise tolerance, and age-related decline. For instance, in aging mice, SS-31 has been shown to improve learning ability after sleep deprivation and enhance physical endurance.

Cardiovascular and Kidney Diseases: Research has explored its use in conditions like heart failure and chronic kidney disease. In animal models, SS-31 has been shown to protect against tissue damage from ischemia-reperfusion injury and restore normal mitochondrial structure in kidney cells. Clinical trials in these areas have yielded mixed or inconclusive results, but its safety profile was generally favorable.

Mitochondrial Myopathies: SS-31 has been investigated for its potential to treat primary mitochondrial myopathies, a group of genetic disorders that directly affect mitochondrial function. A major Phase III clinical trial for this condition, however, failed to meet its primary endpoints, highlighting the complexity of translating preclinical success into effective human treatments for all conditions.

The Mechanism of Action: A Deeper Look

The proposed mechanism of SS-31 goes beyond a simple antioxidant effect. Its unique structure allows it to accumulate in the inner mitochondrial membrane at concentrations thousands of times higher than in other parts of the cell. Once there, it interacts with cardiolipin. This binding action:

Stabilizes the Mitochondrial Structure: The inner mitochondrial membrane is highly folded into structures called cristae, which are essential for efficient energy production. SS-31’s interaction with cardiolipin helps maintain the proper curvature and integrity of these cristae.

Enhances ATP Production: By stabilizing the membrane and helping to organize the protein complexes of the electron transport chain, SS-31 optimizes the flow of electrons, which in turn leads to more efficient ATP synthesis. This effect is a cornerstone of its potential therapeutic benefits.

Reduces Oxidative Stress at the Source: While some antioxidants work by scavenging free radicals after they are produced, SS-31 helps prevent their overproduction in the first place by improving the efficiency of the electron transport chain. This “less leakage” of electrons significantly reduces the generation of reactive oxygen species (ROS).

Clinical Trial Status and Safety

SS-31 (Elamipretide) has been the subject of numerous clinical trials sponsored by Stealth BioTherapeutics. While it has not yet received FDA approval for any specific condition, the trials have consistently demonstrated a favorable safety profile. The most common side effect reported is a mild injection site reaction. Some users have also reported headaches, dizziness, or gastrointestinal issues, which are generally temporary.

It’s important to note that SS-31 is still considered an investigational drug. There is a lack of long-term safety data for human use, and it is not recommended for pregnant or breastfeeding women or individuals with a history of cancer due to the theoretical risk of its effect on cellular function.