SS-31 Injection

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SS-31 Injection, a synthetic tetrapeptide with precise mitochondrial targeting capabilities, breaks through the limitations of traditional therapies by leveraging its unique molecular structure and mechanism of action. It efficiently penetrates the blood-brain barrier and specifically binds to cardiolipin in the inner mitochondrial membrane of neuronal cells. This allows it to regulate oxidative stress balance at its source, stabilize mitochondrial membrane structure, and restore energy metabolism efficiency. It offers a novel targeted therapeutic approach for the intervention of neurodegenerative diseases, and its demonstrated neuroprotective potential across various disease models is increasingly becoming a central focus of research in this field.

 

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sS-31 Powder

sS-31 injection

sS-31 capsules

SS-31 COA

Certificate of Analysis
Compound name	Elamipretide
Grade	Pharmaceutical grade
CAS No.	736992-21-5
Quantity	35g
Packaging standard	PE bag+Al foil bag
Manufacturer	Shaanxi BLOOM TECH Co., Ltd
Lot No.	202501090036
MFG	Jan 9th 2025
EXP	Jan 8th 2028
Structure
Item	Enterprise standard	Analysis result
Appearance	White or almost white powder	Conformed
Water content	≤5.0%	0.38%
Loss on drying	≤1.0%	0.28%
Heavy Metals	Pb≤0.5ppm	N.D.
	As≤0.5ppm	N.D.
	Hg≤0.5ppm	N.D.
	Cd≤0.5ppm	N.D.
Purity (HPLC)	≥99.0%	99.98%
Single impurity	<0.8%	0.45%
Total microbial count	≤750cfu/g	90
E. Coli	≤2MPN/g	N.D.
Salmonella	N.D.	N.D.
Ethanol (by GC)	≤5000ppm	400ppm
Storage	Store in a sealed, dark, and dry place below -20°C

Neurodegenerative diseases (such as Alzheimer's disease and post-stroke neurological dysfunction) have emerged as major global health challenges in the context of aging populations. Their pathological mechanisms are complex and interrelated, with the core issue lying in the progressive dysfunction of mitochondrial function in neuronal cells-where overloaded oxidative stress, depleted energy metabolism, and uncontrolled apoptosis form a vicious cycle. This ultimately leads to neuronal loss, synaptic damage, and cognitive and motor function decline. Current treatment approaches often focus on single pathological aspects, making comprehensive neuroprotection and functional repair difficult to achieve.

I. Molecular Advantages of Blood-Brain Barrier Penetration and Targeted Localization

SS-31, leveraging its unique molecular structural characteristics (cationic aromatic motif balanced with moderate hydrophilicity and hydrophobicity), can overcome the physiological barrier limitations of the blood-brain barrier. Unlike ordinary drugs, which struggle to penetrate brain tissue, the positive charge on its molecular surface can form mild electrostatic interactions with anionic components on the endothelial cell membranes of the blood-brain barrier. Combined with the membrane-penetrating ability of hydrophobic aromatic rings, this enables highly efficient transmembrane transport, ultimately leading to preferential accumulation in the inner mitochondrial membrane of nerve cells. This targeting characteristic allows it to directly act on the damaged core organelles in neurodegenerative diseases, laying the foundation for subsequent neuroprotective effects.

II. Multidimensional Regulatory Mechanisms of Oxidative Stress in Nerve Cells

In neurodegenerative diseases, the imbalance of oxidative stress in nerve cells (excessive accumulation of reactive oxygen species) is a key trigger for cellular damage. SS-31 injection regulates oxidative stress levels through multiple pathways:

III. Blocking Pathological Opening of mPTP and Ensuring Neuronal Survival

 

The abnormal opening of the mitochondrial permeability transition pore (mPTP) is a critical trigger for neuronal apoptosis in neurodegenerative diseases:

Under pathological conditions, stimuli such as ischemia and oxidative stress can lead to excessive opening of mPTP, causing collapse of the mitochondrial membrane potential and swelling or rupture of mitochondria.

By specifically binding to cardiolipin in the inner mitochondrial membrane, SS-31 stabilizes the membrane structure and directly blocks the pathological opening of mPTP, preventing the release of mitochondrial contents (such as cytochrome c) into the cytoplasm.

This process interrupts the cascade reaction of apoptosis, reduces programmed cell death in neurons, and maintains the cellular quantity and functional integrity of neural tissue.

The core pathological process of stroke, particularly that induced by ischemia-reperfusion injury, is characterized by a sudden reduction in mitochondrial energy production following the interruption of cerebral blood perfusion. Subsequently, the restoration of blood flow triggers an outburst of reactive oxygen species, calcium overload, and an inflammatory cascade reaction. Ultimately, this leads to necrosis of nerve cells in the ischemic core area, apoptosis of cells in the penumbra, and continuous expansion of the infarct zone. In response to this pathological cascade, SS-31 exerts multidimensional and targeted neuroprotective effects, specifically manifested in the following aspects:

Mechanisms for Halting Infarct Expansion:

During ischemia-reperfusion injury, the abnormal opening of the mitochondrial permeability transition pore serves as a critical trigger for apoptosis. By specifically binding to cardiolipin in the inner mitochondrial membrane, SS-31 stabilizes the membrane structure and blocks the pathological opening of this pore, thereby preventing mitochondrial swelling, rupture, and the release of cytochrome c. This action reduces programmed cell death in the nerve cells of the ischemic core area.

Additionally, SS-31 optimizes the efficiency of the mitochondrial electron transport system, reduces electron leakage from Complex III, and minimizes the generation of reactive oxygen species such as superoxide anions. This alleviates oxidative stress damage to cells in the ischemic penumbra, achieving a reduction in infarct size by over 17% (based on preclinical model data). 

 Dual Regulation of Inflammation and Edema:

After a stroke, damaged nerve cells release pro-inflammatory factors (such as TNF-α and IL-6), triggering localized inflammatory responses and disrupting the permeability of the blood-brain barrier. This leads to cerebral edema. SS-31 injection inhibits the activation of inflammation signaling pathways mediated by mitochondrial damage, thereby reducing the transcription and release of pro-inflammatory factors. Simultaneously, it stabilizes the mitochondrial function of endothelial cells in the blood-brain barrier, maintains endothelial cell integrity, and reduces vascular permeability. This alleviates cerebral edema and mitigates secondary damage to nerve cells caused by inflammatory factors.

Precise Restoration of Energy Metabolism:

Under ischemic conditions, nerve cells rely on anaerobic glycolysis for energy, resulting in significant accumulation of lactic acid and further exacerbating cellular damage. SS-31 can restore the oxidative phosphorylation function of mitochondria in ischemic areas. By activating the AMPK/PGC-1α signaling pathway, it enhances mitochondrial biogenesis and improves ATP production efficiency.

Furthermore, it promotes a metabolic shift from glucose oxidation to fatty acid oxidation, enhances energy utilization efficiency in the myocardium (which affects cerebral blood supply), reduces lactic acid accumulation, and provides sustained energy support to damaged nerve cells. This increases the survival probability of ischemic brain tissue. 

 

SS-31 cares for Alzheimer's disease patients

 

In Alzheimer's disease models, SS-31 injection demonstrates comprehensive and profound neuroprotective effects by leveraging its unique mitochondrial targeting properties, offering a highly promising new direction for intervention in this disease. The core pathological progression of Alzheimer's disease revolves around the abnormal aggregation of β-amyloid into toxic oligomers and fibrillar plaques, as well as the hyperphosphorylation of tau protein leading to neurofibrillary tangles. Together, these processes trigger mitochondrial dysfunction, oxidative stress imbalance, and synaptic loss in neuronal cells, ultimately resulting in cognitive decline.

This drug penetrates the blood-brain barrier and precisely accumulates in the inner mitochondrial membrane of neuronal cells. By specifically binding to cardiolipin to form a stable complex, it not only enhances the damage resistance of the mitochondrial membrane, effectively defending against the invasion of β-amyloid toxic oligomers, but also optimizes the efficiency of the electron transport chain, reducing the generation of reactive oxygen species at the source.Concurrently, it upregulates the activity of endogenous antioxidant enzymes, alleviates oxidative damage to neuronal membranes and organelles, significantly mitigates the neurotoxicity of β-amyloid, and inhibits further expansion of fibrillar plaques.

Regarding the abnormal phosphorylation of tau protein, it improves cellular energy metabolism by restoring mitochondrial function, downregulates the activity of abnormally activated kinases such as glycogen synthase kinase 3β, and promotes phosphatase-mediated dephosphorylation of tau protein. This reduces the formation and progression of neurofibrillary tangles, thereby maintaining the structural integrity of neuronal cells. Notably, SS-31 targets and protects mitochondrial function in presynaptic neurons, enhances ATP production efficiency, provides ample energy support for the synthesis and release of synaptic neurotransmitters, reduces oxidative damage to postsynaptic membrane receptors, and significantly lowers the synaptic loss rate. Consequently, it preserves normal neural circuit connectivity and signal transmission.

SS-31, with mitochondrial function repair at its core, has opened a highly valuable new pathway for the treatment of neurodegenerative diseases. Through multiple synergistic mechanisms-including penetrating the blood-brain barrier for targeted enrichment, regulating oxidative stress, blocking abnormal opening of the mitochondrial permeability transition pore, and protecting synaptic function-it not only mitigates pathological damage such as β-amyloid deposition and tau protein hyperphosphorylation but also maintains neuronal survival and neural circuit integrity, effectively improving cognitive and motor dysfunction.

Compared to traditional single-target drugs, its multidimensional intervention offers distinct advantages, while its gentle mode of action and excellent biocompatibility further enhance its potential for clinical translation. Although larger-scale clinical studies are still needed to validate its long-term efficacy and individualized adaptability, and challenges such as dosage optimization (e.g., extending half-life) remain to be addressed, SS-31 has clearly demonstrated the potential to break through the current therapeutic impasse in neurodegenerative diseases.

As research advances in the future, this mitochondria-targeted drug holds promise to transition from the laboratory to clinical practice, offering new hope for delaying disease progression and improving the quality of life for a wide range of patients. It may also propel the treatment of neurodegenerative diseases into a new era of precision-targeted repair.

• Can SS-31 help with weight loss?

SS-31 isn't a direct weight-loss drug but supports healthy metabolism and energy by targeting mitochondria, potentially preventing muscle/weight loss in disease states (like cancer cachexia) and improving cellular function, which can indirectly influence body composition and performance, especially alongside diet and exercise, rather than just suppressing appetite. Research shows it can improve metabolic health, enhance physical performance in aged mice, and improve body composition in specific contexts, but its role in general weight loss is more about cellular efficiency and function.

• Is SS-31 FDA-approved?

SS-31: FDA-approved peptide for mitochondrial health.

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