Semax
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Semax

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A synthetic heptapeptide derived from ACTH fragments, studied for neuromodulatory and neuroprotective properties.

Key Research Properties:

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Lyophilized powder form
Manufactured in USA
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$96.00
SKU: ss-32
Purity: >99% (HPLC Verified)
Form: Lyophilized Powder
Storage: Store at -20°C
CAS Number: 80714-61-0
For Research Use Only.
All products are sold strictly for laboratory and research purposes. Products are not intended for human use or consumption of any kind.

The statements presented on this website have not been evaluated by the Food and Drug Administration (FDA). The products of this company are not intended to diagnose, treat, cure, or prevent any medical condition or disease.

What is SS-31 (Elamipretide)?

SS-31, also known as Elamipretide or MTP-131 (D-Arg-Dmt-Lys-Phe-NH₂), is a novel mitochondrial-targeted tetrapeptide that selectively binds to cardiolipin on the inner mitochondrial membrane, optimizing mitochondrial function and energy production[1]. With clinical trials completed for heart failure, Barth syndrome, and primary mitochondrial myopathy, SS-31 represents a breakthrough approach to treating mitochondrial dysfunction[2].

Mitochondrial-Targeted Therapy: SS-31 is the first clinically-tested mitochondrial-targeted peptide. It concentrates 1000-fold in mitochondria, binds cardiolipin, stabilizes cristae structure, and improves ATP production while reducing ROS. Clinical trials show promise for heart failure, mitochondrial diseases, and age-related conditions.
Biochemical Properties
  • Sequence: D-Arg-Dmt-Lys-Phe-NH₂ (Dmt = 2',6'-dimethyltyrosine)
  • Size: Tetrapeptide (4 amino acids, ~640 Da)
  • Structure: Alternating cationic/aromatic residues; cell-penetrating
  • Target: Cardiolipin (inner mitochondrial membrane phospholipid)
  • Developer: Stealth BioTherapeutics
  • Clinical Status: Phase 2/3 trials completed for multiple indications
Primary Benefits
  • Mitochondrial Function: Optimizes ATP production; reduces ROS generation
  • Heart Failure: Improves cardiac function and exercise capacity (clinical trials)
  • Mitochondrial Diseases: Treats Barth syndrome, primary mitochondrial myopathy
  • Cardioprotection: Protects heart from ischemia-reperfusion injury
  • Neuroprotection: Protects neurons in stroke, TBI, neurodegeneration
  • Anti-Aging: Improves age-related mitochondrial decline

Key Research Findings

Clinical & Preclinical Discoveries

  • Cardiolipin Binding: Selectively binds cardiolipin; stabilizes mitochondrial cristae structure
  • Heart Failure Trials: Phase 2 showed improved 6-minute walk distance and quality of life
  • Barth Syndrome: Phase 2 trial showed significant improvement in exercise capacity
  • Primary Mitochondrial Myopathy: Phase 3 MMPOWER-3 trial (results pending)
  • Mitochondrial Concentration: Accumulates 1000× in mitochondria vs. cytoplasm
  • ROS Reduction: Reduces mitochondrial ROS without affecting physiological signaling
Clinical Potential: SS-31 is the most clinically advanced mitochondrial-targeted therapy. With completed Phase 2/3 trials for heart failure and rare mitochondrial diseases, it represents a paradigm shift in treating mitochondrial dysfunction across multiple conditions.

Mechanism of Action

SS-31's unique mechanism involves selective mitochondrial targeting, cardiolipin binding, cristae stabilization, and optimization of electron transport chain function[3].

Mitochondrial Targeting & Cardiolipin Binding

Selective Accumulation

Primary Mechanism: SS-31's alternating cationic/aromatic structure allows it to cross membranes and concentrate in mitochondria.

  • Cell Penetration: Crosses plasma membrane without transporters
  • Mitochondrial Accumulation: Membrane potential-driven uptake; 1000× concentration in mitochondria
  • Cardiolipin Binding: Selectively binds cardiolipin (unique to inner mitochondrial membrane)
  • Cristae Stabilization: Prevents cardiolipin peroxidation; maintains cristae structure
  • Specificity: Does not affect other cellular membranes or organelles

Mitochondrial Function Optimization

Energy Production & ROS Reduction

  • Electron Transport: Optimizes electron flow through Complexes I-IV; reduces electron leak
  • ATP Production: Increases ATP synthesis efficiency; improves energy output
  • ROS Reduction: Reduces superoxide and H₂O₂ generation at source (Complex I/III)
  • Membrane Potential: Stabilizes mitochondrial membrane potential
  • Calcium Handling: Improves mitochondrial calcium buffering

Cytoprotection

Cell Survival & Tissue Protection

  • Anti-Apoptotic: Prevents cytochrome c release; blocks apoptosis initiation
  • Oxidative Stress: Protects against oxidative damage to proteins, lipids, DNA
  • Inflammation: Reduces inflammatory signaling; modulates immune response
  • Ischemia-Reperfusion: Protects tissues from I/R injury (heart, brain, kidney)
Mechanism Summary: SS-31's cardiolipin-targeting mechanism is unique - it addresses mitochondrial dysfunction at its source by stabilizing the inner membrane structure and optimizing electron transport. This makes it effective across diverse conditions with mitochondrial involvement.

Research & Evidence

SS-31 has extensive preclinical research and multiple completed clinical trials for heart failure, Barth syndrome, and primary mitochondrial myopathy[4].

Heart Failure Research

Clinical Trials in Heart Failure

Key Findings: Phase 2 trials showed functional improvements in heart failure patients.

  • 6-Minute Walk Distance: Significant improvement vs. placebo
  • Quality of Life: Improved Kansas City Cardiomyopathy Questionnaire scores
  • Cardiac Function: Trends toward improved ejection fraction and diastolic function
  • Biomarkers: Reduced NT-proBNP (heart failure marker)
  • Safety: Well-tolerated with minimal adverse events

Mitochondrial Diseases

Barth Syndrome & Primary Mitochondrial Myopathy

  • Barth Syndrome: Phase 2 TAZPOWER trial showed improved 6-minute walk distance
  • Primary Mitochondrial Myopathy: Phase 3 MMPOWER-3 trial completed (results pending)
  • Mechanism Relevance: Barth syndrome involves cardiolipin deficiency - SS-31's cardiolipin binding directly addresses pathology
  • Orphan Drug Status: FDA orphan drug designation for Barth syndrome and primary mitochondrial myopathy

Preclinical Research

Animal Model Studies

  • Myocardial Infarction: Reduces infarct size; improves cardiac recovery
  • Stroke: Neuroprotection; reduces infarct volume and neurological deficits
  • Acute Kidney Injury: Protects kidneys from ischemia-reperfusion injury
  • Neurodegenerative Diseases: Protective in Alzheimer's, Parkinson's, ALS models
  • Aging: Improves age-related mitochondrial decline; extends healthspan
Research Status: SS-31 has completed Phase 2/3 clinical trials for heart failure and mitochondrial diseases. FDA approval decision pending. It represents the most clinically advanced mitochondrial-targeted therapy.

Dosing & Administration

Research Use Only: SS-31 is for research purposes. Clinical trials ongoing; not yet FDA-approved.

Clinical Trial Dosing

Intravenous/Subcutaneous Administration

Clinical Trial Protocols: Based on published trial data

  • Heart Failure Trials: 4 mg/kg IV, once daily for 4 hours (Phase 2)
  • Barth Syndrome: 40 mg SC, once daily (TAZPOWER trial)
  • Primary Mitochondrial Myopathy: 40 mg SC, once daily (MMPOWER-3 trial)
  • Duration: Clinical trials: 12-24 weeks
  • Route: IV infusion or subcutaneous injection
Note: Community/research dosing protocols are not well-established for SS-31. Clinical trial data provides guidance, but individual research use requires careful consideration.

Storage

  • Lyophilized Powder: Store at -20°C
  • Reconstituted Solution: Refrigerate at 2-8°C; use within 7 days
  • Handling: Protect from light; gently mix

Safety & Side Effects

SS-31 has demonstrated excellent safety and tolerability in clinical trials with minimal adverse events[5].

Clinical Trial Safety Data

Human Clinical Trials: SS-31 shows excellent tolerability across multiple trials.

  • Well-Tolerated: Minimal adverse events in Phase 2/3 trials
  • Common Side Effects: Injection site reactions (SC administration); mild and transient
  • No Serious AEs: No drug-related serious adverse events in major trials
  • Long-Term Safety: 24-week trials show sustained safety profile
  • No Organ Toxicity: No adverse effects on liver, kidney, or other organ function
Safety Profile: SS-31's excellent safety in clinical trials supports its therapeutic potential. The targeted mitochondrial mechanism avoids off-target effects, contributing to its favorable safety profile.

Frequently Asked Questions

SS-31 is the first mitochondrial-targeted peptide to reach Phase 3 clinical trials. Its unique cardiolipin-binding mechanism directly stabilizes the inner mitochondrial membrane structure, optimizing function at the source. It concentrates 1000× in mitochondria, ensuring targeted action without affecting other cellular processes.

Clinical trials: Heart failure (Phase 2 completed), Barth syndrome (Phase 2 TAZPOWER), Primary mitochondrial myopathy (Phase 3 MMPOWER-3). Preclinical research: stroke, acute kidney injury, neurodegenerative diseases, aging, ischemia-reperfusion injury.

Cardiolipin is a unique phospholipid found only in the inner mitochondrial membrane. It's essential for optimal electron transport chain function, cristae structure, and ATP production. Cardiolipin damage/deficiency is central to mitochondrial dysfunction in aging and disease. SS-31 binds and protects cardiolipin, restoring mitochondrial function.

Not yet. SS-31 has completed Phase 2/3 trials for multiple indications. It has FDA orphan drug designation for Barth syndrome and primary mitochondrial myopathy. Approval decision pending based on trial results. It's currently available for research purposes only.

Clinical Trials

SS-31 (Elamipretide) has undergone extensive clinical development with completed Phase 2/3 trials for heart failure, Barth syndrome, and primary mitochondrial myopathy[6].

Clinical Development Status: SS-31 is the most clinically advanced mitochondrial-targeted therapy. Multiple Phase 2/3 trials completed with positive results. FDA orphan drug designation for rare mitochondrial diseases. Approval decision pending.

Heart Failure Trials

Phase 2 Studies

Study Design: Randomized, placebo-controlled trials in heart failure with preserved ejection fraction (HFpEF) and reduced ejection fraction (HFrEF).

  • Primary Endpoint: 6-minute walk distance (6MWD)
  • Results: Significant improvement in 6MWD vs. placebo
  • Quality of Life: Improved KCCQ scores
  • Cardiac Function: Trends toward improved diastolic function
  • Safety: Well-tolerated; no serious drug-related adverse events

Rare Mitochondrial Diseases

Barth Syndrome & Primary Mitochondrial Myopathy

TAZPOWER (Barth Syndrome): Phase 2 trial in adolescents/adults with Barth syndrome

  • Design: 40 mg SC daily for 12 weeks
  • Results: Significant improvement in 6-minute walk distance
  • Mechanism Relevance: Barth syndrome involves cardiolipin deficiency; SS-31 directly addresses this

MMPOWER-3 (Primary Mitochondrial Myopathy): Phase 3 trial

  • Design: 40 mg SC daily for 24 weeks
  • Status: Completed; results pending
  • Significance: First Phase 3 trial for mitochondrial-targeted therapy
Find More Trials: Search ClinicalTrials.gov: SS-31/Elamipretide Trials
Clinical Evidence Summary: SS-31 has robust clinical trial data demonstrating efficacy and safety for heart failure and rare mitochondrial diseases. As the first mitochondrial-targeted therapy to reach Phase 3, it represents a breakthrough in treating mitochondrial dysfunction.

References & Scientific Citations

Research Integrity:

All references are from peer-reviewed journals and clinical trial registries.

  1. Szeto HH. First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics. Br J Pharmacol. 2014;171(8):2029-2050. PMID: 24117165
  2. Sabbah HN, et al. Chronic therapy with elamipretide (MTP-131), a novel mitochondria-targeting peptide, improves left ventricular and mitochondrial function in dogs with advanced heart failure. Circ Heart Fail. 2016;9(2):e002206. PMID: 26839394
  3. Birk AV, et al. The mitochondrial-targeted compound SS-31 re-energizes ischemic mitochondria by interacting with cardiolipin. J Am Soc Nephrol. 2013;24(8):1250-1261. PMID: 23813215
  4. Butler J, et al. Effects of elamipretide on left ventricular function in patients with heart failure with reduced ejection fraction: the PROGRESS-HF phase 2 trial. J Card Fail. 2020;26(5):429-437. PMID: 32278805
  5. Chatfield KC, et al. Elamipretide improves mitochondrial function in the heart of subjects with Barth Syndrome. JACC Basic Transl Sci. 2019;4(2):147-157. PMID: 31061914
  6. Karaa A, et al. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy. Neurology. 2018;90(14):e1212-e1221. PMID: 29540588
Additional Research: Search PubMed: SS-31/Elamipretide Studies

⚠️ Research Use Only

All products sold by Vital Healer Labs are for laboratory research use only.
Not for human consumption, medical, or veterinary use.

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