Mots-C 10mg/mL

Subcutaneous injection: Administered by subcutaneous injection into the abdomen, upper thigh, or upper arm. Rotate injection sites with each administration to prevent lipodystrophy. Reconstitute lyophilized powder with bacteriostatic water per the dispensing pharmacy's instructions — do not shake vigorously (rolling the vial gently avoids peptide degradation). Inspect the solution for clarity before each use; discard if particulate matter or discoloration is present. Use sterile technique for all injections. Store the reconstituted solution as directed.

No FDA-approved dosing exists for MOTS-c. All dosing is investigational and prescriber-determined.

• Published preclinical and pilot human study contexts have used doses in the range of 5–10 mg per injection, administered 2–3 times per week.
• Cycle length, frequency, and washout periods are at prescriber discretion based on clinical goals and patient response.
• Long-term dosing safety data in humans are absent; the prescriber bears responsibility for informed consent regarding the experimental nature of this therapy.

• MOTS-c: Encoded within the mitochondrial 12S rRNA gene, MOTS-c is released from mitochondria under metabolic stress and acts as a retrograde mitokine. Its primary mechanism is activation of the AMPK pathway via interference with the folate-methionine one-carbon cycle — altering intracellular metabolite ratios that serve as AMPK-activating signals. AMPK activation promotes: (1) GLUT4 translocation to the cell membrane, increasing glucose uptake in skeletal muscle; (2) enhanced fatty acid β-oxidation; (3) inhibition of lipogenesis and gluconeogenesis; and (4) mitochondrial biogenesis. Under cellular stress conditions, MOTS-c translocates to the nucleus where it directly regulates gene expression related to antioxidant defense (Nrf2/ARE pathway) and anti-inflammatory signaling. Circulating MOTS-c levels decline with aging, paralleling the metabolic dysfunction seen in aging populations.

Investigational context: Preclinical data in rodent models demonstrate MOTS-c's ability to prevent diet-induced insulin resistance, obesity, and age-related decline in metabolic and physical function. A Phase 2a human clinical trial (NCT07505745) is evaluating MOTS-c's effect on insulin sensitivity in adults with prediabetes and overweight/obesity. Clinical applications proposed in prescriber-supervised investigational contexts include: metabolic syndrome, insulin resistance, obesity-related metabolic dysfunction, physical performance support, and longevity-oriented protocols.

Prescriber monitoring (investigational use):

• Baseline and periodic fasting glucose, insulin, HbA1c, lipid panel, and body composition
• Injection site assessment at each visit
• Vital signs, cardiac evaluation including ECG if indicated
• Informed consent documentation explicitly acknowledging the investigational, non-FDA-approved nature of this therapy and the limited human safety/efficacy data available

Contraindications:

• Active cancer diagnosis — preclinical data on MOTS-c's role in cancer remain conflicting; use with extreme caution or avoid in oncology patients
• Hypersensitivity to any component of the preparation
• Pregnancy and lactation — no human safety data

Warnings & Precautions:

• This is an investigational peptide with no completed large-scale human clinical trials. Long-term safety is unknown.
• Reported user-reported side effects (from anecdotal sources): injection site irritation, heart palpitations, insomnia, fever, headache, flushing, and GI upset
• Cancer risk signal: some preclinical data suggest pro-proliferative effects in certain cancer cell lines — exercise caution and do not administer to patients with active or recent malignancy without extensive benefit-risk assessment

Drug Interactions:

• Theoretical additive effects with other insulin-sensitizing agents (metformin, GLP-1 agonists) — monitor for hypoglycemia

Common Side Effects: Injection site redness or irritation, transient fatigue, mild insomnia, headache, nausea (from user reports; no controlled clinical trial adverse event data available for human subcutaneous use).

Store lyophilized MOTS-c powder at 2–8°C (refrigerated) or as specified on the vial label, protected from light. After reconstitution with bacteriostatic water, store at 2–8°C and use within the timeframe specified by Genesis Compounding. Do not freeze the reconstituted solution. Protect from light. Observe the beyond-use date. Discard if discolored, cloudy, or if particulate matter is visible.

What conditions might MOTS-c be used for?

Prescribers have explored MOTS-c in the context of insulin resistance, prediabetes, metabolic syndrome, age-related metabolic decline, and physical performance support. These are all investigational applications — MOTS-c is not FDA-approved for any human therapeutic indication.

Is this an FDA-approved medication?

No. MOTS-c is not FDA-approved for any indication and is classified as an investigational peptide. Its use in compounded preparations is subject to evolving FDA regulatory guidance. Prescribers and patients must fully understand the experimental nature of this therapy.

How is the injectable solution prepared?

The lyophilized (freeze-dried) powder is reconstituted with bacteriostatic water. Roll the vial gently to mix — do not shake. The resulting solution should be clear and colorless. Inspect before each use and discard if cloudy or particulate matter is present.

What does MOTS-c do in the body?

MOTS-c is a small peptide produced by mitochondria that declines with age. In preclinical studies it activates AMPK — the body's master metabolic regulator — improving insulin sensitivity, promoting fat oxidation, and stimulating mitochondrial biogenesis. Its physiological similarity to the effects of exercise has generated investigational interest in metabolic medicine.

What are the known risks?

Because human clinical trial data are very limited, the full risk profile is unknown. Reported effects include injection site reactions, palpitations, insomnia, and fever. A potential cancer-promotion risk in specific cell types has been raised in preclinical data. Full informed consent is essential.