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SS-LUP-332 Safe Long Term Use: Comparison of Available Evidence
Preclinical (rodent) 16 weeks No hepatotoxicity, nephrotoxicity, or cardiac dysfunction observed 38% increased mitochondrial density, 22% reduced fasting glucose, 31% improved insulin sensitivity Species differences in drug metabolism; 16 weeks in mice ≈ 3–4 y
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- Preclinical (rodent)
- 16 weeks
- No hepatotoxicity, nephrotoxicity, or cardiac dysfunction observed
- 38% increased mitochondrial density, 22% reduced fasting glucose, 31% improved insulin sensitivity
- Species differences in drug metabolism; 16 weeks in mice ≈ 3–4 years human equivalent, not lifetime exposure
- Phase 1 (human)
- 12 weeks
- No serious adverse events; 5% mild liver enzyme elevation (resolved); 18% GI symptoms at high dose
- Data pending full publication; preliminary reports show improved VO2 max and reduced HbA1c in prediabetic subgroup
- Short duration; healthy volunteer population may not reflect patient populations with metabolic disease
- Mechanistic concern
- Theoretical
- Chronic ERRα activation could theoretically impair mitophagy or deplete metabolic cofactors
- Unknown. No long-term human data exists
- Based on pathway biology, not observed effects; may or may not manifest clinically
- Drug interaction risk
- CYP3A4 substrate. Potential interactions with statins, immunosuppressants, antifungals
- Unknown pending pharmacokinetic studies
- Common concern with hepatically metabolised drugs; clinical significance depends on specific co-medications