Clinical Trials
Multiple clinical trials sponsored by academic and commercial entities, including the University of Athens, Hudson Biotech, and the University of Gaziantep, evaluate the endogenous peptide MOTS-c across metabolic and renal pathologies. Spanning Phase 2 clinical trials and observational studies, these investigations analyze MOTS-c expression, pharmacodynamics, and therapeutic efficacy in prediabetes, insulin resistance, obesity, diabetes with clopidogrel resistance, and end-stage kidney disease in renal transplant recipients. Currently ranging in status from active recruitment to unknown, these studies evaluate vascular, metabolic, and surgical outcomes.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07505745 | RECRUITING | Prediabetes; Insulin Resistance; Overweight/Obesity |
Hudson Biotech |
2026-02-02 | PHASE2 |
| NCT07678073 | RECRUITING | Kidney Disease, End-Stage; Kidney Transplant; Kidney; Kidney Disease; Renal Transplant |
University of Gaziantep |
2026-03-01 | |
| NCT04027712 | Unknown status | Diabetes|Clopidogrel Resistance|Amyloid|Insulin Resistance |
University of Athens |
2014-01-01 | -- |
(data from https://clinicaltrials.gov, updated on 2026-04-01)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).