L-carnosine Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Several clinical trials evaluate the therapeutic applications of L-carnosine for conditions such as muscle weakness and fatigue in older adults, peripheral arterial disease, and chronic traumatic brain injury. Sponsored by academic and clinical institutions—including Indiana University, the University of Louisville, the Centre for Neuro Skills, and the University of Texas—these efforts span early-stage Phase 1/Phase 2 trials as well as non-phase interventional investigations. Currently, this body of research comprises both actively recruiting studies and completed evaluations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05860088	Recruiting	Muscle Weakness\|Muscle; Fatigue Heart\|Older Adults	Indiana University	2023-07-10	Not Applicable
NCT05371145	Recruiting	Peripheral Arterial Disease	University of Louisville	2023-03-01	Phase 1\|Phase 2
NCT04949607	Completed	Brain Injury Chronic\|Brain Injuries Traumatic	Centre for Neuro Skills\|University of Texas	2021-07-28	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the L-carnosine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-carnosine functions as an endogenous dipeptide that chelates transition metal ions and demonstrates superoxide dismutase-like scavenging of reactive oxygen species. By neutralizing oxidative radicals and suppressing non-enzymatic tissue damage, it attenuates inflammatory signaling and preserves tissue integrity, demonstrating clinical relevance in age-related muscle fatigue, peripheral arterial disease, and traumatic brain injury.

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>).