Clinical Trials

Several completed clinical trials have evaluated sarcosine across diverse conditions, including prostate cancer, homocystinuria, traumatic and chronic brain injury, and noise-induced sleep disturbance associated with metabolic and cognitive changes. Ranging from Phase 2 trials to non-applicable phase designations, these fully recruited studies were sponsored by academic medical centers and governmental entities, such as the National Cancer Institute, the University of Michigan, and Assistance Publique - Hôpitaux de Paris.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05319262 Completed
Noise Exposure|Sleep Disturbance|Sleep Hygiene|Metabolic Disturbance|Cognitive Change
Göteborg University|University of Pennsylvania|University of Manitoba
 2022-04-24 Not Applicable
NCT04949607 Completed
Brain Injury Chronic|Brain Injuries Traumatic
Centre for Neuro Skills|University of Texas
 2021-07-28 Not Applicable
NCT02404337 Completed
Homocystinuria
Assistance Publique - Hôpitaux de Paris
 2015-07 Phase 2
NCT02462447 Completed
Prostate Cancer
University of Michigan|National Institutes of Health (NIH)|National Cancer Institute (NCI)
 2015-06 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sarcosine competitively inhibits the type I glycine transporter (GlyT1) while co-agonizing N-methyl-D-aspartate receptors (NMDARs), leading to increased synaptic glycine availability and augmented glutamatergic signaling. This enhancement of NMDAR-mediated neurotransmission and cellular amino acid metabolism regulates central neuronal function, which underscores its clinical investigation in brain injury, homocystinuria, and prostate cancer.

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>).

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Note: Technical data last updated: Sep 1, 2026.