L-serine Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials ranging from Phase 1 to Phase 3 and observational research evaluate diverse conditions, sponsored by academic medical centers, pharmaceutical companies, and government agencies including the NIH and NCATS. Currently, active recruiting efforts include a Phase 2 study on eosinophilic esophagitis treatments and an observational trial examining host genetic factors in COVID-19 severity. Conversely, a Phase 1 safety trial in healthy subjects has an unknown recruitment status, and a Phase 3 trial targeting prostate cancer, androgen deficiency, insulin resistance, and type 2 diabetes mellitus was withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05485155	Recruiting	Eosinophilic Esophagitis	Children''s Hospital Medical Center Cincinnati\|CSL Behring\|National Institutes of Health (NIH)	2024-03-01	Phase 2
NCT05157217	Recruiting	COVID-19	Cairo University\|Misr International University	2021-12-15	--
NCT05186285	Unknown status	Healthy	Keymed Biosciences Co.Ltd	2021-12-11	Phase 1
NCT05098327	Withdrawn	Prostate Cancer\|Insulin Resistance\|Diabetes Mellitus Type 2\|Androgen Deficiency	State University of New York at Buffalo\|National Center for Advancing Translational Sciences (NCATS)	2021-08-01	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-serine serves as a vital substrate for protein, lipid, and nucleic acid synthesis, integrating into single-carbon metabolic pathways to fuel essential anabolic processes and maintain cellular proliferation. Disruption or utilization of serine metabolic pathways modulates cell growth and metabolic dynamics, directly influencing proliferative and endocrine conditions under clinical investigation, such as prostate cancer, insulin resistance, and inflammatory diseases.

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>).