DL-Serine Clinical Trials

Size	Price	Qty
25mg	USD 70
1g	USD 490

Clinical Trials

Multiple clinical trials are investigating conditions such as eosinophilic esophagitis, COVID-19, prostate cancer, insulin resistance, type 2 diabetes mellitus, androgen deficiency, and healthy subjects across Phase 1, Phase 2, Phase 3, and unassigned phase studies. Supported by academic, government, and industry sponsors—including Cairo University, the National Institutes of Health, and CSL Behring—these investigations maintain recruitment statuses ranging from actively recruiting to unknown or withdrawn.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NCT05098327	Withdrawn	Prostate Cancer\|Insulin Resistance\|Diabetes Mellitus Type 2\|Androgen Deficiency	State University of New York at Buffalo\|National Center for Advancing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 DL-Serine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

DL-Serine functions as a natural ligand that selectively binds to and allosterically activates pyruvate kinase M2 (PKM2), thereby accelerating downstream glycolytic catalysis and regulating cellular energy production. This metabolic activation influences cellular nutrient sensing and metabolic homeostasis, providing clinical relevance in modulating metabolic, inflammatory, and proliferative conditions such as type 2 diabetes, insulin resistance, eosinophilic esophagitis, COVID-19, 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>).