L-5-Methyltetrahydrofolate calcium Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Several clinical trials evaluate the biological properties and therapeutic utility of L-5-methyltetrahydrofolate calcium across applications including contraception, infant growth and development, bioavailability and pharmacokinetics, and vitamin B12 deficiency management. Sponsored by commercial and academic entities—including Bayer, dsm-firmenich Switzerland AG, Sichuan Credit Pharmaceutical Co., Ltd., and the University of British Columbia—these Phase I studies incorporate nutritional bioequivalence assessments. Current recruitment statuses across these trials range from completed to enrolling by invitation and not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07461649	NOT_YET_RECRUITING	Bioavailability and Pharmacokinetics	Sichuan Credit Pharmaceutical Co., Ltd.	2026-03-15
NCT06758778	ENROLLING_BY_INVITATION	Bioavailability	Sichuan Credit Pharmaceutical Co., Ltd.	2025-01-03
NCT02437721	COMPLETED	Growth and Development	dsm-firmenich Switzerland AG	2015-05
NCT01584050	COMPLETED	Vitamin B12 Deficiency	University of British Columbia	2012-05
NCT01258660	COMPLETED	Contraception	Bayer	2006-12	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-16)

Check the L-5-Methyltetrahydrofolate calcium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As the primary biologically active metabolite of folate, calcium L-5-methyltetrahydrofolate directly provides essential methyl groups to enzymatic pathways in one-carbon metabolism, facilitating the remethylation of homocysteine to methionine and downstream nucleic acid biosynthesis. Consequently, efficient physiological uptake and metabolic utilization support cell division and tissue expansion, underscoring its therapeutic relevance in clinical settings evaluating bioavailability, nutritional growth and development, contraception, and vitamin B12 deficiency.

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>).