L-Hydroxyproline Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Several clinical trials evaluate L-hydroxyproline or collagen peptide formulations across diverse indications, including nutrient bioavailability in healthy individuals, gut microbiome changes associated with brain injuries, and mass spectrometry-based diagnostic biomarkers in pediatric medulloblastoma. Categorized under non-applicable or unassigned phases, these studies are supported by academic medical centers, university investigators, and private industrial partners such as Rousselot BVBA and BioTeSys GmbH. Recruitment statuses across these investigations range from completed to unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05252962	Unknown status	Healthy	Rousselot BVBA\|BioTeSys GmbH	2021-11-26	Not Applicable
NCT04949607	Completed	Brain Injury Chronic\|Brain Injuries Traumatic	Centre for Neuro Skills\|University of Texas	2021-07-28	Not Applicable
NCT04097808	Completed	Bioavailability	Rousselot BVBA\|BioTeSys GmbH	2019-09-20	Not Applicable
NCT04065204	Unknown status	Pediatric Medulloblastoma	Xinhua Hospital Shanghai Jiao Tong University School of Medicine	2019-06-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a collagen-specific constituent formed via proline hydroxylation, L-hydroxyproline stabilizes triple-helical collagen architecture, and its release into systemic circulation directly reflects extracellular matrix turnover and breakdown. Consequently, measuring L-hydroxyproline levels serves as a critical biochemical marker for connective tissue remodeling, aiding clinical diagnostic evaluations of liver fibrosis, bone turnover, and metabolomic profiling in traumatic brain injury and pediatric medulloblastoma.

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>).