L-Proline Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate L-proline across Phase 1, Phase 2, Phase 3, and non-interventional designs for metabolic, genetic, and structural conditions, such as pyruvate dehydrogenase complex deficiency, gyrate atrophy, post-hernioplasty mesh infections, chronic obstructive pulmonary disease, noise-induced disturbances, periodontal defects, and type 2 diabetes. Sponsored by academic medical centers, non-profits, and corporate entities including Ultragenyx Pharmaceutical, Verona Pharma, and Astellas Pharma Europe B.V., these protocols span recruiting, completed, and not yet recruiting statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07581613	NOT_YET_RECRUITING	Periodontal Disease; Intrabony Periodontal Defects	Siddharth Shanbhag	2026-11-01	PHASE1; PHASE2
NCT06340685	Recruiting	Pyruvate Dehydrogenase Complex Deficiency	Jirair Krikor Bedoyan\|Ultragenyx Pharmaceutical Inc\|University of Pittsburgh	2024-05	Phase 1
NCT05312736	Recruiting	Gyrate Atrophy\|Gyrata of Choroid and Retina; Atrophy\|Ornithine-δ-aminotransferase\|OAT\|Chorioretinal Degeneration	Jaeb Center for Health Research\|Conquering Gyrate Atrophy Foundation\|Food and Drug Administration (FDA)\|Department of Health and Human Services	2023-11-21	--
NCT05775276	Not yet recruiting	Incidence of Mesh Infection In Hernioplasty	Assiut University	2023-03	Not Applicable
NCT05270525	Recruiting	COPD	Verona Pharma plc\|University of Alabama at Birmingham	2022-05-27	Phase 2
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
NCT02794792	COMPLETED	Type 2 Diabetes Mellitus	Astellas Pharma Europe B.V.	2016-05-11	PHASE3

(data from https://clinicaltrials.gov, updated on 2026-05-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a proteinogenic amino acid, L-proline is incorporated into nascent peptide chains during translation to form structural imino residues, facilitating triple-helix collagen folding and maintaining extracellular matrix integrity in connective tissues. This essential role in structural matrix synthesis and cellular metabolism connects to clinical trial investigations evaluating tissue repair, periodontal defect regeneration, and metabolic conditions including gyrate atrophy.

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>).