L-Citrulline Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate L-citrulline across various conditions, including gastrointestinal dysfunction, bronchopulmonary dysplasia with pulmonary hypertension, type 2 diabetes, postmenopausal hypertension, and chemotherapy-induced toxicities in colorectal cancer. Ranging from Early Phase 1 to unassigned or not applicable phases, these interventional and nutritional studies are sponsored by academic and clinical institutions such as Texas Tech University, Tanta University, and The Hospital for Sick Children. Recruitment statuses across these trials currently span from not yet recruiting to actively recruiting and enrolling by invitation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06207461	Not yet recruiting	Traditional Chinese Acupoint Message\|Intestinal Barrier\|Gastrointestinal Dysfunction	Wuhan Union Hospital China	2024-02-15	--
NCT05636397	Recruiting	BPD - Bronchopulmonary Dysplasia\|Pulmonary Hypertension\|NEC	The Hospital for Sick Children	2023-11-01	Not Applicable
NCT06092476	Not yet recruiting	Diabetes Mellitus Type 2	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)\|Fractyl Health Inc.	2023-11-01	Not Applicable
NCT06025383	Recruiting	Menopause\|Hypertension	Texas Tech University	2023-07-20	Not Applicable
NCT05590117	Enrolling by invitation	Colo-rectal Cancer\|Neuropathy;Peripheral\|Mucositis	Tanta University	2022-10-11	Early Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-citrulline acts as an endogenous precursor that increases systemic L-arginine levels to stimulate endothelial nitric oxide synthase and accumulate intracellular cyclic guanosine monophosphate. This biochemical cascade drives vascular smooth muscle relaxation and enhanced tissue microcirculation, providing a direct mechanistic basis for ongoing clinical studies in postmenopausal hypertension, pulmonary hypertension, and gastrointestinal barrier dysfunction.

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>).