D-Phenylalanine Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

A clinical trial sponsored by Assistance Publique - Hôpitaux de Paris is evaluating D-Phenylalanine in rare conditions, including Interstitial Lung and Liver Disease, Infantile Liver Failure Syndrome 1, Neurologic Endocrine and Pancreatic Disease Multisystem Infantile-Onset 2, and Rajab Interstitial Lung Disease With Brain Calcifications 2. With its phase listed as Not Applicable and a status of Not yet recruiting, the study investigates how cytosolic aminoacyl-tRNA synthetase mutations alter cellular stress responses and protein translation. Overall, this reflects early-stage observational research centered on rare metabolic and multisystem pediatric disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05514470	Not yet recruiting	Interstitial Lung and Liver Disease\|Infantile Liver Failure Syndrome 1\|Neurologic Endocrine and Pancreatic Disease Multisystem Infantile-Onset 2\|Rajab Interstitial Lung Disease With Brain Calcifications 2	Assistance Publique - Hôpitaux de Paris	2024-04	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

D-Phenylalanine acts as an inhibitor of carboxypeptidase A, endorphinase, and enkephalinase, which blocks the enzymatic degradation of endogenous enkephalins and endorphins. This accumulation of neuropeptides enhances opioid receptor signaling to diminish pain transmission, providing clinical relevance for pain modulation and serving as a framework for investigating cellular stress responses in rare infantile multisystem disorders.

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>).