Clinical Trials

Multiple clinical trials sponsored by academic and industrial entities evaluate methionine across metabolic, genetic, and oncological indications. Ranging from observational studies to Phase 1 and Phase 1/2 trials, their recruitment statuses include recruiting, not yet recruiting, and withdrawn. Key research focuses encompass metabolic amino acid oxidation in healthy subjects, cytosolic aminoacyl-tRNA synthetase mutations in pediatric pulmonary and hepatic disorders, and targeted therapies in MTAP-deleted solid tumors and esophageal squamous cell carcinoma.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05312372 Withdrawn
Esophageal Squamous Cell Carcinoma
Institut de Recherches Internationales Servier|ADIR a Servier Group company|Servier
 2025-05 Phase 1|Phase 2
NCT03674723 Recruiting
Healthy
The Hospital for Sick Children
 2024-04-01 Not Applicable
NCT06188702 Recruiting
MTAP-deleted Solid Tumors
Servier Bio-Innovation LLC|Institut de Recherches Internationales Servier|Servier
 2024-04-29 Phase 1
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 Methionine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Methionine acts as an activator of the GABAA receptor, binding to functional receptor subunits to facilitate hyperpolarizing chloride influx and reduce neuronal excitability. This modulation of cellular signaling and underlying amino acid metabolic pathways plays a vital role in cellular homeostasis, offering therapeutic relevance in metabolic profiling and targeted cancer strategies such as MTAP-deleted solid tumors.

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>).

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Note: Technical data last updated: Sep 1, 2026.