Clinical Trials

Numerous clinical trials evaluate L-methionine across Phase 1 through Phase 4 and non-applicable study designs, targeting conditions such as MTAP-deleted solid tumors, esophageal squamous cell carcinoma, hepatocellular carcinoma, cardiovascular diseases, and major depressive disorder. Sponsored by academic medical centers, hospital networks, and pharmaceutical companies, these investigations encompass recruiting, active, completed, and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07495995 NOT_YET_RECRUITING
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Cedars-Sinai Medical Center
 2026-04-15 PHASE2
NCT07582003 NOT_YET_RECRUITING
Colorectal Cancer (Diagnosis); Adenoma
Jun Gong, MD
 2026-11-01 PHASE1
NCT06258525 NOT_YET_RECRUITING
Colorectal Cancer; Liver Metastases; Liver Metastasis Colon Cancer; Liver Injury; Sinusoidal Obstruction Syndrome; 5-Fluorouracil Toxicity; Liver Toxicity, Chemically-Induced
Cedars-Sinai Medical Center
 2026-07 PHASE2
NCT07465367 NOT_YET_RECRUITING
Calcium Phosphate Kidney Stones
Ryan L Steinberg
 2026-04-01
NCT04250259 RECRUITING
Alcoholic Cirrhosis
Indiana University
 2020-10-22 PHASE2
NCT05363631 ACTIVE_NOT_RECRUITING
Clear Cell Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma Metastatic
Mohammed Milhem
 2022-09-19 PHASE1; PHASE2
NCT07283328 RECRUITING
Healthy
Centre hospitalier de l'Université de Montréal (CHUM)
 2024-08-20
NCT05312372 Withdrawn
Esophageal Squamous Cell Carcinoma
Institut de Recherches Internationales Servier|ADIR a Servier Group company|Servier
 2025-05 Phase 1|Phase 2
NCT05363020 COMPLETED
Osteoarthritis Hand
Dartmouth-Hitchcock Medical Center
 2022-08-17 PHASE4
NCT06026865 COMPLETED
Primary Sclerosing Cholangitis (PSC)
Medical University of Warsaw
 2023-09-01
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
NCT03178929 UNKNOWN
Primary Liver Cancer
Beijing Insight Science & Technology Co. Ltd.
 2017-07-01
NCT03938662 UNKNOWN
Alcoholic Liver Diseases
University Clinic Dr Dragisa Misovic-Dedinje
 2019-05-09
NCT02586285 UNKNOWN
Hepatocellular Carcinoma
Eastern Hepatobiliary Surgery Hospital
 2015-06 PHASE1
NCT01899521 COMPLETED
Alcoholism
VA Office of Research and Development
 2013-05-01
NCT02557360 COMPLETED
Primary Biliary Cirrhosis
Pomeranian Medical University Szczecin
 2015-11 PHASE4
NCT02024295 UNKNOWN
Hepatitis, Alcoholic
Zhejiang Hisun Pharmaceutical Co. Ltd.
 2013-12 PHASE4
NCT01912196 COMPLETED
Major Depressive Disorder (MDD)
MSI Methylation Sciences, Inc.
 2013-10 PHASE2
NCT02216253 COMPLETED
Urinary Tract Infection; Pelvic Organ Prolapse; Urinary Incontinence
IRCCS San Raffaele
 2014-10
NCT02231333 COMPLETED
Non-alcoholic Steatohepatitis
Institute of Liver and Biliary Sciences, India
 2013-07-01
NCT01998620 UNKNOWN
Hepatitis B; Cholestasis
Zhejiang Hisun Pharmaceutical Co. Ltd.
 2013-11 PHASE4
NCT02063295 COMPLETED
Obesity; Over-weight; Hypothalamic Injury; Craniopharyngioma
Zafgen, Inc.
 2014-04 PHASE2
NCT01754714 COMPLETED
Non Alcoholic Fatty Liver Disease
Abbott
 2012-12 PHASE3
NCT01818921 COMPLETED
Obesity; Over-weight; Prader-Willi Syndrome
Zafgen, Inc.
 2013-06 PHASE2
NCT00473200 COMPLETED
Hyperhomocysteinemia
Baylor Research Institute
 2009-08 PHASE1
NCT04623034 COMPLETED
Major Depressive Disorder
MSI Methylation Sciences, Inc.
 2013-04-17 PHASE1
NCT01666691 COMPLETED
Obesity
Zafgen, Inc.
 2012-08 PHASE2
NCT01140646 COMPLETED
Healthy, no Evidence of Disease; Hot Flashes
Mayo Clinic
 2010-10 PHASE2
NCT00513461 COMPLETED
Adult Primary Liver Cancer; Hepatitis C Infection
Chao Family Comprehensive Cancer Center
 2007-10 PHASE2
NCT01507077 COMPLETED
Obesity
Zafgen, Inc.
 2011-12 PHASE1
NCT01372761 COMPLETED
Obesity
Zafgen, Inc.
 2011-06 PHASE1
NCT00762268 COMPLETED
Bipolar Disorder; Depression; Bipolar Depression
Mclean Hospital
 2008-09
NCT00475176 COMPLETED
Chronic Hepatitis C
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2007-05 PHASE2
NCT00694564 COMPLETED
Abdominal Pain
Huang, Jeannie, M.D.
 2007-06
NCT00101452 COMPLETED
Depression
Maurizio Fava, MD
 2005-04
NCT00851981 COMPLETED
Alcoholic Hepatitis
Loma Linda University
 2008-10 PHASE2
NCT00722124 COMPLETED
Tobacco Dependence
Mayo Clinic
 2008-09 PHASE2; PHASE3
NCT00310336 COMPLETED
Hepatitis C
University Hospital, Basel, Switzerland
 2006-08 PHASE2; PHASE3
NCT00573313 COMPLETED
Liver Disease, Alcoholic
University of California, Davis
 2005-09 PHASE3
NCT00093847 COMPLETED
Depression
Massachusetts General Hospital
 2004-05 PHASE2
NCT00125281 TERMINATED
Liver Cirrhosis, Biliary
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2005-07-25 PHASE2
NCT00226356 COMPLETED
Unipolar Depression
Cambridge Health Alliance
 2004-12 PHASE4
NCT00284011 COMPLETED
Heart Disease
Mayo Clinic
 2005-06
NCT00126347 COMPLETED
Healthy; Cardiovascular Diseases
Wageningen Centre for Food Sciences
 2002-08
NCT00108589 COMPLETED
Hepatitis
US Department of Veterans Affairs
 2004-01 PHASE3
NCT00528710 COMPLETED
Fibromyalgia Syndrome
Deakin University
 2006-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-31)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an essential sulfur-containing amino acid, L-methionine serves as an indispensable precursor for S-adenosyl-L-methionine (SAMe) synthesis, driving enzymatic transmethylation reactions and modulating intracellular antioxidant mechanisms. Disruption or therapeutic modulation of this metabolic axis impacts cellular proliferation, methylation patterns, and oxidative stress pathways, providing the rationale for its clinical investigation in oncology, metabolic conditions, and hepatic 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>).

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