Clinical Trials

Numerous clinical trials evaluate S-adenosyl-L-homocysteine (SAH) across various indications, primarily subarachnoid hemorrhage, traumatic brain injury, stroke, circadian rhythm disorders, endometriosis, and severe alcoholic hepatitis. Spanning Phase 1 and 2 exploratory evaluations to Phase 4 interventional and observational studies, these protocols are sponsored by academic medical centers and commercial entities like Cumberland Pharmaceuticals. Current recruitment statuses across these studies range from not yet recruiting and active to completed and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06803043 ENROLLING_BY_INVITATION
Domestic Violence; Post Traumatic Stress Disorder
Boston University
2025-02-13
NCT07761520 NOT_YET_RECRUITING
Aneurysmal Subarachnoid Hemorrhage
Centre Hospitalier Universitaire de Nice
2026-09
NCT06735261 NOT_YET_RECRUITING
Subarachnoid Hemorrhage in Adult Patients
University Hospital, Grenoble
2025-04-01
NCT06526247 RECRUITING
Intimate Partner Violence
Boston University
2024-11-18
NCT03845205 RECRUITING
Alcohol Use Disorder; Alcoholic Hepatitis
Johns Hopkins University
2020-11-20
NCT04578249 RECRUITING
Circadian Rhythm Disorders
West Virginia University
2021-09-20
NCT03754725 ACTIVE_NOT_RECRUITING
SAH; Dementia
Duke University
2020-10-01 PHASE1; PHASE2
NCT06890039 NOT_YET_RECRUITING
Acute-On-Chronic Liver Failure; Alcoholic Hepatitis; Liver Cirrhosis, Alcoholic
Yaqrit Ltd
2025-09-01 PHASE2
NCT06060756 Not yet recruiting
Endometriosis|Obstructive Sleep Apnea-hypopnea
Elsan
2024-05 --
NCT03249207 UNKNOWN
Subarachnoid Hemorrhage
University of Manchester
2018-10-11 PHASE3
NCT06119061 Recruiting
Subarachnoid Hemorrhage Aneurysmal
Aaron Cook|Cumberland Pharmaceuticals|University of Kentucky
2024-02-29 Phase 4
NCT05994794 COMPLETED
Elevated S-adenosylhomocysteine
Standard Process Inc.
2022-12-09
NCT03691727 COMPLETED
Subarachnoid Hemorrhage, Aneurysmal
David Hasan
2019-01-24 PHASE1; PHASE2
NCT03319173 COMPLETED
Mild Cognitive Impairment; Metabolic Syndrome
Bristlecone Health, Inc.
2017-10-15
NCT02323685 COMPLETED
Cerebral Ischemia
Prolong Pharmaceuticals
2014-12 PHASE2
NCT01799525 COMPLETED
Aneurysmal Subarachnoid Hemorrhage
Wuerzburg University Hospital
2013-01 PHASE1
NCT00830843 COMPLETED
Stroke; Subarachnoid Hemorrhage
Azienda Ospedaliera San Gerardo di Monza
2009-01 PHASE4
NCT00626574 TERMINATED
Subarachnoid Hemorrhage
University of South Florida
2007-07 PHASE4
NCT00199706 COMPLETED
Subarachnoid Hemorrhage
Oslo University Hospital
2002-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-23)

Check the S-Adenosyl-L-Homocysteine (SAH) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

S-Adenosyl-L-homocysteine (SAH) binds to and potently inhibits the METTL3-METTL14 heterodimer complex with an IC50 of 0.9 μM, thereby blocking methyl group transfer to adenosine residues and suppressing N6-methyladenosine (m6A) RNA modification. This enzymatic inhibition alters downstream gene expression and cell survival pathways, providing therapeutic relevance for addressing cellular stress and injury responses in conditions under clinical evaluation such as subarachnoid hemorrhage and traumatic brain injury.

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>).

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