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)
Mechanism and Biochemical Profile
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>).
- S-Adenosyl-L-Homocysteine (SAH) Solubility in DMSO
- S-Adenosyl-L-Homocysteine (SAH) Storage
- S-Adenosyl-L-Homocysteine (SAH) Stability
- S-Adenosyl-L-Homocysteine (SAH) Molecular Weight
- S-Adenosyl-L-Homocysteine (SAH) SMILES
- S-Adenosyl-L-Homocysteine (SAH) CAS Number
- S-Adenosyl-L-Homocysteine (SAH) Chemical Structure (2D and 3D)
- S-Adenosyl-L-Homocysteine (SAH) SDS|MSDS