Clinical Trials

Multiple clinical trials are currently evaluating therapeutics across metabolic and oncology indications, including MASH or NASH with fibrosis, NAFLD with polycystic ovary syndrome, and metastatic breast cancer. Spanning Phase 1 through Phase 3 and unassigned phases, these studies are supported by commercial biotechnology firms alongside academic and government sponsors such as 89bio, Akero Therapeutics, UCSF, and NIDDK. Operational statuses range across actively recruiting, not yet recruiting, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06154590 Not yet recruiting
Metastatic Breast Cancer|Tumor|Muscle Neoplasms|Chronic Pain
DR. DIANE CHISESI NFS. MD. PHD.|IRB|Paradyne Networks A Foundation
 2024-07 --
NCT06322628 Not yet recruiting
Nash
Visirna Therapeutics HK Limited
 2024-04 Phase 2
NCT06318169 Recruiting
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
89bio Inc.
 2024-03-13 Phase 3
NCT05979389 Recruiting
NAFLD|PCOS
University of California San Francisco|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2024-02-14 Phase 1
NCT05118360 Withdrawn
Nonalcoholic Steatohepatitis (NASH)
Gannex Pharma Co. Ltd.
 2023-12-01 Phase 2
NCT06215716 Recruiting
NASH With Fibrosis|MASH With Fibrosis
Akero Therapeutics Inc
 2023-12-01 Phase 3

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

Check the N-Acetyl-5-hydroxytryptamine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

N-Acetyl-5-hydroxytryptamine acts as a potent and selective agonist of the tropomyosin receptor kinase B (TrkB), binding to the receptor to stimulate downstream neurotrophic signaling cascades that enhance cellular survival and metabolic regulation. This activation of TrkB-mediated signaling pathways provides a therapeutic rationale for investigating its cellular protective effects in conditions such as metabolic dysfunction-associated steatohepatitis and liver fibrosis.

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.