Clinical Trials

Multiple clinical trials encompassing Phase 1 through Phase 3, as well as non-phased interventional and diagnostic protocols, evaluate therapeutic indications including soft tissue sarcoma, heart failure with preserved ejection fraction, HIV, gastroenteropancreatic neuroendocrine tumors, tinnitus, and stage III non-small cell lung cancer. Sponsored by government institutions, hospital networks, and industry partners, these studies range in recruitment status from active recruiting and active not recruiting to completed and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06427798 RECRUITING
Somatostatin Receptor Positive; Gastrointestinal Neuroendocrine Tumors; Pheochromocytoma; Paragangliomas
National Cancer Institute (NCI)
 2025-02-07 PHASE1; PHASE2
NCT06256705 RECRUITING
Gastroenteropancreatic Neuroendocrine Tumor; Radiotherapy
Assistance Publique - Hôpitaux de Paris
 2024-03-25
NCT05839730 ACTIVE_NOT_RECRUITING
Heart Failure With Preserved Ejection Fraction; Concentric Hypertrophy
Medtronic Cardiac Rhythm and Heart Failure
 2024-09-11
NCT05351320 UNKNOWN
Non-small Cell Lung Cancer (NSCLC)
Jinming Yu
 2022-04-30 PHASE2
NCT05386888 COMPLETED
NSCLC, Stage III
Genfleet Therapeutics (Shanghai) Inc.
 2022-09-09 PHASE2
NCT05684874 UNKNOWN
Soft Tissue Sarcoma; Adult Soft Tissue Sarcoma; Resectable Soft Tissue Sarcoma
Centre Leon Berard
 2023-04-21
NCT04675112 UNKNOWN
Tinnitus
Gkouskou Kalliopi
 2019-01-01
NCT02938520 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2016-10-27 PHASE3
NCT00235807 COMPLETED
Tinnitus
US Department of Veterans Affairs
 2004-06

(data from https://clinicaltrials.gov, updated on 2026-08-18)

Check the H-Cys(Trt)-OH product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

H-Cys(Trt)-OH functions as a selective and reversible inhibitor of the motor protein Eg5, binding the enzyme to suppress microtubule sliding velocity with an IC50 of 500 nM and preventing proper bipolar spindle assembly during mitosis. This mitotic arrest halts cell division and induces targeted apoptosis, offering therapeutic potential against hyperproliferative malignancies such as soft tissue sarcoma and non-small cell lung cancer evaluated in clinical settings.

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.