Resminostat Clinical Trials

Size	Price	Qty
10mg	USD 270
50mg	USD 870

Clinical Trials

Resminostat has been evaluated in multiple completed Phase 1, Phase 1/2, and Phase 2 clinical trials sponsored primarily by 4SC AG and Yakult Honsha Co., LTD. These studies investigated the compound's safety, pharmacokinetics, and maintenance efficacy in hematologic malignancies, specifically Hodgkin's lymphoma and cutaneous T-cell lymphoma, including mycosis fungoides and Sézary syndrome. Additionally, several clinical trials evaluated combination regimens in patients with advanced solid tumors, including hepatocellular carcinoma and colorectal carcinoma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02953301	COMPLETED	Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous	4SC AG	2016-11	PHASE2
NCT04955340	COMPLETED	Cutaneous T Cell Lymphoma; Mycosis Fungoides; Sezary Syndrome	4SC AG	2021-10-12	PHASE1
NCT04955340	Completed	Cutaneous T Cell Lymphoma\|Mycosis Fungoides\|Sezary Syndrome	4SC AG	2021-10-12	Phase 1
NCT02400788	COMPLETED	Hepatocellular Carcinoma	Yakult Honsha Co., LTD	2013-04	PHASE1; PHASE2
NCT01277406	COMPLETED	Advanced Colorectal Carcinoma	4SC AG	2011-01	PHASE1; PHASE2
NCT01037478	COMPLETED	Hodgkin's Lymphoma	4SC AG	2009-12	PHASE2
NCT01277406	Completed	Advanced Colorectal Carcinoma	4SC AG	2011-01	Phase 1\|Phase 2
NCT01037478	Completed	Hodgkin''s Lymphoma	4SC AG	2009-12	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-08-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Resminostat selectively inhibits histone deacetylases 1, 3, and 6 (HDAC1/3/6), hyperacetylating histone and non-histone proteins to disrupt gene expression and induce cell cycle arrest and apoptosis in tumor cells. This targeted enzymatic blockade reduces cancer cell proliferation and survival, underlying its therapeutic potential evaluated in clinical trials for cutaneous T-cell lymphoma, Hodgkin's lymphoma, hepatocellular carcinoma, and colorectal carcinoma.

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>).