Clinical Trials

Multiple clinical trials evaluate domatinostat (4SC-202) across Phase 1, Phase 2, and Phase 1/2 studies as monotherapy and combination therapy for advanced neoplasms, including hematologic malignancies, melanoma, gastrointestinal cancers, and sarcomas. Sponsored by industry developer 4SC AG alongside academic medical institutions, these investigations exhibit recruitment statuses spanning completed, recruiting, withdrawn, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07725380 RECRUITING
Sarcoma; Osteosarcoma
H. Lee Moffitt Cancer Center and Research Institute
 2026-07-15 PHASE1; PHASE2
NCT04874831 WITHDRAWN
Merkel Cell Carcinoma
4SC AG
 2021-11-01 PHASE2
NCT04393753 COMPLETED
Merkel Cell Carcinoma
4SC AG
 2020-10-13 PHASE2
NCT03278665 COMPLETED
Malignant Melanoma
4SC AG
 2017-09-25 PHASE1; PHASE2
NCT04133948 COMPLETED
Malignant Melanoma Stage III
The Netherlands Cancer Institute
 2020-01-07 PHASE1; PHASE2
NCT03812796 UNKNOWN
Cancer; GI Cancer
Royal Marsden NHS Foundation Trust
 2019-01-11 PHASE2
NCT01344707 COMPLETED
Advanced Hematologic Malignancies
4SC AG
 2011-03 PHASE1
NCT01344707 Completed
Advanced Hematologic Malignancies
4SC AG
 2011-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Domatinostat (4SC-202) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Domatinostat selectively binds to class I histone deacetylases (HDAC1, HDAC2, and HDAC3) and inhibits lysine-specific demethylase 1 (LSD1), thereby blocking chromatin deacetylation and disrupting transcriptional repression mechanisms. This epigenetic modulation increases histone acetylation, arrests cell cycle progression, and triggers apoptosis, suppressing tumor growth in clinical trial settings for advanced hematologic malignancies, malignant melanoma, and solid tumors.

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.