Clinical Trials

Multiple clinical trials evaluate the HDAC inhibitor quisinostat across solid and hematologic malignancies, including cutaneous T-cell lymphoma, non-small cell lung cancer, epithelial ovarian cancer, glioblastoma, and uveal melanoma. Supported by industry sponsors and academic investigators, these Early Phase 1 to Phase 2 studies investigate quisinostat as monotherapy and in combination regimens. While several early trials assessing safety, dosage, and efficacy have been completed, active and recruiting trials continue to evaluate quisinostat in adjuvant and radiotherapeutic combinations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06932757 RECRUITING
Uveal Melanoma
University of Miami
 2025-05-27 PHASE2
NCT06824662 ACTIVE_NOT_RECRUITING
Glioblastoma WHO Grade IV
Nader Sanai
 2025-09-04 EARLY_PHASE1
NCT02948075 COMPLETED
Ovarian Cancer
NewVac LLC
 2015-09 PHASE2
NCT02728492 COMPLETED
Non-small Cell Lung Cancer; Epithelial Ovarian Cancer
NewVac LLC
 2013-08 PHASE1
NCT01486277 COMPLETED
Lymphoma, T-Cell, Cutaneous
Janssen Research & Development, LLC
 2011-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Quisinostat potently binds to and inhibits pan-histone deacetylase (HDAC) enzymes—including HDAC1, HDAC2, HDAC4, HDAC10, and HDAC11—thereby preventing histone deacetylation to promote chromatin relaxation, alter gene expression, and induce cell cycle arrest and apoptosis in transformed cells. This epigenetic modulation and induction of cell death provide the rationale for its clinical evaluation in suppressing tumor growth across malignancies such as ovarian cancer, cutaneous T-cell lymphoma, glioblastoma, and uveal melanoma.

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.