Quisinostat (JNJ-26481585) Dihydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 210
50mg	USD 970

Clinical Trials

Multiple clinical trials evaluate quisinostat (JNJ-26481585) across Early Phase 1 through Phase 2 studies for oncology indications, including ovarian cancer, multiple myeloma, cutaneous T-cell lymphoma, glioblastoma, and advanced hematologic malignancies. Sponsored by pharmaceutical, biotechnology, and academic entities, these studies test quisinostat as monotherapy and in combination with chemotherapeutics, proteasome inhibitors, or radiotherapy. While several trials assessing safety and preliminary efficacy have been completed or terminated, active studies continue to evaluate quisinostat in combination regimens for advanced cancers such as grade 4 glioblastoma.

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
NCT02948075	Completed	Ovarian Cancer	NewVac LLC\|Janssen Pharmaceutica N.V. Belgium	2015-09	Phase 2
NCT01486277	COMPLETED	Lymphoma, T-Cell, Cutaneous	Janssen Research & Development, LLC	2011-11	PHASE2
NCT01464112	COMPLETED	Multiple Myeloma	Janssen Research & Development, LLC	2011-09-16	PHASE1
NCT00676728	TERMINATED	Advanced or Refractory Leukemia; Myelodysplastic Syndromes	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2008-12	PHASE1
NCT00677105	COMPLETED	Lymphoma; Neoplasms	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2007-08	PHASE1
NCT01464112	Completed	Multiple Myeloma	Janssen Research & Development LLC	2011-09-16	Phase 1
NCT00676728	Terminated	Advanced or Refractory Leukemia\|Myelodysplastic Syndromes	Johnson & Johnson Pharmaceutical Research & Development L.L.C.	2008-12	Phase 1
NCT00677105	Completed	Lymphoma\|Neoplasms	Johnson & Johnson Pharmaceutical Research & Development L.L.C.\|Janssen Pharmaceutica N.V. Belgium	2007-08	Phase 1

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

Check the Quisinostat (JNJ-26481585) Dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Quisinostat selectively binds to and inhibits histone deacetylase 1 (HDAC1), leading to the hyperacetylation of histones, upregulation of p21, and activation of the caspase cascade to induce cell cycle arrest and apoptosis. This HDAC-mediated suppression of tumor cell proliferation and angiogenesis underscores its therapeutic potential in clinical trials targeting advanced hematologic malignancies, cutaneous T-cell lymphoma, and solid tumors such as ovarian cancer and glioblastoma.

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>).