Givinostat Clinical Trials

Size	Price	Qty
5mg	USD 197

Clinical Trials

Givinostat has been evaluated across numerous Phase 1, Phase 2, and Phase 3 clinical trials sponsored primarily by Italfarmaco and ITF Therapeutics LLC. Investigating therapeutic efficacy, safety, and pharmacokinetics in healthy volunteers and patient cohorts, these studies target conditions including Duchenne and Becker muscular dystrophies, polycythemia vera, chronic myeloproliferative neoplasms, and juvenile idiopathic arthritis. While several pivotal evaluations have reached completion, other trials remain actively recruiting or active, alongside a minor subset of terminated studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06769633	RECRUITING	Duchenne Muscular Dystrophy	Italfarmaco	2025-01-02	PHASE2
NCT03373968	RECRUITING	Duchenne Muscular Dystrophy	Italfarmaco	2017-10-24	PHASE2; PHASE3
NCT05933057	RECRUITING	Duchenne Muscular Dystrophy	Italfarmaco	2024-02-19	PHASE3
NCT01761968	ACTIVE_NOT_RECRUITING	Chronic Myeloproliferative Neoplasms	Italfarmaco	2013-03	PHASE2
NCT06093672	RECRUITING	Polycythemia Vera	Italfarmaco	2024-03-26	PHASE3
NCT05492318	COMPLETED	Drug-Drug Interaction; Heathy Volunteer	Italfarmaco	2022-03-21	PHASE1
NCT05845567	COMPLETED	Drug Drug Interaction	Italfarmaco	2022-03-21	PHASE1
NCT05860114	COMPLETED	Drug Drug Interaction	Italfarmaco	2022-03-21	PHASE1
NCT02851797	COMPLETED	Duchenne Muscular Dystrophy	Italfarmaco	2017-06-06	PHASE3
NCT04821063	COMPLETED	Duchenne and Becker Muscular Dystrophy; Polycytemia Vera	Italfarmaco	2021-04-13	PHASE1
NCT03238235	COMPLETED	Becker Muscular Dystrophy	Italfarmaco	2018-01-09	PHASE2
NCT01901432	COMPLETED	Polycythemia Vera	Italfarmaco	2013-10	PHASE1; PHASE2
NCT01761292	COMPLETED	Duchenne Muscular Dystrophy (DMD)	Italfarmaco	2013-04	PHASE1; PHASE2
NCT01557452	TERMINATED	Juvenile Idiopathic Arthritis	Italfarmaco	2011-12-28
NCT01261624	TERMINATED	Polyarticular Course Juvenile Idiopathic Arthritis	Italfarmaco	2010-10	PHASE2
NCT00928707	COMPLETED	Polycythemia Vera	Italfarmaco	2009-06	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-07-10)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Givinostat acts as an orally active inhibitor of Class I and Class II histone deacetylases (HDACs), binding to HDAC1 and HDAC3 with IC50 values of 198 nM and 157 nM, respectively, to block lysine deacetylation and alter gene transcription. This enzymatic inhibition reduces pro-inflammatory signaling and suppresses pathological cell proliferation, offering therapeutic potential in clinical conditions such as Duchenne muscular dystrophy, polycythemia vera, and juvenile idiopathic arthritis.

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>).