Clinical Trials

Multiple clinical trials spanning early phase 1 through phase 3 have evaluated pracinostat (SB939) in hematologic malignancies, advanced solid tumors—including acute myeloid leukemia, myelodysplastic syndromes, and metastatic sarcoma—and healthy volunteer pharmacokinetic studies. Notable evaluations include terminated phase 3 trials in acute myeloid leukemia, completed phase 2 studies in sarcoma, and early-phase dose-escalation designs. Sponsored by pharmaceutical entities such as Helsinn Healthcare SA and S*BIO, collaborative groups, and academic institutions like M.D. Anderson Cancer Center, these trials hold recruitment statuses ranging from completed to terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03848754 COMPLETED
Relapsed Adult AML
Medical College of Wisconsin
 2019-05-24 PHASE1
NCT03151304 TERMINATED
Myelodysplastic Syndromes
Helsinn Healthcare SA
 2017-06-01 PHASE2
NCT03151408 TERMINATED
Acute Myeloid Leukemia
Helsinn Healthcare SA
 2017-06-23 PHASE3
NCT02267278 COMPLETED
Myeloproliferative Diseases
M.D. Anderson Cancer Center
 2015-01-12 PHASE2
NCT03495934 COMPLETED
Healthy Subjects
Helsinn Healthcare SA
 2018-02-08 PHASE1
NCT01912274 COMPLETED
Acute Myeloid Leukemia
Helsinn Healthcare SA
 2013-12-24 PHASE2
NCT01873703 COMPLETED
Myelodysplastic Syndrome
Helsinn Healthcare SA
 2013-06 PHASE2
NCT01993641 COMPLETED
Myelodysplastic Syndrome; MDS
Helsinn Healthcare SA
 2013-12 PHASE2
NCT01075308 COMPLETED
Prostate Cancer
NCIC Clinical Trials Group
 2010-06-28 PHASE2
NCT02118909 COMPLETED
Healthy Volunteers; Non-smokers
Helsinn Healthcare SA
 2014-05 PHASE1
NCT02118909 Completed
Healthy Volunteers|Non-smokers
Helsinn Healthcare SA
 2014-05 Phase 1
NCT02058784 COMPLETED
Healthy Volunteers; Moderate to Heavy Smokers; Non-smokers
Helsinn Healthcare SA
 2014-02 EARLY_PHASE1
NCT02058784 Completed
Healthy Volunteers|Moderate to Heavy Smokers|Non-smokers
Helsinn Healthcare SA|Celerion
 2014-02 Early Phase 1
NCT01112384 COMPLETED
Metastatic Sarcoma
NCIC Clinical Trials Group
 2010-10-21 PHASE2
NCT01200498 COMPLETED
Myeloproliferative Disorders
M.D. Anderson Cancer Center
 2010-11 PHASE2
NCT01184274 COMPLETED
Leukemia; Solid Tumours
NCIC Clinical Trials Group
 2010-10-01 PHASE1
NCT00741234 COMPLETED
Solid Tumors; Hematologic Malignancies; Myelodysplastic Syndrome
S*BIO
 2007-04 PHASE1
NCT01112384 Completed
Metastatic Sarcoma
NCIC Clinical Trials Group|S*BIO|Canadian Cancer Trials Group
 2010-10-21 Phase 2
NCT00504296 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
NCIC Clinical Trials Group
 2007-09-14 PHASE1
NCT00741234 Completed
Solid Tumors|Hematologic Malignancies|Myelodysplastic Syndrome
S*BIO
 2007-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2022-06-30)

Check the Pracinostat (SB939) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pracinostat (SB939) is an orally active pan-histone deacetylase inhibitor that potently binds class I, II, and IV histone deacetylase enzymes, thereby suppressing deacetylase activity and driving the sustained accumulation of acetylated histones in target cells. This hyperacetylation alters gene transcription to trigger cell cycle arrest and apoptosis, providing the biological mechanism for targeting hematologic malignancies such as acute myeloid leukemia and myelodysplastic syndromes as well as 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.