MedPath

Pracinostat

Generic Name
Pracinostat
Drug Type
Small Molecule
Chemical Formula
C20H30N4O2
CAS Number
929016-96-6
Unique Ingredient Identifier
GPO2JN4UON

Overview

Pracinostat is a novel HDAC inhibitor with improved in vivo properties compared to other HDAC inhibitors currently in clinical trials, allowing oral dosing. Data demonstrate that Pracinostat is a potent and effective anti-tumor drug with potential as an oral therapy for a variety of human hematological and solid tumors.

Background

Pracinostat is a novel HDAC inhibitor with improved in vivo properties compared to other HDAC inhibitors currently in clinical trials, allowing oral dosing. Data demonstrate that Pracinostat is a potent and effective anti-tumor drug with potential as an oral therapy for a variety of human hematological and solid tumors.

Indication

For the treatment of various forms of cancer.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
2019/02/21
NCT03848754
Phase 1
Completed
Medical College of Wisconsin
A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body
2018/04/12
NCT03495934
Phase 1
Completed
Helsinn Healthcare SA
A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes
2017/05/12
NCT03151304
Phase 2
Terminated
Helsinn Healthcare SA
An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia
2017/05/12
NCT03151408
Phase 3
Terminated
Helsinn Healthcare SA
Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF)
2014/10/17
NCT02267278
Phase 2
Completed
M.D. Anderson Cancer Center
Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects
2014/04/21
NCT02118909
Phase 1
Completed
Helsinn Healthcare SA
Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects
2014/02/10
NCT02058784
Early Phase 1
Completed
Helsinn Healthcare SA
Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA
2013/11/25
NCT01993641
Phase 2
Completed
Helsinn Healthcare SA
Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
2013/07/31
NCT01912274
Phase 2
Completed
Helsinn Healthcare SA
Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome
2013/06/10
NCT01873703
Phase 2
Completed
Helsinn Healthcare SA

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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