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Halofuginone

Generic Name
Halofuginone
Drug Type
Small Molecule
Chemical Formula
C16H17BrClN3O3
CAS Number
55837-20-2
Unique Ingredient Identifier
L31MM1385E
Background

Halofuginone is a low molecular weight quinazolinone alkaloid, and a potent inhibitor of collagen alpha1(I) and matrix metalloproteinase 2 (MMP-2) gene expression. Halofuginone also effectively suppresses tumor progression and metastasis in mice. Collgard Biopharmaceuticals is developing halofuginone for the treatment of scleroderma and received orphan drug designation from the U.S. Food and Drug Administration in March, 2000.

Indication

For the treatment of scleroderma, cancer, and restenosis.

HT-100 Long-term Study in DMD Patients Who Completed HALO-DMD-02

Phase 2
Terminated
Conditions
Duchenne Muscular Dystrophy
Interventions
First Posted Date
2015-08-17
Last Posted Date
2019-03-12
Lead Sponsor
Akashi Therapeutics
Target Recruit Count
10
Registration Number
NCT02525302
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

Kennedy Krieger Institute, Johns Hopkins School of Medicine, Baltimore, Maryland, United States

and more 2 locations

Open Label Extension Study of HT-100 in Patients With DMD

Phase 2
Terminated
Conditions
Duchenne Muscular Dystrophy
Interventions
First Posted Date
2013-11-07
Last Posted Date
2020-09-03
Lead Sponsor
Processa Pharmaceuticals
Target Recruit Count
17
Registration Number
NCT01978366
Locations
🇺🇸

Kennedy Krieger Institute, Johns Hopkins School of Medicine, Baltimore, Maryland, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

and more 2 locations

Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy

Phase 1
Terminated
Conditions
Duchenne Muscular Dystrophy
Interventions
First Posted Date
2013-05-07
Last Posted Date
2020-09-03
Lead Sponsor
Processa Pharmaceuticals
Target Recruit Count
17
Registration Number
NCT01847573
Locations
🇺🇸

University of California, Davis Medical Center, Sacramento, California, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

and more 2 locations

Halofuginone Hydrobromide in Treating Patients With HIV-Related Kaposi's Sarcoma

Phase 2
Completed
Conditions
Recurrent Kaposi Sarcoma
AIDS-related Kaposi Sarcoma
Interventions
Other: placebo
Other: laboratory biomarker analysis
Other: pharmacological study
First Posted Date
2003-07-09
Last Posted Date
2013-06-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
30
Registration Number
NCT00064142
Locations
🇺🇸

AIDS - Associated Malignancies Clinical Trials Consortium, Rockville, Maryland, United States

Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2003-01-27
Last Posted Date
2012-07-24
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
25
Registration Number
NCT00027677
Locations
🇧🇪

U.Z. Gasthuisberg, Leuven, Belgium

🇳🇱

Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam, Netherlands

🇳🇱

University Hospital - Rotterdam Dijkzigt, Rotterdam, Netherlands

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