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Nomination Summary for Halofuginone (N20219)

Nominated Substances: Halofuginone

Nomination Date: 03/26/2002

Nominator: FDA

Rationale: Halofuginone is under investigation for therapeutic use in treatment of scleroderma, cancer, and coronary restenosis. It has been shown to exhibit antitumoral activity in several experimental systems (in vitro and in vivo) which is considered to be mediated by the inhibition of cell proliferation and tumor growth, inhibition of new blood vessels formations - angiogenesis and inhibition of cell migration - metastasis. Halofuginone was also shown to act as a potent inhibitor of Collagen type I synthesis at the transcriptional level. Toxicity studies are needed to further explore the safety profile of Halfuginone and in order to meet regulatory needs.

NTP Principles: not specified

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