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Nicaraven Chugai.

Ronen R Leker1

  • 1Laboratory of Molecular Biology, NIH/NINDS Building 36, Room 3c12, 36 Convent Drive, MSC 4092, Bethesda, MD 20892, USA. lekerr@nih.ninds.gov

Current Opinion in Investigational Drugs (London, England : 2000)
|March 11, 2003
PubMed
Summary

Nicaraven, a water-soluble antioxidant, is being developed for acute cerebrovascular diseases. Chugai filed for registration in Japan in 1995, with an additional filing for subarachnoidal bleeding in 2002.

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Area of Science:

  • Neuroscience
  • Pharmacology
  • Drug Development

Background:

  • Cerebrovascular diseases pose significant health challenges.
  • Antioxidants show potential in mitigating cellular damage.
  • Nicaraven is a novel water-soluble antioxidant developed by Chugai.

Purpose of the Study:

  • To evaluate nicaraven for the treatment of acute cerebrovascular disorders.
  • To seek regulatory approval for nicaraven in Japan.

Main Methods:

  • Nicaraven (Antevas) is a water-soluble antioxidant.
  • Development by Chugai, a subsidiary of Roche.
  • Regulatory filings submitted in Japan.

Main Results:

  • A registration application was filed in April 1995.
  • As of April 2002, nicaraven awaited registration in Japan.
  • An NDA for subarachnoidal bleeding was filed by August 2002.

Conclusions:

  • Nicaraven development for cerebrovascular diseases is ongoing.
  • Regulatory progress in Japan has been lengthy.
  • Expanded indications are being pursued for nicaraven.

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