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XY2405 (Anatibant) is a new potent and selective non-peptide antagonist of the Bradykinin B2 receptor
in-licensed from Fournier, now a subsidiary of Solvay.
Five Phase I clinical trials have evaluated the safety
and the pharmacokinetics of the compound in both healthy
volunteers and in patients with severe Traumatic Brain
Injury (TBI). The compound was shown to be well
tolerated. XY2405 has received Fast Track designation
and Orphan Drug status in the EU and in the US in
January 2004 and April 2005, respectively. TBI is a
major cause of disability and death and generates
significant economic costs to our society. There is
currently no effective therapy available to treat this
condition. The combined incidence rate of moderate and
severe TBI is estimated to about one million cases per
year in the US, Europe and Japan. Severe TBI is often
associated with permanent functional and cognitive
disorders, learning disabilities and a range of
behavioral and emotional problems. The occurrence of TBI
is highest among young and elderly people. The leading
causes of TBI are motor vehicle accidents, firearms and
accidental falls (the leading cause of brain injury in
the elderly). TBI is also a major cause of
hospitalization in the military. The annual market
potential for the first FDA-approved drug treating TBI
in the US alone is estimated above $500 million and the
worldwide market potential above $2 billion.
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