Latest Information Update: 19 Sep 2003
At a glance
- Originator Nonindustrial source
- Developer Department of Veterans Affairs; Indevus Pharmaceuticals; National Institutes of Health (USA); Nonindustrial source
- Mechanism of Action Undefined mechanism
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
On Fast track
Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.
Highest Development Phases
- Discontinued Liver disorders
Most Recent Events
- 17 May 2003 Discontinued - Phase-III for Liver disorders in South Korea (PO)
- 17 May 2003 Discontinued - Phase-III for Liver disorders in Europe (PO)
- 17 May 2003 Discontinued - Phase-III for Liver disorders in Japan (PO)