At a glance
- Originator Rottapharm
- Developer Rottapharm Madaus
- Class Anti-inflammatories; Benzamidines; Small molecules
- Mechanism of Action Metalloprotease inhibitors; Nitric oxide synthase type II inhibitors
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.
- New Molecular Entity Yes
Highest Development Phases
- Phase II Diarrhoea; Inflammatory bowel diseases; Mucositis
Most Recent Events
- 01 Nov 2014 Phase II development for Diarrhoea, Inflammatory bowel disease and Mucositis is ongoing in Italy
- 10 Oct 2014 Rottapharm Madaus has been acquired by Meda
- 31 Dec 2009 Phase-I clinical trials in Mucositis in Italy (unspecified route)