Drug Profile
Ceftobiprole medocaril - Basilea Pharmaceutica
Alternative Names: BAL-5788; BAL-9141; Ceftobiprole; Ceftobiprole medocaril sodium; JNJ-30982081; Mabelio; RO-65-5788; Zeftera; ZevteraLatest Information Update: 05 Nov 2023
Price :
$50
*
At a glance
- Originator Basilea Pharmaceutica
- Developer Avir Pharma; Basilea Pharmaceutica; Department of Health & Human Services; Hikma Pharmaceuticals; Janssen Research & Development; Janssen-Cilag; Johnson & Johnson Pharmaceutical Research & Development; Knight Therapeutics; Shenzhen China Resources Gosun Pharmaceutical
- Class Antibacterials; Cephalosporins; Skin disorder therapies; Small molecules
- Mechanism of Action Cell wall inhibitors; Peptidyltransferase inhibitors
-
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes - Bacteraemia; Community-acquired pneumonia; Skin and soft tissue infections
Highest Development Phases
- Marketed Community-acquired pneumonia; Nosocomial pneumonia
- Registered Bacteraemia
- Preregistration Skin and soft tissue infections
- Phase III Bacterial infections
- No development reported Paediatric infections
Most Recent Events
- 02 Oct 2023 U.S. Food and Drug Administration (FDA) accepts a New Drug Application (NDA) for ceftobiprole for Bacteraemia, Skin and soft tissue infections, and Community-acquired pneumonia
- 02 Oct 2023 US FDA assigns PDUFA action date of 03/April/2024 for ceftobiprole for Bacteraemia, Skin and soft tissue infections, and Community-acquired pneumonia
- 28 Sep 2023 Efficacy data from a phase III ERADICATE trial in Bacteraemia released by Basilea Pharmaceutica