Sonidegib

Drug Profile

Sonidegib

Alternative Names: Erismodegib; LDE-225; NVP-LDE-225; Odomzo

Latest Information Update: 22 Sep 2017

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At a glance

  • Originator Novartis
  • Developer Groupe Francophone des Myelodysplasies; Massachusetts General Hospital; Mayo Clinic; Memorial Sloan-Kettering Cancer Center; National Cancer Institute (USA); Novartis; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Stanford University; University of Alabama at Birmingham
  • Class Antineoplastics; Biphenyl compounds; Morpholines; Phenyl ethers; Pyridines; Small molecules
  • Mechanism of Action SMO protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Basal cell cancer
  • Phase II Haematological malignancies; Medulloblastoma; Multiple myeloma; Solid tumours
  • Phase I/II Myelofibrosis; Ovarian cancer; Pancreatic cancer
  • Phase I Breast cancer; Chronic myeloid leukaemia; Graft-versus-host disease; Hepatocellular carcinoma; Myelodysplastic syndromes; Oesophageal cancer; Prostate cancer; Small cell lung cancer
  • Discontinued Basal cell nevus syndrome

Most Recent Events

  • 21 Sep 2017 The US FDA approves a new label for sonidegib, including long-term data from the 30-month analysis, in Basal cell carcinoma
  • 11 Aug 2017 Novartis completes a phase I trial in Small cell lung cancer (Combination therapy, First-line therapy, Metastatic disease) in USA (PO) (NCT01579929)
  • 22 Dec 2016 Sun Pharma plans to acquire Sonidegib (Odomzo®) worldwide
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