Vismodegib

Drug Profile

Vismodegib

Alternative Names: GDC-0449; R 3616; RG 3616

Latest Information Update: 10 Dec 2016

Price : $50

At a glance

  • Originator Curis
  • Developer Centre Hospitalier Univeristaire De Lille; Clinica Universidad de Navarra; Erasmus Hospital; Genentech; National Cancer Institute (USA); Roche
  • Class Antineoplastics; Benzamides; Small molecules; Sulfones
  • Mechanism of Action Hedgehog cell-signalling pathway inhibitors
  • Orphan Drug Status

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

    No
  • 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Basal cell cancer
  • Phase II Basal cell nevus syndrome; Breast cancer; Chondrosarcoma; Gastric cancer; Medulloblastoma; Pancreatic cancer; Small cell lung cancer
  • Phase I Idiopathic pulmonary fibrosis; Myelofibrosis
  • Discontinued Acute myeloid leukaemia; B cell lymphoma; Chronic lymphocytic leukaemia; Colorectal cancer; Glioblastoma; Myelodysplastic syndromes; Ovarian cancer; Prostate cancer; Sarcoma

Most Recent Events

  • 28 Nov 2016 The EMA's Committee for Medicinal Products for Human Use grants full approval of vismodegib for Basal cell cancer in European Union
  • 07 Oct 2016 Adverse events and Efficacy data from subgroup analysis of the phase II STEVIE trial in Basal cell cancer presented at the 41st European Society for Medical Oncology Congress (ESMO-2016)
  • 07 Oct 2016 Efficacy data from a phase II trial in Basal cell cancer presented at the 41st European Society for Medical Oncology Congress (ESMO-2016)
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