Drug Profile


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

Latest Information Update: 27 Jan 2017

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.

  • 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

  • Marketed Basal cell cancer
  • Phase II Basal cell nevus syndrome; Breast cancer; Chondrosarcoma; Gastric cancer; Medulloblastoma; Pancreatic cancer; Small cell lung cancer
  • Phase I/II Graft-versus-host disease
  • 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

  • 11 Jan 2017 Genentech collaborates with NCI Formulary to co-develop vismodegib in Cancer
  • 11 Jan 2017 Genentech suspends a phase I/II trial in Graft-versus-host disease (Treatment-experienced) in USA as the trial met protocol defined stopping criteria (PO) (NCT02337517)
  • 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
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