Drug Profile


Alternative Names: BKM-120; BKM120-AAA; Buparlisib hydrochloride; NVP-BKM120

Latest Information Update: 02 Dec 2016

Price : $50

At a glance

  • Originator Novartis; University Hospital Tubingen
  • Developer Dana-Farber Cancer Institute; Emory University; Indiana University; M. D. Anderson Cancer Center; Memorial Sloan-Kettering Cancer Center; National Cancer Institute (Canada); National Cancer Institute (USA); Novartis; Novartis Oncology; Ohio State University; Paoli-Calmettes-institute; Sarah Cannon Research Institute; Stanford University; University Hospital Tubingen; University of California at San Francisco
  • Class Amines; Antineoplastics; Morpholines; Piperidines; Pyrimidines; Small molecules
  • Mechanism of Action 1 Phosphatidylinositol 3 kinase 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 III Breast cancer
  • Phase II Chronic lymphocytic leukaemia; CNS cancer; Glioblastoma; Haematological malignancies; Head and neck cancer; Malignant melanoma; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Oesophageal cancer; Prostate cancer; Solid tumours; Thymoma
  • Phase I B cell lymphoma; Basal cell cancer; Diffuse large B cell lymphoma; Follicular lymphoma; Gastrointestinal stromal tumours; Leukaemia; Mantle-cell lymphoma; Renal cell carcinoma
  • Discontinued Endometrial cancer

Most Recent Events

  • 07 Oct 2016 Safety, efficacy and pharmacodynamic results from the phase II trial presented at the 41st European Society for Medical Oncology Congress (ESMO-2016)
  • 01 Oct 2016 M.D. Anderson Cancer Center completes a phase I trial in Leukaemia (Second-line therapy or greater, Late-stage disease) in USA (PO) (NCT01396499)
  • 01 Oct 2016 Memorial Sloan-Kettering Cancer Center and Novartis completes a phase II trial in CNS cancer (Recurrent, Second-line therapy or greater) in USA (NCT02301364)
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