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Buparlisib - Adlai Nortye/Novartis Oncology

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Drug Profile

Buparlisib - Adlai Nortye/Novartis Oncology

Alternative Names: AN-2025; BKM-120; BKM120-AAA; Buparlisib hydrochloride; NVP-BKM120

Latest Information Update: 22 Nov 2023

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At a glance

  • Originator Novartis; University Hospital Tubingen
  • Developer Adlai Nortye; Array BioPharma; Canadian Cancer Society Research Institute; Dana-Farber Cancer Institute; Duke University Medical Center; Emory University; Hospices Civils de Lyon; Indiana University; M. D. Anderson Cancer Center; Memorial Sloan-Kettering Cancer Center; National Cancer Institute (USA); NCIC Clinical Trials Group; Novartis; Novartis Oncology; Ohio State University; Paoli-Calmettes-institute; Sarah Cannon Research Institute; Stanford University; 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Head and neck cancer
  • Phase II Bladder cancer; Breast cancer; Chronic lymphocytic leukaemia; Haematological malignancies; Non-Hodgkin's lymphoma; Thyroid cancer; Ureteral neoplasms; Urethral cancer
  • Phase I/II Colorectal cancer
  • Phase I Solid tumours
  • Preclinical Chronic myeloid leukaemia
  • No development reported B-cell lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma; Leukaemia; Mantle-cell lymphoma; Myelofibrosis; Non-small cell lung cancer; Ovarian cancer
  • Discontinued Basal cell cancer; CNS cancer; Endometrial cancer; Gastrointestinal stromal tumours; Glioblastoma; Malignant melanoma; Oesophageal cancer; Prostate cancer; Renal cell carcinoma; Thymoma

Most Recent Events

  • 17 Nov 2023 Adlai Nortye completes enrolment in the phase III BURAN trial for Head and neck cancer (Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) in United Kingdom, Taiwan, Spain, Poland, South Korea, Japan, Italy, Hungary, Hong Kong, Germany, France, Canada, Belgium, Australia, Argentina, USA and China (PO) (NCT04338399)
  • 20 Oct 2023 Efficacy data from the phase II BERIL-1 trial in Head and neck cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)
  • 08 Jun 2023 Preclinical trials in Chronic myeloid leukaemia in Switzerland (PO), before June 2023
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