Drug Profile

Buparlisib - Adlai Nortye

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

Latest Information Update: 30 Apr 2026

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At a glance

Originator Novartis
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

Phase III Head and neck cancer
Preclinical Chronic myeloid leukaemia
Discontinued B-cell lymphoma; Basal cell cancer; Bladder cancer; Breast cancer; Chronic lymphocytic leukaemia; CNS cancer; Colorectal cancer; Diffuse large B cell lymphoma; Endometrial cancer; Follicular lymphoma; Gastrointestinal stromal tumours; Glioblastoma; Haematological malignancies; Leukaemia; Malignant melanoma; Mantle-cell lymphoma; Myelofibrosis; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Prostate cancer; Renal cell carcinoma; Solid tumours; Thymoma; Thyroid cancer; Ureteral neoplasms; Urethral cancer

21 Apr 2026 Institute Paoli-Calmettes terminates a phase Ib/II trial for Breast cancer (Second-line therapy, Combination therapy, late-stage disease, Metastatic disease, Recurrent) in France (PO) due to discontinuation of drug development (NCT01589861) (EUCT-2011-002167-23)
02 Nov 2025 Adlai Nortye completes a phase III BURAN trial in head and neck cancer (Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) in US, Argentina, Australia, Belgium, Canada, China, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Poland, Spain, Taiwan, UK (NCT04338399)
24 Jan 2025 Adlai Nortye completes a phase Ia trial in Solid tumours (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (PO) (NCT04975958)

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