Buparlisib hydrochloride is under clinical development by Adlai Nortye Biopharma and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Buparlisib hydrochloride’s likelihood of approval (LoA) and phase transition for Recurrent Head And Neck Cancer Squamous Cell Carcinoma took place on 13 Oct 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Buparlisib hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Buparlisib hydrochloride overview

Buparlisib hydrochloride (BKM-120) is under development for the treatment of advanced solid tumors diffuse large B-Cell lymphoma, relapsed or refractory thymomas, ovarian cancer, relapsed and refractory chronic lymphocytic leukemia, mantle cell lymphoma, follicular lymphoma, triple negative breast cancer (TNBC), metastatic transitional cell cancer (urothelial cell cancer), cervical cancer, metastatic colorectal cancer, recurrent glioblastoma, relapsed and refractory acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL) and pancreatic cancer, recurrent or metastatic head and neck squamous cell carcinoma and solid tumor. BKM-120 targets specific oral pan-class I phosphatidylinositol-3-kinase (PI3K).

It was also under development for thrombocythaemia myelofibrosis, HER2-positive breast cancer, myelofibrosis, post-polycythemia vera myelofibrosis (PPV-MF), newly diagnosed glioblastoma, metastatic hormone refractory prostate cancer, estrogen receptor positive and HER2-negative (ER+/HER2-) stage IV metastatic breast cancer and melanoma, advanced or metastatic squamous non-small cell lung cancer and non-small cell lung cancer, gastrointestinal stromal tumor (GIST), thyroid cancer (third line therapy) and prostate cancer

Adlai Nortye Biopharma overview

Adlai Nortye Biopharma (Adlai Nortye) is a biopharmaceutical company that discovers and develops drugs for oncology indications. The company is investigating AN2025, a trial-stage pan-PI3K inhibitor for the treatment of recurrent and metastatic head and neck squamous cell carcinoma; and AN0025, an EP4 antagonist designed against triple negative breast cancer, non-small-cell lung carcinoma, bladder, rectum and cervical cancer, and microsatellite stable colorectal cancer. It is also evaluating AN1004 to treat human epidermal growth factor receptor-2-negative metastatic breast cancer; AN4005 against advanced tumors; AN3025 and AN6025 for solid tumors. Adlai Nortye utilizes PAINT-2D and ANEAT-Id platform technologies to identify and develop immunotherapies and antibodies. The company operates research and development, clinical operation centers in China, and the US. Adlai Nortye is headquartered in Hangzhou, Zhejiang, China.

Quick View Buparlisib hydrochloride LOA Data

Report Segments
  • Innovator
Drug Name
  • Buparlisib hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.