AN2025 (Buparlisib)

Buparlisib (AN2025) is an oral pan-P13K inhibiter that targets all class 1 P13K isoforms and is active in both hemafologic malignancies and solid tumors. It is being studied as a potential combination therapy with pactitaxel in hard-to-treat head and neck squamous cell carcinoma (HNSCC) and has received Fast-Track designation from the FDA.

It has shown promising efficacy in combination with paclitaxel in HNSCC and received a Fast-Track designation and an approval for initiating the phase III clinical study from FDA.

 Mechanism of Action
Clinical research
latest progress
Adlai Nortye Received NMPA, FDA and Health Canada Approval for AN2025 Phase III Clinical Trials.
Adlai Nortye released the animal model data of Buparlisib (AN2025) at the 7th ICHNO, the International Conference on Innovative Approaches in Head & Neck Oncology. The data suggests AN2025 could potentially be a treatment option for anti-PD-1 antibodies refractory tumors.
FDA agreed that the results of a single adequate and well-controlled trial are sufficient to support marketing approval if the trial shows a clinically meaningful, statistically significant effect that is internally consistent across relevant subgroups.

HNSCC is a kind of head and neck tumor, it should include neck tumor, otolaryngology tumor and oral and maxillofacial tumor. HNSCC is the sixth most common cancer in the world, about 10% of all malignancies and more than 90% of squamous-cell carcinoma.


Although anti-PD-1 therapy has been approved by the FDA and EMA for the treatment of relapsed, refractory HNSCC, the response rate of listed PD-1 varieties is lower than 20%. There is still a large unmet medical need for the treatment of HNSCC with no response to PD-1.