Drug

Buparlisib

As of the edition of 20 October 2026, Buparlisib is a small molecule: stopped in 2023; acts on PIK3CA, PIK3CB and PIK3CD and 1 more.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Stopped, 2023
Kind
Small molecule
Registered trials
87, 22 stopped early
Disease areas
Cancer; Skin and connective tissue; Urinary and reproductive; Blood and lymph; Digestive system; Lungs and airways

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

1 company-target row on route B and 10 company-target rows on route A because of this drug.

Companies on route B for this drug

In the product

1 company-target row is on route B because of Buparlisib.

Companies on route A for this drug

In the product

10 company-target rows are on route A because of Buparlisib.

Targets

GeneProteinUniProt
PIK3CDPhosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoformO00329
PIK3CAPhosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoformP42336
PIK3CBPhosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoformP42338
PIK3CGPhosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoformP48736

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 1453708
Phase 23923013
Phase 33201
All trials87

Who ran its trials

CompanyRoleYears
NovartisLead sponsor of trials2008 to now
PfizerLead sponsor of trials2011 to now
SCRI Development InnovationsLead sponsor of trials2011 to now
US OncologyLead sponsor of trials2014 to now
Adlai Nortye BiopharmaLead sponsor of trials2021 to now