Buparlisib

Phase 3Small molecule

Buparlisib is a small molecule that works as a PI3-Kinase Class I Inhibitor.[2] It is being investigated across 24 indications, with its most advanced program in Phase 3.[1]

Buparlisib is one of 692 small molecule programs targeting Basal Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

691

Competitors

Pipeline

Status by Indication[3][1]

Indication

Basal Cell CarcinomaActive, not recruiting

Central Nervous System LymphomaActive, not recruiting

Esophageal CancerActive, not recruiting

Transitional Cell CarcinomaActive, not recruiting

LymphomaActive, not recruiting

Head and Neck Malignant NeoplasiaActive, not recruiting

ThymomaActive, not recruiting

LeukemiaActive, not recruiting

Kidney DiseaseActive, not recruiting

Breast NeoplasmActive, not recruiting

Basal Cell CarcinomaPhase 2

Active, not recruiting

Central Nervous System LymphomaPhase 2

Active, not recruiting

Esophageal CancerPhase 2

Active, not recruiting

Transitional Cell CarcinomaPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Head and Neck Malignant NeoplasiaPhase 3

Active, not recruiting

ThymomaPhase 2

Active, not recruiting

LeukemiaPhase 1

Active, not recruiting

Kidney DiseasePhase 1

Active, not recruiting

Breast NeoplasmPhase 2

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Buparlisib

Novartis

Phase 3

2 2

Trodelvy

Gilead

Preclinical

37 3

Megace

Bristol-Myers Squibb

Preclinical

4 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 7

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—8

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 9

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

1 10

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Lymphoma2 trials

A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT02756247·37 enrolled

Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Completed·MMayo Clinic·Phase 1·NCT01719250·7 enrolled

Non-Small Cell Lung Cancer2 trials

Phase II Study of Buparlisib + Docetaxel in Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) Patients

Terminated· Novartis logo

Novartis·Phase 1·NCT01911325·27 enrolled

Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer

Terminated· Novartis logo

Novartis·Phase 1·NCT01820325·6 enrolled

Breast Cancer2 trials

Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.

Completed· Novartis logo

Novartis·Phase 1·NCT02154776·13 enrolled

A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT02058381·40 enrolled

Chronic Lymphocytic Leukemia2 trials

Buparlisib and Ofatumumab or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Terminated·EEmory University·Phase 1·NCT02614508·1 enrolled

Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia

Completed·CCanadian Cancer Trials Group·Phase 2·NCT02340780·14 enrolled

Patients With Advanced Solid Tumors1 trial

Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors

Withdrawn·RRoswell Park Cancer Institute·Phase 1·NCT01971489

10 more indications

Basal Cell Carcinoma1 trial

Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma

Terminated·AAnne Chang·Phase 2·NCT02303041·10 enrolled

Renal Impairment1 trial

Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment.

Completed· Novartis logo

Novartis·Phase 1·NCT02048787·19 enrolled

Neoadjuvant Treatment1 trial

Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

Completed· Novartis logo

Novartis·Phase 2·NCT01923168·340 enrolled

Metastatic Head and Neck Cancer1 trial

Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy

Terminated· Novartis logo

Novartis·Phase 2·NCT01852292·157 enrolled

Glioblastoma1 trial

Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Glioblastoma

Terminated· Novartis logo

Novartis·Phase 1/2·NCT01870726·43 enrolled

Transitional Cell Carcinoma1 trial

Buparlisib in Metastatic Transitional Cell Carcinoma of the Urothelium

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01551030·19 enrolled

Central Nervous System Lymphoma1 trial

Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02301364·4 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of BKM120 in Relapsed and Refractory NHL

Completed· Novartis logo

Novartis·Phase 2·NCT01693614·72 enrolled

Melanoma1 trial

Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER)

Unknown status·UUniversity Hospital Tuebingen·Phase 2·NCT02452294·22 enrolled

Glioblastoma Multiforme1 trial

Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme

Completed· Novartis logo

Novartis·Phase 1·NCT01934361·35 enrolled

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Buparlisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Buparlisib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Buparlisib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: PI3-Kinase Class I Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

Buparlisib

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Lymphoma2 trials

Non-Small Cell Lung Cancer2 trials

Breast Cancer2 trials

Chronic Lymphocytic Leukemia2 trials

Patients With Advanced Solid Tumors1 trial

Basal Cell Carcinoma1 trial

Renal Impairment1 trial

Neoadjuvant Treatment1 trial

Metastatic Head and Neck Cancer1 trial

Glioblastoma1 trial

Transitional Cell Carcinoma1 trial

Central Nervous System Lymphoma1 trial

Safety and Efficacy1 trial

Melanoma1 trial

Glioblastoma Multiforme1 trial

References

Drug Info

Quick Facts

Related News