PCI 32765

Phase 2Small molecule

Johnson & Johnson

PCI 32765 is one of 206 small molecule programs targeting B-cell neoplasm. It is currently in Phase 2.

Indications

Total Trials

Active Trials

205

Competitors

Pipeline

Status by Indication[3][1]

Indication

B-Cell NeoplasmActive, not recruiting

MacroglobulinemiaActive, not recruiting

LymphomaActive, not recruiting

LeukemiaActive, not recruiting

Mantle Cell LymphomaActive, not recruiting

Multiple MyelomaActive, not recruiting

Chronic Lymphocytic LeukemiaActive, not recruiting

B-Cell NeoplasmPhase 1

Active, not recruiting

MacroglobulinemiaPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

LeukemiaPhase 1/Phase 2

Active, not recruiting

Mantle Cell LymphomaPhase 2

Active, not recruiting

Multiple MyelomaPhase 2

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

PCI 32765

Johnson & Johnson

Phase 2

1 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Velban

EEastern Cooperative Oncology Group

Preclinical

15 4

Oncaspar

SServier

Preclinical

15 5

Zofran

Novartis

Preclinical

2 6

Norvir

AbbVie

Preclinical

1 7

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 8

Tafasitamab

Incyte

Preclinical

7 9

Nuvigil

NNuvo Research GmbH

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

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

Timeline

Expected Milestones

Q3 2034

Phase 2Active, not recruiting

Chronic Lymphocytic Leukemia

NCT01500733

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia5 trials

PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Active, not recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT01500733·86 enrolled

Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)

Completed·PPharmacyclics LLC.·Phase 1·NCT01292135·33 enrolled

Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

Completed·PPharmacyclics LLC.·Phase 2·NCT01109069·199 enrolled

Show 2 more trials

Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01520519·40 enrolled

Safety of PCI-32765 in Chronic Lymphocytic Leukemia

Completed·PPharmacyclics LLC.·Phase 1/2·NCT01105247·133 enrolled

B-cell neoplasm1 trial

A Study to Evaluate the Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Patients With Recurrent Mature B-Cell Neoplasms

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01704963·15 enrolled

Macroglobulinemia1 trial

Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia

Completed·—·Phase 2·NCT01614821·63 enrolled

Efficacy and Safety1 trial

Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL

Completed·PPharmacyclics LLC.·Phase 1/2·NCT01217749·71 enrolled

Mantle Cell Lymphoma1 trial

Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL)

Completed·PPharmacyclics LLC.·Phase 2·NCT01236391·115 enrolled

5 more indications

Lymphoma1 trial

Study of the Safety and Tolerability of PCI-32765 in Patients With Recurrent B Cell Lymphoma

Completed·PPharmacyclics LLC.·Phase 1·NCT00849654·66 enrolled

Multiple Myeloma1 trial

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma

Completed·PPharmacyclics LLC.·Phase 2·NCT01478581·92 enrolled

Leukemia1 trial

Pilot Study to Determine Effects of the Btk Inhibitor PCI-32765 on Leukemia Cell Kinetics and Trafficking, Using Heavy Water Labeling in Subjects With CLL and SLL

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01752426·30 enrolled

Hepatic Impairment1 trial

A Study to Evaluate the Pharmacokinetics of PCI-32765 in Participants With Varying Degrees of Hepatic Impairment

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01767948·30 enrolled

Tics1 trial

A Study to Assess the Effect of Rifampin on the Pharmacokinetics of PCI-32765 in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01763021·18 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for PCI 32765. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — PCI 32765 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for PCI 32765. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Johnson & Johnson

PCI 32765

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2034

Trials by Indication[1]

Chronic Lymphocytic Leukemia5 trials

B-cell neoplasm1 trial

Macroglobulinemia1 trial

Efficacy and Safety1 trial

Mantle Cell Lymphoma1 trial

Lymphoma1 trial

Multiple Myeloma1 trial

Leukemia1 trial

Hepatic Impairment1 trial

Tics1 trial

References

Drug Info

Quick Facts

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