parsaclisib

Phase 2Small molecule

parsaclisib is a small molecule that works as a PI3-Kinase P110-Delta Subunit Inhibitor.[2] It is being investigated across 3 indications, with its most advanced program in Phase 2.[1]

parsaclisib is one of 98 small molecule programs targeting B-cell Malignancies. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

B-Cell MalignanciesActive, not recruiting

Diffuse Large B-Cell LymphomaCompleted

Non-Hodgkins LymphomaActive, not recruiting

B-Cell MalignanciesPhase 2

Active, not recruiting

Diffuse Large B-Cell LymphomaPhase 2

Completed

Non-Hodgkins LymphomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

109 competitors in Diffuse Large B-Cell Lymphoma

#DrugCompanyPhaseTrials

Rituxan

Adriamycin

38 3

Oncovin

Eli Lilly

Phase 3

33 4

Polivy

Roche

Phase 3

20 5

Oncovin

Eli Lilly

Phase 3

18 6

Gazyva

Roche

Phase 3

18 7

Gemzar

Johnson & Johnson

Phase 3

18 8

Adriamycin

Pfizer

Phase 3

18 9

Eloxatin

Teva

Phase 3

16 10

Cytoxan

BBaxter Healthcare Corporation

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

B-Cell Malignancies

NCT04509700

Phase 1/2Active, not recruiting

Non-Hodgkins Lymphoma

NCT04661007

Q1 2027

Not yet recruiting

Hemolytic Anemia

NCT07149818

Q2 2028

Phase 1Active, not recruiting

Diffuse Large B-Cell Lymphoma

NCT04323956

Clinical

Trials by Indication[1]

Lymphoma5 trials

Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas

Completed·WWalter Hanel·Phase 1·NCT04774068·5 enrolled

A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)

Completed· Incyte logo

Incyte·Phase 1·NCT03314922·17 enrolled

A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Completed· Incyte logo

Incyte·Phase 2·NCT03144674·110 enrolled

Show 2 more trials

INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

Completed· Incyte logo

Incyte·Phase 1·NCT03424122·50 enrolled

PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma

Terminated·HHenan Cancer Hospital·Phase 1·NCT05083208·12 enrolled

Follicular Lymphoma5 trials

Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

Completed·IIncyte Biosciences Japan GK·Phase 2·NCT04434937·42 enrolled

To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)

Withdrawn· Incyte logo

Incyte·Phase 3·NCT04796922

Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)

Completed· Incyte logo

Incyte·Phase 1·NCT03039114·26 enrolled

Show 2 more trials

Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Withdrawn· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT05867030

A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

Completed· Incyte logo

Incyte·Phase 2·NCT03126019·126 enrolled

Myelofibrosis3 trials

To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Terminated· Incyte logo

Incyte·Phase 3·NCT04551066·252 enrolled

A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

Terminated· Incyte logo

Incyte·Phase 2·NCT02718300·74 enrolled

To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Terminated· Incyte logo

Incyte·Phase 3·NCT04551053·177 enrolled

Diffuse Large B-Cell Lymphoma2 trials

Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma

Active, not recruiting·MMayo Clinic·Phase 1·NCT04323956·50 enrolled

A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

Completed· Incyte logo

Incyte·Phase 2·NCT02998476·60 enrolled

Mantle Cell Lymphoma2 trials

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

Completed· Incyte logo

Incyte·Phase 2·NCT03235544·162 enrolled

A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

Withdrawn· Incyte logo

Incyte·Phase 3·NCT04849715

10 more indications

Hemolytic Anemia2 trials

A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Completed· Incyte logo

Incyte·Phase 2·NCT03538041·25 enrolled

A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia

Not yet recruiting·PPeking Union Medical College Hospital··NCT07149818·22 enrolled

B-cell Malignancies2 trials

A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)

Completed· Incyte logo

Incyte·Phase 1/2·NCT02018861·88 enrolled

A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Active, not recruiting· Incyte logo

Incyte·Phase 2·NCT04509700·112 enrolled

Pemphigus Vulgaris1 trial

A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris

Withdrawn· Incyte logo

Incyte·Phase 2·NCT03780166

Non-Hodgkins Lymphoma1 trial

To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

Active, not recruiting·IIncyte Biosciences Japan GK·Phase 1/2·NCT04661007·72 enrolled

Renal Impairment1 trial

To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment.

Completed· Incyte logo

Incyte·Phase 1·NCT04831996·48 enrolled

Chronic Lymphocytic Leukemia1 trial

A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

Terminated· Incyte logo

Incyte·Phase 1/2·NCT04809467·54 enrolled

Primary Sjögren's Syndrome1 trial

A Study of INCB050465 in Primary Sjögren's Syndrome

Completed· Incyte logo

Incyte·Phase 2·NCT03627065·10 enrolled

Breast Cancer1 trial

Parsaclisib in Newly Diagnosed Stage I-IIIC Triple Negative or HER2+ Breast Cancer

Withdrawn·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT04142554

CHOP1 trial

Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL

Unknown status·FFudan University·Phase 1/2·NCT05238064·30 enrolled

Hepatic Impairment1 trial

To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.

Completed· Incyte logo

Incyte·Phase 1·NCT04831944·21 enrolled

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for parsaclisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — parsaclisib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for parsaclisib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Incyte company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: PI3-Kinase P110-Delta Subunit Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Incyte

parsaclisib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2028

Trials by Indication[1]

Lymphoma5 trials

Follicular Lymphoma5 trials

Myelofibrosis3 trials

Diffuse Large B-Cell Lymphoma2 trials

Mantle Cell Lymphoma2 trials

Hemolytic Anemia2 trials

B-cell Malignancies2 trials

Pemphigus Vulgaris1 trial

Non-Hodgkins Lymphoma1 trial

Renal Impairment1 trial

Chronic Lymphocytic Leukemia1 trial

Primary Sjögren's Syndrome1 trial

Breast Cancer1 trial

CHOP1 trial

Hepatic Impairment1 trial

References

Drug Info

Quick Facts

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