parsaclisib

Phase 3Small molecule

parsaclisib is a small molecule that works as a PI3-Kinase P110-Delta Subunit Inhibitor.[2] It is being investigated across 13 indications, with its most advanced program in Phase 3.[1]

parsaclisib is one of 320 small molecule programs targeting Pemphigus Vulgaris. It is currently in Phase 3.

Indications

Total Trials

Active Trials

319

Competitors

Pipeline

Status by Indication[3][1]

Indication

Pemphigus VulgarisActive, not recruiting

Non-Hodgkins LymphomaActive, not recruiting

Hemolytic AnemiaActive, not recruiting

Anemia, Hemolytic, AutoimmuneActive, not recruiting

LymphomaActive, not recruiting

MyelofibrosisActive, not recruiting

Sjogren SyndromeActive, not recruiting

Breast CancerActive, not recruiting

Mantle Cell LymphomaActive, not recruiting

Diffuse Large B-Cell LymphomaActive, not recruiting

Pemphigus VulgarisPhase 2

Active, not recruiting

Non-Hodgkins LymphomaPhase 1/Phase 2

Active, not recruiting

Hemolytic AnemiaPreclinical

Active, not recruiting

Anemia, Hemolytic, AutoimmunePhase 3

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

MyelofibrosisPhase 2

Active, not recruiting

Sjogren SyndromePhase 2

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

Mantle Cell LymphomaPhase 3

Active, not recruiting

Diffuse Large B-Cell LymphomaPhase 1

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

parsaclisib

Incyte

Phase 3

1 2

Tecentriq

Roche

Preclinical

36 3

Trodelvy

Gilead

Preclinical

37 4

Halaven

Eisai

Preclinical

38 5

Tykerb

GSK

Preclinical

80 6

Adriamycin

GGynecologic Oncology Group

Preclinical

87 7

Avastin

BBio-Thera Solutions

Preclinical

153 8

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

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]

Follicular Lymphoma5 trials

A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

Completed· Incyte logo

Incyte·Phase 2·NCT03126019·126 enrolled

Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Withdrawn· Innovent Biologics (Suzhou) Co. Ltd.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

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

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

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

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

Lymphoma5 trials

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

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

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

Completed· Incyte logo

Incyte·Phase 1·NCT03314922·17 enrolled

Show 2 more 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 Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Completed· Incyte logo

Incyte·Phase 2·NCT03144674·110 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

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

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

Terminated· Incyte logo

Incyte·Phase 2·NCT02718300·74 enrolled

Diffuse Large B-Cell Lymphoma2 trials

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

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

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 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

A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Completed· Incyte logo

Incyte·Phase 2·NCT03538041·25 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

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

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

Primary Sjögren's Syndrome1 trial

A Study of INCB050465 in Primary Sjögren's Syndrome

Completed· Incyte logo

Incyte·Phase 2·NCT03627065·10 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

Pemphigus Vulgaris1 trial

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

Withdrawn· Incyte logo

Incyte·Phase 2·NCT03780166

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 3[1]
Company: Incyte

parsaclisib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2028

Trials by Indication[1]

Follicular Lymphoma5 trials

Lymphoma5 trials

Myelofibrosis3 trials

Diffuse Large B-Cell Lymphoma2 trials

Mantle Cell Lymphoma2 trials

Hemolytic Anemia2 trials

B-cell Malignancies2 trials

Non-Hodgkins Lymphoma1 trial

Breast Cancer1 trial

CHOP1 trial

Hepatic Impairment1 trial

Primary Sjögren's Syndrome1 trial

Renal Impairment1 trial

Chronic Lymphocytic Leukemia1 trial

Pemphigus Vulgaris1 trial

References

Drug Info

Quick Facts

Related News