pelabresib

Phase 3Small molecule

Novartis

pelabresib is one of 68 small molecule programs targeting Myelofibrosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

MyelofibrosisActive, not recruiting

Advanced MalignanciesRecruiting

Primary Myelofibrosis (PMF)Recruiting

MyelofibrosisPhase 3

Active, not recruiting

Advanced MalignanciesPhase 1

Recruiting

Primary Myelofibrosis (PMF)Phase 3

Recruiting

Competition

Competitive Landscape

139 competitors in Myelofibrosis

#DrugCompanyPhaseTrials

Ojjaara

GGlaxo Dba Glaxosmithkline

Phase 3

6 2

Vonjo

OOrsoBio, Inc

Phase 3

4 3

Rytelo

GGeron Corporation

Phase 3

3 4

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

3 5

Best Available Therapy

Novartis

Phase 3

6 6

Pomalyst

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

2 7

Navitoclax

AbbVie

Phase 3

5 8

Cellcept

Roche

Phase 2

5 9

Fludara

Sanofi

Phase 2

5 10

Fludara

Sanofi

Phase 2

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

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Study completion

NCT06401356

Phase 3Active, not recruiting

Myelofibrosis

NCT04603495

Q2 2028

Phase 1Recruiting

Advanced Malignancies

NCT07340190

Q3 2028

Phase 1Recruiting

Advanced Malignancies

NCT07422610

Q4 2030

Phase 3Recruiting

Primary Myelofibrosis (PMF)

NCT07357727

Clinical

Trials by Indication[1]

Advanced Malignancies3 trials

Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Completed·CConstellation Pharmaceuticals·Phase 1·NCT05391022·35 enrolled

A Phase 1b, Open Label, 2-Part Study to Evaluate the Effect of Pelabresib (DAK539/CPI-0610) on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Patients With Advanced Malignancies

Recruiting· Novartis logo

Novartis·Phase 1·NCT07340190·24 enrolled

A Phase 1b, Open-Label, Multicenter Study to Evaluate the Pharmacokinetic Profile of Pelabresib (DAK539/CPI-0610) in Patients With Advanced Malignancies and Hepatic Impairment

Recruiting· Novartis logo

Novartis·Phase 1·NCT07422610·24 enrolled

Myelofibrosis2 trials

Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis

Not yet recruiting· Novartis logo

Novartis·Phase 1·NCT07340138·6 enrolled

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT04603495·430 enrolled

Malignancies1 trial

A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies

Completed·CConstellation Pharmaceuticals·Phase 1/2·NCT02158858·336 enrolled

Primary Myelofibrosis (PMF)1 trial

A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive

Recruiting· Novartis logo

Novartis·Phase 3·NCT07357727·460 enrolled

Unspecified1 trial

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Recruiting· Novartis logo

Novartis·Phase 3·NCT06401356·50 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for pelabresib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — pelabresib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for pelabresib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

pelabresib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q2 2028

Q3 2028

Q4 2030

Trials by Indication[1]

Advanced Malignancies3 trials

Myelofibrosis2 trials

Malignancies1 trial

Primary Myelofibrosis (PMF)1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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