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INCB000928

DRUG5 trials

Sponsors

Incyte Corp., Incyte Corporation

Conditions

AnemiaFibrodysplasia Ossificans ProgressivaFibrodysplasia Ossificans Progressiva (FOP)HemodialysisMultiple MyelomaMyelodysplastic SyndromesPost-essential Thrombocythemia MyelofibrosisPost-polycythemia Vera Myelofibrosis

Phase 1

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Active, not recruitingNCT04455841
Incyte CorporationAnemia, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis
Start: 2021-03-19End: 2027-11-26Updated: 2026-05-14
To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma
TerminatedNCT04582539
Incyte CorporationAnemia, Multiple Myeloma, Myelodysplastic Syndromes
Start: 2021-08-19End: 2024-08-15Updated: 2025-10-22
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis
CompletedNCT05099445
Incyte CorporationHemodialysis, Renal Impairment
Start: 2021-12-14End: 2023-02-27Updated: 2023-05-15

Phase 2

To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
RecruitingNCT05090891
Incyte CorporationFibrodysplasia Ossificans Progressiva (FOP)
Start: 2022-05-05End: 2033-01-20Target: 98Updated: 2026-05-22
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (PROGRESS)
RecruitingCTIS2023-504129-38-00
Incyte Corp.Fibrodysplasia Ossificans Progressiva
Start: 2022-03-31Target: 18Updated: 2025-07-11

Related Papers

Effects of Renal and Hepatic Impairment on the Pharmacokinetics of Zilurgisertib.
2025-12-08
The activin receptor-like kinase-2 inhibitor zilurgisertib (INCB000928) as monotherapy or with ruxolitinib in patients with anemia due to myelofibrosis: Phase 1/2 study final results
Blood2025-11-03
Study methodology and insights from the palovarotene clinical development program in fibrodysplasia ossificans progressiva.
2023-11-138 citations
Phase 1/2 Study of the Activin Receptor-like Kinase-2 Inhibitor Zilurgisertib (INCB000928, LIMBER-104) As Monotherapy or with Ruxolitinib in Patients with Anemia Due to Myelofibrosis
Blood2023-11-027 citations
ALK2 and JAK2 Inhibition for Improved Treatment of Anemia in Myelofibrosis Patients: Preclinical Profile of an ALK2 Inhibitor Zilurgisertib in Combination with Ruxolitinib
Blood2023-11-025 citations
P1022: PHASE 1/2 STUDY OF THE ACTIVIN RECEPTOR-LIKE KINASE 2 (ALK2) INHIBITOR ZILURGISERTIB (INCB000928, LIMBER-104) AS MONOTHERAPY OR WITH RUXOLITINIB IN PATIENTS WITH ANEMIA DUE TO MYELOFIBROSIS
HemaSphere2023-08-012 citations
Phase 1/2 study of the activin receptor-like kinase (ALK)-2 inhibitor zilurgisertib (INCB000928, LIMBER-104) as monotherapy or with ruxolitinib (RUX) in patients (pts) with anemia due to myelofibrosis (MF).
Journal of Clinical Oncology2023-06-014 citations
Abstract CT243: Clinical trial simulation to inform dose selection of zilurgisertib, an ALK2 inhibitor, in patients with anemia due to myelofibrosis (MF)
Cancer Research2023-04-14
Abstract CT216: A Phase 1/2 Study of INCB000928 as Monotherapy or in Combination with Ruxolitinib in Patients with Anemia Due to Myelofibrosis (INCB 00928-104)
Cancer Research2021-07-011 citations
A Phase 1/2 Study of INCB000928 As Monotherapy or in Combination with Ruxolitinib in Patients with Anemia Due to Myelofibrosis (INCB 00928-104)
Blood2020-11-056 citations