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zilurgisertib (INCB00928)
i
Other names: INCB00928, INCB 00928, INCB000928
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News alerts, weekly reports and conference planners
Company:
Incyte
Drug class:
ACVR1 inhibitor
Related drugs:
7d
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (clinicaltrials.gov)
P2, N=98, Recruiting, Incyte Corporation | Trial primary completion date: Feb 2025 --> Jul 2027
Trial primary completion date
|
zilurgisertib (INCB00928)
2ms
INCB 00928-105: To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma (clinicaltrials.gov)
P1/2, N=22, Terminated, Incyte Corporation | Completed --> Terminated; Strategic Business Decision
Trial termination
|
zilurgisertib (INCB00928)
4ms
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (clinicaltrials.gov)
P2, N=98, Recruiting, Incyte Corporation | Trial primary completion date: Jul 2025 --> Feb 2025
Trial primary completion date
|
zilurgisertib (INCB00928)
5ms
INCB 00928-104: INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders (clinicaltrials.gov)
P1/2, N=84, Active, not recruiting, Incyte Corporation | Trial completion date: Oct 2025 --> Nov 2027
Trial completion date
|
Jakafi (ruxolitinib) • zilurgisertib (INCB00928)
7ms
LIMBER: INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders (clinicaltrials.gov)
P1/2, N=84, Active, not recruiting, Incyte Corporation | Trial completion date: Jun 2026 --> Oct 2025 | Trial primary completion date: Nov 2025 --> Apr 2025
Trial completion date • Trial primary completion date
|
Jakafi (ruxolitinib) • zilurgisertib (INCB00928)
9ms
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (clinicaltrials.gov)
P2, N=98, Recruiting, Incyte Corporation | N=60 --> 98 | Trial completion date: Apr 2028 --> Dec 2032
Enrollment change • Trial completion date
|
zilurgisertib (INCB00928)
9ms
Emerging Pathogenetic Mechanisms and New Drugs for Anemia in Myelofibrosis and Myelodysplastic Syndromes. (PubMed, Am J Hematol)
These include TGF-β ligand traps (luspatercept, elritercept), activin A receptor type 1 (ACVR1)/activin receptor-like kinase 2 (ALK2) inhibitors (momelotinib, zilurgisertib), and anti-hemojuvelin antibody-based therapies (DISC-0974). Luspatercept and momelotinib are approved for anemia related to lower-risk MDS and MF, respectively, and represent an important addition to the treatment armamentarium, along with imetelstat, a telomerase inhibitor, recently ratified for anemia in lower-risk MDS. A promising strategy to overcome the limitations of existing anemia-directed therapies includes the use of drug combinations with complementary mechanisms (luspatercept + erythropoiesis stimulating agents, luspatercept + momelotinib, DISC-0974 + momelotinib), and harnessing the erythropoietic potential of sodium-glucose co-transporter-2 inhibitors (SGLT-2I). Future research should address the complex pathophysiology of anemia, standardize definitions for anemia with gender-specified cutoffs, implement uniform erythroid response criteria, and consider early therapeutic intervention in clinical trials for anemia-directed therapies.
Review • Journal
|
SMAD4 (SMAD family member 4) • ACVR1 (Activin A Receptor Type 1) • TGFB1 (Transforming Growth Factor Beta 1) • SMAD2 (SMAD Family Member 2)
|
Reblozyl (luspatercept-aamt) • Ojjaara (momelotinib) • Rytelo (imetelstat) • elritercept (KER-050) • zilurgisertib (INCB00928)
12ms
LIMBER: INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders (clinicaltrials.gov)
P1/2, N=84, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=206 --> 84
Enrollment closed • Enrollment change
|
Jakafi (ruxolitinib) • zilurgisertib (INCB00928)
1year
Pharmacokinetics of Zilurgisertib With and Without Food from Single and Multiple Ascending Dose Phase 1 Studies in Healthy Adults. (PubMed, Eur J Drug Metab Pharmacokinet)
Zilurgisertib exhibited a favorable pharmacokinetic profile amenable to once-daily dosing that can be administered without regard to food. Study results support further clinical development of zilurgisertib in patients.
P1 data • PK/PD data • Journal
|
ACVR1 (Activin A Receptor Type 1)
|
zilurgisertib (INCB00928)
over1year
INCB 00928-105: To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma (clinicaltrials.gov)
P1/2, N=22, Completed, Incyte Corporation | Active, not recruiting --> Completed
Trial completion
|
zilurgisertib (INCB00928)
over1year
LIMBER: INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders (clinicaltrials.gov)
P1/2, N=206, Recruiting, Incyte Corporation | N=100 --> 206 | Trial completion date: Apr 2024 --> Jun 2026 | Trial primary completion date: Apr 2024 --> Nov 2025
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
Jakafi (ruxolitinib) • zilurgisertib (INCB00928)
almost2years
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (clinicaltrials.gov)
P2, N=60, Recruiting, Incyte Corporation | Trial completion date: Dec 2024 --> Apr 2028 | Trial primary completion date: Dec 2023 --> Apr 2025
Trial completion date • Trial primary completion date
|
zilurgisertib (INCB00928)
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