Momelotinib

DRUG18 trials

Sponsors

Sierra Oncology LLC - a GSK company, Sumitomo Pharma America, Inc., GlaxoSmithKline, Karyopharm Therapeutics Inc, Janssen Research & Development, LLC

Conditions

Chronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaEssential ThrombocythemiaHematopoietic Cell Transplantation (HCT)Metastatic Pancreatic Ductal AdenocarcinomaMild ThrombocytopeniaModerate ThrombocytopeniaMyelodysplastic Syndromes

Early Phase 1

Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia

RecruitingNCT07071155

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsChronic Myelomonocytic Leukemia, Chronic Neutrophilic Leukemia, Myelodysplastic Syndromes +1

Start: 2026-03-19End: 2028-07-30Target: 18Updated: 2026-03-27

Phase 1

Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis

CompletedNCT01423058

Sierra Oncology LLC - a GSK companyPost-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera, Primary Myelofibrosis

Start: 2011-08-31End: 2014-06-30Updated: 2019-02-04

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

RecruitingNCT04176198

Sumitomo Pharma America, Inc.Myelofibrosis

Start: 2019-12-16End: 2030-04-30Target: 240Updated: 2026-03-09

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

RecruitingNCT06150157

Janssen Research & Development, LLCNeoplasms

Start: 2023-12-20End: 2028-04-12Target: 220Updated: 2026-03-16

A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

RecruitingNCT06235801

M.D. Anderson Cancer CenterMyeloid Leukemia

Start: 2024-05-22End: 2029-10-01Target: 20Updated: 2025-11-19

Momelotinib During and After HCT in Myelofibrosis

RecruitingNCT07104799

Massachusetts General HospitalHematopoietic Cell Transplantation (HCT), Myelofibrosis

Start: 2026-02-23End: 2030-01-01Target: 28Updated: 2026-03-31

Phase 2

Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)

CompletedNCT01236638

Sierra Oncology LLC - a GSK companyPost-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Primary Myelofibrosis

Start: 2010-11-30End: 2014-06-30Updated: 2019-02-04

Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia

TerminatedNCT01998828

Sierra Oncology LLC - a GSK companyEssential Thrombocythemia, Polycythemia Vera

Start: 2014-02-19End: 2015-05-07Updated: 2020-04-20

Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia

CompletedNCT02124746

Sierra Oncology LLC - a GSK companyEssential Thrombocythemia, Polycythemia Vera, Post-Essential Thrombocythemia Myelofibrosis +2

Start: 2014-04-30End: 2018-12-06Updated: 2023-06-18

A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

RecruitingNCT05980806

Karyopharm Therapeutics IncMild Thrombocytopenia, Moderate Thrombocytopenia, Myelofibrosis

Start: 2024-04-22End: 2028-10-01Target: 58Updated: 2026-02-12

Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis

RecruitingNCT06517875

GlaxoSmithKlineMyelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis, Primary Myelofibrosis

Start: 2025-02-28End: 2026-11-13Target: 56Updated: 2025-12-16

A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome

RecruitingNCT06847867

GlaxoSmithKlineMyelodysplastic Syndromes

Start: 2025-06-05End: 2029-03-06Target: 80Updated: 2025-06-27

Phase 3

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

CompletedNCT01969838

Sierra Oncology LLC - a GSK companyPost-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Primary Myelofibrosis

Start: 2013-12-06End: 2019-05-02Updated: 2023-05-12

Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

TerminatedNCT02101021

Sierra Oncology LLC - a GSK companyMetastatic Pancreatic Ductal Adenocarcinoma

Start: 2014-06-02End: 2017-04-10Updated: 2023-06-29

Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF

CompletedNCT02101268

Sierra Oncology LLC - a GSK companyPost-essential Thrombocythemia Myelofibrosis (Post-ET MF), Post-polycythemia Vera (Post-PV), Primary Myelofibrosis (PMF)

Start: 2014-06-19End: 2019-04-25Updated: 2023-05-23

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)

CompletedNCT04173494

Sierra Oncology LLC - a GSK companyPost-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Primary Myelofibrosis

Start: 2020-02-07End: 2022-12-29Updated: 2023-11-01

Phase 4

Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts

Not yet recruitingNCT07498205

SWOG Cancer Research NetworkMyelofibrosis, Myelofibrosis (MF)

Start: 2026-08-08End: 2031-08-08Target: 268Updated: 2026-03-27

Unknown Phase

Managed Access Program for Momelotinib in Myelofibrosis

GlaxoSmithKlineMyelofibrosis, Primary Myelofibrosis

Updated: 2023-11-08

Related Papers

Impact of hemoglobin improvement with momelotinib on survival in patients with myelofibrosis and anemia: Post hoc analyses of the simplify-1 and momentum trials

Blood2025-11-031 citations

Dual transfusion independence and spleen volume reduction is associated with overall survival in patients with myelofibrosis treated with momelotinib: Post hoc analyses of SIMPLIFY-1 and MOMENTUM

Blood2025-11-03

Transfusion independence with momelotinib regardless of baseline erythropoietin levels in the Phase 3 SIMPLIFY-1 trial

Blood2025-11-03

Nuvisertib, an oral investigational selective PIM1 kinase inhibitor, showed clinical responses strongly correlating with cytokine modulation in patients with relapsed/refractory myelofibrosis in the ongoing global phase I/II study

Blood2025-11-03

Preliminary experience from the ODYSSEY trial: Efficacy and safety of momelotinib in combination with luspatercept in patients with transfusion-dependent myelofibrosis

Blood2025-11-03

Impact of new or worsening anemia and thrombocytopenia on clinical outcomes in JAK inhibitor–naive myelofibrosis patients treated with ruxolitinib

Blood2025-11-03

Survival outcomes in ruxolitinib-treated patients with myelofibrosis following crossover to momelotinib: Application of the response to ruxolitinib at 6 months (RR6) prognostic model to SIMPLIFY-1

Blood2025-11-03

Association between momelotinib exposure and hemoglobin improvement in patients with myelofibrosis and anemia: An exposure-response and time-to-event analysis

Blood2025-11-03

Preliminary data from the Phase I/II study of nuvisertib, an oral investigational selective PIM1 inhibitor, in combination with momelotinib showed clinical responses in patients with relapsed/refractory myelofibrosis

Blood2025-11-03

Abstract A098: Nuvisertib shows single-agent anti-tumor activity in multiple myeloma nonclinical models

Molecular Cancer Therapeutics2025-10-22

Efficacy and safety of momelotinib in Janus kinase inhibitor-experienced Asian patients with myelofibrosis and anemia

International Journal of Hematology2025-07-21

Time Without Transfusion Reliance (TWiTR): Integrating Survival Quality Into Myelofibrosis Treatment Strategies Based on the Phase 3 SIMPLIFY‐1, SIMPLIFY‐2, and MOMENTUM Trials

eJHaem2025-06-01

Odyssey: A Phase 2 Open-Label Study of Momelotinib in Combination with Luspatercept in Patients with Transfusion-Dependent Myelofibrosis

Blood2024-11-054 citations

A Phase 1/2 Study of Nuvisertib (TP-3654), an Investigational Selective PIM1 Kinase Inhibitor, in Combination with JAK Inhibitors Ruxolitinib or Momelotinib in Patients with Myelofibrosis

Blood2024-11-052 citations

Nuvisertib (TP-3654), an Investigational Selective PIM1 Kinase Inhibitor, Showed Durable Clinical Response and Sustained Hematological Improvement in Relapsed/Refractory Myelofibrosis Patients

Blood2024-11-051 citations

A Phase I/II Study of Gilteritinib and Momelotinib for Patients with Relapsed/Refractory <i>FLT3</i>-Mutated Acute Myeloid Leukemia: A Trial in Progress

Blood2024-11-05

Cytokine Modulation Correlates Strongly with Symptom Improvement in Patients with Myelofibrosis Treated with Nuvisertib (TP-3654), an Investigational Selective PIM1 Kinase Inhibitor

Blood2024-11-05

Longitudinal Assessment of Transfusion Intensity in Patients With JAK Inhibitor-Naive or -Experienced Myelofibrosis Treated With Momelotinib.

2024-10-167 citations

Momelotinib versus Continued Ruxolitinib or Best Available Therapy in JAK Inhibitor-Experienced Patients with Myelofibrosis and Anemia: Subgroup Analysis of SIMPLIFY-2

Advances in Therapy2024-07-1111 citations

Association between hemoglobin (Hb) improvement and patient-reported outcomes (PROs) in patients (pts) with myelofibrosis (MF) and anemia: Post hoc pooled analysis of momelotinib (MMB) phase 3 trials.

Journal of Clinical Oncology2024-06-012 citations

38 more papers not shown