Momelotinib
- Generic Name
- Momelotinib
- Brand Names
- Ojjaara, Omjjara
- Drug Type
- Small Molecule
- Chemical Formula
- C23H22N6O2
- CAS Number
- 1056634-68-4
- Unique Ingredient Identifier
- 6O01GMS00P
- Background
Momelotinib is a Janus Kinase 1 (JAK1) and 2 (JAK2) inhibitor. It is a competitive inhibitor of JAK ATP binding. First approved by the FDA on September 15, 2023, momelotinib is used to treat myelofibrosis. Myelofibrosis (MF) is a group of myeloproliferative neoplasms characterized by abnormal proliferative hematopoietic stem cells, leading to the release of cytokines and growth factors. MF includes primary MF (PMF), post-polycythemia vera (PV) MF, and post-essential thrombocythemia (ET) MF. Clinical manifestations of MF include anemia and thrombocytosis. Momelotinib works to block the JAK-signal transducer and activator of transcription (STAT) signalling pathway, which is aberrant in MF.
- Indication
Momelotinib is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [postpolycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.
- Associated Conditions
- High risk Myelofibrosis, Intermediate risk Myelofibrosis
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
- First Posted Date
- 2025-02-26
- Last Posted Date
- 2025-03-12
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 80
- Registration Number
- NCT06847867
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
- Conditions
- Primary MyelofibrosisMyelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
- Interventions
- First Posted Date
- 2024-07-24
- Last Posted Date
- 2025-03-26
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 56
- Registration Number
- NCT06517875
- Locations
- 🇺🇸
GSK Investigational Site, Nashville, Tennessee, United States
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
- First Posted Date
- 2024-02-01
- Last Posted Date
- 2025-05-22
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 20
- Registration Number
- NCT06235801
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
- Conditions
- Moderate ThrombocytopeniaMyelofibrosis
- Interventions
- First Posted Date
- 2023-08-08
- Last Posted Date
- 2025-02-05
- Lead Sponsor
- Karyopharm Therapeutics Inc
- Target Recruit Count
- 118
- Registration Number
- NCT05980806
- Locations
- 🇧🇬
University Multiprofile Hospital for Active Treatment Sveti George - Base 1, Plovdiv, Bulgaria
🇧🇬University Hospital Sv.Ivan Rilski - Sofia, Sofia, Bulgaria
🇫🇷CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire, Tours Cedex 01, Indre-et-Loire, France
Managed Access Program for Momelotinib in Myelofibrosis
- Conditions
- MyelofibrosisPrimary Myelofibrosis
- First Posted Date
- 2022-10-17
- Last Posted Date
- 2023-11-08
- Lead Sponsor
- GlaxoSmithKline
- Registration Number
- NCT05582083
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis
- Conditions
- Myelofibrosis
- Interventions
- First Posted Date
- 2022-05-12
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- Geron Corporation
- Target Recruit Count
- 51
- Registration Number
- NCT05371964
- Locations
- 🇺🇸
Texas Oncology, Tyler, Texas, United States
🇺🇸City of Hope, Irvine, California, United States
🇺🇸University of Miami, Coral Gables, Florida, United States
A Study of Oral TP-3654 in Patients With Myelofibrosis
- Conditions
- Myelofibrosis
- Interventions
- First Posted Date
- 2019-11-25
- Last Posted Date
- 2025-01-28
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 240
- Registration Number
- NCT04176198
- Locations
- 🇯🇵
Hokkaido University Hospital, Hokkaido, Japan
🇯🇵Mie University Hospital, Tsu, Japan
🇺🇸University of Alabama, Birmingham, Alabama, United States
A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)
- Conditions
- Post-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia MyelofibrosisPrimary Myelofibrosis
- Interventions
- First Posted Date
- 2019-11-22
- Last Posted Date
- 2023-11-01
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 195
- Registration Number
- NCT04173494
- Locations
- 🇺🇸
Irvine Center for Clinical Research, Irvine, California, United States
🇺🇸Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇨🇦Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Efficacy and Safety of Momelotinib Combined With Trametinib in Adults With Metastatic KRAS-mutated Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Platinum-Based Chemotherapy Preceded by a Dose-finding Lead-in Phase
- Conditions
- Relapsed Metastatic KRAS-Mutated Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2014-10-07
- Last Posted Date
- 2019-02-01
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 21
- Registration Number
- NCT02258607
Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
- Conditions
- Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
- Interventions
- First Posted Date
- 2014-09-19
- Last Posted Date
- 2019-02-01
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 16
- Registration Number
- NCT02244489
- Locations
- 🇺🇸
Scottsdale Healthcare Research Institute, Scottsdale, Arizona, United States
🇺🇸Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸Tennessee Oncology, Nashville, Tennessee, United States
Drug Development Updates
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