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
Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- EGFR Mutated EGFR TKI Naive Metastatic NSCLC
- Interventions
- First Posted Date
- 2014-08-01
- Last Posted Date
- 2019-02-01
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 11
- Registration Number
- NCT02206763
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
- Conditions
- Polycythemia VeraEssential ThrombocythemiaPost-Polycythemia Vera MyelofibrosisPrimary MyelofibrosisPost-Essential Thrombocythemia Myelofibrosis
- Interventions
- First Posted Date
- 2014-04-28
- Last Posted Date
- 2023-06-18
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 87
- Registration Number
- NCT02124746
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
- Conditions
- Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)Post-polycythemia Vera (Post-PV)Primary Myelofibrosis (PMF)
- Interventions
- Drug: Best Available Therapy (BAT)
- First Posted Date
- 2014-04-02
- Last Posted Date
- 2023-05-23
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 156
- Registration Number
- NCT02101268
Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
- Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Interventions
- First Posted Date
- 2014-04-01
- Last Posted Date
- 2023-06-29
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 25
- Registration Number
- NCT02101021
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Indiana University Health Goshen Center for Cancer Care, Goshen, Indiana, United States
🇺🇸Cedars-Sinai Medical Center, Los Angeles, California, United States
Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
- First Posted Date
- 2013-12-02
- Last Posted Date
- 2020-04-20
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 39
- Registration Number
- NCT01998828
Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
- Conditions
- Primary MyelofibrosisPost-Polycythemia Vera MyelofibrosisPost-Essential Thrombocythemia Myelofibrosis
- Interventions
- Drug: Placebo to match ruxolitinibDrug: Placebo to match momelotinib
- First Posted Date
- 2013-10-25
- Last Posted Date
- 2023-05-12
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 432
- Registration Number
- NCT01969838
Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis
- Conditions
- Post-Polycythemia VeraPrimary MyelofibrosisPost-Essential Thrombocythemia Myelofibrosis
- Interventions
- First Posted Date
- 2011-08-25
- Last Posted Date
- 2019-02-04
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 61
- Registration Number
- NCT01423058
- Locations
- 🇺🇸
Mayo Clinic, Jacksonville, Florida, United States
🇺🇸MD Anderson Cancer Center, The University of Texas, Houston, Texas, United States
🇨🇦Princess Margaret Hospital, Toronto, Ontario, Canada
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)
- Conditions
- Post-Essential Thrombocythemia MyelofibrosisPrimary MyelofibrosisPost-Polycythemia Vera Myelofibrosis
- Interventions
- First Posted Date
- 2010-11-08
- Last Posted Date
- 2019-02-04
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 120
- Registration Number
- NCT01236638
- Locations
- 🇨🇦
Jewish General Hospital, Montreal, Quebec, Canada
🇺🇸Stanford Cancer Center, Stanford, California, United States
🇨🇦Princess Margaret Hospital, Toronto, Ontario, Canada
Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)
- Conditions
- Primary MyelofibrosisPost-Polycythemia Vera MyelofibrosisPost-Essential Thrombocythemia Myelofibrosis
- Interventions
- First Posted Date
- 2009-07-09
- Last Posted Date
- 2019-02-01
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- Target Recruit Count
- 166
- Registration Number
- NCT00935987
- Locations
- 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸Stanford Cancer Center, Stanford, California, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.