Numerous clinical trials evaluate momelotinib across Early Phase 1 through Phase 4, focusing on primary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis, myelodysplastic syndromes, and VEXAS syndrome. These studies reflect diverse recruitment statuses—including completed, active, and not yet recruiting—and feature pivotal Phase 3 trials. Trial sponsors comprise industry organizations like GlaxoSmithKline and Sierra Oncology as well as academic centers such as M.D. Anderson Cancer Center and Johns Hopkins.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07498205 | NOT_YET_RECRUITING | Myelofibrosis; Myelofibrosis (MF) |
SWOG Cancer Research Network |
2026-08-08 | PHASE4 |
| NCT07569081 | NOT_YET_RECRUITING | VEXAS Syndrome |
GlaxoSmithKline |
2026-08-05 | PHASE2; PHASE3 |
| NCT07734077 | NOT_YET_RECRUITING | Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis |
John Mascarenhas |
2026-12-01 | PHASE1; PHASE2 |
| NCT07424950 | NOT_YET_RECRUITING | Myelofibrosis |
United Lincolnshire Hospitals NHS Trust |
2026-11-01 | PHASE2 |
| NCT07098936 | RECRUITING | VEXAS Syndome; Myelo Dysplastic Syndrome |
Groupe Francophone des Myelodysplasies |
2025-11-25 | PHASE2 |
| NCT07071155 | RECRUITING | Chronic Myelomonocytic Leukemia; Myelodysplastic Syndromes; Myeloproliferative Overlap Neoplasms; Chronic Neutrophilic Leukemia |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2026-03-19 | EARLY_PHASE1 |
| NCT07104799 | RECRUITING | Myelofibrosis; Hematopoietic Cell Transplantation (HCT) |
Massachusetts General Hospital |
2026-02-23 | PHASE1 |
| NCT06235801 | ACTIVE_NOT_RECRUITING | Myeloid Leukemia |
M.D. Anderson Cancer Center |
2024-05-22 | PHASE1; PHASE2 |
| NCT06847867 | RECRUITING | Myelodysplastic Syndromes |
GlaxoSmithKline |
2025-06-05 | PHASE2 |
| NCT05980806 | RECRUITING | Myelofibrosis; Moderate Thrombocytopenia; Mild Thrombocytopenia |
Karyopharm Therapeutics Inc |
2024-04-22 | PHASE2 |
| NCT04176198 | RECRUITING | Myelofibrosis |
Sumitomo Pharma America, Inc. |
2019-12-16 | PHASE1; PHASE2 |
| NCT06517875 | RECRUITING | Primary Myelofibrosis; Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis |
GlaxoSmithKline |
2025-02-28 | PHASE2 |
| NCT03441113 | ACTIVE_NOT_RECRUITING | Neoplasms; Post-polycythemia Vera Myelofibrosis (Post-PV MF); Primary Myelofibrosis (PMF); Post-essential Thrombocythemia Myelofibrosis (Post-ET MF); Primary Myelofibrosis |
GlaxoSmithKline |
2018-05-03 | PHASE2 |
| NCT06150157 | RECRUITING | Neoplasms |
Janssen Research & Development, LLC |
2023-12-20 | PHASE1 |
| NCT04173494 | COMPLETED | Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis |
Sierra Oncology LLC - a GSK company |
2020-02-07 | PHASE3 |
| NCT02124746 | COMPLETED | Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia |
Sierra Oncology LLC - a GSK company |
2014-04-30 | PHASE2 |
| NCT02515630 | COMPLETED | Primary Myelofibrosis (PMF); Post-polycythemia Vera (Post-PV) Myelofibrosis; Postessential Thrombocythemia (Post-ET) Myelofibrosis |
Sierra Oncology LLC - a GSK company |
2016-01-29 | PHASE2 |
| NCT02101021 | TERMINATED | Metastatic Pancreatic Ductal Adenocarcinoma |
Sierra Oncology LLC - a GSK company |
2014-06-02 | PHASE3 |
| NCT02244489 | TERMINATED | Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma |
Sierra Oncology LLC - a GSK company |
2014-11-05 | PHASE1 |
| NCT02206763 | TERMINATED | EGFR Mutated EGFR TKI Naive Metastatic NSCLC |
Sierra Oncology LLC - a GSK company |
2014-10-16 | PHASE1 |
| NCT01969838 | COMPLETED | Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis |
Sierra Oncology LLC - a GSK company |
2013-12-06 | PHASE3 |
| NCT02101268 | COMPLETED | Primary Myelofibrosis (PMF); Post-polycythemia Vera (Post-PV); Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) |
Sierra Oncology LLC - a GSK company |
2014-06-19 | PHASE3 |
| NCT02258607 | TERMINATED | Relapsed Metastatic KRAS-Mutated Non-Small Cell Lung Cancer |
Sierra Oncology LLC - a GSK company |
2015-03-11 | PHASE1 |
| NCT01998828 | TERMINATED | Polycythemia Vera; Essential Thrombocythemia |
Sierra Oncology LLC - a GSK company |
2014-02-19 | PHASE2 |
| NCT01236638 | COMPLETED | Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis |
Sierra Oncology LLC - a GSK company |
2010-11 | PHASE2 |
| NCT01423058 | COMPLETED | Primary Myelofibrosis; Post-Polycythemia Vera; Post-Essential Thrombocythemia Myelofibrosis |
Sierra Oncology LLC - a GSK company |
2011-08 | PHASE1; PHASE2 |
| NCT00935987 | COMPLETED | Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis |
Sierra Oncology LLC - a GSK company |
2009-11 | PHASE1; PHASE2 |
| NCT01236638 | Completed | Primary Myelofibrosis|Post-Polycythemia Vera Myelofibrosis|Post-Essential Thrombocythemia Myelofibrosis |
Sierra Oncology LLC - a GSK company |
2010-11 | Phase 2 |
| NCT00935987 | Completed | Primary Myelofibrosis|Post-Polycythemia Vera Myelofibrosis|Post-Essential Thrombocythemia Myelofibrosis |
Sierra Oncology LLC - a GSK company |
2009-11 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2026-08-28)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Momelotinib (CYT387) Mechanism of Action: JAK2 Inhibition in Hematopoietic Stem Cell Research
- Momelotinib (CYT387): Selectivity & Specificity
- Momelotinib (CYT387) Working Concentration | Cell Culture | Treatment
- Momelotinib (CYT387) Solubility in DMSO
- Momelotinib (CYT387) Storage
- Momelotinib (CYT387) Stability
- Momelotinib (CYT387) Combination Database
- Momelotinib (CYT387) Molecular Weight
- Momelotinib (CYT387) SMILES
- Momelotinib (CYT387) CAS Number
- Momelotinib (CYT387) Chemical Structure (2D and 3D)
- Momelotinib (CYT387) IC50 for Cell-based and Cell-free Assays
- Momelotinib (CYT387) MedChemExpress (HY-10961)? Try a better option.
- Momelotinib (CYT387) Cayman (16246)? Try a better option.
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- Momelotinib (CYT387) SDS|MSDS