Clinical Trials

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)

Check the Momelotinib (CYT387) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Momelotinib functions as an ATP-competitive inhibitor that selectively binds Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2), thereby suppressing downstream STAT5 phosphorylation and intracellular signaling pathways. This inhibition impairs the growth of mutant JAK2-expressing cells and induces apoptosis and autophagy, providing clinical therapeutic utility in treating myelofibrosis conditions such as primary myelofibrosis and post-polycythemia vera myelofibrosis.

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>).

Note: Technical data last updated: Sep 1, 2026.