Drugs / Momelotinib

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Omjjara 2024-01-25 europa.eu
Approved US (FDA) OJJAARA 2023-09-15 fda.gov

Trials 23 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07071155 Mar 2026 → Mar 2028 expected chronic myelomonocytic leukemia, chronic neutrophilic leukemia, myelodysplastic syndrome Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 15 trials
Phase 1 NCT07104799 Feb 2026 → Jan 2028 expected disease related to hematopoietic stem cell transplant, myelofibrosis Massachusetts General Hospital Recruiting No outcome recorded
Phase 1 NCT06150157 Dec 2023 → Dec 2026 expected neoplasm Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 1 NCT02258607 Mar 2015 → Jul 2016 Sierra Oncology LLC - a GSK company Terminated No outcome recorded
Phase 1 NCT02244489 Nov 2014 → Mar 2017 Sierra Oncology LLC - a GSK company Terminated No outcome recorded
Phase 1 NCT02206763 Oct 2014 → Jan 2017 Sierra Oncology LLC - a GSK company Terminated No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT06235801 May 2024 → Oct 2027 expected myeloid leukemia M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 1/2 NCT01423058 Aug 2011 → Jun 2014 acquired polycythemia vera, myelofibrosis, primary myelofibrosis Sierra Oncology LLC - a GSK company Completed No outcome recorded
Phase 1/2 NCT00935987 Nov 2009 → Apr 2012 myelofibrosis, primary myelofibrosis Sierra Oncology LLC - a GSK company Completed No outcome recorded
Phase 28 trials
Phase 2 NCT07098936 Nov 2025 → Jun 2028 expected VEXAS syndrome, myelodysplastic syndrome Groupe Francophone des Myelodysplasies Recruiting No outcome recorded
Phase 2 NCT06847867 Jun 2025 → Jul 2027 expected myelodysplastic syndrome GlaxoSmithKline Recruiting No outcome recorded
Phase 2 NCT06517875 Feb 2025 → Mar 2027 expected myelofibrosis, primary myelofibrosis GlaxoSmithKline Recruiting No outcome recorded
Phase 2 NCT03441113 May 2018 → Dec 2026 expected myelofibrosis, primary myelofibrosis GlaxoSmithKline Active not recruiting No outcome recorded
Phase 2 NCT02515630 Jan 2016 → Jul 2017 myelofibrosis, primary myelofibrosis Sierra Oncology LLC - a GSK company Completed No outcome recorded
Phase 2 NCT02124746 Apr 2014 → Dec 2018 acquired polycythemia vera, essential thrombocythemia, myelofibrosis, primary myelofibrosis Sierra Oncology LLC - a GSK company Completed No outcome recorded
Phase 2 NCT01998828 Feb 2014 → Mar 2015 acquired polycythemia vera, essential thrombocythemia Sierra Oncology LLC - a GSK company Terminated No outcome recorded
Phase 2 NCT01236638 Nov 2010 → Jun 2014 myelofibrosis, primary myelofibrosis Sierra Oncology LLC - a GSK company Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07569081 Aug 2026 → Dec 2028 expected VEXAS syndrome GlaxoSmithKline Not yet recruiting No outcome recorded
Phase 34 trials
Phase 3 NCT04173494 Feb 2020 → Dec 2021 myelofibrosis, primary myelofibrosis Sierra Oncology LLC - a GSK company Completed No outcome recorded
Phase 3 NCT02101268 Jun 2014 → Jul 2016 acquired polycythemia vera, myelofibrosis, primary myelofibrosis Sierra Oncology LLC - a GSK company Completed No outcome recorded
Phase 3 NCT02101021 Jun 2014 → Apr 2017 pancreatic ductal adenocarcinoma Sierra Oncology LLC - a GSK company Terminated No outcome recorded
Phase 3 NCT01969838 Dec 2013 → Sep 2016 myelofibrosis, primary myelofibrosis Sierra Oncology LLC - a GSK company Completed No outcome recorded
Phase not stated1 trial
NCT05582083 myelofibrosis, primary myelofibrosis GlaxoSmithKline No longer available No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT04176198 Background Dec 2019 → Apr 2027 expected myelofibrosis Sumitomo Pharma America, Inc. Recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT07424950 Background Nov 2026 → Nov 2028 expected myelofibrosis United Lincolnshire Hospitals NHS Trust Not yet recruiting No outcome recorded
Phase 2 NCT05980806 Background Apr 2024 → Jun 2027 expected myelofibrosis, thrombocytopenia Karyopharm Therapeutics Inc Recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT07498205 Comparator Aug 2026 → Aug 2029 expected myelofibrosis SWOG Cancer Research Network Not yet recruiting No outcome recorded

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as Momelotinib “assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis” NCT03441113
25

Momelotinib (MMB) tablet administered orally once daily” NCT02515630

Momelotinib 200 mg QD alone” NCT07424950

NCT06235801

NCT01423058

NCT01969838

NCT07104799

NCT07071155

NCT02244489

NCT02124746

NCT05582083

NCT01998828

NCT02258607

NCT07498205

NCT06517875

NCT07098936

NCT06150157

NCT02101021

NCT05980806

NCT02206763

NCT01236638

NCT04173494

NCT06847867

NCT02101268

NCT07569081

NCT04176198

Known as CYT-0387 ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as CYT-11387 ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as CYT-11387 DIHYDROCHLORIDE MONOHYDRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as CYT-387 DIHYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as CYT-387 DIHYDROCHLORIDE MONOHYDRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as CYT387 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00935987
Known as GS-0387 ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as MMB “This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of momelotinib (MMB) and erlotinib” NCT02206763
4

“assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis” NCT03441113

“Momelotinib (MMB) tablet(s) administered orally once or twice daily” NCT02244489

“Momelotinib (MMB) tablet administered orally once daily” NCT02515630

“Momelotinib (MMB)” NCT02258607

Known as MOMELOTINIB DIHYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as Momelotinib hydrochloride hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as Ojjaara ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Known as Omjjara ChEMBL registry synonym — accepted as the source's own label CHEMBL1078178
Action Inhibit “Momelotinib, a small-molecule inhibitor of Janus kinase 1 and Janus kinase 2” PMID 27634203 Sep 2016
Modality Small molecule “Momelotinib, a small-molecule inhibitor of Janus kinase 1 and Janus kinase 2” PMID 27634203 Sep 2016
Route Oral “CYT387 will be orally self-administered as a single daily dose” NCT00935987
Target ACVR1 “also inhibit activin A receptor type 1 (ACVR1)” PMID 37042865 Jul 2023
Target JAK1 “inhibitor of Janus kinase 1 (JAK1)” PMID 37042865 Jul 2023
Target JAK2 “inhibitor of Janus kinase 1 (JAK1) and JAK2PMID 37042865 Jul 2023