Drugs / Momelotinib
Momelotinib
also known as
MMB · CYT-0387 · CYT-11387 · CYT-11387 DIHYDROCHLORIDE MONOHYDRATE · CYT-387 DIHYDROCHLORIDE · CYT-387 DIHYDROCHLORIDE MONOHYDRATE · CYT387 · GS-0387 · +5 more
Small molecule targets ACVR1, JAK1, JAK2, TBK1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed familial myelofibrosis 2 milestones | |||||
| Filed | Japan (PMDA) | — | familial myelofibrosis | 2023-09-11 | “Ministry of Health, Labour and Welfare (MHLW), Japan, has accepted for review a new drug application (NDA) for momelotinib” gsk.com ↗ |
| Filed | EU (EMA) | — | familial myelofibrosis | 2022-12-02 | “European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for momelotinib” gsk.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Omjjara | — | 2024-01-25 | europa.eu ↗ |
| Approved | US (FDA) | OJJAARA | — | 2023-09-15 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | 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 · 1 missed | ||||||
| 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 | Missed primary |
| 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 · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT04173494 | Feb 2020 → Dec 2021 | myelofibrosis, primary myelofibrosis | Sierra Oncology LLC - a GSK company | Completed | Met primary |
| Phase 3 | NCT02101268 | Jun 2014 → Jul 2016 | acquired polycythemia vera, myelofibrosis, primary myelofibrosis | Sierra Oncology LLC - a GSK company | Completed | Missed primary |
| 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 | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT05582083 | — | myelofibrosis, primary myelofibrosis | GlaxoSmithKline | No longer available | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1/2 | NCT04176198 Background | Dec 2019 → Apr 2027 expected | myelofibrosis | Sumitomo Pharma America, Inc. | Recruiting | No outcome recorded |
| 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 4 | NCT07498205 Comparator | Nov 2026 → Aug 2029 expected | myelofibrosis | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | GlaxoSmithKline | Regulatory GSK’s momelotinib granted Orphan Drug Designations in the US and EU for VEXAS syndrome gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that momelotinib, a JAK inhibitor with a differentiated mechanism of action, has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of VEXAS (Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic) syndrome. |
| 2026-05-26 | GlaxoSmithKline | Results GSK to showcase long-term outcomes and pipeline expansion with latest oncology research at ASCO and EHA gsk.com ↗
New analyses will show Ojjaara/Omjjara (momelotinib) delivers benefit across patient subgroups including when switching from ruxolitinib |
| 2025-05-29 | GlaxoSmithKline | Results GSK data at ASCO and EHA showcase latest research and innovation across the oncology portfolio gsk.com ↗
New analyses from MOMENTUM and SIMPLIFY-1 trials at EHA emphasise importance of early intervention with momelotinib |
| 2024-06-24 | GlaxoSmithKline | Regulatory GSK’s Omjjara (momelotinib) approved in Japan for treatment of myelofibrosis gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Omjjara (momelotinib) for the treatment of myelofibrosis. |
| 2024-01-29 | GlaxoSmithKline | Regulatory European Commission authorises GSK’s Omjjara (momelotinib) gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the European Commission* granted marketing authorisation for Omjjara (momelotinib), a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. |
| 2023-11-13 | GlaxoSmithKline | Regulatory GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia gsk.com ↗
The CHMP opinion is one of the final steps prior to a marketing authorisation decision by the European Commission. |
| 2023-09-15 | GlaxoSmithKline | Regulatory Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia. |
| 2023-09-11 | GlaxoSmithKline | Regulatory GSK regulatory submission for momelotinib for the treatment of myelofibrosis accepted for review by Japanese regulator gsk.com ↗ |
| 2023-06-16 | GlaxoSmithKline | Regulatory GSK announces extension of FDA review period for momelotinib gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data. |
| 2022-12-11 | GlaxoSmithKline | Results New data at ASH underscore the potential for durable, clinically important responses with momelotinib for myelofibrosis patients gsk.com ↗
Additionally, new analyses from MOMENTUM showed that TI response with momelotinib at week 24 was associated with overall survival. |
| 2022-12-02 | GlaxoSmithKline | Regulatory European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for momelotinib, a potential new oral treatment for myelofibrosis. |
| 2022-08-17 | GlaxoSmithKline | Regulatory US FDA accepts new drug application for GSK’s momelotinib for the treatment of myelofibrosis gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for momelotinib, a potential new medicine with a proposed differentiated mechanism of action that may address the significant unmet medical needs of myelofibrosis patients with anaemia. |
All press releases naming this drug 12 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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 JAK2” PMID 37042865 ↗ Jul 2023 |