Drug Type Small molecule drug |
Synonyms Momelotinib, Momelotinib dihydrochloride (USAN), Momelotinib dihydrochloride monohydrate + [11] |
Target |
Action inhibitors |
Mechanism ALK2 inhibitors(Activin receptor type-1 inhibitors), JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (15 Sep 2023), |
RegulationOrphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia) |
Molecular FormulaC23H26Cl2N6O3 |
InChIKeyRQKCPSIFARJBOR-UHFFFAOYSA-N |
CAS Registry1841094-17-4 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10358D10889 | Momelotinib Dihydrochloride | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Post-essential thrombocythemia myelofibrosis | Canada | 12 Nov 2024 | |
Post-polycythemia vera myelofibrosis | Canada | 12 Nov 2024 | |
Primary Myelofibrosis | Canada | 12 Nov 2024 | |
Anemia | United Kingdom | 30 Jan 2024 | |
Anemia, Myelophthisic | European Union | 25 Jan 2024 | |
Anemia, Myelophthisic | Iceland | 25 Jan 2024 | |
Anemia, Myelophthisic | Liechtenstein | 25 Jan 2024 | |
Anemia, Myelophthisic | Norway | 25 Jan 2024 | |
Splenomegaly | European Union | 25 Jan 2024 | |
Splenomegaly | Iceland | 25 Jan 2024 | |
Splenomegaly | Liechtenstein | 25 Jan 2024 | |
Splenomegaly | Norway | 25 Jan 2024 | |
Myelofibrosis | United States | 15 Sep 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Thrombocytopenia | Phase 3 | United States | 19 Jun 2014 | |
Thrombocytopenia | Phase 3 | Canada | 19 Jun 2014 | |
Thrombocytopenia | Phase 3 | France | 19 Jun 2014 | |
Thrombocytopenia | Phase 3 | Germany | 19 Jun 2014 | |
Thrombocytopenia | Phase 3 | Israel | 19 Jun 2014 | |
Thrombocytopenia | Phase 3 | Italy | 19 Jun 2014 | |
Thrombocytopenia | Phase 3 | Spain | 19 Jun 2014 | |
Thrombocytopenia | Phase 3 | United Kingdom | 19 Jun 2014 | |
Metastatic Pancreatic Ductal Adenocarcinoma | Phase 3 | United States | 02 Jun 2014 | |
Myelodysplastic Syndromes | Phase 2 | - | 07 Apr 2025 |
Not Applicable | - | - | nhxixbyibk(efmrlikvdh): HR = 0.373 (95% CI, 0.297 - 0.469), P-Value = <.001 | - | 08 Dec 2024 | ||
Best Available Therapy (BAT) | |||||||
Not Applicable | - | vlrrdzcxzy(twldepjmfy) = jimbejstwo tgcefaxjji (qenbmiorff ) View more | - | 07 Dec 2024 | |||
Phase 2/3 | Myelofibrosis JAK inhibitor-naive | - | epxgvdyutv(nqlvwhntyp) = qrjowkxkol vfyrxzjxtt (wlmrspjncw ) | Positive | 01 Oct 2024 | ||
epxgvdyutv(nqlvwhntyp) = gythqcprjd vfyrxzjxtt (wlmrspjncw ) | |||||||
Not Applicable | - | - | vcvsnnfaky(wregxhcjtv) = cezknfukru irindqeyop (pwnuowqpae, 1.0) | - | 04 Sep 2024 | ||
Not Applicable | - | rcleyuxfld(rkejwoyqgi) = Common reasons for stopping MOM/PAC were adverse events (n=3; AKI, diarrhea, rash) kugtvprjun (odnxyosfmu ) View more | - | 04 Sep 2024 | |||
Not Applicable | - | xuxscugluw(xtzgwphnrc) = efnmzkmcdy armdyjssgw (letvytystl ) | - | 04 Sep 2024 | |||
Pacritinib (PAC) | xuxscugluw(xtzgwphnrc) = rspeumypst armdyjssgw (letvytystl ) | ||||||
Phase 3 | 480 | (Hemoglobin improvement) | koietmdogo(cjlohevnqv) = rungmftqvy pwhsnehvwc (grajrwvwwj ) View more | Positive | 04 Sep 2024 | ||
(No hemoglobin improvement) | koietmdogo(cjlohevnqv) = kluiknzbbp pwhsnehvwc (grajrwvwwj ) View more | ||||||
Phase 3 | 156 | bkdhgmmdox(qpyinsoeun) = were generally higher in both subgroups with momelotinib cicprdndfx (eujafmkhoh ) | Positive | 11 Jul 2024 | |||
Continued Ruxolitinib or Best Available Therapy | |||||||
Phase 2/3 | Myelofibrosis JAK2V617F | CALR mutation | 10 | vbsfcwnxht(oxboxodylk) = zayebnulbf nipgmuorlm (xzlkmgzzzf ) | Positive | 14 May 2024 | ||
Not Applicable | - | hpjfxnewbp(lclqibpghu) = fovzkudqwv qxrfllsmff (pvqhjbittn ) View more | Positive | 14 May 2024 |