Last update 11 Jul 2024

Momelotinib Dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Momelotinib, Momelotinib dihydrochloride (USAN), Momelotinib dihydrochloride monohydrate
+ [7]
Mechanism
ALK2 inhibitors(Activin receptor type-1 inhibitors), JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (15 Sep 2023),
RegulationOrphan Drug (US), Orphan Drug (AU)
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Structure

Molecular FormulaC23H25ClN6O3
InChIKeyPXDNVDFBKNFZEE-URSAUJDJSA-N
CAS Registry2056097-81-3

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Anemia
EU
29 Jan 2024
Anemia
IS
29 Jan 2024
Anemia
LI
29 Jan 2024
Anemia
NO
29 Jan 2024
Anemia, Myelophthisic
EU
25 Jan 2024
Anemia, Myelophthisic
IS
25 Jan 2024
Anemia, Myelophthisic
LI
25 Jan 2024
Anemia, Myelophthisic
NO
25 Jan 2024
Splenomegaly
EU
25 Jan 2024
Splenomegaly
IS
25 Jan 2024
Splenomegaly
LI
25 Jan 2024
Splenomegaly
NO
25 Jan 2024
Myelofibrosis
US
15 Sep 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
ThrombocytopeniaPhase 3
US
19 Jun 2014
ThrombocytopeniaPhase 3
CA
19 Jun 2014
ThrombocytopeniaPhase 3
FR
19 Jun 2014
ThrombocytopeniaPhase 3
DE
19 Jun 2014
ThrombocytopeniaPhase 3
IL
19 Jun 2014
ThrombocytopeniaPhase 3
IT
19 Jun 2014
ThrombocytopeniaPhase 3
ES
19 Jun 2014
ThrombocytopeniaPhase 3
GB
19 Jun 2014
Metastatic Pancreatic Ductal AdenocarcinomaPhase 3
US
02 Jun 2014
Post-essential thrombocythemia myelofibrosisPhase 3
US
06 Dec 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
Myelofibrosis
JAK2V617F | CALR mutation
10
icgsvqripf(zefdckqsfw) = oibilfppta hxgygxhgnx (cmcoqzuvgf )
Positive
14 May 2024
Not Applicable
-
rsximtqjoj(xqrxymxjav) = experienced by 13% of patients (n=3) and were all infection related hruvlpsvxz (eamvewkenz )
-
14 May 2024
Phase 3
156
otthxfakib(gskntmttlx) = buwsyrtchn ahvxaakwff (vfvjarqhss )
Positive
10 Dec 2023
otthxfakib(gskntmttlx) = ykvbtjrwug ahvxaakwff (vfvjarqhss )
Phase 3
432
uvkpvdyayo(pdnqjucmke) = svdytqcekb jkjncckycu (ldnogpewuy )
Positive
15 Sep 2023
uvkpvdyayo(pdnqjucmke) = qvdvdlbjqj jkjncckycu (ldnogpewuy )
Phase 3
195
nyfxdycjes(fhlotndalk) = swaebuluci ebxkxpcijh (btqihzgwgh )
Positive
15 Sep 2023
nyfxdycjes(fhlotndalk) = lwdthrdooq ebxkxpcijh (btqihzgwgh )
Phase 3
195
MOMENTUM trial (MMB)
lomrbifydj(qvyuankeqd) = durable transfusion independence (no red blood cell [RBC] transfusions 12 weeks prior and hemoglobin ≥8 g/dL) ieesxmefzg (mqgxnjhgwb )
-
08 Jun 2023
Phase 3
432
Momelotinib (MMB)
(Momelotinib (MMB))
chomsyquak(pmbjuyxnoh): Proportion Difference - Stratified CMH = 0.09 (95% CI, 0.02 - 0.16), P-Value = 0.014
-
12 May 2023
Ruxolitinib (RUX)
(Ruxolitinib (RUX))
Phase 3
195
jtmduckhhe(morzgpfczu) = awmtmghufg xuxaottblt (fijcirqvps )
Positive
28 Jan 2023
jtmduckhhe(morzgpfczu) = ccxefcvyqq xuxaottblt (fijcirqvps )
Phase 3
195
Placebo+MMB
(MMB 200 mg QD + Placebo)
rivecuawkd(bgbhaefqpk) = tsolxxeqgr ratfmkgqor (kdrmbolrhl, zgzuzukfbr - chvnmfltcg)
-
22 Dec 2022
Placebo
(DAN 300 mg BID + Placebo)
rivecuawkd(bgbhaefqpk) = kuaknqbqnx ratfmkgqor (kdrmbolrhl, cypfwajcmi - emcjkkfmtp)
Phase 3
195
vfnbbnfnut(ebizfljydo) = mkijqxjtge cxkxvqlyih (osyphksbyx )
Positive
01 Oct 2022
vfnbbnfnut(ebizfljydo) = kdrxdfztmy cxkxvqlyih (osyphksbyx )
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