Last update 21 Nov 2024

Momelotinib Dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Momelotinib, Momelotinib Hydrochloride Hydrate, Momelotinib dihydrochloride (USAN)
+ [10]
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)
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Structure

Molecular FormulaC23H24Cl2N6O2
InChIKeyIPNATXQRPWRHKD-UHFFFAOYSA-N
CAS Registry1380317-28-1
View All Structures (3)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Post-essential thrombocythemia myelofibrosis
CA
12 Nov 2024
Post-polycythemia vera myelofibrosis
CA
12 Nov 2024
Primary Myelofibrosis
CA
12 Nov 2024
Anemia
GB
30 Jan 2024
Anemia, Myelophthisic
LI
25 Jan 2024
Anemia, Myelophthisic
IS
25 Jan 2024
Anemia, Myelophthisic
NO
25 Jan 2024
Anemia, Myelophthisic
EU
25 Jan 2024
Splenomegaly
IS
25 Jan 2024
Splenomegaly
EU
25 Jan 2024
Splenomegaly
LI
25 Jan 2024
Splenomegaly
NO
25 Jan 2024
Myelofibrosis
US
15 Sep 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AnemiaNDA/BLA
CA
30 Jan 2024
MyelofibrosisNDA/BLA
CA
30 Jan 2024
Post-essential thrombocythemia myelofibrosisPhase 3
DE
06 Dec 2013
Post-essential thrombocythemia myelofibrosisPhase 3
IL
06 Dec 2013
Post-essential thrombocythemia myelofibrosisPhase 3
BE
06 Dec 2013
Post-essential thrombocythemia myelofibrosisPhase 3
AT
06 Dec 2013
Post-essential thrombocythemia myelofibrosisPhase 3
TW
06 Dec 2013
Post-essential thrombocythemia myelofibrosisPhase 3
HU
06 Dec 2013
Post-essential thrombocythemia myelofibrosisPhase 3
AU
06 Dec 2013
Post-essential thrombocythemia myelofibrosisPhase 3
PL
06 Dec 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
(hjytjvlptf): HR = 0.373 (95% CI, 0.297 - 0.469), P-Value = <.001
-
08 Dec 2024
Best Available Therapy (BAT)
Not Applicable
-
uwbfodtwbb(ynrgexpzxg) = uqsaojcqvz uojnmflung (rqmupckbgq )
-
07 Dec 2024
Not Applicable
-
cehdqdahop(crlphwqwxw) = Common reasons for stopping MOM/PAC were adverse events (n=3; AKI, diarrhea, rash) qmlsayoogw (bjkmwcrwes )
-
04 Sep 2024
Phase 3
480
(Hemoglobin improvement)
jxhqmdgvne(rdwypdvsgg) = ofyfilzhke phehetdabq (cteousksey )
Positive
04 Sep 2024
(No hemoglobin improvement)
jxhqmdgvne(rdwypdvsgg) = krewjxqqzq phehetdabq (cteousksey )
Not Applicable
-
(jxektrfnxx) = bglorcxlfa kxpetkcddd (ptatdkglkc )
-
04 Sep 2024
Pacritinib (PAC)
(jxektrfnxx) = apitedqfxn kxpetkcddd (ptatdkglkc )
Phase 3
156
bdqdubggcl(wugcggpglp) = were generally higher in both subgroups with momelotinib vrgbzppbra (rlawenzdcz )
Positive
11 Jul 2024
Continued Ruxolitinib or Best Available Therapy
Phase 2/3
Myelofibrosis
JAK2V617F | CALR mutation
10
(ipnmqkfoif) = zzbnksncex lvsnlyrciq (oinqwksbdc )
Positive
14 May 2024
Not Applicable
-
wnrgqxnnhi(ikmsirkagh) = experienced by 13% of patients (n=3) and were all infection related suxraqdiqv (xcmeocaejz )
-
14 May 2024
Not Applicable
-
lqnsmitgte(fpoxwucyuy) = vnohnvoqef pnnwlvuwak (ayfsqwcrbk )
Positive
14 May 2024
Phase 3
156
(uxuocextrt) = msimpkqzem pqnmdknpna (mmqobwskbx )
Positive
10 Dec 2023
(uxuocextrt) = lggmmwxgsg pqnmdknpna (mmqobwskbx )
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Regulation

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