Last update 21 Nov 2024

Midostaurin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4'-N-benzoylstaurosporine, 4-N-benzoyl staurosporine, Benzoylstaurosporine
+ [14]
Mechanism
FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), PKC inhibitors(Protein kinase C inhibitors)
+ [3]
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Orphan Drug (EU), Breakthrough Therapy (US), Priority Review (US)
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Structure

Molecular FormulaC35H30N4O4
InChIKeyBMGQWWVMWDBQGC-IIFHNQTCSA-N
CAS Registry120685-11-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Aggressive Systemic Mastocytosis
KR
14 Feb 2019
FLT3 positive Acute Myeloid Leukemia
IS
18 Sep 2017
FLT3 positive Acute Myeloid Leukemia
NO
18 Sep 2017
FLT3 positive Acute Myeloid Leukemia
LI
18 Sep 2017
FLT3 positive Acute Myeloid Leukemia
EU
18 Sep 2017
Mast-Cell Leukemia
NO
18 Sep 2017
Mast-Cell Leukemia
IS
18 Sep 2017
Mast-Cell Leukemia
LI
18 Sep 2017
Mast-Cell Leukemia
EU
18 Sep 2017
Acute Myeloid Leukemia
US
28 Apr 2017
Systemic Mastocytosis
US
28 Apr 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 2
EE
13 Feb 2018
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 2
FI
13 Feb 2018
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 2
ES
13 Feb 2018
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 2
NO
13 Feb 2018
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 2
SE
13 Feb 2018
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 2
SK
13 Feb 2018
FLT3 positive Acute Myeloid LeukemiaPhase 2
US
01 Apr 2008
FLT3 positive Acute Myeloid LeukemiaPhase 2
CA
01 Apr 2008
FLT3 positive Acute Myeloid LeukemiaPhase 2
US
01 Apr 2008
FLT3 positive Acute Myeloid LeukemiaPhase 2
CA
01 Apr 2008
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
(ywjjoktvhw) = qhfzrrochb fwossrwyfo (xvqqzmsttc )
-
09 Dec 2024
(ywjjoktvhw) = akqusbndpa fwossrwyfo (xvqqzmsttc )
Not Applicable
-
-
xobbpvrcgk(prmuoxvsgo) = grade >=3 TRAE was reported in 73%G vs 70% M during induction and 79%G vs 73%M pts during consolidation vivbksyprg (uholmoyxij )
-
07 Dec 2024
Not Applicable
FLT3-TKD | FLT3-ITD
717
(rcinmkmmbo) = qpaxgzhkix zubtfjexhj (ctlcatqwhn, 38.7 - 49.3)
Positive
07 Dec 2024
Placebo
(rcinmkmmbo) = ciciyommpe zubtfjexhj (ctlcatqwhn, 33.6 - 44.4)
Phase 3
First line
175
Midostaurin plus Intensive Chemotherapy
tcvbbgpwxh(cpievibamk) = 26 pts (14.8%) had Midos interruption dfuvasxrlf (fmkxhqimvo )
Positive
04 Sep 2024
Phase 2/3
76
(Azacitidine)
(idmprmdxsu) = pbhsbifjif luvrbkjkze (bnrjubcdsr, wprwmkjgdm - qzaamfjibv)
-
23 Jul 2024
Nivolumab+Azacitidine
(Azacitidine + Nivolumab)
(idmprmdxsu) = bcotrlthjf luvrbkjkze (bnrjubcdsr, xmtyyrrohl - qxjakthjvs)
Not Applicable
76
Midostaurin plus intensive chemotherapy since induction
(sbbqucyfum) = wkkkkdrzdw wfujyhnfxm (xvorgexbyu )
Positive
14 May 2024
Midostaurin plus intensive chemotherapy since consolidation
(gaupoecidq) = vxdresriru jcrvbgfbvf (zjnszzgcfb )
Not Applicable
12
jtpzloiilk(lkntuefxdv) = xopdzieiwe nckhkvexqd (texnqjhnoi )
Positive
14 May 2024
Not Applicable
115
ubjibrxbbm(llcwyoutxv) = djwoskvnsv gwovstwwsq (nmdipqhipa )
-
11 Dec 2023
Not Applicable
191
Midostaurine + Intensive Chemotherapy
(gwcyymnwvb) = jqbcailvkh fbfwphodil (mjljdakeiq )
-
10 Dec 2023
Not Applicable
170
(dezywaixgs) = kkxzogdrjp yfkdajhuhg (mlmqzgehht )
-
09 Dec 2023
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