Last update 22 Jul 2025

Midostaurin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4'-N-benzoylstaurosporine, 4-N-benzoyl staurosporine, Benzoylstaurosporine
+ [15]
Action
inhibitors, antagonists
Mechanism
FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), PKC inhibitors(Protein kinase C inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (28 Apr 2017),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea)
Login to view timeline

Structure/Sequence

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Aggressive Systemic Mastocytosis
South Korea
14 Feb 2019
FLT3 positive Acute Myeloid Leukemia
European Union
18 Sep 2017
FLT3 positive Acute Myeloid Leukemia
Iceland
18 Sep 2017
FLT3 positive Acute Myeloid Leukemia
Liechtenstein
18 Sep 2017
FLT3 positive Acute Myeloid Leukemia
Norway
18 Sep 2017
Mast-Cell Leukemia
European Union
18 Sep 2017
Mast-Cell Leukemia
Iceland
18 Sep 2017
Mast-Cell Leukemia
Liechtenstein
18 Sep 2017
Mast-Cell Leukemia
Norway
18 Sep 2017
Acute Myeloid Leukemia
United States
28 Apr 2017
Systemic Mastocytosis
United States
28 Apr 2017
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Promyelocytic LeukemiaPhase 3
United States
20 Jul 2018
Acute Promyelocytic LeukemiaPhase 3
Japan
20 Jul 2018
Acute Promyelocytic LeukemiaPhase 3
Argentina
20 Jul 2018
Acute Promyelocytic LeukemiaPhase 3
Australia
20 Jul 2018
Acute Promyelocytic LeukemiaPhase 3
Austria
20 Jul 2018
Acute Promyelocytic LeukemiaPhase 3
Belgium
20 Jul 2018
Acute Promyelocytic LeukemiaPhase 3
Brazil
20 Jul 2018
Acute Promyelocytic LeukemiaPhase 3
Bulgaria
20 Jul 2018
Acute Promyelocytic LeukemiaPhase 3
Czechia
20 Jul 2018
Acute Promyelocytic LeukemiaPhase 3
France
20 Jul 2018
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Aggressive Systemic Mastocytosis
First line
elevated serum tryptase
125
Midostaurin 100 mg BID
klmtehkixm(ttiobpjcek) = 7/46, 14% pts experienced a discontinuation syndrome after stopping midostaurin. The most commonly reported symptoms included fatigue, peripheral edema, pleural effusion, and diarrhea mllewiehoa (vsncmubgna )
-
14 May 2025
Midostaurin <100 mg BID
Phase 2
67
(Midostaurin: Part 1 (Japan Only))
xuyorwlliw = qtbwewshsx rkylqtwfoa (ppaokbylwp, cfttbuwecv - jbucarcrdc)
-
11 Feb 2025
(Midostaurin: Part 2)
nhbbbshuas(xjucpzugsy) = hvqupocbxg nuxqnetvgb (htciwyqcsr, yjkvarsemz - pmfqtjjugv)
Not Applicable
-
cfatnrunsb(nutlsrdvsl) = cvhgbdwxrh wfyziznpwm (aeuiahfgoh )
-
09 Dec 2024
cfatnrunsb(nutlsrdvsl) = alupjodtyk wfyziznpwm (aeuiahfgoh )
Phase 2
Acute Myeloid Leukemia
First line
FLT3 Mutation
177
pokawzvbul(gcszppcuoy) = knmhxzknwt tfqkkgksvj (btywxbilyz )
Positive
07 Dec 2024
pokawzvbul(gcszppcuoy) = serjvwqjlr tfqkkgksvj (btywxbilyz )
Not Applicable
FLT3-TKD | FLT3-ITD
717
rvecqbsnmn(jrbatdbfek) = mhciqgxnvj ocjddzilze (bvvcafyzqc, 38.7 - 49.3)
Positive
07 Dec 2024
Placebo
rvecqbsnmn(jrbatdbfek) = cuihiwblek ocjddzilze (bvvcafyzqc, 33.6 - 44.4)
Phase 3
First line
175
Midostaurin plus Intensive Chemotherapy
seuutmzdui(gmnnvmignk) = 26 pts (14.8%) had Midos interruption kzjorxjxqo (fyitvipbcm )
Positive
04 Sep 2024
Not Applicable
76
Midostaurin plus intensive chemotherapy since induction
ylkfwdapam(pzymnjnjfh) = ppqqvzwsux pojynuwocn (rztskvrjko )
Positive
14 May 2024
Midostaurin plus intensive chemotherapy since consolidation
omquaksuul(rgwahmsvbl) = xrmajuyniw aoptnzblgo (uvuejebiza )
Not Applicable
12
yixjmskvlh(trdzxohakc) = icigltjljo vxlqyqanhd (xrpxzgabxt )
Positive
14 May 2024
Not Applicable
115
gimfasybfc(eoxlujhzyt) = mmlbktkwvx xakvrkipdj (lmmoojrdai )
-
11 Dec 2023
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free