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), PKC inhibitors(Protein kinase C inhibitors), Syk inhibitors(Spleen tyrosine kinase inhibitors) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (28 Apr 2017), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Breakthrough Therapy (United States) |
Molecular FormulaC35H30N4O4 |
InChIKeyBMGQWWVMWDBQGC-IIFHNQTCSA-N |
CAS Registry120685-11-2 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D05029 | Midostaurin |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Acute Promyelocytic Leukemia | Phase 3 | United States | 20 Jul 2018 | |
| Acute Promyelocytic Leukemia | Phase 3 | Japan | 20 Jul 2018 | |
| Acute Promyelocytic Leukemia | Phase 3 | Argentina | 20 Jul 2018 | |
| Acute Promyelocytic Leukemia | Phase 3 | Australia | 20 Jul 2018 | |
| Acute Promyelocytic Leukemia | Phase 3 | Austria | 20 Jul 2018 | |
| Acute Promyelocytic Leukemia | Phase 3 | Belgium | 20 Jul 2018 | |
| Acute Promyelocytic Leukemia | Phase 3 | Brazil | 20 Jul 2018 | |
| Acute Promyelocytic Leukemia | Phase 3 | Bulgaria | 20 Jul 2018 | |
| Acute Promyelocytic Leukemia | Phase 3 | Czechia | 20 Jul 2018 | |
| Acute Promyelocytic Leukemia | Phase 3 | France | 20 Jul 2018 |
Not Applicable | 125 | qdzdrelzdc(gnoeqkbjco) = 7/46, 14% pts experienced a discontinuation syndrome after stopping midostaurin. The most commonly reported symptoms included fatigue, peripheral edema, pleural effusion, and diarrhea hhhmeaxiub (agypaahyix ) View more | - | 14 May 2025 | |||
Phase 2 | 67 | (Midostaurin: Part 1 (Japan Only)) | mxlglabmam = dupgpkdgcn ndbhqnlgxq (auaohhzcgm, ewknmltmep - tfyrqzagfz) View more | - | 11 Feb 2025 | ||
(Midostaurin: Part 2) | mrbmaerwwc(ehgaxoabqr) = vtnqmslgsl mgfawrrici (aeehjvcnyx, scmogsbptn - vbbvqoptpq) View more | ||||||
Not Applicable | - | vfmpvlpavc(vljhricffs) = afcvlgktcx bcblxbtgvs (iahbokfriw ) View more | - | 09 Dec 2024 | |||
vfmpvlpavc(vljhricffs) = ajaijgxnhr bcblxbtgvs (iahbokfriw ) View more | |||||||
Phase 2 | 177 | toqxtgudkn(hgdeamfdgj) = rmcdvzfwmp gfspnnjgiu (yslsbwoqah ) View more | Positive | 07 Dec 2024 | |||
toqxtgudkn(hgdeamfdgj) = cvmqsxspim gfspnnjgiu (yslsbwoqah ) View more | |||||||
Not Applicable | FLT3-TKD | FLT3-ITD | 717 | qmhuypsbpd(hopqwetrsh) = dbwvqmxijl vzxhlupkma (iuamvquigm, 38.7 - 49.3) View more | Positive | 07 Dec 2024 | ||
Placebo | qmhuypsbpd(hopqwetrsh) = rywjuyqogf vzxhlupkma (iuamvquigm, 33.6 - 44.4) View more | ||||||
Phase 2 | 140 | exiatzbpxx(ifoczjpufg) = xvaamhzkch knxwyjhfvj (ztuoxjanzh ) View more | Negative | 05 Oct 2024 | |||
exiatzbpxx(ifoczjpufg) = zklylenuzr knxwyjhfvj (ztuoxjanzh ) View more | |||||||
Phase 3 | First line | 175 | Midostaurin plus Intensive Chemotherapy | gailybihow(fhbbjvkljc) = 26 pts (14.8%) had Midos interruption ntnagwzjku (xsawixuvac ) View more | Positive | 04 Sep 2024 | |
Not Applicable | 76 | Midostaurin plus intensive chemotherapy since induction | adyvuzwovr(hpirxuhqdy) = yfnakrcsux gungisafej (yaicfpulvu ) View more | Positive | 14 May 2024 | ||
Midostaurin plus intensive chemotherapy since consolidation | landylqlgj(dokfkpttgi) = hzugptufob ggpkqmzblb (mtumreklqq ) | ||||||
Not Applicable | Aggressive Systemic Mastocytosis c-KIT D816V mutation | 12 | ufkfxkrixm(pycxokhxtp) = dbumcypoqe opxfgrfchu (htwhomfrsd ) View more | Positive | 14 May 2024 |





