Product Description
Midostaurin is used with other chemotherapy drugs to treat certain types of acute myeloid leukemia (AML; a type of cancer of the white blood cells). Midostaurin is also used to certain types of mastocytosis (a blood disorder in which there are too many mast cells [a certain kind of white blood cell]). Midostaurin is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of mast and cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a617033.html)
Mechanisms of Action: FLT3 Inhibitor, TK Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Czech Republic, Germany, Italy, Japan, Jordan, Poland, Russia, Slovenia, South Korea, United States, Unknown Location
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Acute Myeloid Leukemia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06313437 |
NCT06313437 | P1 |
Recruiting |
Acute Myeloid Leukemia |
2026-03-02 |
12% |
2025-01-03 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2023-509834-20-00 |
CPKC412A2218 | P2 |
Recruiting |
Acute Myeloid Leukemia |
2029-12-30 |
2025-05-02 |
Treatments |
|
NCT03591510 |
CPKC412A2218 | P2 |
Active, not recruiting |
Acute Myeloid Leukemia |
2027-05-03 |
12% |
2025-09-17 |
Primary Endpoints |
NCT04385290 |
MOSAIC | P2 |
Recruiting |
Acute Myeloid Leukemia |
2027-04-01 |
2% |
2024-11-27 |
Primary Endpoints|Treatments |
2017-002094-18 |
Prospective evaluation of a continuation therapy with Midostaurin in adult patients with core-bindin | P2 |
Completed |
Acute Myeloid Leukemia |
2024-12-13 |
2025-05-10 |
Treatments |
|
jRCT2080224610 |
jRCT2080224610 | P3 |
Completed |
Acute Myeloid Leukemia |
2026-09-29 |