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Rydapt (MIDOSTAURIN)

Novartis · FDA-approved approved Small molecule Quality 62/100

Rydapt blocks the activity of the Kit receptor, which is involved in the growth and survival of cancer cells.

At a glance

Generic nameMIDOSTAURIN
SponsorNovartis
Drug classKinase Inhibitor [EPC]
TargetMast/stem cell growth factor receptor Kit
ModalitySmall molecule
Therapeutic areaOncology
PhaseFDA-approved
First approval2017
Annual revenue200

Mechanism of action

Midostaurin is small molecule that inhibits multiple receptor tyrosine kinases. In vitro biochemical or cellular assays have shown that midostaurin or its major human active metabolites CGP62221 and CGP52421 inhibit the activity of wild type FLT3, FLT3 mutant kinases (ITD and TKD), KIT (wild type and D816V mutant), PDGFR/, as well as members of the serine/threonine kinase PKC (protein kinase C) family.Midostaurin demonstrated the ability to inhibit FLT3 receptor signaling and cell proliferation, and it induced apoptosis in leukemic cells expressing ITD and TKD mutant FLT3 receptors or overexpressing wild type FLT3 and PDGF receptors. Midostaurin also demonstrated the ability to inhibit KIT signaling, cell proliferation and histamine release and induce apoptosis in mast cells.

Approved indications

Common side effects

Key clinical trials

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity
SEC EDGARRevenue + earnings