Rydapt
(Midostaurin)ApprovedSmall molecule
NovartisRydapt is a small molecule that works as a Tyrosine-Protein Kinase Receptor FLT3 Inhibitor; Vascular Endothelial Growth Factor Receptor 2 Inhibitor; Platelet-Derived Growth Factor Receptor Inhibitor; Protein Kinase C (PKC) Inhibitor; Stem Cell Growth Factor Receptor Inhibitor.[2] It is being used across 15 indications, with its most advanced program in Approved.[1]
Rydapt is one of 318 small molecule programs targeting Systemic Mastocytosis. It is currently in Approved.
15
Indications
41
Total Trials
6
Active Trials
317
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[3][1]
Indication
Showing 10 of 15 indications
Competition
Competitive Landscape
949 competitors in Colorectal Cancer
#DrugCompanyPhaseTrials
1Rydapt
NovartisApproved
Eylea
RegeneronPreclinical
Emend IV
Merck & Co.Preclinical
PORTRAZZA
Eli LillyPreclinical
Ketalar
AAultman Health Foundation
Preclinical
Xylocaine
MMEDRx USA, Inc.
Preclinical
Versed
CConrado Roberto Hoffmann Filho
Preclinical
Ultiva
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Bridion
CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Preclinical
Andriol
AAuxilium
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Acute Myeloid Leukemia17 trials
Show 14 more trials
Systemic Mastocytosis3 trials
Leukemia3 trials
Relapsed/Refractory AML2 trials
13 more indications
Myelodysplastic Syndrome2 trials
Induction Chemotherapy1 trial
Hepatic Function1 trial
Post Stem Cell Transplant1 trial
Myelodysplastic Syndromes1 trial
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
Active, not recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 3·NCT04027309·777 enrolled
High Risk1 trial
Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
Active, not recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 2·NCT04097470·140 enrolled
Newly Diagnosed Patients1 trial
Efficacy1 trial
FLT3-mutated Acute Myeloid Leukemia1 trial
Regulatory
FDA Approval Timeline[4]
Apr 28, 2017
RYDAPT
NDA NDA207997
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Midostaurin. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]FDA Orange Book — Patent and exclusivity data for Rydapt. U.S. Food & Drug Administration.
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Tyrosine-Protein Kinase Receptor FLT3 Inhibitor; Vascular Endothelial Growth Factor Receptor 2 Inhibitor; Platelet-Derived Growth Factor Receptor Inhibitor; Protein Kinase C (PKC) Inhibitor; Stem Cell Growth Factor Receptor Inhibitor[2]
- Modality
- Small molecule[2]
- Highest Phase
- Approved[1]
- Company