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 13 indications, with its most advanced program in Approved.[1]
Rydapt is one of 235 small molecule programs targeting Acute Lymphoblastic Leukemia. It is currently in Approved.
13
Indications
41
Total Trials
5
Active Trials
234
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[3][1]
Indication
Showing 10 of 13 indications
Competition
Competitive Landscape
268 competitors in Colorectal Cancer
#DrugCompanyPhaseTrials
1Rydapt
NovartisApproved
Camptosar
PfizerPhase 3
Keytruda
Merck & Co.Phase 3
Platinol
MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Phase 3
Telisotuzumab Adizutecan
AbbViePhase 3
PD-1 Monoclonal Antibody
SSichuan Baili Pharmaceutical Co., Ltd.
Phase 3
Adjuvant Chemotherapy
NNizhny Novgorod Regional Clinical Oncology Center
Phase 3
SHR-A1811
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Phase 3
Biological Check-up
UUniversity Hospital, Bordeaux
Phase 3
Mfolfoxiri Plus Bevacizumab
FFudan University
Phase 3
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
Leukemia3 trials
Systemic Mastocytosis3 trials
Myelodysplastic Syndrome2 trials
13 more indications
Relapsed/Refractory AML2 trials
Efficacy1 trial
Post Stem Cell Transplant1 trial
Induction Chemotherapy1 trial
Hepatic Function1 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
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