midostaurin (rydapt) Report issue

Small molecule Orphan Drug FDA Approved FDA First in Class Fast Track FDA Priority Review FDA
AACT ChEMBL DrugBank Drugs@FDA MeSH PubChem

Active Ingredient History

NOW
  • Now
Midostaurin, a derivate of staurosporine (N-benzoylstaurosporine), is a broad-spectrum inhibitor of Ser/Thr and Tyr protein kinases. Midostaurin showed broad antiproliferative activity against various tumor and normal cell lines in vitro and is able to reverse the p-glycoprotein-mediated multidrug resistance of tumor cells in vitro. Midostaurin showed in vivo antitumor activity as single agent and inhibited angiogenesis in vivo. At the end of 2016 FDA granted Priority Review to the PKC412 (midostaurin) new drug application (NDA) for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, as well as for the treatment of advanced systemic mastocytosis (SM).   NCATS

Chemistry

  • SMILES: CO[C@@H]1[C@@H](C[C@H]2O[C@]1(C)n3c4ccccc4c5c6CNC(=O)c6c7c8ccccc8n2c7c35)N(C)C(=O)C9=CC=CC=C9
  • InChIKey: BMGQWWVMWDBQGC-IIFHNQTCSA-N
  • Mol. Mass: 570.6371
  • ALogP: 5.91
  • ChEMBL Molecule:
    midostaurin  
More Chemistry

Pharmacology

Drug Pricing (per unit)

United States

$111.4129 - $157.5743

Australia

$141.3053
More Pricing Detail

Note: This drug pricing data is preliminary, incomplete, and may contain errors.

Alternative names

4'-n-benzoylstaurosporine | 4'-n-benzoyl staurosporine | benzamide, n-(2,3,9,10,11,12-hexahydro-9-methoxy-8-methyl-1-oxo-8,12-epoxy-1h,8h-2,7b,12a-triazadibenzo(a,g)cyclonona(cde)trinden-10-yl)-n-methyl-, (8alpha,9beta,10beta,12alpha)- | benzoylstaurosporine | cgp 41251 | cgp 41 251 | cgp-41251 | midostaurin | n-((9s,10r,11r,13r)-10-methoxy-9-methyl-1-oxo-2,3,10,11,12,13-hexahydro-9,13-epoxy-1h,9h-diindolo(1,2,3-gh:3',2',1'-lm)pyrrolo(3,4-j)(1,7)benzodiazonin-11-yl)-n-methylbenzamide | nvp-pkc412 | pkc412 | pkc 412 | pkc-412 | rydapt

Organizations (41)

Research & Development (39)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (3)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (10)

Approved Indications (4)


 

Leukemia, Mast-Cell

Leukemia, Myeloid, Acute

Mastocytosis

Mastocytosis, Systemic

Experimental Indications - Clinical Trial Phases 1-4 (10)


 

Colorectal Neoplasms (Phase 1)

Leukemia (Phase 3)

Leukemia, Mast-Cell (Phase 2)

Leukemia, Myeloid, Acute ()

Liver Diseases (Phase 1)

Mastocytosis (Phase 2)

Mastocytosis, Systemic (Phase 2)

Mutation (Phase 2)

Myelodysplastic Syndromes (Phase 3)

Precursor Cell Lymphoblastic Leukemia-Lymphoma (Phase 1/Phase 2)

Overview

  • Highest Phase: Phase 3
  • # of Trials: 44
  • # of Trial Organizations: 39

Trials by Phase

Trial Phase Start Date Organizations Indications

Feedback

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