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Rydapt(midostaurin)
Rydapt (midostaurin) is a small molecule pharmaceutical. Midostaurin was first approved as Rydapt on 2017-04-28. It is used to treat hematologic neoplasms, myeloid leukemia acute, and systemic mastocytosis in the USA. It has been approved in Europe to treat mastocytosis and myeloid leukemia acute. The pharmaceutical is active against receptor-type tyrosine-protein kinase FLT3. In addition, it is known to target dual specificity tyrosine-phosphorylation-regulated kinase 1A.
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Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Rydapt
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Midostaurin
Tradename
Company
Number
Date
Products
RYDAPTNovartisN-207997 RX2017-04-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
rydaptNew Drug Application2020-11-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hematologic neoplasmsD019337
myeloid leukemia acuteD015470C92.0
systemic mastocytosisD034721C96.21
Agency Specific
FDA
EMA
Expiration
Code
MIDOSTAURIN, RYDAPT, NOVARTIS
2024-04-28ODE-140, ODE-141
Patent Expiration
Patent
Expires
Flag
FDA Information
Midostaurin, Rydapt, Novartis
85751462030-12-02U-2008
79730312028-10-09U-2007
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EX: Other protein kinase inhibitors in atc
L01EX10: Midostaurin
HCPCS
No data
Clinical
Clinical Trials
46 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.013196435
Myelodysplastic syndromesD009190D463427
LeukemiaD007938C951213
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Systemic mastocytosisD034721C96.2122
Skin abnormalitiesD012868HP_0000951Q82.911
Biphenotypic leukemia acuteD015456C95.011
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034011
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0111
Mast-cell leukemiaD007946C94.311
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic insufficiencyD04855011
AdenocarcinomaD00023011
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMIDOSTAURIN
INNmidostaurin
Description
Midostaurin is an organic heterooctacyclic compound that is the N-benzoyl derivative of staurosporine. It has a role as an EC 2.7.11.13 (protein kinase C) inhibitor and an antineoplastic agent. It is an indolocarbazole, an organic heterooctacyclic compound, a member of benzamides and a gamma-lactam. It is functionally related to a staurosporine.
Classification
Small molecule
Drug class
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CO[C@@H]1[C@H](N(C)C(=O)c2ccccc2)C[C@H]2O[C@]1(C)n1c3ccccc3c3c4c(c5c6ccccc6n2c5c31)C(=O)NC4
Identifiers
PDB4NCT
CAS-ID120685-11-2
RxCUI1919083
ChEMBL IDCHEMBL608533
ChEBI ID63452
PubChem CID9829523
DrugBankDB06595
UNII IDID912S5VON (ChemIDplus, GSRS)
Target
Agency Approved
FLT3
FLT3
Organism
Homo sapiens
Gene name
FLT3
Gene synonyms
CD135, FLK2, STK1
NCBI Gene ID
Protein name
receptor-type tyrosine-protein kinase FLT3
Protein synonyms
CD135, CD135 antigen, fetal liver kinase 2, Fetal liver kinase-2, FL cytokine receptor, FLK-2, FLT-3, fms related tyrosine kinase 3, Fms-like tyrosine kinase 3, growth factor receptor tyrosine kinase type III, Stem cell tyrosine kinase 1, STK-1
Uniprot ID
Mouse ortholog
Flt3 (14255)
receptor-type tyrosine-protein kinase FLT3 (Q00342)
Alternate
DYRK1A
DYRK1A
Organism
Homo sapiens
Gene name
DYRK1A
Gene synonyms
DYRK, MNB, MNBH
NCBI Gene ID
Protein name
dual specificity tyrosine-phosphorylation-regulated kinase 1A
Protein synonyms
dual specificity tyrosine-(Y)-phosphorylation regulated kinase 1A, Dual specificity YAK1-related kinase, hMNB, HP86, mnb protein kinase homolog hp86, MNB/DYRK protein kinase, MNBH, Protein kinase minibrain homolog, serine/threonine kinase MNB, serine/threonine-specific protein kinase
Uniprot ID
Mouse ortholog
Dyrk1a (13548)
dual specificity tyrosine-phosphorylation-regulated kinase 1A (Q61214)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 2,870 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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740 adverse events reported
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