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
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 |
---|---|---|---|---|
RYDAPT | Novartis | N-207997 RX | 2017-04-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
rydapt | New Drug Application | 2020-11-24 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
MIDOSTAURIN, RYDAPT, NOVARTIS | |||
2024-04-28 | ODE-140, ODE-141 |
HCPCS
No data
Clinical
Clinical Trials
46 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Systemic mastocytosis | D034721 | C96.21 | — | 2 | — | — | — | 2 | |
Skin abnormalities | D012868 | HP_0000951 | Q82.9 | — | 1 | — | — | — | 1 |
Biphenotypic leukemia acute | D015456 | C95.0 | — | 1 | — | — | — | 1 | |
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | 1 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | 1 | — | — | — | 1 | |
Mast-cell leukemia | D007946 | C94.3 | — | 1 | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | MIDOSTAURIN |
INN | midostaurin |
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
PDB | 4NCT |
CAS-ID | 120685-11-2 |
RxCUI | 1919083 |
ChEMBL ID | CHEMBL608533 |
ChEBI ID | 63452 |
PubChem CID | 9829523 |
DrugBank | DB06595 |
UNII ID | ID912S5VON (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:
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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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