Rydapt(midostaurin)
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.
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Midostaurin, Rydapt (discontinued: Midostaurin)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rydapt | New Drug Application | 2024-07-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia acute | — | D015470 | C92.0 |
| hematologic neoplasms | — | D019337 | — |
| systemic mastocytosis | — | D034721 | C96.21 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MIDOSTAURIN, RYDAPT, NOVARTIS | |||
| 2024-04-28 | ODE-140, ODE-141 | ||
HCPCS
No data
Clinical
Clinical Trials
56 clinical trials
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 9 | 11 | 3 | — | 4 | 22 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 9 | 10 | 3 | — | 4 | 22 |
| Myeloid leukemia | D007951 | — | C92 | 7 | 10 | 3 | — | 4 | 20 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 4 | 1 | — | — | — | 4 |
| Systemic mastocytosis | D034721 | — | C96.21 | — | 2 | — | — | 1 | 3 |
| Mast-cell leukemia | D007946 | — | C94.3 | — | 2 | — | — | 1 | 3 |
| Mastocytosis | D008415 | — | D47.09 | — | 2 | — | — | 1 | 3 |
| Aggression | D000374 | EFO_0003015 | — | — | 2 | — | — | 1 | 3 |
| Preleukemia | D011289 | — | — | 2 | 1 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 1 | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | — | — | — | — | 1 | 1 |
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 | — |
| CAS-ID | 120685-11-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL608533 |
| ChEBI ID | 63452 |
| PubChem CID | 9829523 |
| DrugBank | DB06595 |
| UNII ID | ID912S5VON (ChemIDplus, GSRS) |
Target
Agency Approved
No data
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
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,993 adverse events reported
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