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Drug ReportsSelumetinib
Koselugo(selumetinib)
Koselugo (selumetinib) is a small molecule pharmaceutical. Selumetinib was first approved as Koselugo on 2020-04-10. It is used to treat neurofibromatosis 1 in the USA. It has been approved in Europe to treat neurofibromatosis 1. The pharmaceutical is active against dual specificity mitogen-activated protein kinase kinase 1.
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FDA Novel Drug Approvals 2020
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Koselugo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Selumetinib sulfate
Tradename
Company
Number
Date
Products
KOSELUGOAstraZenecaN-213756 RX2020-04-10
2 products, RLD, RS
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
neurofibromatosis 1—D009456Q85.01
Agency Specific
FDA
EMA
Expiration
Code
SELUMETINIB SULFATE, KOSELUGO, ASTRAZENECA
2027-04-10ODE-288
2025-04-10NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Selumetinib Sulfate, Koselugo, Astrazeneca
91567952026-12-12DS, DP
95620172026-12-12DPU-2800
74256372024-03-13DP
81786932023-03-13DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EE: Mitogen-activated protein kinase (mek) inhibitors
— L01EE04: Selumetinib
HCPCS
No data
Clinical
Clinical Trials
132 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
Neurofibromatosis 1D009456—Q85.01792—115
Plexiform neurofibromaD018318EFO_0000658—441——7
Thyroid neoplasmsD013964EFO_0003841——21—14
Small cell lung carcinomaD055752———21——3
GliomaD005910EFO_0000520——21——3
AstrocytomaD001254EFO_0000271—112——3
Uveal neoplasmsD014604EFO_1001230—111——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——914——121
NeoplasmsD009369—C80101———11
MelanomaD008545——46——111
Breast neoplasmsD001943EFO_0003869C5044———8
Pancreatic neoplasmsD010190EFO_0003860C2526———7
Colorectal neoplasmsD015179——34———6
Lung neoplasmsD008175HP_0100526C34.9033———5
Biliary tract neoplasmsD001661—C24.931———4
AdenocarcinomaD000230———3———3
Triple negative breast neoplasmsD064726——13———3
Show 44 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
Colonic neoplasmsD003110—C183————3
Rectal neoplasmsD012004——2————2
Primary myelofibrosisD055728—D47.41————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1————1
Head and neck neoplasmsD006258——1————1
Urinary bladder neoplasmsD001749—C671————1
Kidney neoplasmsD007680EFO_0003865C641————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeurofibromaD009455EFO_0000622—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSelumetinib
INNselumetinib
Description
Selumetinib is a member of the class of benzimidazoles that is 1-methyl-1H-benzimidazole which is substituted at positions 4, 5, and 6 by fluorine, (4-bromo-2-chlorophenyl)amino, and N-(2-hydroxyethoxy)aminocarbonyl groups, respectively. It is a MEK1 and MEK2 inhibitor. It has a role as an EC 2.7.11.24 (mitogen-activated protein kinase) inhibitor, an antineoplastic agent and an anticoronaviral agent. It is a member of benzimidazoles, a hydroxamic acid ester, a member of monochlorobenzenes, a member of bromobenzenes, an organofluorine compound and a secondary amino compound.
Classification
Small molecule
Drug classtyrosine kinase inhibitors: tyrosine kinase inhibitors; MEK (MAPK kinase) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cn1cnc2c(F)c(Nc3ccc(Br)cc3Cl)c(C(=O)NOCCO)cc21
Identifiers
PDB—
CAS-ID606143-52-6
RxCUI—
ChEMBL IDCHEMBL1614701
ChEBI ID90227
PubChem CID10127622
DrugBankDB11689
UNII ID6UH91I579U (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
BRAF
BRAF
Organism
Homo sapiens
Gene name
BRAF
Gene synonyms
BRAF1, RAFB1
NCBI Gene ID
673
Protein name
serine/threonine-protein kinase B-raf
Protein synonyms
94 kDa B-raf protein, B-Raf proto-oncogene serine/threonine-protein kinase (p94), B-Raf serine/threonine-protein, murine sarcoma viral (v-raf) oncogene homolog B1, p94, Proto-oncogene B-Raf, v-raf murine sarcoma viral oncogene homolog B, v-Raf murine sarcoma viral oncogene homolog B1
Uniprot ID
Q9Y6T3
Mouse ortholog
Braf (109880)
serine/threonine-protein kinase B-raf (P28028)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Koselugo – AstraZeneca
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,440 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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232 adverse events reported
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