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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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|
| KOSELUGO | AstraZeneca | N-213756 RX | 2020-04-10 | 2 products, RLD, RS |
| KOSELUGO | AstraZeneca | N-219943 RX | 2025-09-10 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| koselugo | New Drug Application | 2025-09-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neurofibromatosis 1 | — | D009456 | Q85.01 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SELUMETINIB SULFATE, KOSELUGO, ASTRAZENECA | |||
| 2027-04-10 | ODE-288 | ||
| 2025-04-10 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
138 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 |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 9 | 11 | 1 | — | 1 | 20 |
| Neurofibromatosis 1 | D009456 | — | Q85.01 | 6 | 5 | 1 | — | 3 | 13 |
| Plexiform neurofibroma | D018318 | EFO_0000658 | — | 3 | 2 | 1 | — | 3 | 8 |
| Melanoma | D008545 | — | — | 4 | 2 | 1 | — | — | 7 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 1 | 1 | — | — | 3 |
| Small cell lung carcinoma | D055752 | — | — | — | 1 | 1 | — | — | 2 |
| Uveal neoplasms | D014604 | EFO_1001230 | — | 1 | — | 1 | — | — | 2 |
| Uveal melanoma | D000098943 | — | — | 1 | — | 1 | — | — | 2 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | — | 1 | — | 1 | 2 |
| Thyroid diseases | D013959 | — | E00-E07 | — | — | 1 | — | 1 | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | 6 | 6 | — | — | 1 | 12 |
| Neurofibromatoses | D017253 | — | Q85.00 | 4 | 5 | — | — | 3 | 10 |
| Neoplasms | D009369 | — | C80 | 8 | 1 | — | — | — | 9 |
| Neurofibroma | D009455 | EFO_0000622 | — | 4 | 4 | — | — | 3 | 9 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | — | — | — | 6 |
| Colorectal neoplasms | D015179 | — | — | 2 | 3 | — | — | — | 4 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 3 | — | — | — | 4 |
| Squamous cell neoplasms | D018307 | — | — | 1 | 2 | — | — | — | 2 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | 2 | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 3 | — | — | — | — | 3 |
| Rectal neoplasms | D012004 | — | — | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 1 | — | — | — | — | 1 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Selumetinib |
| INN | selumetinib |
| 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 class | tyrosine kinase inhibitors: tyrosine kinase inhibitors; MEK (MAPK kinase) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cn1cnc2c(F)c(Nc3ccc(Br)cc3Cl)c(C(=O)NOCCO)cc21 |
Identifiers
| PDB | — |
| CAS-ID | 606143-52-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1614701 |
| ChEBI ID | 90227 |
| PubChem CID | 10127622 |
| DrugBank | DB11689 |
| UNII ID | 6UH91I579U (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
BRAF
BRAF
Organism
Homo sapiens
Gene name
BRAF
Gene synonyms
BRAF1, RAFB1
NCBI Gene ID
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
Mouse ortholog
Braf (109880)
serine/threonine-protein kinase B-raf (P28028)
Variants
No data
Financial
Revenue by drug
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Koselugo – AstraZeneca
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Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,167 adverse events reported
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