Lumakras, Lumykras(sotorasib)
Lumakras, Lumykras (sotorasib) is a small molecule pharmaceutical. Sotorasib was first approved as Lumakras on 2021-05-28. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. It is known to target GTPase KRas.
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FDA Novel Drug Approvals 2021
Commercial
Trade Name
FDA
EMA
Lumakras
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sotorasib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUMAKRAS | Amgen | N-214665 RX | 2021-05-28 | 2 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lumakras | New Drug Application | 2021-06-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SOTORASIB, LUMAKRAS, AMGEN INC | |||
| 2028-05-28 | ODE-352 | ||
| 2026-05-28 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 13 | — | — | — | — | 13 | ||
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SOTORASIB |
| INN | sotorasib |
| Description | Sotorasib is a pyridopyrimidine that is pyrido[2,3-d]pyrimidin-2(1H)-one substituted by 4-methyl-2-(propan-2-yl)pyridin-3-yl, (2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl, fluoro and 2-fluoro-6-hydroxyphenyl groups at positions 1, 4, 6 and 7, respectively. It is approved for the treatment of patients with non-small cell lung cancer having KRAS(G12C) mutations. It has a role as an antineoplastic agent. It is a member of acrylamides, a N-acylpiperazine, a pyridopyrimidine, a member of monofluorobenzenes, a member of methylpyridines, a tertiary carboxamide, a tertiary amino compound and a member of phenols. |
| Classification | Small molecule |
| Drug class | Kirsten rat sarcoma (KRAS) inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C=CC(=O)N1CCN(c2nc(=O)n(-c3c(C)ccnc3C(C)C)c3nc(-c4c(O)cccc4F)c(F)cc23)[C@@H](C)C1 |
Identifiers
| PDB | — |
| CAS-ID | 2296729-00-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4535757 |
| ChEBI ID | — |
| PubChem CID | 137278711 |
| DrugBank | DB15569 |
| UNII ID | 2B2VM6UC8G (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
KRAS
KRAS
Organism
Homo sapiens
Gene name
KRAS
Gene synonyms
KRAS2, RASK2
NCBI Gene ID
Protein name
GTPase KRas
Protein synonyms
c-K-ras, c-Ki-ras, c-Kirsten-ras protein, cellular c-Ki-ras2 proto-oncogene, cellular transforming proto-oncogene, K-Ras 2, K-ras p21 protein, Ki-Ras, Kirsten rat sarcoma viral oncogene homolog, Kirsten rat sarcoma viral proto-oncogene, oncogene KRAS2, PR310 c-K-ras oncogene, proto-oncogene GTPase, transforming protein p21, v-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog
Uniprot ID
Mouse ortholog
Kras (16653)
GTPase KRas (P32883)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,088 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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63 adverse events reported
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