Retevmo, Retsevmo(selpercatinib)
Retevmo, Retsevmo (selpercatinib) is a small molecule pharmaceutical. Selpercatinib was first approved as Retevmo on 2020-05-08. It is used to treat non-small-cell lung carcinoma and thyroid neoplasms in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma and thyroid neoplasms. It is known to target proto-oncogene tyrosine-protein kinase receptor Ret.
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FDA Novel Drug Approvals 2020
Commercial
Trade Name
FDA
EMA
Retevmo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Selpercatinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RETEVMO | Loxo Oncology | N-213246 RX | 2020-05-08 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| retevmo | New Drug Application | 2021-01-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
| thyroid neoplasms | EFO_0003841 | D013964 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SELPERCATINIB, RETEVMO, LOXO ONCOL ELI LILLY | |||
| 2029-09-21 | ODE-409, ODE-412 | ||
| 2027-05-08 | ODE-301, ODE-302, ODE-303 | ||
| 2025-05-08 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Selpercatinib, Retevmo, Loxo Oncol Eli Lilly | |||
| 10584124 | 2038-10-10 | DP | U-2826, U-2827, U-2828, U-3450, U-3451, U-3452, U-3453 |
| 10786489 | 2038-10-10 | DP | U-2971, U-2972, U-2973, U-2974, U-2975, U-2976, U-2977, U-3450, U-3451, U-3452, U-3453 |
| 10112942 | 2037-10-10 | DS, DP | |
| 10137124 | 2037-10-10 | U-2826, U-2827, U-2828, U-3450, U-3451, U-3452, U-3453 | |
| 10172851 | 2037-10-10 | U-2826, U-2827, U-2828, U-3450, U-3451, U-3452, U-3453 | |
HCPCS
No data
Clinical
Clinical Trials
31 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 | 1 | 5 | 2 | — | 1 | 8 | ||
| Papillary thyroid cancer | D000077273 | 2 | 5 | 1 | — | 1 | 7 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 1 | 5 | — | — | 1 | 6 | |
| Sarcoma | D012509 | 1 | 3 | — | — | — | 3 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | 1 | 2 |
| Non-hodgkin lymphoma | D008228 | C85.9 | — | 2 | — | — | — | 2 | |
| Neuroblastoma | D009447 | EFO_0000621 | — | 2 | — | — | — | 2 | |
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | 2 | |
| Osteosarcoma | D012516 | — | 2 | — | — | — | 2 | ||
| Medulloblastoma | D008527 | — | 2 | — | — | — | 2 | ||
| Rhabdoid tumor | D018335 | — | 2 | — | — | — | 2 | ||
| Ependymoma | D004806 | — | 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 | — | 14 | — | — | — | — | 14 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SELPERCATINIB |
| INN | selpercatinib |
| Description | Selpercatinib, sold under the brand name Retevmo among others, is a medication for the treatment of cancers in people whose tumors have an alteration (mutation or fusion) in a specific gene (RET which is short for "rearranged during transfection"). It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc(CN2C3CC2CN(c2ccc(-c4cc(OCC(C)(C)O)cn5ncc(C#N)c45)cn2)C3)cn1 |
Identifiers
| PDB | — |
| CAS-ID | 2152628-33-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4559134 |
| ChEBI ID | — |
| PubChem CID | 134436906 |
| DrugBank | DB15685 |
| UNII ID | CEGM9YBNGD (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
RET
RET
Organism
Homo sapiens
Gene name
RET
Gene synonyms
CDHF12, CDHR16, PTC, RET51
NCBI Gene ID
Protein name
proto-oncogene tyrosine-protein kinase receptor Ret
Protein synonyms
Cadherin family member 12, cadherin-related family member 16, Proto-oncogene c-Ret, rearranged during transfection, ret proto-oncogene (multiple endocrine neoplasia and medullary thyroid carcinoma 1, Hirschsprung disease), RET receptor tyrosine kinase
Uniprot ID
Mouse ortholog
Ret (19713)
proto-oncogene tyrosine-protein kinase receptor Ret (P35546)
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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12,711 adverse events reported
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