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Drug ReportsSelpercatinib
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
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
respiratory tract diseasesD012140
endocrine system diseasesD004700
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
RETEVMOLoxo OncologyN-213246 RX2020-05-08
2 products, RLD, RS
RETEVMOLoxo OncologyN-218160 RX2024-04-10
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
retevmoNew Drug Application2024-09-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
thyroid neoplasmsEFO_0003841D013964—
Agency Specific
FDA
EMA
Expiration
Code
SELPERCATINIB, RETEVMO, LOXO ONCOL ELI LILLY
2029-09-21ODE-409, ODE-412
2027-05-08ODE-301, ODE-302, ODE-303
2025-05-08NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Selpercatinib, Retevmo, Loxo Oncol Eli Lilly
105841242038-10-10DPU-2826, U-2827, U-2828, U-3450, U-3451, U-3452, U-3453
107864892038-10-10DPU-2971, U-2972, U-2973, U-2974, U-2975, U-2976, U-2977, U-3450, U-3451, U-3452, U-3453
101129422037-10-10DS, DP
101371242037-10-10U-2826, U-2827, U-2828, U-3450, U-3451, U-3452, U-3453
101728512037-10-10U-2826, U-2827, U-2828, U-3450, U-3451, U-3452, U-3453
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX22: Selpercatinib
HCPCS
No data
Clinical
Clinical Trials
35 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thyroid neoplasmsD013964EFO_0003841—261119
Thyroid diseasesD013959HP_0000820E00-E07261119
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——152—29
Papillary thyroid cancerD000077273——251—17
Lung neoplasmsD008175HP_0100526C34.90141——5
Neuroendocrine carcinomaD018278——121——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8019——110
SarcomaD012509——13———3
CarcinomaD002277—C80.0—3———3
Breast neoplasmsD001943EFO_0003869C50—1——12
RecurrenceD012008———2———2
Non-hodgkin lymphomaD008228—C85.9—2———2
LymphomaD008223—C85.9—2———2
NeuroblastomaD009447EFO_0000621——2———2
GliomaD005910EFO_0000520——2———2
OsteosarcomaD012516———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———15————15
Renal insufficiencyD051437HP_0000083N191————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C25————11
Erectile dysfunctionD007172EFO_0004234F52.21————11
EunuchismD005058EFO_0007266E29.1————11
HypogonadismD007006HP_0000044E23.0————11
Physiological sexual dysfunctionD012735——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSelpercatinib
INNselpercatinib
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 classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccc(CN2C3CC2CN(c2ccc(-c4cc(OCC(C)(C)O)cn5ncc(C#N)c45)cn2)C3)cn1
Identifiers
PDB—
CAS-ID2152628-33-4
RxCUI—
ChEMBL IDCHEMBL4559134
ChEBI ID—
PubChem CID134436906
DrugBankDB15685
UNII IDCEGM9YBNGD (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
RET
RET
Organism
Homo sapiens
Gene name
RET
Gene synonyms
CDHF12, CDHR16, PTC
NCBI Gene ID
5979
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
Q9BTB0
Mouse ortholog
Ret (19713)
proto-oncogene tyrosine-protein kinase receptor Ret (P35546)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,245 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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731 adverse events reported
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