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Drug ReportsVandetanib
Caprelsa(vandetanib)
Caprelsa (vandetanib) is a small molecule pharmaceutical. Vandetanib was first approved as Caprelsa on 2011-04-06. It is used to treat thyroid neoplasms in the USA. It has been approved in Europe to treat thyroid neoplasms. The pharmaceutical is active against vascular endothelial growth factor receptor 2 and proto-oncogene tyrosine-protein kinase receptor Ret. In addition, it is known to target epidermal growth factor receptor.
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Financial
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
endocrine system diseasesD004700
Trade Name
FDA
EMA
Caprelsa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vandetanib
Tradename
Company
Number
Date
Products
CAPRELSASanofiN-022405 RX2011-04-06
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
caprelsaNew Drug Application2024-04-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
thyroid neoplasmsEFO_0003841D013964—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Vandetanib, Caprelsa, Genzyme Corp
80674272028-08-08DP
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
— L01EX04: Vandetanib
HCPCS
No data
Clinical
Clinical Trials
114 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—3851317
Thyroid diseasesD013959HP_0000820E00-E073851216
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175HP_0100526C34.908124——24
Non-small-cell lung carcinomaD002289——6104——20
CarcinomaD002277—C80.0491——11
Papillary thyroid cancerD000077273——443—210
Neuroendocrine carcinomaD018278——234—29
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80108——118
Breast neoplasmsD001943EFO_0003869C5027———9
Colorectal neoplasmsD015179——52———7
Prostatic neoplasmsD011471—C6114———5
GlioblastomaD005909EFO_0000515—42———5
GliosarcomaD018316——32———4
Kidney neoplasmsD007680EFO_0003865C6414———4
Urinary bladder neoplasmsD001749—C67—3———3
Transitional cell carcinomaD002295———3———3
Pancreatic neoplasmsD010190EFO_0003860C2521———3
Show 41 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GliomaD005910EFO_0000520—6———17
AdenocarcinomaD000230——3————3
Healthy volunteers/patients———3————3
Esophageal neoplasmsD004938—C152————2
LymphomaD008223—C85.91————1
Lymphoproliferative disordersD008232Orphanet_2442D47.91————1
Intestinal neoplasmsD007414—C26.01————1
Rectal neoplasmsD012004——1————1
Diffuse intrinsic pontine gliomaD000080443——1————1
RecurrenceD012008——1————1
Show 7 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastrointestinal neoplasmsD005770—C26.9————11
AggressionD000374EFO_0003015—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVandetanib
INNvandetanib
Description
Vandetanib is a quinazoline that is 7-[(1-methylpiperidin-4-yl)methoxy]quinazoline bearing additional methoxy and 4-bromo-2-fluorophenylamino substituents at positions 6 and 4 respectively. Used for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. It has a role as a tyrosine kinase inhibitor and an antineoplastic agent. It is an aromatic ether, a secondary amine, a member of quinazolines, a member of piperidines, an organobromine compound and an organofluorine compound.
Classification
Small molecule
Drug classangiogenesis inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1cc2/c(=N/c3ccc(Br)cc3F)nc[nH]c2cc1OCC1CCN(C)CC1
Identifiers
PDB—
CAS-ID443913-73-3
RxCUI—
ChEMBL IDCHEMBL24828
ChEBI ID49960
PubChem CID3081361
DrugBankDB08764
UNII IDYO460OQ37K (ChemIDplus, GSRS)
Target
Agency Approved
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)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Caprelsa
Adverse Events
Top Adverse Reactions
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1,879 adverse events reported
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