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Drug ReportsIrinotecan
Camptosar, Onivyde pegylated liposomal (previously known as onivyde)(irinotecan)
Camptosar, Onivyde (irinotecan) is a small molecule pharmaceutical. Irinotecan was first approved as Camptosar on 1996-06-14. It is used to treat breast neoplasms, colonic neoplasms, leukemia, lymphoma, and neoplasm metastasis amongst others in the USA. It has been approved in Europe to treat pancreatic neoplasms. The pharmaceutical is active against DNA topoisomerase 1.
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Target
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1M
3M
6M
YTD
1Y
2Y
5Y
Max
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
respiratory tract diseasesD012140
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Camptosar, Onivyde (generic drugs available since 2008-02-27)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Irinotecan hydrochloride
Tradename
Company
Number
Date
Products
ONIVYDEIpsenN-207793 RX2015-10-22
1 products, RLD, RS
CAMPTOSARPfizerN-020571 RX1996-06-14
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
camptosarNew Drug Application2023-05-16
irinotecan hydrochloideANDA2023-10-31
irinotecan hydrochloide irinotecan hydrochlorideANDA2022-02-24
irinotecan hydrochlorideANDA2023-12-28
onivydeNew Drug Application2023-02-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
colonic neoplasms—D003110C18
leukemia—D007938C95
lymphoma—D008223C85.9
neoplasm metastasisEFO_0009708D009362—
non-small-cell lung carcinoma—D002289—
pancreatic neoplasmsEFO_0003860D010190C25
rectal neoplasms—D012004—
stomach neoplasmsEFO_0003897D013274C16
Agency Specific
FDA
EMA
Expiration
Code
IRINOTECAN HYDROCHLORIDE, ONIVYDE, IPSEN
2031-02-13ODE-463
Patent Expiration
Patent
Expires
Flag
FDA Information
Irinotecan Hydrochloride, Onivyde, Ipsen
104563602036-10-15DP
109939142036-10-15DP
93394972033-06-12U-1848
93644732033-06-12U-1856
94521622033-06-12U-1899
94924422033-06-12U-1848, U-1899, U-1917
97177242033-06-12U-1848, U-2091
109807952033-06-12U-1848
113695972033-06-12U-1848
81478672028-08-29DS, DP
83292132027-01-06DS, DP
87031812025-05-02U-1434
89929702025-05-02DS, DP
97243032025-05-02DS, DP
97308912025-05-02U-1848
97823492025-05-02DS, DP
107225082025-05-02DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01C: Plant alkaloids and other natural products, antineoplastic drugs
— L01CE: Topoisomerase 1 (top1) inhibitors
— L01CE02: Irinotecan
HCPCS
Code
Description
J9205
Injection, irinotecan liposome, 1 mg
J9206
Injection, irinotecan, 20 mg
Clinical
Clinical Trials
1828 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——1353971071049619
NeoplasmsD009369—C80154661112202
Stomach neoplasmsD013274EFO_0003897C1630691934114
Rectal neoplasmsD012004——1845141676
AdenocarcinomaD000230——203841255
Small cell lung carcinomaD055752——163281247
NeuroblastomaD009447EFO_0000621—232421—43
Neoplasm metastasisD009362EFO_0009708—312121330
Liver neoplasmsD008113EFO_1001513C22.091022121
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C257513430—12215
Esophageal neoplasmsD004938—C1510426—258
Colonic neoplasmsD003110—C1822318—456
Lung neoplasmsD008175HP_0100526C34.9014272——42
Breast neoplasmsD001943EFO_0003869C5014231—439
GlioblastomaD005909EFO_0000515—19223——37
Pancreatic ductal carcinomaD021441——14233—136
RhabdomyosarcomaD012208——15152—125
SarcomaD012509——12133—125
Ewing sarcomaD012512EFO_0000173—13141—224
Show 40 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——1426——133
Central nervous system neoplasmsD016543——1514———24
Biliary tract neoplasmsD001661—C24.9319——120
Ovarian neoplasmsD010051EFO_0003893C561110——119
GliomaD005910EFO_0000520—712———17
Triple negative breast neoplasmsD064726——108———14
AstrocytomaD001254EFO_0000271—75———11
GliosarcomaD018316——66———11
Gallbladder neoplasmsD005706EFO_0004606C2364——110
Fallopian tube neoplasmsD005185——37———9
Show 68 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A5————5
Appendiceal neoplasmsD001063EFO_0003880C18.15————5
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.03———14
Hodgkin diseaseD006689—C813————3
Anus neoplasmsD001005EFO_0003835C213————3
B-cell chronic lymphocytic leukemiaD015451—C91.12————2
ChondrosarcomaD002813——2————2
Weight lossD015431HP_0001824—1———12
Burkitt lymphomaD002051—C83.72————2
GanglioneuromaD005729——1————1
Show 23 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PrognosisD011379——————22
ChemoradiotherapyD059248——————11
Brain deathD001926—G93.82————11
Male breast neoplasmsD018567——————11
Rectal diseasesD012002——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIrinotecan
INNirinotecan
Description
Irinotecan is a member of the class of pyranoindolizinoquinolines that is the carbamate ester obtained by formal condensation of the carboxy group of [1,4'-bipiperidine]-1'-carboxylic acid with the phenolic hydroxy group of (4S)-4,11-diethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2- hydrochloride]quinoline-3,14-dione. Used (in the form of its hydrochloride salt trihydrate) in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. It is converted via hydrolysis of the carbamate linkage to its active metabolite, SN-38, which is ~1000 times more active. It has a role as an apoptosis inducer, an EC 5.99.1.2 (DNA topoisomerase) inhibitor, an antineoplastic agent and a prodrug. It is a pyranoindolizinoquinoline, a N-acylpiperidine, a carbamate ester, a tertiary alcohol, a tertiary amino compound, a delta-lactone and a ring assembly. It is functionally related to a SN-38. It is a conjugate base of an irinotecan(1+).
Classification
Small molecule
Drug classantineoplastics (camptothecin derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)[C@]3(O)CC
Identifiers
PDB—
CAS-ID97682-44-5
RxCUI—
ChEMBL IDCHEMBL481
ChEBI ID80630
PubChem CID60838
DrugBankDB00762
UNII ID7673326042 (ChemIDplus, GSRS)
Target
Agency Approved
TOP1
TOP1
Organism
Homo sapiens
Gene name
TOP1
Gene synonyms
NCBI Gene ID
7150
Protein name
DNA topoisomerase 1
Protein synonyms
DNA topoisomerase I, Scl-70 antigen, topoisomerase (DNA) I, type I DNA topoisomerase
Uniprot ID
Q9UJN0
Mouse ortholog
Top1 (21969)
DNA topoisomerase 1 (Q04750)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Camptosar, Irinotecan hydrochloide, Irinotecan hydrochloide irinotecan hydrochloride, Irinotecan hydrochloride, Onivyde
Adverse Events
Top Adverse Reactions
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29,349 adverse events reported
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