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Drug ReportsIrinotecan
Camptosar, Onivyde pegylated liposomal (previously known as onivyde)(irinotecan)
Camptosar, Irinotecan, 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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Clinical
Drug
Target
Variants
Financial
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5D
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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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, Irinotecan, Onivyde (discontinued: Irinotecan)
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 Application2024-12-30
irinotecan hydrochloideANDA2025-03-19
irinotecan hydrochloide irinotecan hydrochlorideANDA2022-03-03
irinotecan hydrochlorideANDA2025-01-16
onivydeNew Drug Application2025-03-03
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
1991 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 neoplasmsD0151791624601271162734
NeoplasmsD009369C8020211726212309
AdenocarcinomaD0002306513932112222
Stomach neoplasmsD013274EFO_0003897C1635812249138
Neoplasm metastasisD009362EFO_0009708195727317114
Rectal neoplasmsD012004226519111109
Lung neoplasmsD008175C34.9029731234106
Esophageal neoplasmsD004938C151758131586
Small cell lung carcinomaD0557522454123584
Colonic neoplasmsD003110C182444181883
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C25931833823290
CarcinomaD002277C80.03575213118
RecurrenceD01200829419372
Non-small-cell lung carcinomaD00228924351251
SarcomaD01250922285350
Pancreatic ductal carcinomaD02144117306350
GlioblastomaD005909EFO_00005152328345
Breast neoplasmsD001943EFO_0003869C5016251544
Ewing sarcomaD012512EFO_000017315202232
RhabdomyosarcomaD01220814194131
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GliomaD005910EFO_0000520202640
Central nervous system neoplasmsD0165431714127
Nervous system neoplasmsD009423151424
Ovarian neoplasmsD010051EFO_0003893C561112121
Triple negative breast neoplasmsD06472611816
LymphomaD008223C85.911415
AstrocytomaD001254EFO_00002718713
Ovarian epithelial carcinomaD0000772167712
GliosarcomaD0183166611
MedulloblastomaD0085274810
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Indications Phases 1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PrognosisD01137922
Lymphoid leukemiaD007945C9111
Body weightD001835EFO_000433811
Weight lossD01543111
HypertensionD006973EFO_0000537I1011
ChemoradiotherapyD05924811
Brain deathD001926G93.8211
MucositisD052016EFO_100189811
Male breast neoplasmsD01856711
Ultrasonic therapyD01446411
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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
Protein name
DNA topoisomerase 1
Protein synonyms
DNA topoisomerase I, Scl-70 antigen, topoisomerase (DNA) I, type I DNA topoisomerase
Uniprot ID
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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38,191 adverse events reported
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