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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Camptosar, Irinotecan, Onivyde (discontinued: Irinotecan)
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| camptosar | New Drug Application | 2024-12-30 |
| irinotecan hydrochloide | ANDA | 2025-03-19 |
| irinotecan hydrochloide irinotecan hydrochloride | ANDA | 2022-03-03 |
| irinotecan hydrochloride | ANDA | 2025-06-05 |
| onivyde | New Drug Application | 2025-03-03 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
IRINOTECAN HYDROCHLORIDE, ONIVYDE, IPSEN | |||
| 2031-02-13 | ODE-463 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Irinotecan Hydrochloride, Onivyde, Ipsen | |||
| 10456360 | 2036-10-15 | DP | |
| 10993914 | 2036-10-15 | DP | |
| 9339497 | 2033-06-12 | U-1848 | |
| 9364473 | 2033-06-12 | U-1856 | |
| 9452162 | 2033-06-12 | U-1899 | |
| 9492442 | 2033-06-12 | U-1848, U-1899, U-1917 | |
| 9717724 | 2033-06-12 | U-1848, U-2091 | |
| 10980795 | 2033-06-12 | U-1848 | |
| 11369597 | 2033-06-12 | U-1848 | |
| 8147867 | 2028-08-29 | DS, DP | |
| 8329213 | 2027-01-06 | DS, DP | |
| 8703181 | 2025-05-02 | U-1434 | |
| 8992970 | 2025-05-02 | DS, DP | |
| 9724303 | 2025-05-02 | DS, DP | |
| 9730891 | 2025-05-02 | U-1848 | |
| 9782349 | 2025-05-02 | DS, DP | |
| 10722508 | 2025-05-02 | DS, DP | |
Clinical
Clinical Trials
2003 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 neoplasms | D015179 | — | — | 4 | 16 | 7 | 2 | — | 25 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 4 | 4 | 2 | — | — | 9 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 4 | 2 | — | — | 5 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | 4 | 1 | — | — | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 3 | 2 | — | — | 4 |
| Lung neoplasms | D008175 | — | C34.90 | — | 4 | 1 | — | — | 4 |
| Small cell lung carcinoma | D055752 | — | — | — | 3 | 2 | — | — | 4 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 1 | 1 | — | — | 3 |
| Rectal neoplasms | D012004 | — | — | — | 1 | 1 | — | — | 2 |
| Drug therapy | D004358 | — | — | 1 | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | — | 3 | — | — | — | 3 |
| Colorectal neoplasms | D015179 | — | — | 2 | 2 | — | — | — | 3 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 1 | 2 | — | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | 1 | — | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 1 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 2 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | 1 | — | — | — | 2 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | — | 2 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Mucinous cystadenocarcinoma | D018282 | — | — | 1 | — | — | — | — | 1 |
| Mucinous adenocarcinoma | D002288 | — | — | 1 | — | — | — | — | 1 |
| Peritoneal neoplasms | D010534 | — | — | 1 | — | — | — | — | 1 |
| Mesothelioma | D008654 | — | C45 | 1 | — | — | — | — | 1 |
| Pseudomyxoma peritonei | D011553 | EFO_0007456 | — | 1 | — | — | — | — | 1 |
| Cystadenocarcinoma | D003536 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Irinotecan |
| INN | irinotecan |
| 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 class | antineoplastics (camptothecin derivatives) |
| Image (chem structure or protein) |  |
| 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-ID | 97682-44-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL481 |
| ChEBI ID | 80630 |
| PubChem CID | 60838 |
| DrugBank | DB00762 |
| UNII ID | 7673326042 (ChemIDplus, GSRS) |
Target
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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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39,038 adverse events reported
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