Overview
Irinotecan is an antineoplastic enzyme inhibitor primarily used in the treatment of colorectal cancer. It is a derivative of camptothecin that inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex, and causes double-strand DNA breakage and cell death. It is a derivative of camptothecin. Irinotecan was approved for the treatment of advanced pancreatic cancer in October, 2015 (irinotecan liposome injection, trade name Onivyde).
Background
Irinotecan is an antineoplastic enzyme inhibitor primarily used in the treatment of colorectal cancer. It is a derivative of camptothecin that inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex, and causes double-strand DNA breakage and cell death. It is a derivative of camptothecin. Irinotecan was approved for the treatment of advanced pancreatic cancer in October, 2015 (irinotecan liposome injection, trade name Onivyde).
Indication
For the treatment of metastatic colorectal cancer (first-line therapy when administered with 5-fluorouracil and leucovorin). Also used in combination with cisplatin for the treatment of extensive small cell lung cancer. Irinotecan is currently under investigation for the treatment of metastatic or recurrent cervical cancer. Also used in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Associated Conditions
- Esophageal Cancer
- Ewing's Sarcoma
- Gastric Cancer
- High Grade Glioma: Glioblastoma (GBM)
- Metastatic Cervical Cancer
- Non-Small Cell Lung Cancer (NSCLC)
- Ovarian Cancer
- Pancreatic Cancer
- Rhabdomyosarcomas
- Small Cell Lung Cancer (SCLC)
- Stage IV Colorectal Cancer
- Recurrent, metastatic Colorectal carcinoma
- Refractory, metastatic Pancreatic adenocarcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/18 | Phase 1 | Not yet recruiting | Steven DuBois, MD | ||
2025/06/17 | Phase 1 | Not yet recruiting | |||
2025/06/11 | Phase 4 | Not yet recruiting | Beijing GoBroad Hospital | ||
2025/05/31 | Phase 3 | Not yet recruiting | |||
2025/05/30 | Phase 1 | Not yet recruiting | |||
2025/05/15 | Phase 1 | Not yet recruiting | |||
2025/05/06 | Phase 3 | Not yet recruiting | |||
2025/05/01 | Phase 3 | Recruiting | |||
2025/04/30 | Phase 3 | Not yet recruiting | |||
2025/04/24 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Areva Pharmaceuticals,Inc. | 59923-702 | INTRAVENOUS | 20 mg in 1 mL | 4/9/2019 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9583 | INTRAVENOUS | 20 mg in 1 mL | 6/28/2020 | |
| Ipsen Biopharmaceuticals, Inc. | 15054-0043 | INTRAVENOUS | 4.3 mg in 1 mL | 2/16/2024 | |
| Gland Pharma Limited | 68083-382 | INTRAVENOUS | 20 mg in 1 mL | 3/3/2022 | |
| Areva Pharmaceuticals, Inc. | 59923-716 | INTRAVENOUS | 20 mg in 1 mL | 1/14/2021 | |
| Areva Pharmaceuticals, Inc. | 59923-714 | INTRAVENOUS | 20 mg in 1 mL | 1/14/2021 | |
| Ingenus Pharmaceuticals, LLC | 50742-402 | INTRAVENOUS | 100 mg in 5 mL | 7/8/2022 | |
| Qilu Pharmaceutical Co., Ltd. | 67184-0511 | INTRAVENOUS | 20 mg in 1 mL | 4/15/2020 | |
| Ingenus Pharmaceuticals, LLC | 50742-401 | INTRAVENOUS | 40 mg in 2 mL | 7/8/2022 | |
| Eugia US LLC | 55150-355 | INTRAVENOUS | 20 mg in 1 mL | 7/25/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| IRINO Solution for I.V Infusion 20mg/ml | SIN14373P | INFUSION, SOLUTION CONCENTRATE | 20 mg/ml | 6/21/2013 | |
| IRITEC CONCENTRATE FOR SOLUTION FOR INFUSION 40mg/2ml | SIN15058P | INFUSION, SOLUTION CONCENTRATE | 40mg/vial | 8/2/2016 | |
| ONIVYDE PEGYLATED LIPOSOMAL (IRINOTECAN) CONCENTRATE FOR DISPERSION FOR INFUSION 4.3 mg/mL | SIN15397P | INFUSION, SOLUTION CONCENTRATE | 4.33 mg/mL | 12/28/2017 | |
| Irinotesin Concentrate for Solution for Infusion 20mg/ ml | SIN13857P | INFUSION, SOLUTION CONCENTRATE | 20mg/ ml | 8/26/2010 | |
| CAMPTO FOR INFUSION 20 mg/ml | SIN09428P | INJECTION | 20 mg/ml | 7/31/1997 | |
| IRINOX 100 IRINOTECAN HYDROCHLORIDE CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ 5 ML | SIN15612P | INFUSION, SOLUTION CONCENTRATE | 100mg/vial | 1/18/2019 | |
| IRINOTECAN HYDROCHLORIDE ADVAGEN CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML | SIN15701P | INFUSION, SOLUTION CONCENTRATE | 20 mg/ ml | 5/29/2019 | |
| IRNIZET 100 CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/5ML | SIN16797P | INFUSION, SOLUTION CONCENTRATE | 100mg/5mL | 5/30/2023 | |
| DBL Irinotecan Injection Concentrate 20mg/ml | SIN13367P | INJECTION, SOLUTION, CONCENTRATE | 20mg/mL | 10/26/2007 | |
| IRINOTEL INJECTION 20 MG/ML | SIN16266P | INJECTION, SOLUTION | 20.0 mg/ml | 7/7/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Irinotecan Hydrochloride Liposome Injection | 国药准字HJ20220034 | 化学药品 | 注射剂 | 4/12/2022 | |
| Irinotecan Hydrochloride Liposome Injection | 国药准字H20234150 | 化学药品 | 注射剂 | 9/12/2023 | |
| Irinotecan Hydrochloride Liposome Injection | 国药准字H20254172 | 化学药品 | 注射剂 | 5/13/2025 | |
| Irinotecan Hydrochloride Liposome Injection（Ⅱ） | 国药准字H20230036 | 化学药品 | 注射剂 | 1/9/2024 | |
| Irinotecan Hydrochloride Injection | 国药准字H20153209 | 化学药品 | 注射剂 | 9/7/2020 | |
| Irinotecan Hydrochloride Injection | 国药准字HJ20160577 | 化学药品 | 注射剂 | 3/11/2021 | |
| Irinotecan Hydrochloride Injection | 国药准字H20213206 | 化学药品 | 注射剂 | 3/23/2021 | |
| Irinotecan Hydrochloride Injection | 国药准字H20223909 | 化学药品 | 注射剂 | 5/4/2023 | |
| Irinotecan Hydrochloride Injection | 国药准字H20213205 | 化学药品 | 注射剂 | 3/23/2021 | |
| Irinotecan Hydrochloride Injection | 国药准字H20153210 | 化学药品 | 注射剂 | 9/7/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| IRINOTECAN HYDROCHLORIDE CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/5ML | N/A | N/A | N/A | 7/10/2014 | |
| IRINOTECAN HYDROCHLORIDE CONCENTRATE FOR SOLUTION FOR INFUSION 40MG/2ML | N/A | N/A | N/A | 7/10/2014 |