IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochloride helps patients with metastatic cancer of the colon or rectum. It is used as part of a first-line treatment regimen alongside 5-fluorouracil and leucovorin. Additionally, it treats patients whose colorectal cancer has returned or progressed after receiving initial fluorouracil-based therapies.
How IRINOTECAN HYDROCHLORIDE Works
This drug works by binding to topoisomerase I, an enzyme responsible for relieving tension in DNA by creating temporary single-strand breaks. By preventing these breaks from being repaired, the medication and its active metabolite cause permanent double-strand DNA damage when cells attempt to replicate. Because cells cannot easily repair this damage, the drug effectively stops cancer cell growth.
Details
- Status
- Prescription
- First Approved
- 2008-02-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
IRINOTECAN HYDROCHLORIDE Approval History
What IRINOTECAN HYDROCHLORIDE Treats
2 indicationsIRINOTECAN HYDROCHLORIDE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Colon Cancer
- Rectal Cancer
IRINOTECAN HYDROCHLORIDE Boxed Warning
DIARRHEA and MYELOSUPPRESSION Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt irinotecan hydrochloride injection and reduce subsequent dose...
WARNING: DIARRHEA and MYELOSUPPRESSION Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt irinotecan hydrochloride injection and reduce subsequent doses if severe diarrhea occurs [see (2.2) (5.1) ]. Severe myelosuppression may occur [see (5.2) ]. •Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt irinotecan hydrochloride injection and reduce subsequent doses if severe diarrhea occurs. ( 2.2 , 5.1 ) •Severe myelosuppression may occur. ( 5.2 )
IRINOTECAN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in IRINOTECAN HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IRINOTECAN HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to IRINOTECAN HYDROCHLORIDE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
78 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02595931 | NCI-2015-01915 NCI-2015-01915, HCC 15-164 | Ph 1 | active not recruiting | M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery |
| NCT07582315 | BL-B01D1-317 | Ph 3 | not yet recruiting | A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy and PD-1/PD-L1 Monoclonal Antibody Therapy(PANKU-BTC01) |
| NCT02192359 results posted | 14108 NCI-2014-01463, 14108 | Ph 1 | active not recruiting | Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas |
| NCT06662786 OrigAMI-2 | 61186372COR3001 2024-513852-13-00 | Ph 3 | recruiting | A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer |
| NCT06995872 | 10001842 001842-C | Ph 1 | recruiting | Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma |
| NCT06958328 LAP100 | NRG-GI011 NCI-2025-01624, NRG-GI011 | Ph 3 | recruiting | Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer |
| NCT00980460 results posted | NCI-2011-01975 NCI-2011-01975, AHEP0731 | Ph 3 | active not recruiting | Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer |
| NCT02567435 results posted | NCI-2015-01644 NCI-2015-01644, ARST1431 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma |
| NCT01787500 | 2012-0748 NCI-2013-00541, 2012-0748 | Ph 1 | completed | Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery |
| NCT07518147 | BL-M05D1-301 | Ph 3 | not yet recruiting | A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment |
| NCT02366819 | IRB14-0594 NCI-2014-02574, IRB14-0594 | Ph 4 | suspended | Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer |
| NCT07466316 | ARST2531 NCI-2026-00319, ARST2531 | Ph 3 | not yet recruiting | A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS) |
| NCT02047474 results posted | 1306012255 NCI-2013-02349, 1306012255 | Ph 2 | completed | Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer |
| NCT02890355 results posted | NCI-2015-02248 NCI-2015-02248, S1513 | Ph 2 | completed | FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer |
| NCT04094688 SOLARIS results posted | A021703 NCI-2019-01034, U10CA180821 | Ph 3 | active not recruiting | Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer |
| NCT03794349 results posted | ANBL1821 NCI-2018-03377, ANBL1821 | Ph 2 | active not recruiting | Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma |
| NCT06820957 | AEWS2431 NCI-2025-00801, AEWS2431 | Ph 2, Ph 3 | active not recruiting | Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body |
| NCT04340141 | A021806 NCI-2020-01560, U10CA180821 | Ph 3 | active not recruiting | Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer |
| NCT03365882 results posted | S1613 NCI-2016-01422, S1613 | Ph 2 | completed | S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery |
| NCT04539808 results posted | STUDY00021614 NCI-2020-06277, STUDY00021614 | Ph 2 | active not recruiting | NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer |
| NCT03977233 | LCCC1843 | Ph 2 | recruiting | Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer |
| NCT03290937 | 2017-0180 NCI-2018-01036, 2017-0180 | Ph 1 | completed | Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer |
| NCT07271355 | 24756 NCI-2025-08527, 24756 | Ph 3 | not yet recruiting | Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial |
| NCT04205968 | S1922 NCI-2019-04213, S1922 | Ph 2 | recruiting | Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers |
| NCT04821284 | 20F.1207 R01CA199646, JT 15477 | Ph 1, Ph 2 | active not recruiting | Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer |
| NCT02419495 | 2014-0640 NCI-2015-00693, 2014-0640 | Ph 1 | terminated | Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies |
| NCT00576654 | NCI-2009-01057 NCI-2009-01057, 1410014852 | Ph 1 | completed | Veliparib and Irinotecan Hydrochloride in Treating Patients With Cancer That Is Metastatic or Cannot Be Removed by Surgery |
| NCT04514497 results posted | NCI-2020-05958 NCI-2020-05958, 10402 | Ph 1 | active not recruiting | Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer |
| NCT01814501 results posted | OSU-11131 NCI-2013-00432 | Ph 2 | completed | Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab |
| NCT02975882 results posted | ADVL1514 NCI-2016-01412, ADVL1514 | Ph 1 | completed | Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors |
| NCT01167725 | CDR0000681540 WRAMC-8214, Z6091, CDR0000681540 | Ph 3 | terminated | Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer |
| NCT04927780 PREOPANC-3 | MEC-2021-0002 2020-005141-16 | Ph 3 | active not recruiting | Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer |
| NCT03336216 results posted | CA025-006 | Ph 2 | completed | A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer |
| NCT04641871 | Sym021-02 | Ph 1 | completed | Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies |
| NCT01897454 results posted | 2012-570 NCI-2013-01213, 12-017 | Ph 2 | terminated | Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer |
| NCT02095132 results posted | NCI-2014-00547 NCI-2014-00547, ADVL1312 | Ph 1, Ph 2 | completed | Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors |
| NCT04072445 results posted | MC1941 NCI-2019-05653, MC1941 | Ph 2 | completed | Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer |
| NCT00535353 | I187 CAN-NCIC-IND187, IND187 | Ph 1 | completed | AZD2281 and Irinotecan in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer |
| NCT01835041 | IRB00022532 NCI-2013-00674, P30CA012197 | Ph 1 | completed | CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer |
| NCT01079780 results posted | E7208 CDR0000666736 | Ph 2 | completed | Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy |
| NCT02333188 | IRB14-0595 NCI-2014-02407, IRB14-0595 | Ph 1 | completed | Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer |
| NCT02620865 results posted | 2015-100 NCI-2015-01942, 2015-100 | Ph 1, Ph 2 | completed | BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer |
| NCT01767194 results posted | NCI-2012-03125 NCI-2012-03125, CDR0000745188 | Ph 2 | completed | Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma |
| NCT02562716 results posted | S1505 NCI-2015-01236, S1505 | Ph 2 | completed | S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery |
| NCT02049593 | 13-001857 NCI-2014-00048, TRIO-US GI-07 | Ph 1 | completed | PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic Solid Tumors |
| NCT00936832 | CDR0000637832 FFCD-0801, EUDRACT-2008-005959-19 | Ph 2 | withdrawn | Sunitinib Malate and Combination Chemotherapy as Front-Line Therapy in Treating Patients With Metastatic Rectal Cancer That Cannot Be Removed by Surgery |
| NCT03245450 results posted | E7389-G000-213 2016-003352-67 | Ph 1, Ph 2 | completed | Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors |
| NCT03110510 | 2017-02-094 | Ph 2 | withdrawn | FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study |
| NCT05042934 | 2017-0607 NCI-2019-01258, 2017-0607 | Ph 1, Ph 2 | withdrawn | Lurbinectedin With or Without Irinotecan in Treating Patients With Relapsed or High Risk Metastatic Ewing Sarcoma |
| NCT00655499 PIMABI results posted | CDR0000593012 GERCOR-PIMABI-C07-1, 2007-004806-28 | Ph 2 | completed | Panitumumab and Irinotecan as Third-Line Therapy in Treating Patients With Metastatic Colorectal Cancer |
Showing 50 of 78 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IRINOTECAN HYDROCHLORIDE FDA Label Details
Indications & Usage
IRINOTECAN HYDROCHLORIDE is indicated for the treatment of Colon Cancer; Rectal Cancer.
WARNING: DIARRHEA and MYELOSUPPRESSION Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with ...
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Full clinical data, patents, trials, and competitive landscape for irinotecan hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.