ONIVYDE (irinotecan hydrochloride)
Onivyde helps adults with metastatic pancreatic cancer when used as part of a combination chemotherapy regimen. It is used as a first-line option alongside oxaliplatin, fluorouracil, and leucovorin, or for patients whose disease has progressed after receiving gemcitabine-based therapy. Because it is not used as a standalone therapy, it is always administered with other specific medications to manage the spread of the disease.
How ONIVYDE Works
This medication is a topoisomerase 1 inhibitor encapsulated within a liposome (lipid bilayer vesicle). Topoisomerase 1 relieves torsional strain in DNA by inducing single-strand breaks. Irinotecan and its active metabolite, **SN-38**, bind reversibly to the topoisomerase 1-DNA complex, preventing the re-ligation of these single-strand breaks. This leads to exposure-dependent double-strand DNA damage and cell death. The liposomal formulation is designed to alter pharmacokinetics and improve intratumoral exposure of the active therapy.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-10-22
- Patent Cliff
- 2036
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE, LIPOSOMAL
ONIVYDE Approval History
What ONIVYDE Treats
1 indicationsONIVYDE is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pancreatic Adenocarcinoma
ONIVYDE Boxed Warning
SEVERE NEUTROPENIA AND SEVERE DIARRHEA Neutropenia Severe and life-threatening neutropenia, including fatal neutropenic sepsis and fatal neutropenic fever, has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin. Withhold ONIVYDE for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment [see Dosage and Administration (2.2) and Warni...
WARNING: SEVERE NEUTROPENIA AND SEVERE DIARRHEA Neutropenia Severe and life-threatening neutropenia, including fatal neutropenic sepsis and fatal neutropenic fever, has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin. Withhold ONIVYDE for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ]. Diarrhea Severe and life-threatening diarrhea has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin. Do not administer ONIVYDE to patients with bowel obstruction. Withhold ONIVYDE for diarrhea of Grade 2-4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity [see Dosage and Administration (2.2) and Warnings and Precautions (5.2) ]. WARNING: SEVERE NEUTROPENIA and SEVERE DIARRHEA See full prescribing information for complete boxed warning Neutropenia Severe or life-threatening neutropenia , including fatal neutropenic sepsis and fatal neutropenic fever, has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin. Withhold ONIVYDE for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment ( 2.2 ), ( 5.1 ). Diarrhea Severe and life-threatening diarrhea has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin. Do not administer ONIVYDE to patients with bowel obstruction. Withhold ONIVYDE for diarrhea of Grade 2-4 severity. Administer loperamide for late diarrhea of any severity. Administer atrop
ONIVYDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 ONIVYDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ONIVYDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ONIVYDE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
81 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 |
| NCT04901702 | ONITT NCI-2021-02843 | Ph 1, Ph 2 | recruiting | Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma |
| 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 |
| NCT03719924 OESIRI | PRODIGE 62 - OESIRI | Ph 2 | completed | Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma |
| 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 |
| NCT03524508 | NIFTY | Ph 2 | completed | Nal-IRI(Nanoliposomal Irinotecan) Plus 5-FU/LV in Metastatic Biliary Tract Cancer |
| 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 |
Showing 50 of 81 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.
ONIVYDE FDA Label Details
Indications & Usage
FDA Label (PDF)ONIVYDE is indicated for the treatment of Pancreatic Adenocarcinoma.
WARNING: SEVERE NEUTROPENIA AND SEVERE DIARRHEA Neutropenia Severe and life-threatening neutropenia, including fatal neutropenic sepsis and fatal neutropenic fever, has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorou...
ONIVYDE Patents & Exclusivity
Patents (14 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ONIVYDE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 17 active patents
Trial Analysis
- • 82 total trials
- • Stage: Stable
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment