Liposomal Irinotecan

Phase 3Small molecule

Liposomal Irinotecan is one of 295 small molecule programs targeting Metastatic Colorectal Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

294

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Colorectal CancerRecruiting

Pancreatic AdenocarcinomaActive, not recruiting

Metastatic Pancreatic AdenocarcinomaActive, not recruiting

Solid TumorRecruiting

Rectal CancerActive, not recruiting

Esophageal CancerActive, not recruiting

Advanced Solid MalignanciesNot yet recruiting

RhabdomyosarcomaRecruiting

Pancreatic CancerNot yet recruiting

OsteosarcomaRecruiting

Metastatic Colorectal CancerPhase 2

Recruiting

Pancreatic AdenocarcinomaPhase 2

Active, not recruiting

Metastatic Pancreatic AdenocarcinomaPhase 2

Active, not recruiting

Solid TumorPhase 1

Recruiting

Rectal CancerPhase 2

Active, not recruiting

Esophageal CancerPhase 2

Active, not recruiting

Advanced Solid MalignanciesPhase 1

Not yet recruiting

RhabdomyosarcomaPhase 2

Recruiting

Pancreatic CancerPhase 3

Not yet recruiting

OsteosarcomaPhase 2

Recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

Liposomal Irinotecan

Astellas

Phase 3

1 2

Nubeqa

Bayer

Preclinical

2 3

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

2 4

Zejula

GGlaxo Dba Glaxosmithkline

Preclinical

2 5

Epivir

GGlaxo Dba Glaxosmithkline

Preclinical

1 6

Navmi

SSummit Therapeutics

Preclinical

1 7

Proleukin

IIovance Biotherapeutics, Inc.

Preclinical

1 8

Carboplatin AUC-5

Merck & Co.

Preclinical

1 9

Soc

Pfizer

Preclinical

1 10

Chemotherapy Drug

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Not yet recruiting

Metastatic Colorectal Cancer

NCT06192680

Q4 2026

Phase 2Active, not recruiting

Pancreatic Adenocarcinoma

NCT03483038

Phase 2Active, not recruiting

Esophageal Cancer

NCT03764553

Phase 2Active, not recruiting

Metastatic Pancreatic Adenocarcinoma

NCT04233866

Q1 2027

Phase 2Recruiting

Metastatic Colorectal Cancer

NCT06184698

Q2 2027

Phase 2Recruiting

Rectal Cancer

NCT07104604

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer4 trials

Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer

Not yet recruiting·SSun Yat-sen University·Phase 1/2·NCT06434090·74 enrolled

Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer

Not yet recruiting·HHarbin Medical University·Phase 2·NCT06192680·63 enrolled

Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer

Recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT06184698·173 enrolled

Show 1 more trial

Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Recruiting·UUniversity of Wisconsin, Madison·Phase 2·NCT05854498·50 enrolled

Pancreatic Cancer3 trials

Liposomal Irinotecan Plus 5-FU / LV Combined With Paricalcitol in Patients With Advanced Pancreatic Cancer Progressed on Gemcitabine-based Therapy

Completed·WWashington University School of Medicine·Phase 1·NCT03883919·20 enrolled

Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer

Not yet recruiting·CCSPC Ouyi Pharmaceutical Co., Ltd.·Phase 3·NCT06571461·408 enrolled

A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma

Recruiting· Astellas logo

Astellas·Phase 3·NCT07409272·614 enrolled

Pancreatic Adenocarcinoma2 trials

A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

Active, not recruiting·UUniversity of Florida·Phase 2·NCT03483038·45 enrolled

Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma

Recruiting·MMedical University of South Carolina·Phase 2·NCT07076212·52 enrolled

Rectal Cancer2 trials

Exploratory Study on the Efficacy and Safety of Long-course Neoadjuvant Chemoradiation With Liposomal Irinotecan and Capecitabine Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer

Active, not recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT06210971·60 enrolled

Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement

Recruiting·AAffiliated Cancer Hospital of Shantou University Medical College·Phase 2·NCT07104604·51 enrolled

Induction Therapy1 trial

NALIRIFOX as Induction Therapy in LAPC

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06467565·20 enrolled

17 more indications

High Grade Neuroendocrine Cancer1 trial

Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin

Terminated·RRoswell Park Cancer Institute·Phase 2·NCT03736720·11 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

MM-398 and Ramucirumab in Treating Patients With Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Withdrawn·UUniversity of Southern California·Phase 1/2·NCT03739801

Sintilimab1 trial

SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC

Recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·N/A·NCT07474103·49 enrolled

Neuroendocrine Carcinoma1 trial

Second-line Therapy for Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma

Completed·TThe Christie NHS Foundation Trust·Phase 2·NCT03837977·58 enrolled

Pancreatic Carcinoma1 trial

Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:

Completed·NNelson Yee·Phase 2·NCT03861702·28 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Active, not recruiting· Revolution Medicines logo

Revolution Medicines·Phase 3·NCT06625320·501 enrolled

Triple-Negative Breast Cancer1 trial

Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)

Withdrawn·WWashington University School of Medicine·Phase 2·NCT05255666

Second-line Therapy1 trial

Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC

Not yet recruiting·RRui-hua Xu, MD, PhD·Phase 3·NCT06501664·360 enrolled

Pancreas Cancer1 trial

Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer

Withdrawn·DDevalingam Mahalingam·Phase 1/2·NCT05251038

Rhabdomyosarcoma1 trial

Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06023641·135 enrolled

Osteosarcoma1 trial

Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

Recruiting·PPeking University People's Hospital·Phase 1/2·NCT07479732·56 enrolled

Pancreas Ductal Adenocarcinoma1 trial

A Prospective, Phase II Study of Gemcitabine and Nab-paclitaxel in Combination With Liposomal Irinotecan (II) With or Without SHR-1701 as Neoadjuvant Therapy for Resectable/Borderline Resectable Pancreatic Cancer.

Active, not recruiting·TThe First Hospital of Jilin University·Phase 2·NCT07806110·62 enrolled

Metastatic Pancreatic Cancer1 trial

A Randomized, Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of YL201 Versus Liposomal Irinotecan in Combination With 5-Fluorouracil/Leucovorin in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed Prior Gemcitabine-based Systemic Therapy

Not yet recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 3·NCT07803783·320 enrolled

Advanced Solid Malignancies1 trial

Phase I Trial to Evaluate Safety and Efficacy of Combination of Liposomal Irinotecan (Nal-IRI; ONIVYDE®) and Cisplatin in Patients With Advanced or Metastatic Solid Malignancies (ICONIC Study)

Not yet recruiting·NNational Health Research Institutes, Taiwan·Phase 1·NCT07782346·44 enrolled

Esophageal Cancer1 trial

Liposomal iRInotecan, Carboplatin or oXaliplatin in the First Line Treatment of Esophagogastric Cancer: a Randomized Phase 2 Study

Active, not recruiting·AAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·Phase 2·NCT03764553·320 enrolled

Solid Tumor1 trial

A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation

Recruiting· Astellas logo

Astellas·Phase 1·NCT05382559·681 enrolled

Metastatic Pancreatic Adenocarcinoma1 trial

A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients With Treatment Naïve Metastatic Pancreatic Cancer (GIANT)

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 2·NCT04233866·176 enrolled

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for Liposomal Irinotecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Liposomal Irinotecan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Liposomal Irinotecan. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Astellas

Liposomal Irinotecan

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Metastatic Colorectal Cancer4 trials

Pancreatic Cancer3 trials

Pancreatic Adenocarcinoma2 trials

Rectal Cancer2 trials

Induction Therapy1 trial

High Grade Neuroendocrine Cancer1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Sintilimab1 trial

Neuroendocrine Carcinoma1 trial

Pancreatic Carcinoma1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Triple-Negative Breast Cancer1 trial

Second-line Therapy1 trial

Pancreas Cancer1 trial

Rhabdomyosarcoma1 trial

Osteosarcoma1 trial

Pancreas Ductal Adenocarcinoma1 trial

Metastatic Pancreatic Cancer1 trial

Advanced Solid Malignancies1 trial

Esophageal Cancer1 trial

Solid Tumor1 trial

Metastatic Pancreatic Adenocarcinoma1 trial

References

Drug Info

Quick Facts

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