Liposomal Irinotecan

Phase 3Small molecule

Astellas

Liposomal Irinotecan is one of 326 small molecule programs targeting Pancreatic Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

325

Competitors

Pipeline

Status by Indication[3][1]

Indication

Pancreatic CarcinomaActive, not recruiting

Gastroesophageal Junction AdenocarcinomaActive, not recruiting

OsteosarcomaActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

Rectal AdenocarcinomaActive, not recruiting

Neuroendocrine CarcinomaActive, not recruiting

Pancreatic Ductal AdenocarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Pancreatic AdenocarcinomaActive, not recruiting

Pancreatic CancerRecruiting

Pancreatic CarcinomaPhase 2

Active, not recruiting

Gastroesophageal Junction AdenocarcinomaPhase 1/Phase 2

Active, not recruiting

OsteosarcomaPhase 1/Phase 2

Active, not recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

Rectal AdenocarcinomaPhase 1

Active, not recruiting

Neuroendocrine CarcinomaPhase 2

Active, not recruiting

Pancreatic Ductal AdenocarcinomaPhase 3

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Pancreatic AdenocarcinomaPhase 2

Active, not recruiting

Pancreatic CancerPhase 3

Recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

1063 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Liposomal Irinotecan

Astellas

Phase 3

3 2

MS Contin

Merck & Co.

Preclinical

1 3

Medrol

Pfizer

Preclinical

1 4

Byetta

AstraZeneca

Preclinical

1 5

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 6

LDE225

Novartis

Preclinical

1 7

Sulfonylureas

Eli Lilly

Preclinical

1 8

Thiazolidinediones

Sanofi

Preclinical

1 9

Alpha-Glucosidase Inhibitors

Sanofi

Preclinical

1 10

Meglitinides

Sanofi

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

Metastatic Pancreatic Adenocarcinoma

NCT04233866

Q1 2027

Phase 2Recruiting

Metastatic Colorectal Cancer

NCT06184698

Q2 2027

Phase 1Recruiting

Rectal Adenocarcinoma

NCT07104604

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer4 trials

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

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

Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Active, not recruiting·UUniversity of Wisconsin, Madison·Phase 2·NCT05854498·25 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

Show 1 more trial

Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer

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

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

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

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

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

15 more indications

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

Chemoradiation1 trial

Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer

Recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT06210971·60 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

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

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

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

Rectal Adenocarcinoma1 trial

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

Recruiting·—·Phase 1·NCT07104604·59 enrolled

Gastric Cancer1 trial

Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer

Active, not recruiting·—·Phase 2·NCT03764553·320 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

Withdrawn·DDevalingam Mahalingam·Phase 1/2·NCT05251038

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

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

Sources

References

[1]
ClinicalTrials.gov — 26 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

High Grade Neuroendocrine Cancer1 trial

Pancreatic Carcinoma1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Chemoradiation1 trial

Osteosarcoma1 trial

Neuroendocrine Carcinoma1 trial

Rhabdomyosarcoma1 trial

Second-line Therapy1 trial

Rectal Adenocarcinoma1 trial

Gastric Cancer1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Sintilimab1 trial

Induction Therapy1 trial

Triple-Negative Breast Cancer1 trial

Pancreas Cancer1 trial

Metastatic Pancreatic Adenocarcinoma1 trial

Solid Tumor1 trial

References

Drug Info

Quick Facts

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