Nanoliposomal irinotecan

Phase 2Small molecule

AstraZeneca

Nanoliposomal irinotecan is one of 98 small molecule programs targeting Adenocarcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

AdenocarcinomaRecruiting

EfficacyRecruiting

GI CancersActive, not recruiting

AdenocarcinomaPhase 2

Recruiting

EfficacyPhase 2

Recruiting

GI CancersPhase 2

Active, not recruiting

Competition

Competitive Landscape

139 competitors in Efficacy

#DrugCompanyPhaseTrials

Rayos

RRoxane Laboratories

Phase 3

5 2

Paraplatin

AAvyxa

Phase 3

4 3

Alimta

SShawn Eagle

Phase 3

3 4

Cytoxan

BBaxter Healthcare Corporation

Phase 3

3 5

Cetaphil

GGalderma R&D

Phase 3

1 6

Levocept

SSebela Women's Health Inc.

Phase 3

1 7

Veracept

SSebela Women's Health Inc.

Phase 3

1 8

Aralen

Sanofi

Preclinical

2 9

Primaquine

Sanofi

Preclinical

2 10

Proamatine

Takeda

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Advanced Biliary Tract Cancer

NCT04005339

Q2 2027

Phase 2Recruiting

Gastric Cancer

NCT06219941

Q4 2027

Phase 2Recruiting

Efficacy

NCT05472259

Q3 2028

Phase 2Recruiting

Adenocarcinoma

NCT06835387

Clinical

Trials by Indication[1]

Efficacy1 trial

A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)

Recruiting·BBelgian Group of Digestive Oncology·Phase 2·NCT05472259·134 enrolled

Trial1 trial

Phase I Trial HIPEC With Nal-irinotecan

Completed·SStony Brook University·Phase 1·NCT04088786·18 enrolled

GI Cancers1 trial

TAS102 in Combination With NAL-IRI in Advanced GI Cancers

Active, not recruiting·EEmory University·Phase 1/2·NCT03368963·64 enrolled

Pancreatic Adenocarcinoma1 trial

Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma

Unknown status·NNational Taiwan University Hospital·Phase 2·NCT05363007·60 enrolled

Biliary Tract Cancer1 trial

Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT03785873·34 enrolled

8 more indications

Glioma1 trial

Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma

Completed·UUniversity of California, San Francisco·Phase 1·NCT02022644·18 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma

Completed·CCardiff Oncology·Phase 2·NCT04752696·41 enrolled

Chemoradiotherapy1 trial

Nanoliposomal Irinotecan in Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy

Completed·NNational Health Research Institutes, Taiwan·Phase 2·NCT03712397·59 enrolled

Refractory Solid Tumors1 trial

Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors

Completed·PPharmaEngine·Phase 1·NCT03810742·44 enrolled

Glioblastoma1 trial

BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma

Terminated·—·Phase 1/2·NCT03119064·12 enrolled

Advanced Biliary Tract Cancer1 trial

NAPOLI-2: Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer

Active, not recruiting·GGeorgetown University·Phase 2·NCT04005339·48 enrolled

Gastric Cancer1 trial

A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06219941·226 enrolled

Adenocarcinoma1 trial

Phase II Study of NALIRIFOX (Nanoliposomal Irinotecan + Oxaliplatin With Fluorouracil and Folinic Acid) in Advanced Unresectable Small Bowel Tumors

Recruiting·TTiago Biachi de Castria·Phase 2·NCT06835387·36 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Nanoliposomal irinotecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nanoliposomal irinotecan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nanoliposomal irinotecan. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: AstraZeneca

Nanoliposomal irinotecan

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q3 2028

Trials by Indication[1]

Efficacy1 trial

Trial1 trial

GI Cancers1 trial

Pancreatic Adenocarcinoma1 trial

Biliary Tract Cancer1 trial

Glioma1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Chemoradiotherapy1 trial

Refractory Solid Tumors1 trial

Glioblastoma1 trial

Advanced Biliary Tract Cancer1 trial

Gastric Cancer1 trial

Adenocarcinoma1 trial

References

Drug Info

Quick Facts

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