Irinotecan Hydrochloride Liposome

Phase 3Small molecule

Irinotecan Hydrochloride Liposome is one of 183 small molecule programs targeting Chemoradiotherapy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

182

Competitors

Pipeline

Status by Indication[3][1]

Indication

ChemoradiotherapyRecruiting

Metastatic Biliary Tract CarcinomaNot yet recruiting

Biliary Tract CarcinomaNot yet recruiting

Ewing SarcomaRecruiting

Colorectal CancerRecruiting

Small Cell Lung CancerRecruiting

Neuroendocrine CarcinomaNot yet recruiting

Gastric CancerNot yet recruiting

Hypofractionated RadiotherapyRecruiting

ChemoradiotherapyPreclinical

Recruiting

Metastatic Biliary Tract CarcinomaPhase 2

Not yet recruiting

Biliary Tract CarcinomaPreclinical

Not yet recruiting

Ewing SarcomaPhase 1

Recruiting

Colorectal CancerPhase 2

Recruiting

Small Cell Lung CancerPhase 3

Recruiting

Neuroendocrine CarcinomaPhase 3

Not yet recruiting

Gastric CancerPhase 3

Not yet recruiting

Hypofractionated RadiotherapyPhase 2

Recruiting

Competition

Competitive Landscape

268 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

25 2

Opdivo

Bristol-Myers Squibb

Phase 3

24 3

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

8 4

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

3 5

Mfolfox6

Roche

Phase 3

5 6

PD-1 Monoclonal Antibody

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

2 7

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Phase 3

2 8

Irinotecan Hydrochloride Liposome

Luye Pharma Group Ltd.

Phase 3

1 9

IBI363

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

1 10

Iron Isomaltoside

TThomas Jefferson University

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Ewing Sarcoma

NCT06340204

N/ANot yet recruiting

Biliary Tract Carcinoma

NCT06463548

Phase 2Recruiting

Colorectal Cancer

NCT06763029

Q4 2027

Post-ApprovalNot yet recruiting

Gastric Cancer

NCT06499610

N/ARecruiting

Chemoradiotherapy

NCT06894797

Post-ApprovalNot yet recruiting

Neuroendocrine Carcinoma

NCT07014540

Clinical

Trials by Indication[1]

Small Cell Lung Cancer2 trials

Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

Recruiting· Luye Pharma Group Ltd. logo

Luye Pharma Group Ltd.·Phase 3·NCT06128837·686 enrolled

Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer

Recruiting·TTang-Du Hospital·Phase 4·NCT06467786·24 enrolled

Biliary Tract Cancer2 trials

A Phase III Randomized Controlled Clinical Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07606599·398 enrolled

A Phase III Randomized Controlled Clinical 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(PANKU-BTC01)

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07582315·538 enrolled

Ewing sarcoma1 trial

Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma

Recruiting·PPeking University People's Hospital·Phase 1·NCT06340204·44 enrolled

Gastric Cancer1 trial

Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer

Not yet recruiting·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 4·NCT06499610·44 enrolled

Biliary Tract Carcinoma1 trial

Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma

Not yet recruiting·YYunpeng Liu·N/A·NCT06463548·30 enrolled

5 more indications

Chemoradiotherapy1 trial

Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer.

Recruiting·PPeking University Cancer Hospital & Institute·N/A·NCT06894797·68 enrolled

Metastatic Biliary Tract Carcinoma1 trial

Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma

Not yet recruiting·BBa Yi·Phase 2·NCT06430827·20 enrolled

Colorectal Cancer1 trial

Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer

Recruiting·FFudan University·Phase 2·NCT06763029·36 enrolled

Neuroendocrine Carcinoma1 trial

A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma

Not yet recruiting·—·Phase 4·NCT07014540·45 enrolled

Hypofractionated Radiotherapy1 trial

Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R)

Recruiting·FFudan University·Phase 2·NCT07183865·44 enrolled

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Irinotecan Hydrochloride Liposome. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Irinotecan Hydrochloride Liposome compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Irinotecan Hydrochloride Liposome. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Luye Pharma Group Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Luye Pharma Group Ltd.

Irinotecan Hydrochloride Liposome

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Small Cell Lung Cancer2 trials

Biliary Tract Cancer2 trials

Ewing sarcoma1 trial

Gastric Cancer1 trial

Biliary Tract Carcinoma1 trial

Chemoradiotherapy1 trial

Metastatic Biliary Tract Carcinoma1 trial

Colorectal Cancer1 trial

Neuroendocrine Carcinoma1 trial

Hypofractionated Radiotherapy1 trial

References

Drug Info

Quick Facts

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