Galunisertib

Phase 2Small molecule

Eli Lilly

Galunisertib is one of 233 small molecule programs targeting Carcinosarcoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

232

Competitors

Pipeline

Status by Indication[3][1]

Indication

CarcinosarcomaActive, not recruiting

Breast CancerActive, not recruiting

Colorectal CancerActive, not recruiting

Pancreatic CancerActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

GlioblastomaActive, not recruiting

Myelodysplastic SyndromesActive, not recruiting

CarcinosarcomaPhase 1

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

Colorectal CancerPhase 1/Phase 2

Active, not recruiting

Pancreatic CancerPhase 1/Phase 2

Active, not recruiting

Hepatocellular CarcinomaPhase 1/Phase 2

Active, not recruiting

GlioblastomaPhase 2

Active, not recruiting

Myelodysplastic SyndromesPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Galunisertib

Eli Lilly

Phase 2

1 2

MS Contin

Merck & Co.

Preclinical

2 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 6

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 7

Spravato

WWim Janssens

Preclinical

2 8

Chirocaine

PPurdue Pharma LP

Preclinical

1 9

Acupan

YYonsei University

Preclinical

1 10

Chantix

PPrism Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Biomarker

NCT04605562

Clinical

Trials by Indication[1]

Pancreatic Cancer2 trials

A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1/2·NCT01373164·170 enrolled

A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02734160·37 enrolled

Carcinosarcoma1 trial

Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary

Completed·UUniversity of Oklahoma·Phase 1·NCT03206177·26 enrolled

Colorectal Cancer1 trial

Galunisertib and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer

Withdrawn·TThe Netherlands Cancer Institute·Phase 1/2·NCT03470350

Immune System1 trial

A Study of Galunisertib on the Immune System in Participants With Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02304419·10 enrolled

Hepatocellular Carcinoma1 trial

A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma

Completed· Eli Lilly logo

Eli Lilly·Phase 1/2·NCT02423343·41 enrolled

5 more indications

Glioblastoma1 trial

A Study in Recurrent Glioblastoma (GB)

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01582269·158 enrolled

ART1 trial

Study of Galunisertib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02752919·40 enrolled

Breast Cancer1 trial

Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT02672475·29 enrolled

Myelodysplastic Syndromes1 trial

A Study of Galunisertib in Participants With Myelodysplastic Syndromes

Completed· Eli Lilly logo

Eli Lilly·Phase 2/3·NCT02008318·43 enrolled

Biomarker1 trial

Umbrella Biomarker-Guided Therapy in NPC

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT04605562·206 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Galunisertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Galunisertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Galunisertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Eli Lilly

Galunisertib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Pancreatic Cancer2 trials

Carcinosarcoma1 trial

Colorectal Cancer1 trial

Immune System1 trial

Hepatocellular Carcinoma1 trial

Glioblastoma1 trial

ART1 trial

Breast Cancer1 trial

Myelodysplastic Syndromes1 trial

Biomarker1 trial

References

Drug Info

Quick Facts

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