Drugs / Galunisertib
Trials 25 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT03206177 | Aug 2017 → Jul 2021 | ovarian carcinosarcoma | University of Oklahoma | Completed | No outcome recorded |
| Phase 1 | NCT02906397 | Mar 2017 → Jul 2021 | hepatocellular carcinoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02734160 | Jun 2016 → Aug 2018 | malignant pancreatic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02752919 | Apr → Jun 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02672475 | Mar 2016 → Apr 2021 | triple-negative breast carcinoma | Vanderbilt-Ingram Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02304419 | May 2015 → Aug 2016 | neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02240433 | Nov 2014 → Jul 2017 | hepatocellular carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02154646 | May → Sep 2014 | malignant pancreatic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01965808 | Oct → Nov 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01746004 | Jan → Feb 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01722825 | Nov 2012 → Jun 2014 | metastatic neoplasm, neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01682187 | Dec 2005 → May 2012 | glioma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT05700656 | Jul 2023 → Dec 2026 expected | colorectal cancer, peritoneal carcinomatosis | The Netherlands Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03470350 | Aug 2018 → Jun 2020 | colorectal cancer | The Netherlands Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02423343 | Jan 2015 → Dec 2018 | hepatocellular carcinoma, non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/2 | NCT01373164 | Jun 2011 → Nov 2015 | malignant pancreatic neoplasm, metastatic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/2 | NCT01220271 | Apr 2011 → Aug 2015 | glioma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT04605562 | Jun 2022 → Dec 2026 expected | nasopharyngeal carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02452008 | May 2016 → Dec 2025 overdue | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02688712 | Mar 2016 → Jan 2026 overdue | rectum adenocarcinoma | Providence Health & Services | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02538471 | Aug 2015 → Sep 2018 | breast cancer | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 2 | NCT02178358 | Aug 2014 → Jun 2017 | hepatocellular carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01582269 | Apr 2012 → Jul 2014 | glioblastoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01246986 | Mar 2011 → Jun 2019 | hepatocellular carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02008318 | Mar 2014 → Mar 2016 | myelodysplastic syndrome | Eli Lilly and Company | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT07321860 Comparator | Jun 2026 → Jun 2027 expected | amyotrophic lateral sclerosis | Gipfel Life Sciences GmbH | Not yet recruiting | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | galunisertib | “Galunisertib (LY2157299), a small molecule inhibitor of TGF-beta RI serine/threonine kinase, had antitumor effects with acceptable safety/tolerability in a first-in-human dose...” PMID 26526984 ↗ Nov 201518“Phase 1b/2a study of galunisertib, a small molecule inhibitor of transforming growth factor-beta receptor I, in combination with standard temozolomide-based radiochemotherapy...” PMID 32140889 ↗ Mar 2020 “Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma.” PMID 30963691 ↗ Jun 2019 “Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer” NCT02452008 ↗ “150 mg galunisertib administered orally” NCT02178358 ↗ |
| Known as | [^14C]-LY2157299 | “Drug: [^14C]-LY2157299” NCT01746004 ↗ |
| Known as | LY2157299 | “Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma.” PMID 30963691 ↗ Jun 201910“Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer” NCT02452008 ↗ “LY2157299 monohydrate (LY2157299) is a small molecule that inhibits the TGF-β receptor type 1 kinase activity.” NCT02538471 ↗ |
| Known as | LY2157299 monohydrate | “This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate in healthy participants.” NCT01746004 ↗1“LY2157299 monohydrate (LY2157299) is a small molecule that inhibits the TGF-β receptor type 1 kinase activity.” NCT02538471 ↗ |
| Action | Inhibit | “a small molecule inhibitor of transforming growth factor-beta receptor I” PMID 32140889 ↗ Mar 2020 |
| Modality | Small molecule | “a small molecule inhibitor of transforming growth factor-beta receptor I” PMID 32140889 ↗ Mar 2020 |
| Route | Oral | “Administered orally” NCT01246986 ↗ |
| Target | TGFBR1 | “Transforming Growth Factor-beta Receptor I Kinase Inhibitor (Galunisertib)” NCT02423343 ↗ |