Drugs / Selonsertib
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03087968 | Jul 2016 → Sep 2017 | alcoholic hepatitis | HepQuant, LLC | Withdrawn | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02509624 | Aug → Dec 2015 | diabetic kidney disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 27 trials · 4 missed | ||||||
| Phase 2 | NCT04026165 | Jul 2019 → Sep 2021 | diabetic kidney disease | Gilead Sciences | Completed | Missed primary |
| Phase 2 | NCT03449446 | Mar 2018 → Oct 2019 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | Missed primary |
| Phase 2 | NCT02854631 | Sep 2016 → Feb 2018 | alcoholic hepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02781584 | Jun 2016 → Dec 2020 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02466516 | Jun 2015 → Oct 2016 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02234141 | Nov 2014 → Apr 2016 | pulmonary arterial hypertension | Gilead Sciences | Completed | Missed primary |
| Phase 2 | NCT02177786 | Jun 2014 → Jul 2016 | diabetic kidney disease | Gilead Sciences | Completed | Missed primary |
| Phase 32 trials · 2 missed | ||||||
| Phase 3 | NCT03053050 | Feb 2017 → Jun 2019 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Terminated | Missed primary |
| Phase 3 | NCT03053063 | Jan 2017 → May 2019 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2019-12-16 | Gilead Sciences | Results Gilead Announces Topline Results From Phase 2 ATLAS Study in Patients With Bridging Fibrosis (F3) and Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH) gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the 48-week, Phase 2 ATLAS study of combination and monotherapy investigational treatments for advanced fibrosis (F3-F4) due to NASH. |
| 2019-05-02 | Gilead Sciences | Results Gilead Sciences Announces First Quarter 2019 Financial Results gilead.com ↗ |
| 2019-04-25 | Gilead Sciences | Results Gilead Announces Topline Data From Phase 3 STELLAR-3 Study of Selonsertib in Bridging Fibrosis (F3) Due to Nonalcoholic Steatohepatitis (NASH) gilead.com ↗
Selonsertib was generally well tolerated and safety results were consistent with prior studies. |
| 2019-03-27 | Gilead Sciences | Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗
Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib (poster #0273) |
| 2019-02-11 | Gilead Sciences | Results Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH) gilead.com ↗
STELLAR-4, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH), did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH. |
| 2018-10-11 | Gilead Sciences | Results Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018 gilead.com ↗
Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib |
| 2018-04-13 | Gilead Sciences | Results Gilead Presents Data on Multiple Investigational Regimens for the Treatment of Patients With Nonalcoholic Steatohepatitis (NASH) and Advanced Fibrosis at The International Liver Congress™ 2018 gilead.com ↗
The initial data presented today are important advances toward our goal of improving outcomes for patients with advanced fibrosis due to NASH. |
| 2017-10-24 | Gilead Sciences | Results Gilead Announces Phase 2 Results for GS-0976 in Nonalcoholic Steatohepatitis (NASH) gilead.com ↗
Additional abstracts describe the accuracy of noninvasive markers to predict improvements in liver histology in response to treatment in a Phase 2 study of selonsertib, including reductions in fibrosis with MRE (Abstract #2104) and liver fat with MRI-PDFF (Abstract #2169). |
| 2016-11-14 | Gilead Sciences | Results Phase 2 Data for Selonsertib in Nonalcoholic Steatohepatitis (NASH) Presented at The Liver Meeting® 2016 gilead.com ↗
The data demonstrate regression in fibrosis that was, in parallel, associated with reductions in other measures of liver injury in patients treated with selonsertib for 24 weeks. |
| 2016-10-20 | Gilead Sciences | Results Gilead Announces Top-Line Phase 2 Results for GS-4997 (Selonsertib) in Nonalcoholic Steatohepatitis (NASH), Pulmonary Arterial Hypertension (PAH) and Diabetic Kidney Disease (DKD) gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced the top-line results from three Phase 2 studies of GS-4997 (selonsertib), an investigational inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in nonalcoholic steatohepatitis (NASH), pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). |
All press releases naming this drug 10 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | selonsertib | “The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis...” NCT03053063 ↗9“Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials” PMID 32147362 ↗ Mar 2020 “Selonsertib is an apoptosis signal–regulating kinase 1 inhibitor that reduces inflammation, fibrosis, and apoptosis.” PMID 39018154 ↗ Jul 2024 “GS-4997 (selonsertib \[SEL\]) alone or in combination with simtuzumab (SIM)” NCT02466516 ↗ “receive selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks.” NCT02781584 ↗ “Selonsertib (SEL)” NCT03449446 ↗ |
| Known as | GS-4997 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03087968 ↗ |
| Known as | SEL | “The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney...” NCT04026165 ↗4“The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis...” NCT03053063 ↗ “GS-4997 (selonsertib \[SEL\]) alone or in combination with simtuzumab (SIM)” NCT02466516 ↗ “receive selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks.” NCT02781584 ↗ “Selonsertib (SEL)” NCT03449446 ↗ |
| Action | Inhibit | “Findings in animal models identified selonsertib, a selective ASK1 inhibitor, as a potential therapeutic agent.” PMID 31506292 ↗ Sep 20191“Mitogen-activated protein kinase kinase kinase 5 inhibitor” CHEMBL3916717 ↗ |
| Modality | Small molecule | — CHEMBL3916717 ↗ |
| Route | Oral | “Tablets administered orally once daily” NCT02177786 ↗ |
| Target | MAP3K5 | “Mitogen-activated protein kinase kinase kinase 5 inhibitor” CHEMBL3916717 ↗ |