Drugs / Selonsertib
last change Jul 2024 re-read 2 minutes ago

Selonsertib

also known as SEL · GS-4997

Small molecule targets MAP3K5 via inhibition

Developed for
metabolic dysfunction-associated steatohepatitis · diabetic kidney disease · alcoholic hepatitis · NAFLD1 · pulmonary arterial hypertension
Investigated by
Gilead Sciences · HepQuant, LLC

Trials 11 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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Phase 0 NCT03087968 Jul 2016 → Sep 2017 alcoholic hepatitis HepQuant, LLC Withdrawn No outcome recorded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
Phase 2 NCT04026165 Jul 2019 → Sep 2021 diabetic kidney disease Gilead Sciences Completed No outcome recorded
Phase 2 NCT03449446 Mar 2018 → Oct 2019 metabolic dysfunction-associated steatohepatitis Gilead Sciences Completed No outcome recorded
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 No outcome recorded
Phase 2 NCT02177786 Jun 2014 → Jul 2016 diabetic kidney disease Gilead Sciences Completed No outcome recorded
Phase 32 trials
Phase 3 NCT03053050 Feb 2017 → Jun 2019 metabolic dysfunction-associated steatohepatitis Gilead Sciences Terminated No outcome recorded
Phase 3 NCT03053063 Jan 2017 → May 2019 metabolic dysfunction-associated steatohepatitis Gilead Sciences Terminated No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2019-04-25 Gilead Sciences Gilead Announces Topline Data From Phase 3 STELLAR-3 Study of Selonsertib in Bridging Fibrosis (F3) Due to Nonalcoholic Steatohepatitis (NASH) gilead.com
2019-02-11 Gilead Sciences Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH) gilead.com
2016-11-14 Gilead Sciences Phase 2 Data for Selonsertib in Nonalcoholic Steatohepatitis (NASH) Presented at The Liver Meeting® 2016 gilead.com
2016-10-20 Gilead Sciences 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

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited 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

NCT02854631

NCT02234141

NCT02177786

NCT02509624

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 2019
1

“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