Drugs / Linerixibat
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LYNAVOY | — | 2026-03-17 | fda.gov ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT05435170 | Aug → Oct 2022 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT05393076 | Jul → Dec 2022 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT05133830 | Nov 2021 → May 2022 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT04053023 | Aug → Nov 2019 | cholestasis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT03992014 | Jul → Aug 2019 | cholestasis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01416324 | Jun → Sep 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT02966834 | Jan 2017 → Apr 2020 | cholestasis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02202161 | Aug 2014 → Jan 2015 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01899703 | Mar 2014 → Oct 2015 | intrahepatic cholestasis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01929863 | Aug → Nov 2013 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04950127 | Aug 2021 → Oct 2024 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04167358 | Jul 2020 → Sep 2026 expected | cholestasis | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05448170 | — | — | GlaxoSmithKline | Available | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01607385 Comparator | May → Dec 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Linerixibat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03992014 ↗ |
| Known as | GSK2330672 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02202161 ↗ |
| Action | Inhibit | “a selective inhibitor of human ileal bile acid transporter (IBAT)” PMID 28187915 ↗ Feb 20171“Ileal bile acid transporter inhibitor” CHEMBL2387408 ↗ |
| Modality | Small molecule | “Linerixibat is a selective small molecule inhibitor of the ileal bile acid transporter” PMID 37953500 ↗ Dec 2023 |
| Route | Oral | “GSK2330672 oral preserved solution 1.5mg/g will be supplied in amber glass bottles” NCT01899703 ↗ |
| Target | SLC10A2 | “Ileal bile acid transporter inhibitor” CHEMBL2387408 ↗ |