Drugs / Linerixibat
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pruritus, hereditary localized 1 milestone | |||||
| Filed | US (FDA) | — | pruritus, hereditary localized | 2025-06-02 | “FDA has accepted for review the NDA for linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), for the treatment of cholestatic pruritus” gsk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | LYNAVOY | — | 2026-03-17 | fda.gov ↗ |
Trials 14
| 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 · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT02966834 | Jan 2017 → Apr 2020 | cholestasis | GlaxoSmithKline | Completed | Missed primary |
| Phase 2 | NCT02202161 | Aug 2014 → Jan 2015 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| 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 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07860710 | Oct 2026 → Oct 2028 expected | — | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04950127 | Aug 2021 → Oct 2024 | — | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT04167358 | Jul 2020 → Sep 2026 overdue | cholestasis | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05448170 | — | — | GlaxoSmithKline | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT01607385 Comparator | May → Dec 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-03-19 | GlaxoSmithKline | Regulatory Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC) gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. |
| 2026-02-26 | GlaxoSmithKline | Regulatory Linerixibat accepted for priority review in China for cholestatic pruritus in patients with primary biliary cholangitis gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that its new drug application for the use of linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease, has been accepted for priority review by China’s National Medical Products Administration. |
| 2025-06-23 | GlaxoSmithKline | Regulatory Linerixibat accepted for review by the European Medicines Agency for cholestatic pruritus in patients with primary biliary cholangitis (PBC) gsk.com ↗
The EMA acceptance of this file marks another significant step forward in the progress of linerixibat, following FDA acceptance earlier this month. |
| 2025-06-02 | GlaxoSmithKline | Regulatory Linerixibat New Drug Application (NDA) accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC) gsk.com ↗
The FDA’s acceptance of this file is an important milestone in the development of linerixibat. |
| 2025-05-08 | GlaxoSmithKline | Results GLISTEN phase III trial results show linerixibat significantly improves cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC) gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive results from the GLISTEN phase III trial evaluating linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), in adults with cholestatic pruritus and PBC, a rare autoimmune liver disease. |
| 2024-11-19 | GlaxoSmithKline | Results Linerixibat shows positive Phase III results in cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC) gsk.com ↗
GLISTEN met its primary endpoint, with linerixibat resulting in an improvement in itch, as demonstrated by a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo. |
| 2024-11-13 | GlaxoSmithKline | Results GSK highlights key data from hepatology portfolio at the AASLD’s The Liver Meeting® 2024, emphasising patient impact in areas of high unmet need gsk.com ↗
Baseline data from GLISTEN phase III trial confirms the need for new therapies for patients with cholestatic pruritus of primary biliary cholangitis (PBC) |
| 2022-06-15 | GlaxoSmithKline | Results GSK to present new data from the B-Clear phase IIb trial for bepirovirsen in chronic hepatitis B at the International Liver Congress 2022 gsk.com ↗
New analysis to be presented from the GLIMMER phase II trial comparing the health-related quality of life of patients with cholestatic pruritus in PBC to several more common diseases, using EQ-5D, a standardised measure of health utility. |
| 2020-11-13 | GlaxoSmithKline | Results GSK presents Phase 2b data on linerixibat for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC) gsk.com ↗
The Phase 2b GLIMMER study (GSK2330672 trial of IBAT inhibition with Multidose Measurement for Evaluation of Response), presented today at The Liver Meeting® 2020 as a late breaking abstract, reported that linerixibat significantly improved itch (cholestatic pruritus) in some treatment groups compared to placebo. |
All press releases naming this drug 11 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Linerixibat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04167358 ↗ |
| Known as | GSK2330672 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02966834 ↗ |
| 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 ↗ |