Linerixibat
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| Clinical data | |
|---|---|
| Trade names | Lynavoy |
| Other names | GSK-2330672 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a626054 |
| License data |
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| Routes of administration | By mouth |
| Drug class | Ileal bile acid transporter inhibitor |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| PubChem CID | |
| DrugBank | |
| ChemSpider | |
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C28H38N2O7S |
| Molar mass | 546.68 g·mol−1 |
| 3D model (JSmol) | |
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Linerixibat, sold under the brand name Lynavoy, is a medication used for the treatment of cholestatic pruritus. Linerixibat is an ileal bile acid transporter (IBAT) inhibitor.[1][2][3] It is taken by mouth.[1]
The most common side effects are diarrhea, abdominal pain and transaminase elevations.[2]
Linerixibat was approved for medical use in the United States in March 2026.[4][5][6]
Medical uses
[edit]Linerixibat is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis in adults.[1]
History
[edit]The benefits of linerixibat were demonstrated in a double-blind, placebo-controlled, multi-center, global phase III study.[2]
Society and culture
[edit]Legal status
[edit]Linerixibat was approved for medical use in the United States in March 2026.[5]
In July 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Lynavoy, intended for the treatment of cholestatic pruritus in adults with primary biliary cholangitis.[2] The applicant for this medicinal product is Glaxosmithkline Trading Services Limiteds.[2]
Names
[edit]Linerixibat is the international nonproprietary name.[7]
Linerixibat is sold under the brand name Lynavoy.[8]
References
[edit]- ↑ Silveira IB, Rezende RA, Neto CA, Rossi YI, Leite MD, Cançado GG (August 2025). "Ileal Bile Acid Transporter Inhibitors for Adult Patients with Autoimmune Cholestatic Liver Diseases: A Systematic Review and Meta-Analysis". Gastroenterology Insights. 16 (3): 30. doi:10.3390/gastroent16030030.
- ↑ "Drug Approval Package: Lynavoy". U.S. Food and Drug Administration (FDA). 13 May 2026. Retrieved 26 July 2026.
- 1 2 "Novel Drug Approvals for 2026". U.S. Food and Drug Administration (FDA). 26 March 2026. Retrieved 5 April 2026.
This article incorporates text from this source, which is in the public domain. - ↑ "Lynavoy (linerixibat) FDA Approval History". Drugs.com. 20 March 2026. Retrieved 24 March 2026.
- ↑ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information. 32 (3). hdl:10665/330907.
- ↑ "Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC)". GSK (Press release). 19 March 2026. Retrieved 5 April 2026.
