GSK plc has entered a licensing agreement with Alfasigma S.p.A., granting the Italian pharmaceutical company worldwide exclusive rights to develop, manufacture, and commercialize the investigational therapy Linerixibat.
The drug is being developed to treat cholestatic pruritus, a severe itching condition associated with the rare autoimmune liver disease Primary Biliary Cholangitis (PBC).
Under the agreement:
The transaction remains subject to regulatory clearances, including review under the Hart-Scott-Rodino Antitrust Improvements Act in the United States.
Linerixibat has already received several regulatory incentives:
Marketing applications are currently under regulatory review in:
These submissions are supported by results from the Phase 3 GLISTEN trial. The study met its primary and key secondary endpoints, showing rapid and sustained reductions in itching and sleep disruption compared with placebo.
However, linerixibat has not yet been approved anywhere in the world.
Linerixibat is an ileal bile acid transporter (IBAT) inhibitor.
By blocking bile acid reabsorption in the intestine, the drug lowers circulating bile acids—molecules believed to trigger the severe itching experienced by many patients with PBC.
The mechanism may reduce several biological mediators responsible for cholestatic pruritus, a symptom that can severely affect sleep, daily functioning, and quality of life.
Tony Wood, Chief Scientific Officer at GSK, said the partnership aligns with the company’s evolving liver disease strategy.
He noted that transferring linerixibat to Alfasigma allows GSK to focus on advancing other hepatology programs, including potential therapies for:
These liver conditions collectively account for around two million deaths globally each year.
Meanwhile, Francesco Balestrieri, CEO of Alfasigma, said the company’s hepatology expertise and global presence position it well to lead the drug’s commercialization.
In patients with Primary Biliary Cholangitis, impaired bile flow causes bile acids to accumulate in the body.
This can lead to cholestatic pruritus, an internal itching sensation that cannot be relieved by scratching.
The condition can be debilitating, causing:
Research suggests that up to one-third of patients with significant itching receive no treatment, highlighting a major unmet medical need.
If approved, linerixibat could offer a targeted oral therapy designed specifically to address this difficult symptom.