CSL, Alentis sign $1.6bn lixudebart pact

CSL and Alentis Therapeutics have entered an exclusive global collaboration to co-develop and co-promote lixudebart, an investigational therapy targeting claudin-1. The agreement was announced on October 4, 2026 and covers the development and potential commercialisation of lixudebart across multiple kidney, liver and other diseases.

Lixudebart is described as having the potential to become a first-in-class therapy targeting claudin-1. The collaboration is structured to enable development across a range of indications in parallel, focusing on serious and often rare conditions.

Under the collaboration agreement, CSL will make an initial payment of US$355 million to Alentis. In addition, Alentis is eligible to receive up to US$1.2 billion in commercial milestone payments tied to the future performance of lixudebart.

Beyond the upfront and milestone payments, the companies have agreed to share global profits from any commercialised lixudebart product. Profits will be allocated 55% to CSL and 45% to Alentis, reflecting CSL’s expanded funding role and Alentis’s contribution to the program.

Lixudebart is currently being evaluated in the ongoing Phase 2 RENAL trial in patients with ANCA-associated vasculitis with rapidly progressive glomerulonephritis (AAV‑RPGN). This indication is characterised by rapid decline in kidney function, and the RENAL study is a key component of the program.

As part of the agreement, CSL will fully fund completion of the Phase 2 RENAL trial and a planned Phase 3 trial in AAV‑RPGN. This commitment positions CSL to support late-stage development in this rare kidney disease setting.

The partners also plan to advance lixudebart into Phase 2 trials for focal segmental glomerulosclerosis (FSGS) and primary sclerosing cholangitis (PSC). CSL will fully fund these studies as well as other supporting development activities required to progress the therapy.

The collaboration centers on lixudebart’s targeting of claudin-1, with the aim of addressing unmet needs in kidney and liver diseases. By combining CSL’s development and commercial capabilities with Alentis’s clinical-stage expertise, the agreement is designed to accelerate work across multiple rare-disease indications.

The structure of the deal, with substantial development funding and a defined profit-sharing model, underscores a shared commitment to advancing lixudebart through mid- and late-stage trials. The focus now shifts to the outcomes of the ongoing and planned studies in AAV‑RPGN, FSGS and PSC.