Novartis ends mid-stage Fabhalta trial targeting serious kidney condition

A view of the Novartis booth and logo at the BIO International Convention 2026, a meeting of pharmaceutical and biotechnology leaders in San Diego, California, U.S. June 23, 2026.

A view of the Novartis booth and logo at the BIO International Convention 2026, a meeting of pharmaceutical and biotechnology leaders in San Diego, California, U.S. June 23, 2026. (REUTERS/Mike Blake/File Photo)


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Oct 16 — Swiss drugmaker Novartis has terminated a ​mid-stage study testing its drug Fabhalta in patients with a serious kidney ‌condition, citing "strategic considerations", according to a federal clinical ⁠trials registry.

• The ​trial was evaluating whether ⁠the oral medication was safe ‌and effective for ‌treating lupus nephritis when added to ⁠standard medical care

• ⁠Lupus nephritis is a severe inflammation of the kidneys caused by the autoimmune disease lupus

• The government database, last updated on October 15, shows Novartis ‌decided to conclude the ​study after completing the first part

• It gives no other explanation and does not say whether safety or effectiveness played a role

• Endpoints News reported the development earlier on Friday

• Novartis ​did not immediately respond to a ‌Reuters request ‌for ⁠comment

• The US FDA first approved Fabhalta in 2023 for a rare blood disorder called PNH. It has since been ‌approved for two ​kidney diseases, IgA ‌nephropathy and C3 ⁠glomerulopathy

(Reporting ​by Kamal Choudhury in Bengaluru; Editing by Shilpi ​Majumdar)

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