Swiss drugmaker Novartis has terminated a mid-stage clinical trial evaluating its oral drug Fabhalta (iptacopan) in patients with lupus nephritis, according to an October 15, 2026 update to a federal clinical trials registry. Novartis cited strategic considerations for concluding the trial after completing its first part, without stating whether safety or efficacy was a factor. First approved in 2023 for PNH, Fabhalta is approved for IgA nephropathy and C3 glomerulopathy.
Reporting on trial termination
- ▪Swiss drugmaker Novartis terminated a mid-stage clinical trial evaluating its oral medication Fabhalta in patients with lupus nephritis, according to an October 15, 2026 update to a federal clinical trials database
- ▪Endpoints News first reported on October 16, 2026 that Novartis terminated its mid-stage trial for Fabhalta in lupus nephritis
Reasons for trial termination
- ▪Novartis cited strategic considerations on a federal clinical trials registry for concluding its mid-stage Fabhalta lupus nephritis trial after completing the trial's first part, providing no further explanation and not stating whether safety or effectiveness influenced the trial's termination
- ▪Novartis decided to conclude the mid-stage clinical study evaluating Fabhalta in lupus nephritis after completing the first part of the trial
Lupus nephritis study background
- ▪The mid-stage Fabhalta study that Novartis terminated evaluated whether the oral medication was safe and effective for treating lupus nephritis when added to standard medical care
- ▪Lupus nephritis is a severe kidney condition characterized by inflammation of the kidneys caused by the autoimmune disease lupus
Fabhalta profile and approvals
- ▪The U.S. Food and Drug Administration first approved Novartis's drug Fabhalta in 2023 to treat a rare blood disorder called paroxysmal nocturnal hemoglobinuria
- ▪Novartis's drug Fabhalta has received approvals for two kidney diseases, IgA nephropathy and C3 glomerulopathy
- ▪Novartis's drug Fabhalta is also known by the generic name iptacopan
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