Novo Nordisk stops the ocedurenone CLARION-CKD trial and recognises impairment loss

Novo Nordisk announced that the CLARION-CKD phase 3 trial failed to meet its primary endpoint and that it will recognise an impairment loss of around DKK 5.7 billion related to the intangible asset ocedurenone in the second quarter of 2024.

Novo Nordisk acquired ocedurenone from KBP Biosciences PTE., Ltd. in 2023. The phase 3 lead indication trial CLARION-CKD, which investigated ocedurenone in patients with uncontrolled hypertension and advanced chronic kidney disease, was conducted by KBP Biosciences.

The trial design included a prespecified interim analysis after all trial participants had completed 12 weeks of treatment. Based on the interim analysis, an independent data monitoring committee concluded that the trial met the prespecified futility criteria – meaning that the trial did not meet its primary endpoint of change in systolic blood pressure from baseline to week 12. As a result, Novo Nordisk has decided to stop the CLARION-CKD trial.

Consequently, Novo Nordisk will recognise an impairment loss of around DKK 5.7 billion. This corresponds to an estimated negative impact of around 6 percentage points on operating profit growth at CER in 2024 compared to the operating profit outlook communicated in the financial report for the period 1 January 2024 to 31 March 2024 (Company Announcement No 35/2024).

Novo Nordisk’s disclosure of the financial results for the first six months of 2024 and financial outlook for 2024 will be published on 7 August 2024.

Further development of ocedurenone in other indications is now being evaluated.