Novo Nordisk Terminates Development of Kidney Disease Drug Ocedurenone After Phase 3 Failure

Acquisition and Trial Background:
Novo Nordisk acquired ocedurenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA), from KBP Biosciences in a deal worth up to $1.3 billion in 2023. The drug was being evaluated in the Phase 3 CLARION-CKD trial for treating patients with uncontrolled hypertension and advanced chronic kidney disease (CKD).

Phase 3 Trial Failure:
The CLARION-CKD trial failed to meet its primary endpoint, which was the change in systolic blood pressure from baseline by Week 12. This led to Novo Nordisk terminating the trial due to futility criteria being met.

Financial Impact:
The failure resulted in an impairment loss of 5.7 billion Danish kroner ($816.5 million) for Novo Nordisk in the second quarter of 2024, negatively impacting the company’s expected operating profit growth by about 6 percentage points.

Future Development:
Despite the failure in the CLARION-CKD trial, Novo Nordisk is evaluating further development of ocedurenone in other therapeutic areas.

Strategic Context:
The acquisition of ocedurenone was part of Novo Nordisk’s strategy to expand its focus beyond diabetes into other serious chronic diseases, including cardiovascular and kidney diseases.