Upacicalcet Meets Primary Endpoints in Phase 3 Trials for Secondary Hyperparathyroidism
Clinical trials for the drug upacicalcet have successfully met primary endpoints for treating secondary hyperparathyroidism in dialysis patients. The drug showed significant efficacy in reducing parathyroid hormone levels compared to a placebo with a manageable safety profile.
Why it matters
This development offers a potential new treatment option for patients with end-stage kidney disease, addressing a difficult-to-treat condition with a novel intravenous delivery method.
Both Phase 3 trials of upacicalcet hit their primary endpoint, but the number that matters for how Pathalys will position this drug at the FDA is the gap between arms: roughly 42–44% of patients on upacicalcet achieved at least a 30% reduction in intact parathyroid hormone during the efficacy assessment period, compared with about 17% on placebo. That is not a narrow win in a notoriously difficult-to-treat dialysis population.
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