Septerna Begins Phase 1 Trial of Oral SEP-479 for Hypoparathyroidism
Tuesday, April 14, 2026
Septerna, Inc. has started a Phase 1 clinical trial of SEP-479, an oral small molecule designed to treat hypoparathyroidism. The company has dosed the first participants in the study.
The Phase 1 trial includes both single-ascending dose (SAD) and multiple-ascending dose (MAD) parts. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SEP-479 in healthy adult volunteers.
The randomised, placebo-controlled study is expected to enrol up to 150 participants. Dosing is currently ongoing in the SAD stage, where increasing oral doses are being tested. The MAD stage will examine the safety and tolerability of once-daily dosing over several days. Secondary and exploratory measures include changes in endogenous parathyroid hormone levels, serum calcium and other biomarkers. Initial data from the trial is expected in late 2026 or early 2027.
SEP-479 is an oral parathyroid hormone 1 receptor agonist developed to address hypoparathyroidism, a long-term condition often managed with frequent calcium supplements or hormone injections. Preclinical studies showed that the drug produced activity similar to parathyroid hormone peptides in laboratory and animal models. It also normalised serum calcium levels in a rat model and increased calcium levels while reducing endogenous hormone levels in non-human primates. The drug was generally well tolerated in 28-day toxicology studies across multiple species.
Source: globenewswire.com
