Septerna, Inc. Announces Initiation of Phase 1 Trial for Oral PTH1R Agonist SEP-479 in Hypoparathyroidism

Published: 2026-04-13 09:20:37 ET SEPN

Published on 04/13/2026 at 09:20 am EDT

Septerna, Inc. announced the dosing of the first participants in its Phase 1 clinical trial of SEP-479, its potent oral small molecule PTH1R agonist being developed for the treatment of patients with hypoparathyroidism. The Phase 1 clinical trial is a single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SEP-479 in healthy adult volunteers. The randomized, placebo-controlled Phase 1 clinical trial is expected to enroll up to 150 healthy adult participants.

Dosing is underway in the SAD portion of the clinical trial, which will evaluate the safety and tolerability of SEP-479 at escalating oral doses. The MAD portion of the clinical trial is designed to evaluate the safety and tolerability of once-daily oral dosing of SEP-479 over multiple days of treatment, with secondary and exploratory endpoints including PK and PD, with the latter assessed by changes in endogenous PTH and serum calcium, as well as other biomarkers. Septerna anticipates reporting data from the trial in late 2026 or early 2027.