SEP-631 / Septerna - LARVOL DELTA

A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Septerna, Inc.

New P1 trial

SEP-631: A Novel Selective and Potent Oral MRGPRX2 Inhibitor for the Treatment of Chronic Spontaneous Urticaria (EAACI 2025) - "This targeted mechanism minimizes the risk of broad immunosuppression. Our results support further development of SEP-631 as a promising novel oral therapy for potential treatment of CSU and other mast cell-mediated diseases."

Immunology • Inflammation • CORT

Septerna Provides Corporate Overview and Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "Septerna is advancing several lead compounds with distinct chemical structures unrelated to SEP-786 and favorable pharmacokinetics profiles. The Company plans to select a next-generation oral small molecule PTH1R agonist development candidate to accelerate toward clinical development by the end of 2025....Septerna continues to advance SEP-631, a selective oral small molecule MRGPRX2 negative allosteric modulator (NAM), for the treatment of mast cell diseases, including chronic spontaneous urticaria. The company anticipates initiating a Phase 1 clinical trial in 2025 to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of SEP-631 in healthy volunteers."

New P1 trial • Pipeline update • Chronic Spontaneous Urticaria • Hypoparathyroidism