SEP-631
/ Septerna
- LARVOL DELTA
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July 17, 2025
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
March 26, 2025
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
March 27, 2025
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
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