This section highlights FDA-related milestones and regulatory updates for drugs developed by Septerna (SEPN).
Over the past two years, Septerna has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SEP-631 and SEP-786. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
SEP-631 FDA Regulatory Events
SEP-631 is a drug developed by Septerna for the following indication: For Mast Cell Diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SEP-631
- Announced Date:
- August 21, 2025
- Indication:
- For Mast Cell Diseases
Announcement
Septerna, announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2 (MRGPRX2) negative allosteric modulator (NAM) being developed for the treatment of chronic spontaneous urticaria (CSU) and other mast cell-driven diseases.
AI Summary
Septerna, Inc. announced it has dosed the first participants in its first-in-human Phase 1 clinical study of SEP-631, a new oral small-molecule drug that selectively blocks the MRGPRX2 receptor. Septerna is using its Native Complex Platform to advance GPCR drug discovery.
This Phase 1 trial includes single-ascending dose (SAD) and multiple-ascending dose (MAD) portions in up to 150 healthy volunteers. Participants will receive escalating oral doses of SEP-631. Researchers will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) using an icatibant skin challenge.
MRGPRX2 plays a key role in mast cell activation and degranulation, leading to the itchy hives and swelling in chronic spontaneous urticaria (CSU). Current antihistamines do not help all patients, leaving millions with persistent symptoms. SEP-631’s negative allosteric modulation could provide a convenient oral treatment for CSU and other mast cell–driven conditions, including asthma, atopic dermatitis, interstitial cystitis, and migraine.
Read Announcement- Drug:
- SEP-631
- Announced Date:
- March 27, 2025
- Indication:
- For Mast Cell Diseases
Announcement
Septerna, Inc Provides Corporate Overview
AI Summary
Septerna, Inc. provided a corporate overview highlighting its advances in GPCR drug discovery using its Native Complex Platform™. The company is focused on developing next-generation oral small molecule therapies, with plans to select a promising PTH1R agonist candidate for clinical development later this year. Septerna is also preparing to initiate a Phase 1 clinical trial for its SEP-631, a selective MRGPRX2 negative allosteric modulator intended to treat mast cell diseases, in 2025.
In addition to its innovative drug development pipeline, Septerna reported a strong financial position with a cash balance of $420.8 million at the end of 2024, which is expected to sustain its operations into early 2028. The corporate update emphasized the company’s commitment, experienced team, and strategic initiatives in endocrinology, immunology, and metabolic diseases as it continues to advance its multiple GPCR product candidates.
Read Announcement
SEP-786 FDA Regulatory Events
SEP-786 is a drug developed by Septerna for the following indication: PTH1R Agonist.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SEP-786
- Announced Date:
- February 18, 2025
- Indication:
- PTH1R Agonist
Announcement
Septerna, announced its decision to discontinue the Phase 1 single- and multiple-ascending dose (SAD/MAD) clinical trial of SEP-786 in healthy volunteers.
AI Summary
Septerna, Inc. has decided to stop its Phase 1 clinical trial of SEP-786, an oral small molecule PTH1R agonist being developed for hypoparathyroidism. The decision came after two healthy volunteer participants in the multiple-ascending dose portion experienced unexpected severe (Grade 3) increases in unconjugated bilirubin levels. Although these bilirubin spikes were reversible and not accompanied by related liver enzyme elevations or signs of liver injury, the safety signal prompted an immediate discontinuation of dosing in the affected individuals.
Despite these events, early pharmacological effects such as increased serum calcium and decreased endogenous PTH were observed. Septerna remains committed to advancing its PTH1R program, with plans to select a next-generation candidate from its diverse compound portfolio for accelerated clinical development later this year. Nonclinical studies are currently underway to understand the underlying cause of the bilirubin elevation.
Read Announcement
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