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SEP-631 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose | EXPERIMENTAL | - |
| Multiple Ascending Dose | EXPERIMENTAL | - |
| Food Effect | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SEP-631 | DRUG | Oral, tablet |
| Placebo | OTHER | Oral, tablet |
Inclusion Criteria: 1. Subjects who are able and willing to provide informed consent 2. Aged 18 to 60 years at the time of consent 3. Have a BMI within the range 18.5 to 32.0 kg/m2 4. In general good health Exclusion Criteria: 1. Any condition, which in the investigator's opinion might jeopardize...
SEP-631 is an investigational small molecule drug developed by Septerna, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. SEP-631 is designed to act on MRGPRX2, a G protein-coupled receptor. It is not approved for any indication and remains in clinical development.
SEP-631 targets MRGPRX2, a G protein-coupled receptor (GPCR). MRGPRX2 is a mast cell receptor, and SEP-631 is a small molecule designed to act on this target. Targeting MRGPRX2 is the mechanism under investigation for SEP-631 in its clinical program.
SEP-631 is being developed by Septerna, Inc., a biotechnology company that trades under the ticker symbol SEPN. Septerna is the sponsor of the clinical program evaluating SEP-631.
SEP-631 is in Phase 1 clinical development. Its single Phase 1 trial has been completed. SEP-631 is investigational and has not been approved by the FDA for any indication.
SEP-631 has been evaluated in one Phase 1 trial, NCT07069036, titled "A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers." The trial enrolled 120 healthy adult volunteers in Australia, was randomized, double-blind, and controlled, and is now completed.
SEP-631 has been studied in healthy adult volunteers in a Phase 1 trial, not in patients with a specific disease. It is an investigational drug and is not approved for any therapeutic use. Its clinical development remains at the Phase 1 stage.