Education
About Us
Working with TipRanks
Follow Us
Septerna, Inc. (SEPN)
NASDAQ:SEPN
Sep-631
Healthy Volunteers
Phase I
Not Yet Recruiting
A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers
Jun 30, 2025
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Septerna, Inc. (SEPN) have in its pipeline
SEPN is currently developing the following drugs: Sep-631. These drug candidates are in various stages of clinical development as the company works toward FDA approval.