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Astria Therapeutics (ATXS)
NASDAQ:ATXS
navenibart
Hereditary Angioedema (Hae)
Phase III
Enrolling By Invitation
A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
Sep 30, 2025
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navenibart
Hereditary Angioedema (Hae)
Phase III
Recruiting
A Study of Navenibart in Participants With Hereditary Angioedema
Feb 19, 2025
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Star-0310
Healthy Participants
Phase I
Recruiting
A Study of STAR-0310 in Healthy Adult Participants
Jan 15, 2025
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Star-0215
Hereditary Angioedema
Phase II
Active Not Recruiting
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
Aug 17, 2023
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Star-0215
Hereditary Angioedema
Phase I/II
Completed
A Study of STAR-0215 in Participants With Hereditary Angioedema
Jan 06, 2023
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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 Astria Therapeutics (ATXS) have in its pipeline
ATXS is currently developing the following drugs: navenibart, navenibart, Star-0310. These drug candidates are in various stages of clinical development as the company works toward FDA approval.