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Zura Bio (ZURA)
NASDAQ:ZURA
Tibulizumab Dose A, Tibulizumab Dose B
Hidradenitis Suppurativa (Hs)
Phase II
Recruiting
Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
May 19, 2025
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Tibulizumab
Scleroderma, Systemic Sclerosis (Ssc)
Phase II
Recruiting
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
Feb 07, 2025
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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 Zura Bio (ZURA) have in its pipeline
ZURA is currently developing the following drugs: Tibulizumab Dose A, Tibulizumab Dose B, Tibulizumab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.