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Arbutus Biopharma (ABUS)
:ABUS
Ab-101, Nucleos(T)Ide Analogue
Chronic Hepatitis B
Phase I
Active Not Recruiting
Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
Jul 14, 2023
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Ab-729, Peg-Ifnα-2A
Chronic Hepatitis B
Phase II
Completed
Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection
Jul 19, 2021
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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 Arbutus Biopharma (ABUS) have in its pipeline
ABUS is currently developing the following drugs: Ab-101, Nucleos(T)Ide Analogue, Ab-729, Peg-Ifnα-2A. These drug candidates are in various stages of clinical development as the company works toward FDA approval.