Abi-6250
Hepatitis Delta Virus, Hepatitis D
Phase I
Recruiting
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants
Dec 13, 2024
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Abi-1179
Recurrent Genital Herpes Simplex Type 2
Phase I
Recruiting
A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes
Nov 08, 2024
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Abi-4334
Chronic Hepatitis B
Phase I
Completed
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
Apr 22, 2024
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Abi-5366
Recurrent Genital Herpes Simplex Type 2
Phase I
Recruiting
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes
Apr 18, 2024
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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 Assembly Biosciences (V7B) have in its pipeline
V7B is currently developing the following drugs: Abi-6250, Abi-1179, Abi-4334. These drug candidates are in various stages of clinical development as the company works toward FDA approval.