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Aligos Therapeutics (ALGS)
NASDAQ:ALGS
Alg-000184, Tdf
Chronic Hepatitis B Infection
Phase II
Recruiting
A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)
Apr 22, 2025
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Alg-055009
Healthy Volunteer Study
Phase I
Completed
A Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of ALG-055009 Formulations
Mar 24, 2025
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Alg-097558
Covid 19
Phase I
Completed
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function
Nov 12, 2024
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Carbamazepine, Itraconazole (Sporanox), Alg-000184
Healthy Volunteer
Phase I
Active Not Recruiting
A Multi-part Study of ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Drug-drug Interaction Potential After Single and Multiple Doses in Healthy Volunteers
Sep 25, 2024
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Alg-097558
Covid-19
Phase I
Completed
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Aug 20, 2024
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Alg-055009
Nonalcoholic Steatohepatitis, Metabolic Dysfunction-associated Steatohepatitis, Nash, Mash
Phase II
Completed
ALG-055009 in Non-cirrhotic Adults With MASH (HERALD)
Mar 15, 2024
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Rosuvastatin, Atorvastatin, Alg-055009
Healthy Volunteers
Phase I
Completed
A Phase 1 Study to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)
Nov 03, 2023
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Midazolam, Carbamazepine, Itraconazole, Alg-097558, Alg-097558 In Solution Formulation, Alg-097558 In Tablet Formulation
Covid-19
Phase I
Completed
A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558
Apr 10, 2023
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Alg-000184, Entecavir
Chronic Hepatitis B
Phase I
Active Not Recruiting
A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
Aug 28, 2020
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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 Aligos Therapeutics (ALGS) have in its pipeline
ALGS is currently developing the following drugs: Alg-000184, Tdf, Alg-055009, Alg-097558. These drug candidates are in various stages of clinical development as the company works toward FDA approval.