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New hepatitis b drug shows promise in Mid-Stage trial

NCT ID NCT06963710

Disease control Sponsor: Aligos Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This Phase 2 study tests an experimental drug called ALG-000184 against a standard hepatitis B medication (tenofovir) in 200 adults with chronic hepatitis B. Participants take one pill daily for 48 weeks. The main goal is to see if the new drug can lower hepatitis B virus levels in the blood more effectively than the current treatment. Researchers will also monitor for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ALG-000184 (an experimental antiviral drug)
What this could lead to
If successful, ALG-000184 could offer a new oral treatment option for chronic hepatitis B, potentially suppressing the virus more effectively than current therapies.
What could go wrong
This is an early Phase 2 study with only 200 participants, so results may not apply to everyone. The drug may not prove superior to existing treatments, and side effects are still being evaluated.
Why investors are watching

Aligos Therapeutics is running a Phase 2 trial of its oral drug ALG-000184 against a standard hepatitis B treatment, tenofovir, in 200 untreated adults. For a micro-cap company, this readout tests whether its drug can control the virus as well as or better than the existing option, which would validate its main pipeline asset.

If it works: A positive result could position ALG-000184 as a credible alternative to tenofovir, giving Aligos a lead candidate to advance toward later-stage trials. That outcome would strengthen the company's pipeline and its negotiating position with partners or investors.

If it fails: A failure or delay could set back the program and hurt the company's prospects, since it relies heavily on this drug. Trials often fail to show an advantage over existing treatments, so a negative result is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements). 2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2). 3. HBsAg ≥LLOQ. 4. HBV DNA ≥20,000 IU/mL. 5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening. 6. Must have the following chronic hepatitis B virus infection treatment status at screening: 1. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \[i.e., Treatment Naïve (TN) subjects\], OR 2. Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects). Key Exclusion Criteria: 1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology. 2. Positive for anti-HBs antibodies. 3. History or current evidence of cirrhosis. 4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease. 5. History of, or current evidence of, hepatic decompensation. 6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound. 7. Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug 8. Exclusionary screening laboratory values include: 1. Aspartate aminotransferase (AST) \>8×ULN, 2. Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected) 3. International Normalization Ratio (INR) \>1.2×ULN

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis B infection

Contacts and locations

Locations

  • Aligos Investigational Site

    Coronado, California, 92118, United States

  • Aligos Investigational Site

    Pasadena, California, 91105, United States

  • Aligos Investigational Site

    Rialto, California, 92377, United States

  • Aligos Investigational Site

    San Francisco, California, 94117, United States

  • Aligos Investigational Site

    San Jose, California, 95116, United States

  • Aligos Investigational Site

    Miami, Florida, 33136, United States

  • Aligos Investigational Site

    Edmonton, Canada

  • Aligos Investigational Site

    Ottawa, Canada

  • Aligos Investigational Site

    Toronto, Canada

  • Aligos Investigational Site

    Changchun, China

  • Aligos Investigational Site

    Chengdu, China

  • Aligos Investigational Site

    Chongqing, China

  • Aligos Investigational Site

    Nanjing, China

  • Aligos Investigational Site

    Clichy, France

  • Aligos Investigational Site

    Limoges, France

  • Aligos Investigational Site

    Nice, France

  • Aligos Investigational Site

    Toulouse, France

  • Aligos Investigational Site

    Milan, Italy

  • Aligos Investigational Site

    Chisinau, Moldova

  • Aligos Investigational Site

    Auckland, New Zealand

  • Aligos Investigational Site

    Ansan, South Korea

  • Aligos Investigational Site

    Busan, South Korea

  • Aligos Investigational Site

    Ulsan, South Korea

  • Aligos Investigational Site

    Yangsan, South Korea

  • Aligos Investigational Site

    Pontevedra, Spain

  • Aligos Investigational Site

    Chiayi City, Taiwan

  • Aligos Investigational Site

    Kaohsiung City, Taiwan

  • Aligos Investigational Site

    Taichung, Taiwan

  • Aligos Investigational Site

    Tainan, Taiwan

  • Aligos Investigational Site

    Taipei, Taiwan

  • Aligos Investigational Site

    Glasgow, United Kingdom

  • Aligos Investigational Site

    Leicester, United Kingdom

  • Aligos Investigational Sites

    Sofia, Bulgaria

  • Aligos Investigational Sites

    Vancouver, Canada

  • Aligos Investigational Sites

    Beijing, China

  • Aligos Investigational Sites

    Guangzhou, China

  • Aligos Investigational Sites

    Shanghai, China

  • Aligos Investigational Sites

    Hong Kong, Hong Kong

  • Aligos Investigational Sites

    Bucharest, Romania

  • Aligos Investigational Sites

    Seoul, South Korea

  • Aligos Investigational Sites

    London, United Kingdom

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Other studies related to the condition(s) this trial covers.