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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR ENTECAVIR


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All Clinical Trials for Entecavir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00035633 ↗ A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen Completed Bristol-Myers Squibb Phase 3 2001-12-01 The purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen positive.
NCT00035789 ↗ A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen Completed Bristol-Myers Squibb Phase 3 2001-11-01 The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen negative.
NCT00036608 ↗ A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine Completed Bristol-Myers Squibb Phase 3 2002-01-01 The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.
NCT00051038 ↗ Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients Completed Bristol-Myers Squibb Phase 2/Phase 3 2002-09-01 The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, when being added to lamivudine, in the treatment of adults with chronic hepatitis B infection who are co-infected with HIV.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Entecavir

Condition Name

Condition Name for Entecavir
Intervention Trials
Chronic Hepatitis B 85
Hepatitis B, Chronic 48
Hepatitis B 42
HBV 6
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Condition MeSH

Condition MeSH for Entecavir
Intervention Trials
Hepatitis B 218
Hepatitis 200
Hepatitis A 172
Hepatitis B, Chronic 170
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Clinical Trial Locations for Entecavir

Trials by Country

Trials by Country for Entecavir
Location Trials
China 289
United States 254
Korea, Republic of 68
Taiwan 46
Japan 36
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Trials by US State

Trials by US State for Entecavir
Location Trials
California 24
New York 21
Maryland 17
Texas 17
Florida 16
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Clinical Trial Progress for Entecavir

Clinical Trial Phase

Clinical Trial Phase for Entecavir
Clinical Trial Phase Trials
Phase 4 93
Phase 3 35
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Entecavir
Clinical Trial Phase Trials
Completed 93
Unknown status 63
Recruiting 37
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Clinical Trial Sponsors for Entecavir

Sponsor Name

Sponsor Name for Entecavir
Sponsor Trials
Bristol-Myers Squibb 33
National Taiwan University Hospital 12
Sun Yat-sen University 9
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Sponsor Type

Sponsor Type for Entecavir
Sponsor Trials
Other 395
Industry 130
NIH 7
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Entecavir: Clinical Trials, Market Analysis, and Projections

Introduction to Entecavir

Entecavir is a potent nucleoside analog used in the treatment of chronic hepatitis B infection. It has been a cornerstone in the management of hepatitis B due to its high barrier to resistance and potent antiviral activity.

Current Clinical Trials and Research

While entecavir itself is an established treatment, ongoing research and clinical trials are focused on optimizing its use and exploring combination therapies to enhance treatment outcomes.

Combination Therapies

Recent studies have highlighted the benefits of combining entecavir with other antiviral agents or immune modulators. For instance, combining entecavir with pegylated interferon has shown promising results in boosting the immune system’s ability to fight the virus and achieving higher rates of sustained virological response (SVR)[3].

Emerging Treatments and Comparisons

Other clinical trials are investigating new treatments that could potentially complement or replace entecavir. For example, Aligos Therapeutics is conducting Phase 1 and upcoming Phase 2 trials for ALG-000184, an oral treatment candidate for hepatitis B. Preliminary data indicate that ALG-000184, when used alone or in combination with entecavir, leads to significant reductions in viral load and sustained viral suppression[4].

Market Analysis

Global Market Size and Growth

The global entecavir market was valued at US$ 3673 million in 2023 and is expected to reach US$ 5821.6 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.8% during the forecast period of 2024-2030[5].

Regional Market Segmentation

The market is segmented across various regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to see significant growth due to the high prevalence of hepatitis B in countries like China and India[2].

Key Players

The major global manufacturers of entecavir include Zhejiang Huahai Pharmaceutical, Teva, Aurobindo, Bristol-Myers Squibb, CTTQ Pharma, DAWNRAYS, Qingfeng Pharmaceutical Group, BrightGene Bio-Medical Technology, and Haisco Pharmaceutical Group. These companies account for a significant portion of the market revenue[2][5].

Market Segmentation

By Type

Entecavir is available in two primary dosages: 0.5mg and 1mg per tablet. These dosages cater to different patient needs and are prescribed based on the severity of the infection and the patient's response to treatment[2][5].

By Application

Entecavir is used to treat both adults and children with chronic hepatitis B infection. The drug's efficacy and safety profile make it a preferred choice for long-term antiviral therapy in these patient groups[2][5].

Market Trends and Forecast

Advancements in Antiviral Therapies

The hepatitis B market is witnessing significant advancements in antiviral therapies, with a focus on safer and more effective treatment alternatives. New drugs like tenofovir alafenamide (TAF) have shown superior efficacy and a better safety profile compared to older treatments, which is driving market growth[3].

Combination Therapies

The trend towards combination therapies is expected to continue, with studies exploring the efficacy of combining nucleos(t)ide analogs like entecavir with immune-modulating agents. This approach aims to enhance treatment outcomes, reduce the risk of drug resistance, and improve patient outcomes[3].

Regional Analysis

North America

The North American market for entecavir is expected to grow significantly, driven by the increasing prevalence of hepatitis B and the availability of advanced healthcare facilities. The U.S. and Canada are key markets in this region[2].

Asia-Pacific

The Asia-Pacific region is anticipated to be a major growth driver due to the large patient population and increasing healthcare expenditure in countries like China and India. This region is expected to see a high CAGR during the forecast period[2].

Challenges and Opportunities

Drug Resistance

One of the significant challenges in the treatment of hepatitis B is the risk of drug resistance. Combination therapies and the development of new antiviral agents are critical in addressing this issue and providing better treatment options for patients[3].

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, offer significant opportunities for growth. Increasing awareness about hepatitis B, improving healthcare infrastructure, and government initiatives to combat the disease are expected to drive market expansion in these regions[2].

Key Takeaways

  • Market Growth: The global entecavir market is projected to grow at a CAGR of 6.8% from 2024 to 2030.
  • Combination Therapies: The trend towards combination therapies, such as combining entecavir with pegylated interferon, is expected to enhance treatment outcomes.
  • Regional Growth: The Asia-Pacific region is anticipated to be a major growth driver due to its large patient population and increasing healthcare expenditure.
  • Drug Development: New treatments like ALG-000184 are being developed to complement or potentially replace entecavir, offering improved viral suppression and reduced risk of drug resistance.

FAQs

What is the current market size of entecavir?

The global entecavir market was valued at US$ 3673 million in 2023[5].

What is the projected growth rate of the entecavir market?

The market is expected to grow at a CAGR of 6.8% from 2024 to 2030[5].

Who are the major manufacturers of entecavir?

Key manufacturers include Zhejiang Huahai Pharmaceutical, Teva, Aurobindo, Bristol-Myers Squibb, and others[2][5].

What are the primary dosages of entecavir available?

Entecavir is available in 0.5mg and 1mg per tablet dosages[2][5].

What is the significance of combination therapies in hepatitis B treatment?

Combination therapies aim to enhance treatment efficacy, reduce the risk of drug resistance, and improve patient outcomes by combining nucleos(t)ide analogs like entecavir with immune-modulating agents[3].

Sources

  1. New Phase 3 Clinical Trial Opportunity for People Living with Chronic Hepatitis B - Hepatitis B Foundation[1].
  2. Global Entecavir Market Research Report 2024 - QYResearch[2].
  3. Hepatitis B Market Estimated to Reach USD 4.9 Billion by 2034 - BioSpace[3].
  4. Aligos Planning Phase 2 Trial of Treatment for Hepatitis B - Liver Disease News[4].
  5. Global Entecavir Market Research Report 2024 - Valuates Reports[5].

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