CLINICAL TRIALS PROFILE FOR ENTECAVIR

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.
NCT00065507 ↗	Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation	Completed	Bristol-Myers Squibb	Phase 3	2003-08-01	This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.
NCT00096785 ↗	Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection	Completed	Bristol-Myers Squibb	Phase 3	2004-12-01	The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

Clinical Trial Conditions for ENTECAVIR

Condition Name

Condition Name for ENTECAVIR
Intervention	Trials
Chronic Hepatitis B	89
Hepatitis B, Chronic	49
Hepatitis B	42
HBV	6

Condition MeSH

Condition MeSH for ENTECAVIR
Intervention	Trials
Hepatitis B	223
Hepatitis	200
Hepatitis B, Chronic	175
Hepatitis A	172

Clinical Trial Locations for ENTECAVIR

Trials by Country

Trials by Country for ENTECAVIR
Location	Trials
China	309
United States	254
Korea, Republic of	68
Taiwan	46
Japan	36

Trials by US State

Trials by US State for ENTECAVIR
Location	Trials
California	24
New York	21
Texas	17
Maryland	17
Florida	16

Clinical Trial Progress for ENTECAVIR

Clinical Trial Phase

Clinical Trial Phase for ENTECAVIR
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	3

Clinical Trial Status

Clinical Trial Status for ENTECAVIR
Clinical Trial Phase	Trials
Completed	95
Unknown status	63
Recruiting	38

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	10

Sponsor Type

Sponsor Type for ENTECAVIR
Sponsor	Trials
Other	409
Industry	134
UNKNOWN	18

Entecavir: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical trials for Entecavir?

Entecavir, approved by the FDA in 2005 for chronic hepatitis B virus (HBV) infection, remains under investigation in various phases for additional indications and formulations. Its primary data stems from hepatitis B treatment, with ongoing trials exploring extended applications, resistance management, and combination therapies.

Ongoing and Recent Clinical Trials

• Phase IV/Post-Marketing Studies: Focus on long-term efficacy and safety, particularly in diverse populations such as HBV/HIV co-infection and pediatric patients.
• Combination Therapy Trials: Testing Entecavir with other antivirals like tenofovir in resistant HBV strains.
• Novel Formulation Trials: Developing extended-release formulations aiming for reduced dosing frequency.

According to ClinicalTrials.gov, over 30 clinical trials involve Entecavir, mainly focusing on antiviral efficacy (NCT number: 01212304, 01755804).

Key Trial Data

• Efficacy: Entecavir maintains high viral suppression rates (>90%) over a 5-year period.
• Resistance: Resistance develops in approximately 1% of treatment-naive patients over 5 years.
• Safety: Long-term safety profile remains favorable, with low rates of adverse events comparable to placebo.

Gaps in Research

• Limited data on pediatric use beyond initial approval.
• Needs larger, multicenter randomized trials for resistant HBV cases.
• Absence of trials focusing on Entecavir’s utility in HBV/HCV co-infections.

Market Analysis

Current Market Landscape

• Global HBV Market (2023): Estimated at USD 4.5 billion, with Entecavir comprising approximately 35% of antiviral treatment sales.
• Leading Competitors:
  • Tenofovir (Viread): 45%
  • Entecavir: 35%
  • Others (lamivudine, adefovir): 20%

Key Market Drivers

• Increasing HBV prevalence, especially in Asia-Pacific (WHO, 2022).
• Rising awareness and screening programs.
• Long-term safety profile supporting chronic therapy.

Market Challenges

• Patent expiration for Entecavir expected in key markets by 2028.
• Competition from generic tenofovir and emerging drugs like tenofovir alafenamide.
• Price erosion pressure, especially in low-income regions.

Regional Insights

Region	Market Share (2023)	Growth Rate (CAGR 2023-2028)	Key Factors
Asia-Pacific	45%	5%	High HBV endemicity, government healthcare initiatives
North America	25%	2%	Established treatment protocols, generic entry imminent
Europe	20%	3%	Increasing screening, aging population
Rest of World	10%	4%	Growing healthcare access in emerging markets

Future Market Projections

• 2028 Market Value: Forecasted to reach USD 6 billion.

• Growth Drivers:

  • Expansion into pediatric and co-infected populations.
  • Development of fixed-dose combination therapies.
  • Patent expiry and entry of generics.

• Market Opportunities:

  • Developing countries with high HBV prevalence.
  • Combination regimens targeting resistance.
  • New formulations reducing dosing frequency.

Strategic Outlook

• Research Focus: Enhancing resistance profile, pediatric formulations, and combination treatments.
• Regulatory Environment: Increased scrutiny on safety data; accelerated approval pathways for new indications.
• Competitive Positioning: Entecavir maintains a strong market share because of its efficacy and safety record but faces commoditization amid patent expiry threats.

Key Takeaways

Entecavir’s approval in 2005 established it as a first-line HBV therapeutic. Ongoing trials expand its indications, especially in resistant or co-infected populations. The drug commands a significant market share, particularly in Asia-Pacific regions where HBV prevalence remains high. Patent expiries will challenge its market dominance, pushing manufacturers toward new formulations and combination therapies. Long-term sales growth is expected but reliant on pipeline innovation and competitive landscape shifts.

FAQs

1. Are there new formulations of Entecavir in development?
Yes. Trials are exploring extended-release tablets aiming to reduce dosing frequency and improve adherence.

2. What is the resistance rate for Entecavir?
Approximately 1% after five years of therapy in treatment-naive patients, higher in resistant populations.

3. Is Entecavir effective in pediatric patients?
Data suggest safety and efficacy, but further large-scale trials are ongoing to confirm its pediatric utility.

4. How does Entecavir compare to Tenofovir?
Both drugs show high efficacy with similar resistance profiles. Tenofovir has a wider generic presence, impacting Entecavir’s market share.

5. What markets are most promising for future growth?
Asia-Pacific and emerging markets in Africa and Latin America, where HBV prevalence is high and healthcare infrastructure expanding.

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References

1. ClinicalTrials.gov. (2023). Entecavir clinical studies. https://clinicaltrials.gov
2. WHO. (2022). Global hepatitis report. World Health Organization.
3. MarketWatch. (2023). Global antiviral drug market size and forecast.
4. U.S. Food and Drug Administration. (2005). Entecavir approval documentation.
5. IMS Health. (2022). Global antiviral market dynamics.