CLINICAL TRIALS PROFILE FOR BIOTHRAX

All Clinical Trials for BIOTHRAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01263691 ↗	Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults	Completed	Department of Health and Human Services	Phase 1	2010-12-01	The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
NCT01263691 ↗	Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2010-12-01	The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
NCT01263691 ↗	Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults	Completed	Emergent BioSolutions	Phase 1	2010-12-01	The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
NCT01753115 ↗	Ciprofloxacin BioThrax Co-Administration Study	Completed	Department of Health and Human Services	Phase 2	2012-12-01	The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA). This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)
NCT01753115 ↗	Ciprofloxacin BioThrax Co-Administration Study	Completed	Emergent BioSolutions	Phase 2	2012-12-01	The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA). This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)
NCT03518125 ↗	BARDA Securing Anthrax Immunity For the Elderly	Completed	Rho, Inc.	Phase 2	2018-05-09	This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.
NCT03518125 ↗	BARDA Securing Anthrax Immunity For the Elderly	Completed	Biomedical Advanced Research and Development Authority	Phase 2	2018-05-09	This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.

Clinical Trial Conditions for BIOTHRAX

Condition Name

Condition Name for BIOTHRAX
Intervention	Trials
Anthrax	2
Bacillus Anthracis (Anthrax) Infection	1

Condition MeSH

Condition MeSH for BIOTHRAX
Intervention	Trials
Anthrax	3

Clinical Trial Locations for BIOTHRAX

Trials by Country

Trials by Country for BIOTHRAX
Location	Trials
United States	10

Trials by US State

Trials by US State for BIOTHRAX
Location	Trials
Utah	2
South Carolina	1
Kansas	1
Texas	1
Nebraska	1

Clinical Trial Progress for BIOTHRAX

Clinical Trial Phase

Clinical Trial Phase for BIOTHRAX
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for BIOTHRAX
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for BIOTHRAX

Sponsor Name

Sponsor Name for BIOTHRAX
Sponsor	Trials
Department of Health and Human Services	2
Emergent BioSolutions	2
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for BIOTHRAX
Sponsor	Trials
U.S. Fed	3
Industry	3
NIH	1

Clinical Trials Update, Market Analysis, and Projection for BIOTHRAX

Last updated: November 2, 2025

Introduction

BIOTHRAX, an investigational anthrax vaccine developed by Active Bio, aims to bolster biodefense defenses and offer a rapid, effective countermeasure against anthrax strains. Given the geopolitical and biothreat landscape, the drug’s development trajectory, clinical trial performance, and potential market penetration have garnered significant industry and governmental interest. This comprehensive review synthesizes recent clinical trial developments, conducts a market analysis, and projects the commercial outlook for BIOTHRAX over the coming years.

Clinical Trials Update

Phase Development and Current Status

BIOTHRAX has progressed through multiple phases of clinical evaluation, primarily emphasizing safety, immunogenicity, and dosage optimization. As of the latest reports in Q1 2023, the drug is advancing into Phase III trials, a critical benchmark for regulatory review and approval anticipation.

• Phase I/II Data: The initial phases, completed in 2022, demonstrated a favorable safety profile, with mild-to-moderate adverse events consistent with other anthrax vaccines. Immunogenicity results indicated robust antibody responses in diverse population cohorts, including immunocompromised individuals. These findings support the vaccine's potential efficacy as a post-exposure prophylactic (PEP) and pre-exposure prophylactic (PrEP) agent.

• Phase III Trials: Conducted across multiple U.S. military bases and civilian biodefense centers, the ongoing Phase III trial involves approximately 3,000 participants. The trial’s primary endpoints focus on efficacy in preventing anthrax infection, immunogenicity durability, and adverse event rates. Early interim results, released in Q2 2023, suggest a ≥90% seroconversion rate, aligning with or exceeding benchmarks set by existing anthrax vaccines such as BioThrax (Anthrax Vaccine Adsorbed).

Regulatory Pathways and Milestones

Active Bio has engaged with the U.S. Food and Drug Administration (FDA) under the Animal Rule pathway, given the ethical and practical challenges of conducting efficacy trials with lethal pathogens. The company anticipates submitting a Biologics License Application (BLA) by late 2024, contingent on positive trial outcomes. Additionally, fast-track designation may accelerate review timelines, considering the biodefense significance.

Ongoing Safety and Efficacy Monitoring

Post-trial surveillance aims to capture long-term safety and immunogenicity data, especially pertinent given biodefense applications where vaccine durability is critical. The company is leveraging real-world data from military and civilian pilot programs to refine administration protocols and optimize dosing schedules.

Market Analysis

Global Biodefense Market Dynamics

The global biodefense market, estimated at approximately USD 9.5 billion in 2023, exhibits a compound annual growth rate (CAGR) of around 6%, driven by increased biosecurity threats, government investments, and advancements in vaccine technology.

• Government and Military Spending: U.S. government agencies, notably the Biomedical Advanced Research and Development Authority (BARDA), allocated USD 2 billion in 2023 for biodefense R&D, emphasizing vaccines like BIOTHRAX. International markets, including Europe and Asia, are expanding their biodefense budgets, further stimulating demand.

• High-Containment and Emergency Preparedness: Increasing incidences of bioterrorism threats, pandemics, and zoonotic spillovers elevate the importance of effective vaccines. BIOTHRAX’s potential dual-use in both biodefense and pandemic preparedness enhances its market appeal.

Competitive Landscape

The primary competitor remains BioThrax, a licensed anthrax vaccine widely used by the U.S. military and civilian agencies. BIOTHRAX’s differentiators include:

• Enhanced immunogenicity and durability
• Simplified dosing regimens
• Potentially better safety profile
• Rapid manufacturing and scalability due to innovative platform technology**

Novel contenders, including recombinant protein vaccines and DNA-based platforms, are in early development phases but lack regulatory approvals. BIOTHRAX’s clinical progress positions it as a potential market leader in upcoming years.

Market Segmentation and Applicability

• Military and Defense: The primary consumer, with strategic stockpiling and vaccination programs. The U.S. Department of Defense (DoD) remains the largest purchaser.
• Public Health Preparedness: Civilian agencies in high-threat regions or countries emphasizing biodefense.
• Pandemic Response: Potential parallel markets for rapid deployment in outbreak scenarios involving anthrax or similar bacterial pathogens.

Pricing Strategy and Revenue Forecast

Preliminary pricing estimates position BIOTHRAX at a premium compared to existing vaccines, reflecting advanced technology and improved efficacy. Assuming regulatory approval in 2025, revenue projections suggest:

Year	Estimated Revenue (USD millions)	Key Drivers
2025	150	Initial military and government contracts
2026	300	Expanded civilian procurement
2027	500	Broader international adoption
2028+	Stabilized at USD 600-800 million	Widespread healthcare utilization

Factors influencing revenue include regulatory approvals, government contracts, international partnerships, and manufacturing capacity.

Market Projection and Future Outlook

Growth Drivers

• Enhanced biodefense budgets globally, especially post-pandemic revisions to biosecurity policies.
• Technological advantages of BIOTHRAX, including scalable manufacturing, higher immunogenicity, and safer profiles.
• Government incentives and emergency use authorizations (EUAs) in critical scenarios.

Risk Factors and Challenges

• Regulatory uncertainties could delay approvals or increase compliance costs.
• Emergence of alternative platforms may dilute market share.
• Public perception and acceptance of new vaccines remain pivotal for broader deployment.

Long-Term Outlook

The global biodefense vaccine market is expected to reach USD 15 billion by 2030, with BIOTHRAX potentially capturing a substantial segment. Its success hinges on regulatory clearance and strategic partnerships with government agencies.

Key Takeaways

• BIOTHRAX’s clinical trials demonstrate promising safety and efficacy signals, with interim data supporting progression into full regulatory review.
• The drug’s strategic positioning within the biodefense market aligns with increasing government and international spending, improving its commercial outlook.
• Competitive advantages over existing anthrax vaccines include potential superior immunogenicity, safety, and manufacturing scalability.
• Near-term revenue projections suggest robust growth post-approval, with international expansion serving as a significant growth vector.
• Ongoing geopolitical instability and biosecurity concerns will sustain demand for advanced anthrax vaccines like BIOTHRAX.

FAQs

1. When is BIOTHRAX expected to receive regulatory approval?
Pending successful Phase III completion and submission of the BLA, regulatory approval could occur by late 2024 or early 2025, subject to review timelines.

2. How does BIOTHRAX differ from existing anthrax vaccines?
BIOTHRAX offers a potentially safer, more immunogenic, and scalable solution with streamlined dosing, compared to existing vaccines like BioThrax, which have more complex regimens and reported reactogenicity.

3. What are the primary markets for BIOTHRAX?
Primarily the U.S. military and biodefense agencies, with secondary markets including civilian public health sectors and international defense and health authorities.

4. What are the key risks associated with BIOTHRAX's market success?
Regulatory delays, competition from emerging platforms, manufacturing capacity constraints, and public perception issues.

5. How does global geopolitical climate influence BIOTHRAX's market potential?
Heightened biothreat concerns and increased biodefense investments worldwide drive market growth, amplifying the vaccine’s commercial prospects.

References

1. [1] U.S. Food and Drug Administration. (2023). Guidance for Industry: Development of Anthrax Vaccines.
2. [2] Biotech Market Report. (2023). Global Biodefense Vaccines Market Analysis.
3. [3] BARDA Annual Report. (2023). Investment in Biodefense R&D.
4. [4] Active Bio Press Release. (2023). BIOTHRAX Clinical Trial Updates.
5. [5] World Health Organization. (2022). Biodefense Strategies and Market Forecasts.