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Last Updated: January 20, 2025

Investigational Drug Information for Amdoxovir


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What is the drug development status for Amdoxovir?

Amdoxovir is an investigational drug.

There have been 5 clinical trials for Amdoxovir. The most recent clinical trial was a Phase 2 trial.

The most common disease conditions in clinical trials are HIV Infections, Acquired Immunodeficiency Syndrome, and Virus Diseases. The leading clinical trial sponsors are RFS Pharma, LLC, National Institute of Allergy and Infectious Diseases (NIAID), and [disabled in preview].

Recent Clinical Trials for Amdoxovir
TitleSponsorPhase
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced SubjectsRFS Pharma, LLCPhase 2
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.RFS Pharma, LLCPhase 2
Safety, Tolerance, Pharmacokinetic and Antiviral Study of Amdoxovir in Combination With Zidovudine in Adults With HIVRFS Pharma, LLCPhase 1/Phase 2

See all Amdoxovir clinical trials

Clinical Trial Summary for Amdoxovir

Top disease conditions for Amdoxovir
trials011223344556HIV InfectionsAcquired Immunodeficiency SyndromeVirus DiseasesImmunologic Deficiency Syndromes[disabled in preview]
Top clinical trial sponsors for Amdoxovir
trials0112233RFS Pharma, LLCNational Institute of Allergy and Infectious Diseases (NIAID)[disabled in preview]

See all Amdoxovir clinical trials

Amdoxovir: Development Update and Market Projections

Introduction

Amdoxovir, also known as DAPD, is an investigational guanosine nucleoside analogue that has been under development for the treatment of HIV and chronic hepatitis B. Here, we will provide an update on its development status and explore the market projections for this drug candidate.

Historical Development

Amdoxovir was initially developed under a licensing agreement between Gilead Sciences and Emory University, along with the University of Georgia Research Foundation. The drug was in Phase II clinical trials for the treatment of HIV and had also been tested for chronic hepatitis B infection[4].

Current Development Status

As of 2004, Gilead Sciences ended its licensing agreement for the development and commercialization of amdoxovir due to strategic reasons. Despite this, the universities involved remained committed to the continued development of the drug. Existing clinical trials, including those sponsored by the NIH (ACTG 5118 and ACTG 5165), were continued, and the technology was transitioned to a new licensee[4].

Clinical Trials and Efficacy

Amdoxovir has shown potential as a salvage therapy for HIV-infected individuals. It has been evaluated in Phase II clinical trials, which indicated its efficacy in treating HIV and chronic hepatitis B. However, the drug's development has faced challenges, including the need for further clinical validation and regulatory approval[4].

Market Projections

Given the current status of amdoxovir's development, it is challenging to make precise market projections. Here are a few key points to consider:

Competitive Landscape

The antiviral market, particularly for HIV and hepatitis B, is highly competitive. Companies like Gilead Sciences have established strong portfolios with drugs such as Viread (tenofovir disoproxil fumarate) and Hepsera (adefovir dipivoxil)[2].

Market Trends

The global pharmaceutical market is expected to grow significantly, driven by the demand for treatments for major diseases. However, the focus is shifting towards "big drugs for big diseases," such as obesity and oncology, rather than niche treatments like those for HIV and hepatitis B[3].

Potential Market Impact

If amdoxovir were to be successfully developed and approved, it could potentially capture a segment of the market for HIV and hepatitis B treatments. However, its market impact would depend on various factors, including its efficacy, safety profile, and pricing strategy compared to existing treatments.

Challenges and Opportunities

Regulatory Hurdles

Amdoxovir faces significant regulatory hurdles before it can be approved for market use. The drug needs to complete its clinical trials and undergo rigorous regulatory review, which can be time-consuming and costly[1].

Technological Innovations

The pharmaceutical industry is witnessing a hot innovation era with new modalities and technologies such as antibody-drug conjugates, cell/gene therapies, and radiopharmaceuticals. Amdoxovir could benefit from these advancements if integrated into its development process[3].

Partnership and Licensing

The transition of amdoxovir's development to a new licensee presents both challenges and opportunities. A new partner could bring fresh resources and expertise, potentially accelerating the drug's development and market entry.

Conclusion

Amdoxovir, despite its promising potential as a treatment for HIV and chronic hepatitis B, faces significant challenges in its development journey. The ending of the licensing agreement with Gilead Sciences and the transition to a new licensee have introduced uncertainties. However, with continued commitment from the universities and potential new partners, there is still a window of opportunity for this drug candidate.

Key Takeaways

  • Development Status: Amdoxovir is currently in Phase II clinical trials but has faced setbacks due to the termination of its licensing agreement with Gilead Sciences.
  • Market Potential: The drug has potential in the antiviral market, but its impact will depend on its efficacy, safety, and competitive positioning.
  • Regulatory Challenges: Completing clinical trials and obtaining regulatory approval are critical steps for amdoxovir’s market entry.
  • Technological Innovations: Integrating new technologies could enhance the drug’s development and market prospects.
  • Partnership and Licensing: A new licensee could bring necessary resources and expertise to advance the drug’s development.

FAQs

  1. What is Amdoxovir? Amdoxovir, also known as DAPD, is an investigational guanosine nucleoside analogue being developed for the treatment of HIV and chronic hepatitis B.

  2. What is the current development status of Amdoxovir? As of 2004, Gilead Sciences ended its licensing agreement for Amdoxovir, and the technology was transitioned to a new licensee. The drug remains in Phase II clinical trials.

  3. What are the potential market challenges for Amdoxovir? Amdoxovir faces challenges such as a competitive market, regulatory hurdles, and the need for further clinical validation.

  4. How does Amdoxovir fit into the broader pharmaceutical market trends? The global pharmaceutical market is shifting towards treatments for major diseases like obesity and oncology, which could impact the market potential for niche treatments like Amdoxovir.

  5. What are the opportunities for Amdoxovir in the current pharmaceutical landscape? Amdoxovir could benefit from new technological innovations and partnerships that could accelerate its development and enhance its market prospects.

Sources

  1. Drug development in Alzheimer's disease: The path to 2025 - This source provides context on the challenges and timelines in drug development, although it is focused on Alzheimer's disease[1].
  2. Gilead Sciences to Acquire Triangle Pharmaceuticals for $464 Million - This source details Gilead's acquisition and its portfolio of antiviral drugs, providing insight into the competitive landscape[2].
  3. Evaluate Releases 2030 Forecasts for Global Pharmaceutical Market - This source outlines the future trends and projections in the global pharmaceutical market[3].
  4. Gilead, Emory University and the University of Georgia Research Foundation End Licensing Agreement for Amdoxovir - This source provides specific information on the development status and licensing agreement for Amdoxovir[4].

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