ERegulatory & Access

Navigating Regulations, Ensuring Global Access: Our Pathway to Delivering Therapies

Attune Biotech is strategically positioned to efficiently navigate the regulatory landscape and ensure broad patient access to our innovative therapies. Our approach leverages established regulatory pathways and a strong foundation in manufacturing and clinical data to facilitate the timely delivery of our treatments to global markets.

Regulatory Readiness

Attune Biotech has established a robust regulatory framework to support the development and commercialization of our lead compound

  • Active Phase 2b/3 IND: “Attune has an active Investigational New Drug (IND) application in Phase 2b/3 clinical trials, demonstrating advanced development progress.”
  • 505(b)(2) Pathway Designation: “Attune’s immune modulator has obtained FDA 505(b)(2) regulatory pathway, which allows for a faster and more streamlined approval process by leveraging existing data.”
  • Extensive FDA & International Data: “Attune has accumulated extensive clinical data and regulatory experience, both in the United States and internationally, further strengthening its development position.”
  • Complete CMC Package and Validated Production Processes: “Attune has a comprehensive Chemistry, Manufacturing, and Controls (CMC) package and has validated its production processes, ensuring seamless manufacturing readiness and the ability to supply high-quality products at scale.”

Global Market Access Strategy

Attune Biotech is committed to bringing its therapies to patients worldwide. Our global market access strategy is informed by our regulatory readiness and aims for efficient and broad distribution.

  • Long COVID (Lodonal):
    • “File FDA Emergency Use Authorization (EUA) for Long COVID” in Q2 2025.  
    • This strategy leverages the urgent unmet need for Long COVID treatments and Attune’s potential to address this condition.  
  • HIV (Lodonal):
    • File FDA Fast Track Approval for HIV Program in Q3 2025.  
    • Focus on treatment-experienced HIV patients, non-responders, and treatment failures, with potential expansion into adjunct therapies.  
    • Pursue market share in the US, EU, and NATO countries.  
  • Chronic Pain (Lodonal):
    • Initiate 12-Month Open Label Clinical Trial for Chronic Pain in Q4 2025.  
  • Military Health (Lodonal):
    • Open discussions with the DoD for a Sole Source Contract in Q3 2025.  
    • Aims to address complex health challenges in the military, including chronic pain and opioid dependence.  
  • Africa Market (Lodonal):
    • Launch Attune Africa with NAFDAC approval of Lodonal for HIV/AIDS immune maintenance in 2025.  
    • Employ a pricing strategy to ensure affordability and broader access.