A Historic Milestone for Auxesis Pharma
Today, we are pleased to share one of the most significant announcements in the history of Auxesis Pharma.
The Swedish Medical Products Agency has approved the application for the clinical trial of ASA.P®.
This decision means that Auxesis has received regulatory authorization to initiate the clinical development of our drug candidate—an important step on the path toward a future approved pharmaceutical product.
For us, this represents far more than a regulatory decision. It is confirmation of the extensive work carried out over many years in research, formulation development and quality assurance.
Development According to Plan
Since the formulation of ASA.P® was finalized during the autumn of 2025, development has progressed rapidly. Throughout the spring we have communicated clear milestones to the market, and we are proud to confirm that the project continues to follow the timeline we have presented.
The application for the clinical trial was submitted on 11 May 2026.
This was followed by an intensive regulatory process:
- The application was granted Fast Track status on 14 June 2026.
- The Swedish Ethical Review Authority issued its final approval on 22 June 2026.
- The Swedish Medical Products Agency subsequently approved the clinical trial.
The Regulatory Process
The process has been conducted in accordance with the European Union Clinical Trials Regulation (EU 536/2014) and Swedish pharmaceutical legislation.
Next Steps
With regulatory approval now in place, Auxesis is entering the next phase of development.
The clinical study of ASA.P® is planned to begin during the autumn.
The results from this study will form a key part of the continued regulatory process towards future marketing authorization.
At the same time, work continues on business development and international partnerships to create the best possible conditions for future commercialization.
Looking Ahead
To carry out the clinical study according to plan, the Company must now secure financing for the next phase of development.
Each regulatory milestone reduces the project's development risk, and for us today's announcement represents a significant step closer to our goal – to develop a new locally administered pharmaceutical product based on our own patent-pending technology.
We would like to extend our sincere thanks to all our shareholders for your continued trust and support. Your commitment makes it possible for us to continue advancing Swedish pharmaceutical innovation towards the next major milestone.
The journey continues – and today it has taken a decisive step forward.
