A decisive breakthrough —
the start of the next phase for
Auxesis Pharma
During the autumn, Auxesis Pharma reached a very important scientific milestone that now lays the foundation for the next phase of our growth journey.
From research to reality
During the autumn, Auxesis Pharma reached a very important scientific milestone that now lays the foundation for the next phase of our growth journey. Our future drug candidate ASA.P® has successfully been proven stable and robust for at least two years — a decisive requirement to initiate clinical studies in line with regulatory guidelines from the Swedish Medical Products Agency.
This breakthrough marks the start of the regulatory and clinical path towards a finished medicine, with the objective of developing an effective and safe treatment to alleviate pain via the skin.
Stability confirmed
2+ years of shelf life verified
Meets requirements
Meets regulatory requirements
Innovative pain relief
Transdermal application
Clinical trial — from research to humans
A clinical trial, also called a clinical study, is a systematic investigation of a medicine’s effect, safety and tolerability. Clinical trials are carried out either at dedicated clinical trial units — so-called CROs (Contract Research Organisations) — or within healthcare services, for example at primary care clinics or hospital departments.
The studies are conducted on behalf of drug-development companies and are performed in close collaboration with responsible physicians and clinical staff.
For Auxesis, the clinical development follows the established plan. The regulatory work is finalised in quarter 1, after which the application is submitted to the Swedish Medical Products Agency for approval. Once approval is obtained, the clinical phase begins with studies in healthy volunteers — the first clinical evaluation of ASA.P in humans.
Auxesis development plan 2026
Regulatory work
The regulatory work is finalised, after which the application is submitted to the Swedish Medical Products Agency for approval.
Clinical phase begins
Once approval is obtained, the clinical phase begins with studies in healthy volunteers.
Phase I completed
Phase I clinical trials are conducted at CTC’s research unit in Uppsala and are expected to be completed.
Selection of clinical partner — CTC in Uppsala
A well-renowned clinical partner
Auxesis has selected CTC in Uppsala as the clinical partner for conducting the clinical studies. CTC is a well-renowned and certified CRO with extensive experience in clinical trials, including advanced human skin studies.
Quality framework
CTC operates under a robust Quality Management System (QMS) based on risk-driven internal audits, fully aligned with applicable GxP guidelines and relevant regulatory requirements.
Connection to leading university hospitals
- Karolinska University Hospital
- Uppsala University Hospital (Akademiska)
- Örebro University Hospital
- Linköping University Hospital
Areas of expertise
New research areas and future
opportunities
Parallel development of new formulations
In parallel with the development of ASA.P, Auxesis is also working on new formulations with the aim of enabling treatment of other skin-related conditions where ASA.P can be a strong and valuable complement.
Best wishes for the year ahead!