Expanded Access Policy

Effective Date: August 6, 2026

Our Approach

Alzprotect is developing Ezeprogind, an investigational medicine for the treatment of progressive supranuclear palsy (PSP) as well as other tauopathy-related disorders. The medicine is currently being evaluated in clinical trials to better understand its safety, efficacy, and appropriate use in people living with PSP.

Our priority is to complete the clinical development programme and generate the evidence needed to support regulatory review and potential approval.

What is Expanded Access?

Expanded Access, sometimes referred to as Compassionate Use, is a regulatory pathway that may allow patients with serious or life-threatening diseases to receive an investigational medicine outside of a clinical trial when certain criteria are met. Expanded Access is generally considered when no comparable or satisfactory treatment options are available and when participation in a clinical trial is not possible. Requests for Expanded Access are subject to applicable regulatory requirements and must be supported by the treating physician and the relevant health authorities.

Our Current Policy

At this time, Alzprotect does not offer an Expanded Access programme for its investigational medicine and is not currently planning to make the medicine available through Expanded Access.

Accordingly, we are unable to consider requests for access to the investigational medicine outside of participation in an authorised clinical trial.

Why We Have This Policy

Progressive supranuclear palsy is a serious neurodegenerative disease with substantial unmet medical need, and we recognise the importance of developing new treatment options as quickly and responsibly as possible.

Our current development strategy is focused on completing the ongoing clinical programme. At this stage, concentrating our available investigational product supply, scientific expertise, and operational resources on clinical trials provides the most effective pathway to generate reliable clinical evidence and advance the development of the medicine.

Introducing an Expanded Access programme during this phase of development could affect the conduct and timely completion of clinical trials, reduce the availability of investigational product for study participants, and limit the resources required to support the clinical development programme.

Future Review

As development progresses, Alzprotect will periodically review this policy. Any future decision to establish an Expanded Access programme will depend on a number of factors, including:

  • The stage of clinical development;
  • The available clinical data to support dosing and appropriate monitoring;
  • Manufacturing capacity and product supply and;
  • Applicable regulatory requirements.

Eligibility of patients for any future Expanded Access programme, in addition to the criteria outlined above, would be reviewed based on:

  • The patient has a serious and life-threatening condition;
  • The patient having exhausted all reasonable and available treatment options, including appropriate clinical trials;
  • Sufficient evidence that the patient in question could potentially benefit from treatment with Ezeprogind and that this benefit outweighs the potential risks; 
  • Ezeprogind remains within active clinical development;
  • Drug supply is sufficient to support ongoing treatment for the requested patient without compromising ongoing and future clinical development activities and;
  • The request is made by a licensed physician, specialized in the condition.

Publication of this policy does not create any obligation for Alzprotect to provide access to its investigational medicine outside of a clinical trial.

Healthcare professionals seeking information about ongoing or planned clinical studies should refer to ClinicalTrials.gov or contact Alzprotect via the contact page of the website.