Expanded Access Policy

Company Statement on Expanded Access (Compassionate Use)

RXC008 received Fast Track Designation from the US FDA on 26 February 2026. Redx is committed to developing investigational medicines through well-designed clinical trials to evaluate safety and effectiveness in patients with serious diseases.

At this time, Redx does not offer expanded access (also known as compassionate use or pre-approval access) to our investigational products outside of ongoing clinical trials.

 

Rationale

Our investigational products are currently in clinical development. Providing expanded access outside of controlled clinical trials may:

  • Interfere with the initiation, conduct, or completion of clinical trials
  • Limit drug supply needed for clinical trials
  • Expose patients to investigational products for which potential risks and benefits have not yet been established

Our priority is to complete clinical development as efficiently and safely as possible to obtain regulatory approval and make our medicines broadly available.

 

Future Review

Status at March 2026. This policy may be updated at any time and reconsidered as development progresses and additional safety and efficacy data become available.

Company Statement on Expanded Access (Compassionate Use)

RXC008 received Fast Track Designation from the US FDA on 26 February 2026. Redx is committed to developing investigational medicines through well-designed clinical trials to evaluate safety and effectiveness in patients with serious diseases.

At this time, Redx does not offer expanded access (also known as compassionate use or pre-approval access) to our investigational products outside of ongoing clinical trials.

 

Rationale

Our investigational products are currently in clinical development. Providing expanded access outside of controlled clinical trials may:

  • Interfere with the initiation, conduct, or completion of clinical trials
  • Limit drug supply needed for clinical trials
  • Expose patients to investigational products for which potential risks and benefits have not yet been established

Our priority is to complete clinical development as efficiently and safely as possible to obtain regulatory approval and make our medicines broadly available.

 

Future Review

Status at March 2026. This policy may be updated at any time and reconsidered as development progresses and additional safety and efficacy data become available.