Expanded Access Policy

Calluna Pharma is dedicated to developing innovative and effective treatments for patients with serious diseases.

An investigational medicine is a drug that has not yet been approved by regulatory authorities for general use. Before an investigational medicine can be made available to patients outside of clinical trials, it must go through multiple phases of testing to ensure its safety, efficacy, and appropriate usage. These evaluations are conducted through carefully designed clinical trials that help us gather critical data to support regulatory approval and widespread availability.

Expanded access refers to the use of an investigational medicine outside of a clinical trial designed to evaluate safety and efficacy. The purpose of expanded access is to diagnose, prevent, or treat a serious or immediately life-threatening condition in a patient using medicines that have not yet been approved by the regulatory authorities.

CAL101, is an investigational medicine being evaluated in a Phase 2 clinical study and undergoing other clinical research and development activities. Until we have completed the necessary evaluations to determine the full risk benefit profile of the medicine, we are unable to provide it through expanded access. We understand the urgency and need for new treatments for serious and life-threatening conditions. As we progress through the clinical development of CAL101, we will continually reassess our expanded access policy. Our goal is to provide access to our medicines at the appropriate time, once their benefits and risks are fully understood.

For more information about our research and clinical trials, or future updates on our expanded access policy, please contact us: info@callunapharma.com