Expanded Access

Access to Investigational Medicines at Alfasigma 

At Alfasigma, our mission is to improve the health and quality of life of patients through science and innovation. While clinical trials remain the primary pathway for accessing investigational medicines, we recognize that not all patients are eligible to participate. In line with our commitment to ethical responsibility and patient care, we have established a policy to guide access to our investigational medicinal products outside of clinical trials. 

What is Expanded Access? 

Expanded Access (EA), also known as compassionate use or special access, allows patients with serious or life-threatening conditions to access investigational medicines when no satisfactory alternatives exist and participation in a clinical trial is not possible. 

What is Post-Trial Access? 

Post-Trial Access (PTA) refers to continued treatment with an investigational medicine for patients who have completed participation in an Alfasigma clinical trial and may benefit from ongoing therapy before the product becomes commercially available. 

How to Request Access 

All requests for Expanded Access or Post-Trial Access must be submitted by a licensed treating physician. Alfasigma evaluates each request carefully, based on medical, ethical, and regulatory criteria, including: 

• The severity of the patient’s condition and lack of alternatives 

• The stage of development and availability of the investigational product 

• The physician’s qualifications and agreement to comply with regulatory and safety standards 

To initiate a request, physicians can submit an application through our secure online portal: 

Click here to SUBMIT A REQUEST – MyTomorrows Portal 
(Please do not include any patient-identifying information in the request.) 

For more information or questions: 

• Physicians: [email protected]  

• Patients and Caregivers: Please speak with your physician about whether this option may be appropriate for you. 

Please note: Access is not guaranteed and may be discontinued at any time. This policy is subject to change.