Tenaya’s Expanded Access Policy
Tenaya is committed to improving and extending the lives of individuals by discovering, developing and delivering therapies that address the underlying causes of heart disease. The most efficient and effective way to ensure patients can benefit from our investigational medicines in the future is through clinical trials carried out in collaboration with researchers, patient groups and physicians.
Companies like Tenaya are required to evaluate the safety, tolerability and effectiveness of our investigational medicines in clinical studies and submit results to regulatory agencies for consideration to obtain marketing approvals. Marketing approval indicates that a medicine has met objective criteria for safety and efficacy and is necessary before that medicine can be made broadly available.
Currently, access to our investigational medicines is only through participation in clinical trials. The best way to ensure fair and equitable access to our medicines and to safeguard the welfare of patients is through clinical trials. Offering access outside of these trials could jeopardize the conduct of these trials, delay or prevent future clinical development programs and potentially create a setback to all patients in need. Therefore, Tenaya does not offer expanded access to its investigational medicines. We will review and reevaluate our expanded access policy as new data becomes available.
For additional information about this policy, please contact firstname.lastname@example.org.
Find information on currently enrolling clinical trials for Tenaya’s investigational therapies on clinicaltrials.gov.
We at Tenaya are deeply grateful for the involvement of patients and their families, as well as clinical researchers and their staff in our clinical programs. Without your commitment, we could not pursue our mission to develop new medicines for the treatment of cardiovascular diseases.
Tenaya Therapeutics reserves the right to revise this policy at any time and this posting will be updated should there be any policy change.