Expanded Access

03/05/2026
The FDA granted Fast Track designation to HFpEF (Heart Failure with preserved Ejection Fraction) (clinicaltrials.gov NCT06061549) and DMD-CM (Cardiomyopathy secondary to Duchenne Muscular Dystrophy) (clinicaltrials.gov NCT06224660). According to section 561A(f)(2) of the FDCA, Sardocor Corp, the Sponsor of the INDs, is making its expanded access policy for SRD-001 publicly available.

Sardocor Corp announces that, in general, Expanded Access to SRD-001 is not offered outside clinical trials. The company’s current priority is completing clinical studies to evaluate the safety and potential effectiveness of SRD‑001 and to support regulatory review. However, if there is a critical need with strong medical justification and no alternative treatments available to save a patient's life, patients or medical professionals should follow the FDA's outlined procedures and contact Sardocor for further discussion (info@sardocorcorp.com, or (781) 230-9896)

Sardocor will make every effort to help save the patient’s life if the scientific mechanism of action of SRD-001 gene therapy supports such intervention.