We’ve initiated the clinical development of ifetroban for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy (DMD). Based on pre-clinical findings, the U.S. FDA has cleared our application to study ifetroban in DMD patients, 7 years of age and older.


In conjunction with the clearance of our application to begin patient studies, we were awarded just over $1 million in funding from the FDA through their Orphan Drug Grant.


This funding will support a Phase II multicenter study evaluating ifetroban for safety and efficacy in the treatment of DMD heart muscle disease while improving the quality of life in children and men with DMD. For more information about enrollment in this clinical trial please email the Company at research@cumberlandpharma.com.


The FDA Orphan Drug Grant program’s mission is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Cumberland’s study is the very first DMD clinical study approved for FDA Orphan Product Development funding.


Additionally, we also have Phase II clinical programs underway evaluating ifetroban in patients with Systemic Sclerosis, Aspirin-Exacerbated Respiratory Disease, Hepatorenal Syndrome and Portal Hypertension. We are excited to begin this fifth ifetroban study as we continue to harness the power of the ifetroban molecule and seek out ways to develop medicines for unmet medical needs.