The Food and Drug Administration (FDA) has granted Orphan Drug Designation to Tacrolimus Inhalation Powder (TFF Pharmaceuticals) for prophylaxis of lung allograft rejection.

Currently available in oral and intravenous formulations, the investigational agent is a dry powder version of tacrolimus, a calcineurin inhibitor immunosuppressant. Using proprietary technology, the Company believes the dry powder particles will be able to “supersaturate” when they come into contact with lung tissue. Direct delivery to the target site would then bypass potential systemic side effects associated with tacrolimus such as nephrotoxicity.

A phase 1 study is expected to begin this month in Australia with multiple ascending dose studies planned for the third quarter of 2020.

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The FDA’s Orphan Drug designation is granted to treatments for rare diseases/disorders that affect ≤200,000 individuals in the US.

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