Opelconazole (PC945) Drug Granted Orphan Designation By U.S FDA

Release Date: 03-Oct-2021

U.S FDA has granted Orphan Drug, Fast Track and Qualified Infectious Disease Product designations for opelconazole (PC945) for the treatment of invasive pulmonary aspergillosis (IPA).


Opelconazole (PC945), is an antifungal therapy specially designed for inhaled use to maximize the amount of drug in the lung and spare systemic exposure. Under a Special Needs program across several clinical centers in the United Kingdom, opelconazole was found to be well tolerated and demonstrated remarkable clinical responses. This drug is useful in a variety of conditions where Aspergillus has been implicated, including cystic fibrosis, chronic pulmonary obstructive disease, chronic pulmonary aspergillosis, severe asthma, allergic bronchopulmonary aspergillosis, severe flu, and post-COVID-19-associated lung damage.

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