Cidara Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to CD101 IV for the treatment of candidemia and invasive candidiasis.

A recent Phase 1 multiple ascending dose (MAD) clinical trial demonstrated an excellent safety and tolerability profile for CD101 IV across a broad range of doses. Cidara intends to initiate a Phase 2 clinical trial in patients with candidemia in the first half of 2016.

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CD101 IV is a novel, long-acting echinocandin antifungal under development for the treatment and prevention of serious fungal infections that are associated with high mortality rates and rising drug resistance.

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