Scynexis has secured FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for its next-generation antifungal SCY-247, underscoring the drug’s potential to address the escalating global threat of multidrug-resistant fungal infections such as Candida auris.
This past week, Scynexis announced the FDA granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations to SCY-247, the company’s second-generation triterpenoid antifungal therapy. These regulatory decisions demonstrate the FDA’s recognition of the urgent need for new treatments targeting serious and life-threatening fungal infections that are increasingly resistant to existing therapies.
SCY-247 is being developed to combat a broad range of difficult-to-treat fungal pathogens, including multidrug-resistant Candida auris and echinocandin-resistant Candida glabrata. These pathogens have emerged as major public health concerns, particularly in hospital settings and among immunocompromised patients. Recent scientific and media reports have documented the rapid global spread and increasing virulence of C auris, with some strains showing resistance to all currently approved antifungal drug classes.
Back in November it was announced that Scynexis was collaborating With Hackensack Meridian CDI and Johns Hopkins to develop therapeutics for drug-resistant fungal infections. Read more about that
According to Scynexis, preclinical studies have consistently demonstrated potent antifungal activity of SCY-247 across multiple efficacy models, along with extensive tissue distribution. The company has also reported positive phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) data, showing a favorable safety profile and pharmacokinetics. Notably, SCY-247 achieved target drug exposures for invasive fungal disease at lower doses than Scynexis’ first-generation antifungal candidate, supporting its potential as a differentiated therapy.
The FDA’s QIDP designation, established under the Generating Antibiotic Incentives Now (GAIN) Act, provides significant development incentives for antifungal and antibacterial drugs intended to treat serious or life-threatening infections. If approved, SCY-247 would be eligible for an additional five years of market exclusivity on top of existing exclusivity periods, resulting in at least 10 years of post-approval protection. The Fast Track designation further enables more frequent interactions with the FDA, eligibility for Accelerated Approval and Priority Review, and the possibility of rolling submission of a future New Drug Application.
FDA QIDP and Fast Track designations signal strong recognition of SCY-247’s potential and provide meaningful incentives to accelerate development.
SCY-247 has shown activity against highly resistant fungi, including Candida auris, a rapidly spreading global “superbug.”
SCYNEXIS plans multiple clinical milestones in 2026, including Phase 1 and Phase 2 studies and proof-of-concept data for invasive candidiasis.
Looking ahead, Scynexis plans to advance SCY-247 into the clinic in 2026, initiating a phase 1 study of an intravenous formulation and a phase 2 study of an oral formulation in invasive candidiasis. The company also expects to release proof-of-concept data for the oral formulation in the same year and continues to explore non-dilutive funding opportunities to support development.
With antifungal resistance increasingly viewed as a health security threat, Scynexis believes SCY-247’s broad-spectrum activity and novel profile position it as a promising candidate to help fill a critical gap in the antifungal treatment landscape.
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