Drug used in other indications

Additional Indications for REZZAYO™ (Rezafungin for Injection)

Based on the available information, there are no specific details about additional clinical indications beyond candidemia and invasive candidiasis being investigated for REZZAYO™ (rezafungin for injection) in clinical trials.

The current information indicates that rezafungin has been approved by the FDA specifically for treating candidemia and invasive candidiasis. While rezafungin has certain characteristics that might make it suitable for other applications, no specific trials for other indications are mentioned in the available data.

Potential Future Applications

Although not currently being trialed for other indications according to the available information, rezafungin has properties that could make it valuable for future investigations:

• As a next-generation echinocandin with differentiated pharmacokinetic characteristics
• Its prolonged half-life allowing for extended-interval dosing
• Potent in vitro activity against most wild-type and azole-resistant Candida species, including Candida auris
• Once weekly dosing capability that could reduce catheter overuse
• Potential for rapid transition to outpatient treatment for Candida infections where azoles cannot be used
• Good penetration into anatomically challenging sites
• Reduced probability of local resistance promotion

These properties make rezafungin potentially suitable for deep-seated infections that could warrant dedicated clinical investigation in the future.

Current Clinical Positioning

Currently, rezafungin is described as a once-weekly dosed echinocandin that will likely be reserved for combination therapy or refractory/intolerance scenarios with no other options.

The available information does not provide details about intervention models for trials investigating rezafungin for indications beyond candidemia and invasive candidiasis, as such trials are not specifically mentioned in the data provided.

Company drugs approved in other indications

CorMedix Inc. Drug Approvals Beyond Candidemia and Invasive Candidiasis

Based on a comprehensive review of CorMedix Inc.'s regulatory approvals over the past three years (2020-2023), there is no evidence of the company having received FDA approval for any drugs to treat indications other than Candidemia and invasive candidiasis.

The company's primary investigational product has been DefenCath (taurolidine-heparin-citrate), which has been under development as a catheter lock solution for the prevention of catheter-related bloodstream infections (CRBSIs) in patients with end-stage renal disease who are receiving hemodialysis via central venous catheters.

DefenCath has faced regulatory challenges during its FDA review process, with the company receiving Complete Response Letters that have delayed potential market approval. The product contains taurolidine, an antimicrobial agent that has shown efficacy against a broad range of microorganisms including bacteria and fungi.

While CorMedix has been actively pursuing the development and approval of DefenCath, as of the latest available information, the company has not received final FDA approval for this product or any others in their pipeline for indications beyond Candidemia and invasive candidiasis.

The company continues to work through the regulatory pathway for DefenCath, addressing manufacturing and other concerns raised by the FDA. Their focus remains on bringing this product to market to address the significant unmet medical need for preventing dangerous bloodstream infections in vulnerable hemodialysis patients.

CorMedix's product portfolio remains relatively focused, with DefenCath representing their lead asset. The company has not announced successful regulatory approvals for any other therapeutic indications within the specified timeframe.

For investors and those following the company, the regulatory status of DefenCath continues to be the primary focus of CorMedix's business development efforts and potential future revenue streams.