Milestones
A metered oro-buccal tadalafil spray in development for erectile dysfunction
Milestones
Human proof is targeted for mid-2027
Next three value inflections / Critical Path
Addresses the local buccal-safety gate and supports the base-case HREC response.
First human evidence of exposure profile and the key potential valuation inflection.
Completes the clinical readout; FDA interaction remains to be scheduled.
Base case uses preliminary minipig data to support HREC; later registration activities remain planning estimates pending FDA alignment.
A well understood route to ED
Cresaryn’s lead program, currently designated NCV01, is a metered oro-buccal tadalafil spray in development for erectile dysfunction. Erectile dysfunction is the persistent difficulty in achieving or maintaining an erection sufficient for satisfactory sexual activity. It is common, becomes more prevalent with age and is associated with cardiovascular, metabolic, neurological, psychological and lifestyle factors.
Tadalafil is an established phosphodiesterase type 5 inhibitor. During sexual stimulation, nitric-oxide signalling increases cyclic guanosine monophosphate in penile tissue. PDE5 breaks down this signalling molecule; tadalafil inhibits PDE5 and thereby supports the physiological pathway involved in erection. Tadalafil is distinguished within the PDE5 class by its long duration of action.
A faster route to a proven molecule
NCV01 applies the NanoCelle delivery platform to tadalafil in a discreet spray directed toward the inside of the cheek. Nano-sized structures support dispersion of the active ingredient, and the formulation is designed to enable absorption across the buccal mucosa. The target product profile seeks earlier exposure than a conventional swallowed tablet while retaining tadalafil’s established duration. Management is targeting an onset of approximately seven minutes, subject to human confirmation.