A first-in-class oral therapeutic for neuropathic pain (NP) with complex regional pain syndrome (CRPS) as the first indication and a perfect steppingstone for introducing this candidate into the field of chronic NP.
For decades, CRPS has remained without a single FDA or EMA-approved treatment, creating a profound and desperate unmet medical need. Our program represents the only scientifically robust and clinically efficacious late-stage effort poised to become the definitive 1st‑line standard of care for this devastating orphan disease.
This program is a novel repurposed formulation that has been marketed globally for treatment of lung cancer for over a decade. Our strategy enables a highly efficient and de‑risked development path by leveraging the existing pre‑clinical and safety data. We have Orphan Drug Designation in both the US and EU, providing powerful regulatory and commercial advantages.
We have secured a comprehensive data package from the originator including full preclinical and Phase 1 safety data, which significantly de‑risks the development path allowing us to proceed directly to a single pivotal trial.