505(b)(2)
(2)
Auxilius Pharma
Auxilius Pharma is a clinical-stage cardiovascular pharmaceutical company developing AUX-001, a once-daily extended-release formulation of nicorandil for the roughly 11 million Americans living with chronic stable angina. By reformulating an established molecule through the FDA's 505(b)(2) pathway, the company aims to deliver what would be the first new innovative oral angina therapy in the US since 2006 - improving adherence, tolerability and outcomes for patients who still suffer symptoms despite optimal treatment.
Jedrzej Litwiniuk
Jedrzej (Jed) Litwiniuk is the co-founder and CEO of Auxilius Pharma, a Boston- and New York-based pharmaceutical company built on the idea that the next breakthrough heart drug might already exist - it just needs to be reformulated. A corporate-finance and investment hand who crossed from PZU and LUX MED deal tables into the lab, he is steering AUX-001, a once-daily reformulation of nicorandil aimed at becoming the first new oral therapy for chronic stable angina in the US since 2006. In December 2025 the company closed a $4 million Series A to push the candidate through pharmaceutical optimization and a Phase Ib trial.