# 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.

- **Founded:** 2019
- **Headquarters:** Boston, Massachusetts, United States (operations also in Warsaw, Poland)
- **Founders:** Jed Litwiniuk (Co-Founder & Chief Executive Officer (MHA)), Uwe Tigör (Co-Founder & Chief Medical Officer (MD))
- **Team size:** ~7 employees
- **Products:** AUX-001
- **Notable:** Revived AUX-001, a cardiovascular asset discontinued by Roche, into an active clinical program, Positive Phase Ia safety profile announced March 2024, Secured FDA agreement to pursue a 505(b)(2) NDA, eliminating the need for Phase II trials

## Products & services

- **AUX-001** — An oral, extended-release, once-daily formulation of nicorandil for chronic stable angina pectoris. Originally developed by Chugai Pharmaceutical and later acquired and discontinued by Roche, the asset was revived by Auxilius. A Phase I pharmacokinetic study showed a once-daily profile with a half-life exceeding nine hours and improved safety/tolerability versus immediate-release nicorandil, with no risk of drug tolerance. Being advanced via the FDA 505(b)(2) NDA pathway and positioned to address both macrovascular and microvascular angina while reducing hospitalizations.

## Achievements

- Revived AUX-001, a cardiovascular asset discontinued by Roche, into an active clinical program
- Positive Phase Ia safety profile announced March 2024
- Secured FDA agreement to pursue a 505(b)(2) NDA, eliminating the need for Phase II trials
- Demonstrated a once-daily PK profile with a half-life exceeding nine hours
- Raised $1M seed (2023) and $4M Series A (Dec 2025) for clinical advancement

## Latest updates

- **2025-12** — Closed a $4 million Series A financing to fund pharmaceutical optimization and a Phase Ib clinical trial for AUX-001.
- **2024-03** — Announced positive Phase Ia safety results for AUX-001 and detailed plans for a bioequivalence Phase Ib study and a 12-week, ~250-patient Phase III trial.

## Links

- Website: https://auxiliuspharma.com
- LinkedIn: https://www.linkedin.com/company/auxilius-pharma

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Last updated: 2026-06-16