nicorandil extended release (AUX-001) / Auxilius Pharma - LARVOL DELTA

Cardiac Electrophysiologic Response to Single-dose AUX-001, a Once-Daily Extended-Release Nicorandil in Development for Chronic-stable Angina in Adult Healthy Volunteers under Fasting and Fed Conditions (AHA 2024) - "Findings highlight no relevant AUX-001 effect on electrophysiological safety providing additional safety information supporting development of ER NIC. Findings also confirm previous healthy volunteer trials with IR NIC highlighting no tendency promoting arrhythmia in normal, non-ischemic myocardium."

Clinical • Cardiovascular

Safety, tolerability, and basic pharmacokinetic parameters of AUX-001, a once-daily extended release nicorandil in healthy volunteers under fasting and fed conditions (ESC 2024) - "AUX-001 was safe and well tolerated. Initial vasodilator-induced headaches were manageable by using simple OTC NSAIDs and led to no dropouts. No patients discontinued due to AEs or tolerability issues."

Clinical • PK/PD data • Cardiovascular • Hypotension

Pharmacokinetics of AUX-001 40mg Once-daily in Healthy Subjects Under Fasting and Fed Conditions (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Auxilius Pharma sp.z.o.o.

New P1 trial • Cardiovascular