Phuturdex › Drugs › Nicorandil
Drugs in development · updated 11 November 2026
Nicorandil: clinical trials and development status
As of 11 November 2026 Nicorandil is in 4 active clinical trials (recruiting or ongoing, phases I–III) for 6 diseases. The most advanced phase is III.
Authorisation
- EU no (EMA)
- Italy not in the AIFA register
- Germany not available
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
A niacinamide derivative, a plasma membrane adenosine triphosphate (ATP)-sensitive potassium (K+) (KATP) channel activator and a nitric oxide (NO) donor, with vasodilatory, antihypertensive and potential cardio- and lung-protective activities. Upon administration, nicorandil binds to and opens KATP channels, which causes relaxation of vascular smooth muscles, stimulates vasodilatation, reduces vasoresistance, decreases blood pressure and protects the myocardium against ischemia. In addition, nicorandil exerts nitrate-like properties, through the stimulation of guanylate cyclase, the downregulation of Rho-kinase activity and the further promotion of venous vasodilation. Although the mechanism of action has not been fully elucidated, nicorandil may exhibit protective activity against radiation-induced lung and heart toxicity, possibly by preventing both accumulation of reactive oxygen species (ROS) and ROS-induced cellular damage.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Rheumatoid arthritis | III | 2 | NCT07800351 |
| Atherosclerosis | III | 1 | NCT07800351 |
| Autoimmune disease | II–III | 1 | NCT07730723 |
| Inflammation | II–III | 1 | NCT07730723 |
| Cardiomyopathies | II | 1 | NCT07897409 |
| Cardiotoxicity | II | 1 | NCT07897409 |
Everything on Nicorandil
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 11 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.