In short
Ataciguat is an investigational substance being studied for moderate calcific aortic valve stenosis (CAVS). One Phase 3 trial, KATALYST-AV (NCT07001800), is authorised and plans to enroll 1276 participants. The trial measures whether ataciguat can slow the loss of aortic valve area and improve exercise capacity.
Key points
- Ataciguat is an investigational substance with no marketing authorisation in these records.
- It is being studied in moderate calcific aortic valve stenosis (CAVS).
- The KATALYST-AV trial is a Phase 3 study with an authorised status.
- 1276 participants are planned for enrollment.
- The trial compares ataciguat 200 mg taken orally against a placebo.
- Main outcomes include change in aortic valve area (AVA) and peak VO2 at Week 48.
What is ataciguat?
Ataciguat is an investigational substance being studied in clinical trials. It has no marketing authorisation in the registry records, meaning it is not yet approved as a medicine. The substance is given by oral use in the clinical trial setting. No other names or development codes for ataciguat are listed in the available data.
How does ataciguat work?
The available trial data do not describe the mechanism of action of ataciguat. The registry record does not state the molecular target or the pharmacological class of the substance. Without supplementary sources, the way ataciguat acts in the body cannot be described here.
Which conditions is ataciguat studied for?
- Moderate calcific aortic valve stenosis (CAVS) — a condition in which the aortic valve narrows and hardens due to calcium build-up, making it harder for the heart to pump blood to the body.
This is the only condition listed for ataciguat in the available trial record.
How is ataciguat given?
In the KATALYST-AV trial, ataciguat is given as a 200 mg dose by oral use. The trial also includes a placebo arm for comparison. No other pharmaceutical forms or routes of administration are reported in the available data.
What do the clinical trials show?
One clinical trial of ataciguat is listed in the registry: the KATALYST-AV study (NCT07001800). It is a Phase 3, interventional trial with an authorised status, planning to enroll 1276 participants. The trial investigates ataciguat 200 mg taken orally compared with a placebo in people with moderate calcific aortic valve stenosis.
The study has two primary outcomes. The first is the percent change in aortic valve area (AVA), measured by echocardiogram, from baseline to Week 48. The second is the change in peak VO2, assessed by cardiopulmonary exercise testing (CPET), from baseline to Week 48. The aim of the trial is to determine whether ataciguat slows the rate of AVA loss and to evaluate its effect on peak VO2.
What side effects are known?
The available trial record does not report side effects for ataciguat. No supplementary sources were provided, so no information on known side effects can be given here.