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Ataciguat

Phase 2

Moderate Aortic Valve Stenosis | Small molecule | Cardiovascular |Kardigan, Inc.|Trials Updated: Jul 6, 2026

Ataciguat development status

Highest phase Phase 2
Registered trials 2 across 2 sponsors since Jun 2025

Ataciguat target and mechanism

Molecular targetGUCY1B1, GUCY1A2, GUCY1A1
Target classActivator
ModalitySmall molecule
ChEMBLCHEMBL2107729

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,276

FDA Designations

No designations recorded

Ataciguat clinical trials

Ataciguat · 1 trial · 1 indication

Phase 2 1
NCT07001800Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled StudyModerate Aortic Valve Stenosis
RECRUITING1,276 Analytics
PHASE2RECRUITING
Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
Moderate Aortic Valve Stenosis
NCT070018001,276
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Study Endpoints

Primary Endpoints

(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24
Week 24
(Part B Dual-Primary) Percent change in Aortic Valve Area (AVA) as measured by echocardiogram from baseline to Week 48
Week 48
(Part B Dual-Primary) Change in peak VO2 by CPET from baseline to Week 48
Week 48

Secondary Endpoints

(Part A) Correlation in the change in AVC as assessed by non-contrast CT and change in VO2 at Week 48
Week 48
(Part A) Change in VO2 from baseline to Week 48
Week 48
Change in left ventricular diastolic function as assessed by E/e' from baseline to Week 48
Week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AtaciguatEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AtaciguatDRUGAtaciguat will be administrated daily for up to 156 weeks
PlaceboDRUGPlacebo will be administrated daily for up to 156 weeks
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites74

Key Inclusion Criteria: 1. Adult male or female at least 50 years of age 2. Has moderate CAVS as defined by: 1. An AVA of ≥1.0 cm2 to ≤1.50 cm2 2. An AVC score between \>300 to 1200 Agatston units (AU) for women and between \>300 to 2000 AU for men 3. Has a left ventricular ejection fraction...

Countries:United StatesCanada
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Other drugs targeting GUCY1B1

Praliciguat AKBA· PHASE2 Riociguat BAYRY· PHASE3 Riociguat immediate release of BAYRY· PHASE1 runcaciguat BAYRY· PHASE2 Vericiguat BAYRY· PHASE2 olinciguat CYCN· PHASE1 Riociguat MRK· PHASE3 Vericiguat MRK· PHASE3 Nitric Oxide XAIR· PHASE3

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