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Selnoflast

Phase 2

Atherosclerosis | Small molecule | Cardiovascular |Roche Holding AG|Last Updated: Sep 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment162

FDA Designations

No designations recorded

Clinical trial landscape

Selnoflast · 1 trial · 1 indication

Phase 2 1
NCT07448038A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac EventsAtherosclerosis
RECRUITING162 Analytics
PHASE2RECRUITING
A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events
AtherosclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in mdsTBR (Most-diseased Segment TBR [Target-to-background Ratio]) of Index Vessel From Baseline to Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 milligrams per liter [mg/L])
Baseline up to Week 12

hsCRP=high-sensitivity C-reactive protein.

Secondary Endpoints

Change From Baseline in mdsTBR of Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2mg/L)
Baseline and Week 12
Change From Baseline in mdsTBR of Carotids at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L)
Baseline and Week 12
Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L)
Baseline and Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SelnoflastEXPERIMENTALParticipants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo, PO, BID for 12 weeks.

Interventions

NameTypeDescription
SelnoflastDRUGSelnoflast will be administered as per the schedule specified in the respective arm.
PlaceboDRUGPlacebo will be administered as per the schedule specified in the respective arm.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Confirmed evidence of atherosclerosis * Left or right carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0 on centrally-assessed 18F-fluorodeoxyglucose-Positron Emission Tomography (18F-FDG-PET) scan * Stable treatment of atherosclerosis through the use of SOC medications or revascularization...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07448038lastUpdatePostDate: changed
LOWSep 3, 2026NCT07448038lastUpdatePostDate: changed
LOWJul 31, 2026NCT07448038lastUpdatePostDate: changed
LOWJul 31, 2026NCT07448038lastUpdatePostDate: changed

Frequently asked questions about Selnoflast

What is Selnoflast used for?

Selnoflast is an investigational small molecule being developed for the treatment of atherosclerosis, a cardiovascular condition characterized by the buildup of plaque in the arteries. It is intended for use in patients with atherosclerosis who are at risk for major adverse cardiac events, as part of a Phase 2 clinical trial.

Who makes Selnoflast?

Selnoflast is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is currently conducting a Phase 2 clinical trial to evaluate the drug's efficacy and safety in patients with atherosclerosis.

What phase is Selnoflast in?

Selnoflast is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to study its effects in reducing vascular inflammation in atherosclerosis.

What clinical trials is Selnoflast in?

Selnoflast is being studied in a single Phase 2 clinical trial with the identifier NCT07448038. This randomized, double-blind, placebo-controlled trial is recruiting 162 participants in the United States and Canada to evaluate the drug's efficacy, safety, pharmacodynamics, and pharmacokinetics in reducing vascular inflammation in atherosclerosis.

How does Selnoflast work?

Selnoflast is a small molecule designed to reduce vascular inflammation in patients with atherosclerosis. The exact molecular target of Selnoflast has not been disclosed in the available information, so its specific mechanism of action is not detailed here.