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RO7486967

Phase 2

Parkinson Disease | Small molecule | Neurology |Roche Holding AG|Trials Updated: Sep 29, 2026

RO7486967 development status

Highest phase Phase 2 (NCT07448038)
Phase scored for RHHBYPhase 1
Registered trials 2 across 2 sponsors since Jun 2023

RO7486967 target and mechanism

ModalitySmall molecule

Also known as Selnoflast

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment222

FDA Designations

No designations recorded

RO7486967 clinical trials

RO7486967 · 2 trials · 2 indications

Phase 2 1Phase 1 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.

Percentage of Participants with adverse events (AEs)
Up to 45 Days
The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline
From Baseline to Up to 45 Days

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.
RO7486967 ArmEXPERIMENTALParticipants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose.

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.
RO7486967DRUGFor up to approximately 28 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

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 StatesCanadaNetherlandsUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 29, 2026NCT07448038lastUpdatePostDate: changed
LOWSep 29, 2026NCT07448038lastUpdatePostDate: changed
LOWSep 3, 2026NCT07448038lastUpdatePostDate: changed
LOWSep 3, 2026NCT07448038lastUpdatePostDate: changed
LOWJul 31, 2026NCT07448038lastUpdatePostDate: changed
LOWJul 31, 2026NCT07448038lastUpdatePostDate: changed

Frequently asked questions about RO7486967

What is RO7486967?

RO7486967 is an investigational small molecule drug being developed by Roche Holding AG for Parkinson disease. It is in Phase 1 clinical development and has been studied in a single completed trial in participants with early idiopathic Parkinson's disease. It is not an approved therapy.

What is RO7486967 used for in Parkinson disease?

RO7486967 is being studied for the treatment of early idiopathic Parkinson's disease. The Phase 1 trial enrolled participants aged 40 years and older with that condition, and it was biomarker selected, meaning enrollment was tied to a biomarker. It is investigational and has not been approved for any use.

Who makes RO7486967?

RO7486967 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program studying the compound in Parkinson disease.

What phase is RO7486967 in?

RO7486967 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and is not approved by the FDA for Parkinson disease or any other indication.

What clinical trials is RO7486967 in?

RO7486967 has been evaluated in one Phase 1 trial, NCT05924243, titled a study of its safety, tolerability, pharmacokinetics and pharmacodynamics in participants with early idiopathic Parkinson's disease. The trial enrolled 60 participants across the United States, Netherlands and United Kingdom, was randomized, double blind and placebo controlled, and is completed.

How does RO7486967 work?

RO7486967 is a small molecule developed for Parkinson disease, and the Phase 1 trial NCT05924243 assessed its pharmacokinetics and pharmacodynamics in participants with early idiopathic Parkinson's disease. The study was biomarker selected, indicating a biomarker-guided approach to the trial population.