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VTX2735

Phase 2

Cryopyrin Associated Periodic Syndrome | Small molecule | Rare Disease |Ventyx Biosciences, Inc.|Trials Updated: Oct 9, 2026

VTX2735 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Apr 2023

VTX2735 target and mechanism

Molecular targetNLRP3
Target classInhibitor
ModalitySmall molecule

Also known as LY5625574

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment57

FDA Designations

No designations recorded

VTX2735 clinical trials

VTX2735 · 2 trials · 2 indications

Phase 2 2
NCT06836232An Open-Label Pilot Study of VTX2735 in Recurrent PericarditisRecurrent Pericarditis
RECRUITING50 Analytics
NCT05812781A Study to Evaluate VTX2735 in Patients With Cryopyrin-associated Periodic SyndromeCryopyrin Associated Periodic Syndrome
COMPLETED7 Analytics
PHASE2RECRUITING
An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
Recurrent PericarditisUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate VTX2735 in Patients With Cryopyrin-associated Periodic Syndrome
Cryopyrin Associated Periodic SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of VTX2735
Day 1 of treatment period through study completion, up to 26 weeks

Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation

Secondary Endpoints

Effect of VTX2735 on pericardial pain
Day 1 of treatment period to Week 6 of treatment period
Effect of VTX2735 on inflammation
Day 1 of treatment period to Week 6 of treatment period
Mean change in the mean key symptom score (KSS) derived from the Daily Health Assessment Form, Second Generation (DHAF2) from baseline
From Day 1 to completion of treatment with VTX2735, up to Day 28
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort AEXPERIMENTAL -
Cohort B Treatment Group B1EXPERIMENTAL -
Cohort B Treatment Group B2EXPERIMENTAL -
Cohort C Treatment Group C1EXPERIMENTAL -
Cohort C Treatment Group C2EXPERIMENTAL -
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -

Interventions

NameTypeDescription
VTX2735DRUGDose A, Daily
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Participants are male or female ≥ 18 years up to ≤ 75 years of age. * Capable of giving signed informed consent and able to comply with the protocol * Previously had an index (first) episode of pericarditis which met the criteria for an acute pericarditis event * Ongoing sympt...

Countries:United StatesBelgiumCanadaGreece
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Recent Changes (Last 90 Days)

LOWOct 9, 2026NCT06836232lastUpdatePostDate: changed
LOWOct 9, 2026NCT06836232lastUpdatePostDate: changed
LOWOct 6, 2026NCT06836232lastUpdatePostDate: changed
LOWOct 6, 2026NCT06836232lastUpdatePostDate: changed
LOWSep 22, 2026NCT06836232lastUpdatePostDate: changed
LOWSep 22, 2026NCT06836232lastUpdatePostDate: changed
LOWSep 9, 2026NCT06836232lastUpdatePostDate: changed
LOWSep 9, 2026NCT06836232lastUpdatePostDate: changed

Frequently asked questions about VTX2735

What is VTX2735?

VTX2735 is an investigational oral small molecule developed by Ventyx Biosciences, Inc. for rare inflammatory diseases. It is being studied in Cryopyrin Associated Periodic Syndrome (CAPS) and recurrent pericarditis. VTX2735 is in Phase 2 clinical development and has not been approved by the FDA.

What is VTX2735 used for in Cryopyrin Associated Periodic Syndrome?

VTX2735 is being evaluated for the treatment of Cryopyrin Associated Periodic Syndrome, a rare autoinflammatory condition. A Phase 2 study of VTX2735 in patients with CAPS has been completed. The drug is investigational and is not approved for CAPS or any other indication.

What does VTX2735 target?

VTX2735 targets NLRP3, a component of the inflammasome, and acts as an NLRP3 inhibitor. By inhibiting NLRP3, the drug is designed to reduce inflammasome-driven inflammation, which is relevant to conditions such as Cryopyrin Associated Periodic Syndrome and recurrent pericarditis.

Who is developing VTX2735?

VTX2735 is being developed by Ventyx Biosciences, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol VTYX. Ventyx is the sponsor of the clinical trials evaluating VTX2735 in Cryopyrin Associated Periodic Syndrome and recurrent pericarditis.

What phase is VTX2735 in?

VTX2735 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Ventyx Biosciences is evaluating VTX2735 in a completed Phase 2 study in Cryopyrin Associated Periodic Syndrome and an ongoing Phase 2 study in recurrent pericarditis.

What clinical trials is VTX2735 in?

VTX2735 has been studied in two Phase 2 trials. NCT05812781 evaluated VTX2735 in patients with Cryopyrin Associated Periodic Syndrome and is completed. NCT06836232 is an open-label pilot study of VTX2735 in recurrent pericarditis that is currently recruiting in the United States, Belgium, Canada, and Greece.