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Buloxibutid

Phase 2

Idiopathic Pulmonary Fibrosis (IPF) | Small molecule | Respiratory |Vicore Pharma Holding AB American Depositary Shares|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment378

FDA Designations

No designations recorded

Clinical trial landscape

Buloxibutid · 1 trial · 1 indication

Phase 2 1
NCT06588686A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.Idiopathic Pulmonary Fibrosis (IPF)
ACTIVE NOT_RECRUITING378 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)Unlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the efficacy of buloxibutid compared to placebo in participants with IPF as assessed by FVC
week 52

• Absolute change from baseline in FVC (mL) at week 52

Secondary Endpoints

To further evaluate the effects of buloxibutid on disease progression, respiratory-related hospitalization or death compared to placebo in participants with IPF
week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Buloxibutid 100 mg BIDEXPERIMENTALFor 52 weeks.
Buloxibutid 50 mg BIDEXPERIMENTALFor 52 weeks.
Placebo BIDPLACEBO_COMPARATORFor 52 weeks.

Interventions

NameTypeDescription
BuloxibutidDRUGBuloxibutid
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites104

Inclusion Criteria 1. Age ≥ 40 years at the time of signing the informed consent. 2. Diagnosed with IPF within 7 years prior to visit 1, as per applicable ATS/ERS/JRS/ALAT guidelines at the time of diagnosis. 3. HRCT scan within 36 months prior to visit 1 with central reading confirming either a or...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaGermanyGreeceItalyMexicoPolandSouth KoreaTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 17, 2026NCT06588686lastUpdatePostDate: changed
LOWAug 17, 2026NCT06588686lastUpdatePostDate: changed

Frequently asked questions about Buloxibutid

What is Buloxibutid used for?

Buloxibutid is an investigational small molecule being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a progressive lung disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Buloxibutid?

Buloxibutid is being developed by Vicore Pharma Holding AB, a biopharmaceutical company listed on the stock exchange under the ticker VCRE. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with Idiopathic Pulmonary Fibrosis.

What phase is Buloxibutid in?

Buloxibutid is in Phase 2 clinical development. It is currently being evaluated in an active, not recruiting clinical trial (NCT06588686) that is randomized, double-blind, and placebo-controlled, with an enrollment of 378 participants.

What clinical trials is Buloxibutid in?

Buloxibutid is being studied in a Phase 2 clinical trial with the identifier NCT06588686. This trial is evaluating the efficacy and safety of Buloxibutid in people with Idiopathic Pulmonary Fibrosis. The study is active but not recruiting participants and includes 378 patients across multiple countries.

Is Buloxibutid FDA approved?

Buloxibutid is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for Idiopathic Pulmonary Fibrosis. The drug has not yet completed the clinical development process required for regulatory approval.