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Buloxibutid

Phase 2

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

Buloxibutid development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2024

Buloxibutid target and mechanism

Molecular targetAT2R
ModalitySmall molecule

Also known as C21, Compound 21

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment378

FDA Designations

ORPHAN_DRUGFAST_TRACK

Buloxibutid clinical trials

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 in Idiopathic Pulmonary Fibrosis?

Buloxibutid is an investigational small molecule being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a chronic and progressive lung disease. It is currently in Phase 2 clinical development and has not yet been approved by regulatory authorities. The drug is being studied to evaluate its efficacy and safety in people with IPF.

What does Buloxibutid target?

Buloxibutid targets the angiotensin II type 2 receptor (AT2R). By acting on this receptor, the drug is intended to modulate pathways relevant to fibrosis in Idiopathic Pulmonary Fibrosis. The specific mechanism of action is under investigation in clinical trials.

Who makes Buloxibutid?

Buloxibutid is being developed by Vicore Pharma Holding AB, a biopharmaceutical company. The company's American Depositary Shares trade under the ticker symbol VCRE. Vicore Pharma is conducting clinical trials to evaluate the drug's potential in treating Idiopathic Pulmonary Fibrosis.

What phase is Buloxibutid in?

Buloxibutid is currently in Phase 2 clinical development for Idiopathic Pulmonary Fibrosis. It is an investigational drug and has not received regulatory approval. The drug has been granted Orphan Drug and Fast Track designations by the FDA, reflecting its potential to address an unmet medical need.

What clinical trials is Buloxibutid in?

Buloxibutid is being evaluated in a Phase 2 clinical trial with the identifier NCT06588686. This randomized, double-blind, placebo-controlled study is assessing the efficacy and safety of the drug in people with Idiopathic Pulmonary Fibrosis. The trial is active but not recruiting, with an enrollment target of 378 participants across multiple countries.

Is Buloxibutid FDA approved?

No, Buloxibutid is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for Idiopathic Pulmonary Fibrosis. The FDA has granted it Orphan Drug and Fast Track designations, which are intended to expedite development and review of therapies for serious conditions with unmet needs.