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BCX4208

Phase 2

Gout | Small molecule | Metabolic |BioCryst Pharmaceuticals, Inc.|Last Updated: Jan 23, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

BCX4208 · 1 trial · 1 indication

Phase 2 1
NCT00985127Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With GoutGout
COMPLETED99 Analytics
PHASE2COMPLETED
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
Gout
NCT0098512799
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Study Endpoints

Primary Endpoints

To determine the effect of different doses of orally administered BCX4208 on serum uric acid (sUA)levels in subjects with gout.
Day 22
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
40 mgEXPERIMENTAL40 mg BCX4208
80 mgEXPERIMENTALBCX4208
120 mgEXPERIMENTALBCX4208
sugar pillPLACEBO_COMPARATOR -
160mgEXPERIMENTALBCX4208
240mgEXPERIMENTALBCX4208
320mgEXPERIMENTALBCX4208

Interventions

NameTypeDescription
placeboDRUGadministered daily for 21 days
BCX4208DRUGAdministered daily for 21 days.
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Eligibility Criteria

Age Range18 Years to 69 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: 1. Age ≥18 to \<70 years 2. Have read and signed the ICF after the nature of the study has been fully explained 3. Screening sUA ≥8.0 mg/dL 4. Diagnosis of gout according to the preliminary criteria of the American Rheumatism Association (1977) 5. Female participants must meet a...

Countries:United States
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Competitive Landscape -Gout 5 trials

CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN1PHASE3Pegloticase, Methotrexate
Protalix BioTherapeutics, Inc. (DE)PLX1PHASE2PRX-115, Methotrexate
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE1NNC4004-0002
TJ Biopharma Co., Ltd.IMAB1PHASE2Plonmarlimab, Compound betamethasone
Sunshine Biopharma IncorporatedSBFM1PHASE1Pegylated Recombinant Candida Utilis Uricase
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Frequently asked questions about BCX4208

What is BCX4208 used for?

BCX4208 is an investigational small molecule being developed for the treatment of gout. It is designed to lower urate levels in the blood, which is a key factor in managing this condition. The drug is currently in clinical development and has not been approved for use.

Who makes BCX4208?

BCX4208 is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCRX. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of gout.

What phase is BCX4208 in?

BCX4208 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not been approved by regulatory authorities for any use.

What clinical trials is BCX4208 in?

BCX4208 has one completed clinical trial registered under NCT00985127, titled "Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout." This Phase 2 study enrolled 99 participants in the United States and was placebo-controlled.

How does BCX4208 work?

BCX4208 is a small molecule designed to lower urate levels in the body, which is the underlying cause of gout. By reducing urate, it aims to prevent the formation of uric acid crystals that lead to painful joint inflammation. The specific molecular target of BCX4208 has not been disclosed.