Recent Updates
Recently added Catalysts

BAY85-8501

Phase 2

Bronchiectasis | Small molecule | Respiratory |Bayer AG|Last Updated: Jul 9, 2015

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

BAY85-8501 · 1 trial · 1 indication

Phase 2 1
NCT01818544Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) BronchiectasisBronchiectasis
COMPLETED94 Analytics
PHASE2COMPLETED
Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis
Bronchiectasis
NCT0181854494
Unlock trial analytics

Study Endpoints

Primary Endpoints

Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination
From start of study treatment up to follow up visit (28 days after last dose)
Change From Baseline in Systolic Blood Pressure At Days 7, 14, 21, 28, 56
Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56
Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56
Baseline (Day 1), Day 7, 14, 21, 28, 56
Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28
Baseline (Day 1), Day 7, 14, 21, 28
Number of Subjects who Show Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TB) Abnormalities in Their Safety Lab Assessment
Baseline (Day 1), Day 7, 14, 21, 28, 56
Number of Subjects With Drug Related Adverse Events as a Measure of Safety And Tolerability
Baseline (Day 1), Day 7, 14, 21, 28, 56

Secondary Endpoints

Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56
Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) at Days 7, 14, 21, 28, 56
Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Pulmonary Function Test Forced Expiratory Flow Over the Middle Half of Subject's Forced Vital Capacity (FVC) (FEF2575) at Days 7, 14, 21, 28, 56
Baseline (Day 1), Day 7, 14, 21, 28, 56
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAY85-8501EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BAY85-8501DRUGBAY85-8501 (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning
PlaceboDRUGPlacebo (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Proven and documented diagnosis of non-CF (cystic fibrosis) idiopathic or post-infectious BE (bronchiectasis) by computed tomography (CT) scan \[conventional high resolution CT is considered the standard\], including 2 or more lobes and dilated airways compatible with BE at in...

Countries:FranceGermanyItalySpainUnited Kingdom
Unlock Eligibility Criteria

Competitive Landscape -Bronchiectasis 8 trials

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN2PHASE2AZD0292
GSK plc Sponsored ADRGSK1PHASE2GSK3862995B
Merck & Co., Inc.MRK1PHASE2Nebulized Ensifentrine
Baxter International Inc.BAX1N/AUndisclosed
Inogen, Inc.INGN1N/AUndisclosed
Unlock Competitive Intelligence

Frequently asked questions about BAY85-8501

What is BAY85-8501 used for?

BAY85-8501 is an investigational small molecule being developed for the treatment of bronchiectasis, a respiratory condition. It is currently in Phase 2 clinical development and has been studied in patients with non-CF (cystic fibrosis) bronchiectasis.

Who makes BAY85-8501?

BAY85-8501 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the over-the-counter market.

What phase is BAY85-8501 in?

BAY85-8501 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial has been completed to evaluate its safety and efficacy in patients with bronchiectasis.

What clinical trials is BAY85-8501 in?

BAY85-8501 has been studied in one completed Phase 2 clinical trial, identified as NCT01818544. This trial evaluated the safety and efficacy of oral BAY85-8501 in patients with non-CF bronchiectasis and enrolled 94 participants across France, Germany, Italy, Spain, and the United Kingdom.

Is BAY85-8501 the same as any other drug?

No alternative names for BAY85-8501 have been reported. It is identified solely by its development code BAY85-8501 in clinical trial registries and scientific literature.