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Omadacycline

Phase 3

Community-acquired Bacterial Pneumonia | Small molecule | Infectious Disease |Zai Lab Limited|Last Updated: Jun 14, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06162286A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABPPHASE3 RECRUITING 100Nov 17, 2023Nov 30, 2025Jun 14, 202440 China
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Study Endpoints
Primary Endpoints
Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.
18 months
Secondary Endpoints
Clinical response rate at the Early Clinical Response (ECR) assessment (72 to 120 hours after administration of the first dose of test article) in the mITT population.
72 to 120 hours
Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population.
18 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MoxifloxacinACTIVE_COMPARATORMoxifloxacin IV/PO
OmadacyclineEXPERIMENTALOmadacycline IV/PO
Interventions
NameTypeDescription
OmadacyclineDRUGOmadacycline IV/PO
MoxifloxacinDRUGMoxifloxacin IV/PO
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: 1. Written and signed informed consent obtained before any protocol specific assessment is performed. 2. Male or female, ages 18 years or older. 3. Has at least 3 of the following symptoms: * Cough * Production of purulent sputum * Dyspnea (shortness of breath) * Ch...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06162286primaryCompletionDate: changed
LOWMay 24, 2026NCT06162286studyFirstPostDate: changed