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Eravacycline /kg

Phase 2

Complicated Intra-abdominal Infections (cIAI) | Small molecule | Other |Innoviva, Inc.|Last Updated: May 5, 2026

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06794541A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)PHASE2 RECRUITING 35 — — May 22, 2025Mar 19, 2029May 5, 20265 United States
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Study Endpoints
Primary Endpoints
Proportion of patients with Adverse Events (AEs) from the first dose of any amount of eravacycline
28 days
Change from baseline values over time in electrocardiogram (ECG) QT measurements
Day 28
Change from baseline values over time in diastolic blood pressure
Day 28
Change from baseline values over time in systolic blood pressure
Day 28
Change from baseline values over time in liver function tests assessed by Comprehensive Metabolic Panel (CMP)
Day 28
Change from baseline values over time of hemoglobin
Day 28
Change from baseline values over time in white blood count
Day 28
Change from baseline values over time in platelets
Day 28
Change from baseline values over time in kidney function assessed by CMP
Day 28
Secondary Endpoints
Steady state area under the curve (AUC (0-24)) of eravacycline
Dose cycle 4
Steady state maximum concentration (Cmax) of eravacycline
Dose cycle 4
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALEravacycline intravenous (IV) will be administered every 12 hours for participants 12 to \<18 years of age
Cohort 2aEXPERIMENTALEravacycline IV will be administered every 12 hours for participants 10 to \<12 years of age
Cohort 2bEXPERIMENTALEravacycline IV will be administered every 12 hours for participants aged 8 to \<10 years of age
Interventions
NameTypeDescription
IV Eravacycline 2mg/kgDRUGinfused over a 60-minute period
IV Eravacycline 1.5mg/kgDRUGinfused over a 60-minute period
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Eligibility Criteria
Age Range8 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Children from 8 to \<18 years of age (as of the day of the informed consent \[and assent, if applicable\] is obtained), hospitalized for cIAI with one of the following diagnoses: 1. Intra-abdominal abscess (including hepatic and splenic abscesses). 2. Gastric or intest...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06794541primaryCompletionDate: changed
LOWMay 24, 2026NCT06794541studyFirstPostDate: changed