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Nemonoxacin

Phase 2

Pneumonia | Small molecule | Infectious Disease |Co-Diagnostics, Inc.|Last Updated: Jul 1, 2025

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment207
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01944774Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium ChloridePHASE2 COMPLETED 207Mar 1, 2013Dec 1, 2013Jul 1, 20252 China, Taiwan
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Study Endpoints
Primary Endpoints
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.

Secondary Endpoints
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population
Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population
Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population
Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Nemonoxacin 500 mgEXPERIMENTALNemonoxacin 500mg/250mL.
Nemonoxacin 650 mgEXPERIMENTALNemonoxacin 650 mg/325mL
Moxifloxacin 400 mgACTIVE_COMPARATORMoxifloxacin 400mg/250mL
Interventions
NameTypeDescription
Nemonoxacin 500 mgDRUGIV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mgDRUGIV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mgDRUGIV Infusion, once daily for 7\~14 days
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Ages between 18 and 75; 2. Weighs between 40 \~ 100 kg, and BMI ≥ 18 kg/m2; 3. Must have a clinical diagnosis of CAP 4. Chest X-ray and /or CT scan show new or persist/progressive infiltrates 5. Patients with PORT/PSI score II, III or IV. 6. If female, non-lactating and at no...

Countries:ChinaTaiwan
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