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Loxoprofen

Phase 3

Pain | Small molecule | Pain |Co-Diagnostics, Inc.|Last Updated: Jul 20, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02831569Japanese IP-TN TrialPHASE3 COMPLETED 80Jul 27, 2016Oct 19, 2016Jul 20, 20183 Japan
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Study Endpoints
Primary Endpoints
Percentage of Patients With Drug-related Adverse Events [AEs]
Up to 3 weeks.

The outcome measure presents percentage of patients with drug-related AEs.

Secondary Endpoints
Assessment of Pain Due to Low Back Pain, Scapulohumeral Periarthritis or Cervico-omo-brachial Syndrome After 2 Weeks of Treatment
Post 2 weeks.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Loxoprofen sodium/methocarbamol FDCEXPERIMENTALfixed dose combination (FDC) tablets
Interventions
NameTypeDescription
Loxoprofen sodiumDRUG -
MethocarbamolDRUG -
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Eligibility Criteria
Age Range15 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: * Male or female outpatients aged \>=15 years at the time of giving consent. * Patients diagnosed with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome prior to giving consent. Patients with cervico-omo-brachial syndrome must have the associated symp...

Countries:Japan
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