Recent Updates
Recently added Catalysts

TR-701 FA

Phase 3

Skin and Subcutaneous Tissue Bacterial Infections | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Aug 29, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,333
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01421511TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure InfectionsPHASE3 COMPLETED 666 — — Sep 15, 2011Jan 10, 2013Aug 29, 2018117 United States, Argentina +9
NCT01170221TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.PHASE3 COMPLETED 667 — — Aug 15, 2010Sep 30, 2011Aug 29, 201884 United States, Argentina +9
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The Early Clinical Response Rate
48-72 hours

Responder: No increase in lesion surface area from baseline.

Early Clinical Response Rate
48-72 hours

Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

Secondary Endpoints
Clinical Response at the End of Therapy Visit
Day 11
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set
End of Therapy Day 11
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
Post-Treatment Evaluation (7-14 days after the End of Therapy)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TR-701 FAEXPERIMENTAL• TR-701 FA IV followed by TR-701 FA tablets
LinezolidACTIVE_COMPARATOR• Linezolid IV followed by Linezolid Tablets
Interventions
NameTypeDescription
TR-701 FADRUG* TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion * TR-701 FA Tablets, 200 mg, orally once daily
LinezolidDRUG* Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion * Linezolid Tablets, 600 mg, orally every 12 hours
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites117

Inclusion Criteria: * Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI. * Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections Exclusion Criteria: * Uncomplicated skin infections * Severe sepsis or septic shock * AB...

Countries:United StatesArgentinaAustraliaBrazilGermanyMexicoNew ZealandPolandRussiaSouth AfricaSpainCanadaCzechiaHungaryLatviaPeruSlovakiaUkraine
Unlock Eligibility Criteria