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TD-1792

Phase 2

Staphylococcal Skin Infection | Small molecule | Dermatology |Theravance Biopharma, Inc.|Last Updated: Jan 20, 2021

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 Enrollment203
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00442832TD-1792 in Gram-positive Complicated Skin and Skin Structure InfectionPHASE2 COMPLETED 203Dec 1, 2006May 1, 2007Jan 20, 20211 United States
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Study Endpoints
Primary Endpoints
Clinical response
7 to 14 days after last antibiotic dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TD-1792EXPERIMENTAL -
VancomycinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
TD-1792DRUGTD-1792 2 mg/kg/day IV
VancomycinDRUGVancomycin 1 Gm IV q 12 hrs
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections * requires at least 7 days of intravenous antibiotic treatment Exclusion Criteria: * more than 24 hours of antibiotic therapy * moderate or sever...

Countries:United States
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