Recent Updates
Recently added Catalysts

TR-701

Phase 2

Skin Diseases, Infectious | Small molecule | Dermatology |Merck & Company, Inc.|Trials Updated: Nov 25, 2019

TR-701 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2008

TR-701 target and mechanism

ModalitySmall molecule

Also known as TR-701 (pro-drug)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment192

FDA Designations

No designations recorded

TR-701 clinical trials

TR-701 · 1 trial · 2 indications

Phase 2 1
NCT00761215Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure InfectionsSkin Diseases, Infectious
COMPLETED192 Analytics
PHASE2COMPLETED
Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
Skin Diseases, InfectiousUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
7 to 14 days after the last dose of study drug

Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set
7-14 days after last dose of study drug

Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

Secondary Endpoints

Response Rate at End of Therapy
last day of study treatment
Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set
7-14 days after last dose of study drug
Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set
21 to 28 days after the last study drug
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TR-701 200 mgEXPERIMENTAL -
TR-701 300 mgEXPERIMENTAL -
TR-701 400 mgEXPERIMENTAL -

Interventions

NameTypeDescription
TR-701 200 mgDRUGoral TR-701 200 mg for 5 to 7 days
TR-701 300 mgDRUGoral TR-701 300 mg for 5 to 7 days
TR-701 400 mgDRUGTR-701 400 mg for 5 to 7 days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms * Suspected or confirmed infection due to a gram-positive organism Exclusion Criteria: * Complicated skin and skin structure infection due to gram-negative organisms * Complicated...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about TR-701

What is TR-701 used for?

TR-701 is an investigational small molecule being studied for complicated skin and skin structure infections, including bacterial skin diseases. It is in Phase 2 clinical development and is not approved for commercial use. The development program has focused on infectious skin conditions in adult patients.

Who is developing TR-701?

TR-701 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating TR-701 in infectious skin diseases.

What phase is TR-701 in?

TR-701 is in Phase 2 clinical development. One Phase 2 trial has been completed, and there are currently no active trials listed for the program. TR-701 is investigational and has not been approved by the FDA.

What clinical trials is TR-701 in?

TR-701 has been evaluated in one completed Phase 2 trial, NCT00761215, titled Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections. The randomized, double-blind, controlled study enrolled 192 adults aged 18 years and older in the United States.