Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TR701 FA · 1 trial · 3 indications
Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).
| Arm | Type | Description |
|---|---|---|
| TR-701 FA | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TR701 FA | DRUG | 1 tablet 200 mg once daily |
Inclusion Criteria: * Male or female patients ≥ 18 years of age * Suspected or documented gram-positive infection from baseline Gram stain or culture. * Cellulitis/erysipelas or major cutaneous abscesses at Screening Exclusion Criteria: * Postsurgical or open wound infections * Severe sepsis or s...
TR-701 FA is an investigational small molecule being studied for bacterial infections, including skin and subcutaneous tissue bacterial infections such as major cutaneous abscess, cellulitis, and erysipelas. It has also been evaluated in healthy volunteers and in subjects with hepatic impairment.
TR-701 FA is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company has sponsored clinical trials of the drug in the United States.
TR-701 FA is in Phase 1 clinical development. It has completed Phase 1 trials, and one Phase 2 trial has also been completed. The drug remains investigational and is not yet approved for any use.
TR-701 FA has completed several clinical trials, including NCT00983255, a Phase 1 ascending dose pharmacokinetic and absolute bioavailability study in bacterial infections; NCT01461460, a thorough QT study in healthy subjects; NCT01496677, a pharmacokinetics, safety, and tolerability study in elderly subjects; and NCT01519778, a Phase 2 safety and exploratory skin lesion measurement study.
Yes, TR-701 FA stands for TR-701 free acid. Clinical trial titles refer to TR-701 free acid (FA), and the drug is identified by the same name across studies. It is an investigational small molecule being studied for bacterial infections.