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TR-701 FA
TR-701 FA is a Oxazolidinone antibiotic Small molecule drug developed by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). It is currently in Phase 3 development for Acute bacterial skin and skin structure infections (ABSSSI), Community-acquired bacterial pneumonia (CABP). Also known as: Tedizolid Phosphate, TR-700 active moiety, Tedizolid.
TR-701 FA is a prodrug of TR-700 that inhibits bacterial protein synthesis by binding to the bacterial ribosome.
TR-701 FA is a prodrug of TR-700 that inhibits bacterial protein synthesis by binding to the bacterial ribosome. Used for Acute bacterial skin and skin structure infections (ABSSSI), Community-acquired bacterial pneumonia (CABP).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | TR-701 FA |
|---|---|
| Also known as | Tedizolid Phosphate, TR-700 active moiety, Tedizolid |
| Sponsor | Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
| Drug class | Oxazolidinone antibiotic |
| Target | Bacterial 70S ribosome |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
TR-701 FA (tedizolid phosphate) is rapidly converted to TR-700 (tedizolid) in vivo. TR-700 is an oxazolidinone antibiotic that binds to the bacterial 70S ribosome and inhibits protein synthesis, making it effective against gram-positive bacteria including multidrug-resistant pathogens. It has enhanced potency and improved pharmacokinetics compared to linezolid, the parent oxazolidinone class drug.
Approved indications
- Acute bacterial skin and skin structure infections (ABSSSI)
- Community-acquired bacterial pneumonia (CABP)
Common side effects
- Nausea
- Headache
- Diarrhea
- Vomiting
- Peripheral neuropathy
Key clinical trials
- A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018) (PHASE3)
- A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043) (PHASE1)
- A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013) (PHASE1)
- Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg (PHASE1)
- Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002) (PHASE3)
- Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients (PHASE1)
- A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects (PHASE1)
- A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TR-701 FA CI brief — competitive landscape report
- TR-701 FA updates RSS · CI watch RSS
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) portfolio CI
Frequently asked questions about TR-701 FA
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Related
- Drug class: All Oxazolidinone antibiotic drugs
- Target: All drugs targeting Bacterial 70S ribosome
- Manufacturer: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Acute bacterial skin and skin structure infections (ABSSSI)
- Indication: Drugs for Community-acquired bacterial pneumonia (CABP)
- Also known as: Tedizolid Phosphate, TR-700 active moiety, Tedizolid