Last reviewed · How we verify
TR701 FA
TR701 FA is a Small molecule drug developed by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). It is currently in Phase 2 development. Also known as: Tedizolid.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | TR701 FA |
|---|---|
| Also known as | Tedizolid |
| Sponsor | Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Nausea
- diarrhea
- cellulitis
- abscess
- vomiting
- dizziness
- headache
- chills
- constipation
- somnolence
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:
- TR701 FA CI brief — competitive landscape report
- TR701 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 TR701 FA
What is TR701 FA?
Who makes TR701 FA?
Is TR701 FA also known as anything else?
What development phase is TR701 FA in?
What are the side effects of TR701 FA?
Related
- Manufacturer: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full pipeline
- Also known as: Tedizolid