NDAINTRAVENOUSPOWDERPriority Review
Approved
Jun 2014
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
12
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 33m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SIVEXTRO (tedizolid phosphate) is an IV oxazolidinone antibiotic approved by the FDA in June 2014 for treating acute bacterial skin and skin structure infections (ABSSSI). It is a next-generation linezolid analog that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. The drug addresses resistant gram-positive pathogens including MRSA and VRE.
Peak4.2 years to LOE
Product is at peak commercial maturity with high competitive pressure (8/10), indicating stable but intense market dynamics requiring sophisticated positioning and cross-functional excellence.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044)
Started Jul 2024
18 enrolled
Healthy
A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)
Started Mar 2022
36 enrolled
Healthy
A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)
Started Feb 2019
47 enrolled
Gram-Positive Infections
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)
Started Jan 2019
100 enrolled
Acute Bacterial Skin and Skin Structure Infections
Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study
Started Dec 2016
108 enrolled
Skin Disease, Infectious
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.