SIVEXTRO (tedizolid phosphate)
SIVEXTRO is indicated for the treatment of Acute Bacterial Skin and Skin Structure Infections.
How SIVEXTRO Works
Tedizolid phosphate is a prodrug converted by phosphatases to tedizolid, the active moiety. Tedizolid exerts its antibacterial activity by binding to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome. This action inhibits bacterial protein synthesis by preventing the formation of the 70S initiation complex, which is essential for the translation process.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-06-20
- Patent Cliff
- 2030
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- TABLET, POWDER
SIVEXTRO Approval History
What SIVEXTRO Treats
1 indicationsSIVEXTRO is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Bacterial Skin and Skin Structure Infections
SIVEXTRO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SIVEXTRO
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03176134 results posted | 1986-018 MK-1986-018, 2016-003884-20 | Ph 3 | completed | 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) |
| NCT02019420 results posted | 1986-002 TR701-132, 2013-004154-22 | Ph 3 | completed | Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002) |
| NCT02342418 results posted | 14-019 | Ph 4 | completed | Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults |
| NCT02477514 | 1986-004 TR701-133 | Ph 1 | completed | A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SIVEXTRO FDA Label Details
Indications & Usage
FDA Label (PDF)SIVEXTRO is indicated for the treatment of Acute Bacterial Skin and Skin Structure Infections.
SIVEXTRO Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SIVEXTRO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 14 active patents
Trial Analysis
- • 4 total trials
- • Stage: Declining
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment