NUZYRA (omadacycline tosylate)
NUZYRA is indicated for the treatment of Community-Acquired Bacterial Pneumonia; Acute Bacterial Skin and Skin Structure Infections.
How NUZYRA Works
Omadacycline is a protein synthesis inhibitor. It exerts its antibacterial effect by binding to the 30S ribosomal subunit of susceptible bacteria, thereby blocking the binding of aminoacyl-tRNA to the mRNA-ribosome complex. This prevents the addition of amino acids to the growing peptide chain, halting bacterial protein synthesis. It is designed to overcome the two main mechanisms of tetracycline resistance: ribosomal protection and efflux pumps.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-10-02
- Patent Cliff
- 2037
- Routes
- INTRAVENOUS, ORAL
- Dosage Forms
- POWDER, TABLET
NUZYRA Approval History
What NUZYRA Treats
2 indicationsNUZYRA is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Community-Acquired Bacterial Pneumonia
- Acute Bacterial Skin and Skin Structure Infections
NUZYRA 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 NUZYRA
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04779242 results posted | PTK0796-CABP-19302 | Ph 3 | completed | Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia |
| NCT06030219 | G0505124 | Ph 1 | completed | Microbiome Effect of Omadacycline on Healthy Volunteers |
| NCT06162286 public | ZL-2401-004 | Ph 3 | recruiting | A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP |
| NCT04160260 results posted | PTK0796-CABPPO-19109 | Ph 1 | completed | Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia |
| NCT04144374 | HHC-2019-0220 | Ph 1 | completed | Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis |
| NCT03757234 results posted | PTK0796-AP-17202 | Ph 2 | completed | IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis |
| NCT02378480 results posted | PTK0796-ABSI-1108 | Ph 3 | completed | Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23) |
| NCT02531438 results posted | PTK0796-CABP-1200 | Ph 3 | completed | Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13) |
| NCT02877927 results posted | PTK0796-ABSI-16301 | Ph 3 | completed | Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI |
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.
NUZYRA FDA Label Details
Indications & Usage
FDA Label (PDF)NUZYRA is indicated for the treatment of Community-Acquired Bacterial Pneumonia; Acute Bacterial Skin and Skin Structure Infections.
NUZYRA Patents & Exclusivity
Patents (8 active)
Exclusivity
Pro Intelligence Preview
Deep insights for NUZYRA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 13 active patents
Trial Analysis
- • 10 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