KIMYRSA (oritavancin diphosphate) · MELINTA THERAP
Kimyrsa (oritavancin) is a lipoglycopeptide antibacterial indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms. Its spectrum of activity includes *Staphylococcus aureus* (including methicillin-susceptible and methicillin-resistant/MRSA isolates), *Streptococcus pyogenes*, *Streptococcus agalactiae*, *Streptococcus dysgalactiae*, *Streptococcus anginosus* group (*S. anginosus*, *S. intermedius*, *S. constellatus*), and vancomycin-susceptible isolates of *Enterococcus faecalis*. To maintain effectiveness and reduce the development of drug-resistant bacteria, Kimyrsa should be reserved for infections proven or strongly suspected to be caused by susceptible bacteria.
How KIMYRSA Works
Oritavancin exerts bactericidal activity against susceptible Gram-positive bacteria through three distinct mechanisms of action: (1) inhibition of the transglycosylation (peptidoglycan synthesis) step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors; (2) inhibition of the transpeptidation (cross-linking) step of cell wall biosynthesis by binding to the peptide bridges of the cell wall; and (3) disruption of bacterial cell membrane integrity, leading to depolarization and permeabilization that causes rapid cell death.
Details
- Status
- Prescription
- First Approved
- 2021-03-12
- Patent Cliff
- 2035
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
KIMYRSA Approval History
What KIMYRSA Treats
1 indicationsKIMYRSA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Bacterial Skin and Skin Structure Infections
KIMYRSA 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 KIMYRSA
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05599295 | ML-ORI-201 2024-516385-10-00 | Ph 2 | completed | Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections |
| NCT03873987 results posted | ML-ORI-102 | Ph 1 | completed | Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients |
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.
KIMYRSA FDA Label Details
Indications & Usage
FDA Label (PDF)KIMYRSA is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA and other antibacterial drugs, KIMYRSA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Acute Bacterial Skin and Skin Structure Infections KIMYRSA ® is indicated for the treatment of ...
KIMYRSA Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for KIMYRSA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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.