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Omadacycline Injection
Omadacycline Injection is a Tetracycline antibiotic Small molecule drug developed by Wake Forest University Health Sciences. It is currently FDA-approved for Acute bacterial skin and skin structure infections (ABSSSI), Community-acquired bacterial pneumonia (CABP). Also known as: Omadacycline oral, NUZYRA, Nuzyra.
Omadacycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by binding to the ribosome.
Omadacycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by binding to the ribosome. Used for Acute bacterial skin and skin structure infections (ABSSSI), Community-acquired bacterial pneumonia (CABP).
At a glance
| Generic name | Omadacycline Injection |
|---|---|
| Also known as | Omadacycline oral, NUZYRA, Nuzyra |
| Sponsor | Wake Forest University Health Sciences |
| Drug class | Tetracycline antibiotic |
| Target | Bacterial 30S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Omadacycline is a broad-spectrum tetracycline antibiotic that works by binding to the bacterial 30S ribosomal subunit, thereby inhibiting protein synthesis and preventing bacterial growth. It has enhanced activity against gram-positive and gram-negative bacteria, including some resistant strains. The drug is administered intravenously and is used to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Approved indications
- Acute bacterial skin and skin structure infections (ABSSSI)
- Community-acquired bacterial pneumonia (CABP)
Common side effects
- Nausea
- Vomiting
- Photosensitivity
- Diarrhea
- Headache
Key clinical trials
- Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections (PHASE1)
- Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia (PHASE3)
- Effects of Intravenous (IV) Omadacycline on Gut Microbiome (PHASE4)
- Pharmacokinetics of Omadacycline in Cystic Fibrosis (PHASE4)
- Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI) (PHASE3)
- Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI) (PHASE2)
- Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23) (PHASE3)
- Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13) (PHASE3)
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:
- Omadacycline Injection CI brief — competitive landscape report
- Omadacycline Injection updates RSS · CI watch RSS
- Wake Forest University Health Sciences portfolio CI
Frequently asked questions about Omadacycline Injection
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Related
- Drug class: All Tetracycline antibiotic drugs
- Target: All drugs targeting Bacterial 30S ribosomal subunit
- Manufacturer: Wake Forest University Health Sciences — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Acute bacterial skin and skin structure infections (ABSSSI)
- Indication: Drugs for Community-acquired bacterial pneumonia (CABP)
- Also known as: Omadacycline oral, NUZYRA, Nuzyra
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing