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Nuzyra (OMADACYCLINE)
Nuzyra works by inhibiting protein synthesis in bacteria, ultimately leading to their death.
Nuzyra (omadacycline) is a tetracycline-class antibacterial drug developed by Paratek Pharms Inc. It is a small molecule modality approved by the FDA in 2018 for the treatment of bacterial infections of the skin and bacterial pneumonia. As a patented drug, Nuzyra is not yet available as a generic. Key safety considerations include its potential to cause gastrointestinal side effects and photosensitivity. Nuzyra's commercial status is that of a branded, patented product.
At a glance
| Generic name | OMADACYCLINE |
|---|---|
| Sponsor | Paratek Pharms |
| Drug class | Tetracycline-class Antibacterial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
NUZYRA is an antibacterial drug [see Microbiology (12.4)].
Approved indications
- Bacterial infection of skin
- Bacterial pneumonia
Common side effects
- Alanine aminotransferase increased
- Hypertension
- Gamma-glutamyl transferase increased
- Insomnia
- Vomiting
- Constipation
- Nausea
- Aspartate aminotransferase increased
- Headache
- Diarrhea
- Infusion site reactions
- Worsening and/or complications of infection
Key clinical trials
- Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis
- Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections (PHASE1)
- Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection (PHASE2)
- Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc) (PHASE2)
- Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia (PHASE3)
- Microbiome Effect of Omadacycline on Healthy Volunteers (PHASE1)
- Effects of Intravenous (IV) Omadacycline on Gut Microbiome (PHASE4)
- A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nuzyra CI brief — competitive landscape report
- Nuzyra updates RSS · CI watch RSS
- Paratek Pharms portfolio CI