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Baxdela (DELAFLOXACIN)
Baxdela (generic name: DELAFLOXACIN) is a Fluoroquinolone Antibacterial Small molecule drug developed by Melinta. It is currently FDA-approved (first approved 2017) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP).
Baxdela works by blocking bacterial enzymes that replicate DNA.
Baxdela (Delafloxacin) is a small molecule fluoroquinolone antibacterial developed by Melinta Therapeutics Inc. It is FDA-approved to treat bacterial skin infections. As a fluoroquinolone, Baxdela works by inhibiting bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication. Baxdela is a patented medication with no generic manufacturers available. Key safety considerations include potential side effects such as tendonitis and QT interval prolongation.
At a glance
| Generic name | DELAFLOXACIN |
|---|---|
| Sponsor | Melinta |
| Drug class | Fluoroquinolone Antibacterial |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
BAXDELA is an antibacterial drug [see Microbiology (12.4)].
Approved indications
- Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
- Community-Acquired Bacterial Pneumonia (CABP)
Boxed warnings
- WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1), including: Tendinitis and tendon rupture (5.2) Peripheral neuropathy (5.3) Central nervous system effects (5.4) Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions (5.1) Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis. (5.5) WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, and EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning. Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ), including: Tendinitis and tendon rupture ( 5.2 ) Peripheral neuropathy ( 5.3 ) Central nervous system effects ( 5.4 ) Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions. ( 5.1 ) Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis. ( 5.5 )
Common side effects
- Nausea
- Diarrhea
- Headache
- Transaminase elevations
- Vomiting
- Urticaria
- Hypersensitivity
- Rash
- Infusion site extravasation
- Infusion site reactions
- Serious adverse reactions
- Discontinuation due to an adverse reaction
Key clinical trials
- Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections.
- Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients
- A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults (PHASE1)
- Comparing Oral Versus Parenteral Antimicrobial Therapy (PHASE4)
- Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections (PHASE3)
- Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia (PHASE3)
- A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections (PHASE2)
- Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults (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:
- Baxdela CI brief — competitive landscape report
- Baxdela updates RSS · CI watch RSS
- Melinta portfolio CI
Frequently asked questions about Baxdela
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Related
- Drug class: All Fluoroquinolone Antibacterial drugs
- Manufacturer: Melinta — 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)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing