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Nadixa (NADIFLOXACIN)
Nadixa (generic name: NADIFLOXACIN) is a nadifloxacin drug. It is currently in Phase 3 development for Acne vulgaris.
Nadixa works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and transcription.
Nadifloxacin is a small molecule that inhibits bacterial DNA gyrase, a mechanism that is classified as an inhibitor. It has been studied in clinical trials for the treatment of acne vulgaris, including a comparison of its effectiveness alone and in combination with benzoyl peroxide.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | NADIFLOXACIN |
|---|---|
| Drug class | nadifloxacin |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Think of Nadixa like a key that locks up a bacterial cell's ability to make copies of itself. By blocking these enzymes, Nadixa prevents the bacteria from multiplying and eventually kills them. This helps to clear up acne by reducing the number of bacteria on the skin.
Approved indications
- Acne vulgaris
Common side effects
Key clinical trials
- Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas (Study P04460) (PHASE4)
- Dalacin-T Gel Post Approval Study (PHASE4)
- Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne (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:
- Nadixa CI brief — competitive landscape report
- Nadixa updates RSS · CI watch RSS
Frequently asked questions about Nadixa
What is Nadixa?
How does Nadixa work?
What is Nadixa used for?
What is the generic name of Nadixa?
What drug class is Nadixa in?
What development phase is Nadixa in?
Related
- Drug class: All nadifloxacin drugs
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Acne vulgaris
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing