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nadifloxacine
nadifloxacine is a Small molecule drug developed by Marmara University. It is currently in Phase 3 development. Also known as: Nadixa 1% cream.
Nadifloxacine is a small molecule that inhibits bacterial DNA gyrase, a mechanism that is consistent with its classification 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).
| 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 | nadifloxacine |
|---|---|
| Also known as | Nadixa 1% cream |
| Sponsor | Marmara University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- 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:
- nadifloxacine CI brief — competitive landscape report
- nadifloxacine updates RSS · CI watch RSS
- Marmara University portfolio CI
Frequently asked questions about nadifloxacine
What is nadifloxacine?
Who makes nadifloxacine?
Is nadifloxacine also known as anything else?
What development phase is nadifloxacine in?
Related
- Manufacturer: Marmara University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Nadixa 1% cream
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing