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Dicoferin (NIFUROXAZIDE)
Dicoferin (generic name: NIFUROXAZIDE) is a nifuroxazide drug. It is currently in Phase 3 development.
Dicoferin works by inhibiting the activity of STAT3, a protein involved in cell signaling and inflammation.
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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 | NIFUROXAZIDE |
|---|---|
| Drug class | nifuroxazide |
| Target | Signal transducer and activator of transcription 3 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Mechanism of action
Think of STAT3 like a messenger that helps cells respond to signals. When it's overactive, it can lead to inflammation and other problems. Dicoferin blocks this messenger, which can help reduce inflammation and other symptoms.
Approved indications
Common side effects
- Trimethylaminuria
- Pseudomembranous colitis
- Megacolon
- Dysbiosis
- Intestinal perforation
- Peritonitis
- Clostridium difficile infection
Key clinical trials
- Efficacy and Safety of Nifuroxazide in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis (PHASE3)
- Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis (PHASE2,PHASE3)
- The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers (NA)
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:
- Dicoferin CI brief — competitive landscape report
- Dicoferin updates RSS · CI watch RSS
Frequently asked questions about Dicoferin
What is Dicoferin?
How does Dicoferin work?
What is the generic name of Dicoferin?
What drug class is Dicoferin in?
What development phase is Dicoferin in?
What are the side effects of Dicoferin?
What does Dicoferin target?
Related
- Drug class: All nifuroxazide drugs
- Target: All drugs targeting Signal transducer and activator of transcription 3
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing