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Niflec
Niflec is a Small molecule drug developed by Fu Jen Catholic University Hospital. It is currently in Phase 3 development.
Niflec is a combination of polyethylene glycol and lubiprostone used in bowel preparation for colonoscopy and other gastrointestinal procedures. It has been studied in clinical trials for conditions such as gastrointestinal bleeding, bowel preparation, and colon cleansing in preparation for colonoscopy.
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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 | Niflec |
|---|---|
| Sponsor | Fu Jen Catholic University Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Comparing the Bowel Cleansing Efcacy of Picosulfate Sodium/ Citric Acid / Magnesium Oxide and Polyethylene Glycol: A Randomized Trial in Taiwan (NA)
- Colon Preparation With 2L PEG in Combination With Lubiprostone vs 4L PEG (PHASE4)
- A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing (PHASE3)
- Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding (NA)
- Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy (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:
- Niflec CI brief — competitive landscape report
- Niflec updates RSS · CI watch RSS
- Fu Jen Catholic University Hospital portfolio CI
Frequently asked questions about Niflec
What is Niflec?
Who makes Niflec?
What development phase is Niflec in?
Related
- Manufacturer: Fu Jen Catholic University Hospital — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing