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Refralon
Refralon is a Small molecule drug developed by R-Pharm. It is currently in Phase 2 development. Also known as: 4-nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride, Niferidyl.
Refralon is a medication used for pharmacological cardioversion in patients with atrial fibrillation, including paroxysmal and persistent forms, as well as atrial flutter. It has been studied in clinical trials for its efficacy in treating these conditions, often in comparison to Amiodarone.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Refralon |
|---|---|
| Also known as | 4-nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride, Niferidyl |
| Sponsor | R-Pharm |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter (PHASE4)
- Refralon in Patients With Recurrence Paroxysmal and Persistent Forms of Atrial Fibrillation Who Underwent Catheter Ablation (NA)
- A Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form (PHASE2)
- Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter
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:
- Refralon CI brief — competitive landscape report
- Refralon updates RSS · CI watch RSS
- R-Pharm portfolio CI
Frequently asked questions about Refralon
What is Refralon?
Who makes Refralon?
Is Refralon also known as anything else?
What development phase is Refralon in?
Related
- Manufacturer: R-Pharm — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: 4-nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride, Niferidyl
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing