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Cordarone
Cordarone is a Small molecule drug developed by Prism Pharmaceuticals. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Cordarone |
|---|---|
| Sponsor | Prism Pharmaceuticals |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies (NA)
- Comparative Efficacy of 100-, 200-, & 400-mg Amiodarone in Patients With Paroxysmal AF Depending on Plasma Concentration (PHASE4)
- The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients (PHASE4)
- Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery (PHASE4)
- Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia (NA)
- Pharmacokinetics of Amiodarone in Children (NA)
- Role of Combination Therapy of Glucose Insulin Potassium Infusion (GIK), Intravenous Hydrocortisone and Oral Sevelamer in Treatment of Acute Aluminum Phosphide Poisoned Cases Admitted to Intensive Care Unit (ICU) at Sohag University Hospitals. (NA)
- Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation (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:
- Cordarone CI brief — competitive landscape report
- Cordarone updates RSS · CI watch RSS
- Prism Pharmaceuticals portfolio CI
Frequently asked questions about Cordarone
What is Cordarone?
Who makes Cordarone?
What development phase is Cordarone in?
Related
- Manufacturer: Prism Pharmaceuticals — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing