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AZIMILIDE
AZIMILIDE is a azimilide drug. It is currently in Phase 3 development.
AZIMILIDE works by blocking potassium channels in the heart, which helps to regulate heart rhythm.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | AZIMILIDE |
|---|---|
| Drug class | azimilide |
| Target | Potassium voltage-gated channel subfamily H member 2, Potassium voltage-gated channel subfamily H member 2, Potassium voltage-gated channel subfamily KQT member 1 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Think of your heart as a pump that beats in a regular rhythm. Potassium channels help control how fast the heart beats. AZIMILIDE blocks these channels, which helps to slow down the heart rate and prevent irregular rhythms.
Approved indications
Common side effects
Key clinical trials
- Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient (PHASE2)
- Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs) (PHASE3)
- Effect of Azimilide Dihydrochloride on Renal Function (PHASE1)
- Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2) (PHASE3)
- Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation. (PHASE3)
- Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators (PHASE3)
- Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation (PHASE3)
- Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation. (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:
- AZIMILIDE CI brief — competitive landscape report
- AZIMILIDE updates RSS · CI watch RSS
Frequently asked questions about AZIMILIDE
What is AZIMILIDE?
How does AZIMILIDE work?
What drug class is AZIMILIDE in?
What development phase is AZIMILIDE in?
What does AZIMILIDE target?
Related
- Drug class: All azimilide drugs
- Target: All drugs targeting Potassium voltage-gated channel subfamily H member 2, Potassium voltage-gated channel subfamily H member 2, Potassium voltage-gated channel subfamily KQT member 1
- Therapeutic area: All drugs in Cardiovascular
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing