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Dronedarone Hydrochloride Tablets
Dronedarone Hydrochloride Tablets is a Class III antiarrhythmic agent Small molecule drug developed by Shandong New Time Pharmaceutical Co., LTD. It is currently in Phase 1 development.
Dronedarone blocks multiple cardiac ion channels including potassium, sodium, and calcium channels, and has antiadrenergic properties.
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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 | Dronedarone Hydrochloride Tablets |
|---|---|
| Sponsor | Shandong New Time Pharmaceutical Co., LTD |
| Drug class | Class III antiarrhythmic agent |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Dronedarone is a multichannel blocker that inhibits potassium currents (IKr, IKs, IKur, IKAch), sodium channels, L-type calcium channels, and has non-competitive beta-adrenergic blocking properties. These actions prolong cardiac action potential duration and refractory period, helping to maintain normal sinus rhythm.
Approved indications
Common side effects
Key clinical trials
- Bioequivalence Study of Dronedarone Hydrochloride Tablets in Healthy Subjects Under Fasting Conditions (NA)
- Bioequivalence Study of Dronedarone Hydrochloride Tablets (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:
- Dronedarone Hydrochloride Tablets CI brief — competitive landscape report
- Dronedarone Hydrochloride Tablets updates RSS · CI watch RSS
- Shandong New Time Pharmaceutical Co., LTD portfolio CI
Frequently asked questions about Dronedarone Hydrochloride Tablets
What is Dronedarone Hydrochloride Tablets?
How does Dronedarone Hydrochloride Tablets work?
Who makes Dronedarone Hydrochloride Tablets?
What drug class is Dronedarone Hydrochloride Tablets in?
What development phase is Dronedarone Hydrochloride Tablets in?
Related
- Drug class: All Class III antiarrhythmic agent drugs
- Manufacturer: Shandong New Time Pharmaceutical Co., LTD — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing