Drugs / Dronedarone
Dronedarone
also known as
SR33589 · Dronedarona · Dronedarone hcl · DRONEDARONE HYDROCHLORIDE · Multaq · SR-33598B
Small molecule targets HCN4, KCNJ2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MULTAQ | — | 2023-10-23 | fda.gov ↗ |
| Approved | EU (EMA) | Multaq | — | 2009-11-25 | europa.eu ↗ |
| Approved | US (FDA) | MULTAQ | — | 2009-07-01 | fda.gov ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 missed | ||||||
| Phase 1 | NCT01306162 | Feb → May 2011 | — | Boehringer Ingelheim | Completed | Missed primary |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT01522651 | Jan 2012 → Mar 2014 | atrial fibrillation | Gilead Sciences | Completed | Met primary |
| Phase 2 | NCT01213368 | Sep 2010 → Apr 2011 | atrial fibrillation | Sanofi | Completed | No outcome recorded |
| Phase 38 trials · 4 met primary · 3 missed | ||||||
| Phase 3 | NCT01182376 | Nov 2010 → Dec 2012 | atrial fibrillation | University of Utah | Completed | No outcome recorded |
| Phase 3 | NCT01151137 | Jul 2010 → Sep 2011 | atrial fibrillation | Sanofi | Terminated | Missed primary |
| Phase 3 | NCT00489736 | Jun 2007 → Oct 2008 | atrial fibrillation | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00174785 | Jun 2005 → Mar 2008 | atrial fibrillation, atrial flutter | Sanofi | Completed | Met primary |
| Phase 3 | NCT00697086 | Aug 2002 → Jun 2004 | atrial fibrillation | Sanofi | Completed | Met primary |
| Phase 3 | NCT00696631 | Jun 2002 → Jan 2003 | congestive heart failure | Sanofi | Terminated | Missed primary |
| Phase 3 | NCT00259428 | Nov 2001 → Aug 2003 | atrial fibrillation, atrial flutter | Sanofi | Completed | Met primary |
| Phase 3 | NCT00259376 | Nov 2001 → Sep 2003 | atrial fibrillation, atrial flutter | Sanofi | Completed | Met primary |
| Phase 410 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07270848 | Jan 2026 → Jun 2028 expected | atrial fibrillation | Inha University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05655468 | Mar 2023 → Apr 2025 | atrial fibrillation | Shanghai East Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05130268 | Oct 2021 → Jan 2024 | atrial fibrillation | American Heart Association | Completed | No outcome recorded |
| Phase 4 | NCT01199081 | Oct 2010 → Apr 2012 | atrial fibrillation | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT01140581 | Sep 2010 → Dec 2011 | atrial fibrillation | Sanofi | Completed | Missed primary |
| Phase 4 | NCT01198873 | Sep 2010 → Jan 2012 | atrial fibrillation | Sanofi | Terminated | No outcome recorded |
| Phase 4 | NCT01135017 | Jul 2010 → Feb 2012 | atrial fibrillation | Sanofi | Terminated | Met primary |
| Phase 4 | NCT01047566 | Apr 2010 → Sep 2011 | atrial fibrillation | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT01070667 | Mar 2010 | paroxysmal atrial fibrillation | Eastbourne General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01026090 | Nov 2009 → Dec 2011 | atrial fibrillation | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable3 trials · 1 met primary | ||||||
| — | NCT07447297 | Jan 2024 → Dec 2027 expected | atrial fibrillation, atrial flutter | Samsung Medical Center | Recruiting | No outcome recorded |
| — | NCT02825979 | Jan 2017 → Sep 2022 | atrial fibrillation | Jason Andrade | Unknown | Met primary |
| — | NCT01430806 | Oct 2011 → Dec 2014 | — | Rabin Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 2/3 | NCT03905759 Comparator | Apr 2019 → Apr 2020 | atrial fibrillation | doaa rashwan | Unknown | No outcome recorded |
| Phase 3 | NCT05939076 Comparator | Aug 2023 → Dec 2027 expected | persistent atrial fibrillation | Region Örebro County | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04037397 Comparator | Sep 2019 → Oct 2024 | atrial fibrillation | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT04704050 Comparator | May 2021 → Dec 2022 | atrial fibrillation | Tulane University School of Medicine | Terminated | No outcome recorded Stop: Business |
| — | NCT06699342 Comparator | Jan 2025 → Dec 2027 expected | atrial fibrillation | Seoul National University Hospital | Recruiting | No outcome recorded |
| — | NCT06096337 Comparator | Dec 2023 → Feb 2026 overdue | persistent atrial fibrillation | Boston Scientific Corporation | Active not recruiting | No outcome recorded |
| — | NCT06125925 Comparator | Nov 2023 → Nov 2026 expected | atrial fibrillation, heart failure | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| — | NCT04942834 Comparator | Oct 2021 → Jul 2025 | persistent atrial fibrillation | Ruijin Hospital | Unknown | No outcome recorded |
| — | NCT05514860 Comparator | Jan 2017 → Sep 2022 | atrial fibrillation | University of British Columbia | Unknown | No outcome recorded |
| — | NCT01991119 Comparator | May 2011 → Oct 2013 | atrial fibrillation | Samsung Medical Center | Completed | No outcome recorded |
| — | NCT01266681 Comparator | Mar 2011 → May 2012 | atrial fibrillation | Eastbourne General Hospital | Unknown | No outcome recorded |
| — | NCT00911508 Comparator | Nov 2009 → Dec 2017 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
| — | NCT02294955 Comparator | May 2008 → Sep 2018 | atrial fibrillation | Uppsala University Hospital | Unknown | No outcome recorded |
| — | NCT01411371 Comparator | Mar 2005 → Feb 2013 | heart failure, persistent atrial fibrillation | Barts & The London NHS Trust | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-02-01 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Dronedarone Tablets, USP lupin.com ↗ |
| 2022-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory 101h January, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dronedarone Tablets USP, 400 mg. |
| 2014-05-10 | Gilead Sciences | Results Gilead Announces Results from Phase 2 Study Showing Reduction in Atrial Fibrillation Burden with the Investigational Combination of Ranolazine and Low-Dose Dronedarone gilead.com ↗
In HARMONY, the combination of ranolazine and low-dose dronedarone provided greater reductions in AFB from baseline than either therapy used alone. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-02-01 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Dronedarone Tablets, USP lupin.com ↗ |
| 2022-01-01 | Alembic Pharmaceuticals Ltd. | 101h January, 2022, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2014-05-10 | Gilead Sciences | Gilead Announces Results from Phase 2 Study Showing Reduction in Atrial Fibrillation Burden with the Investigational Combination of Ranolazine and Low-Dose Dronedarone gilead.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dronedarone | “Pharmacologic therapy includes rate control with beta-blockers (e.g., bisoprolol), calcium channel blockers (e.g., diltiazem), or antiarrhythmic drugs (e.g., flecainide,...” NCT06699342 ↗37“Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as...” NCT01411371 ↗ “Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according...” NCT05514860 ↗ “Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according...” NCT02825979 ↗ “AADs should be prescribed according to the current guidelines, such as amiodarone, dronedarone, or propafenone.” NCT06125925 ↗ “flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on” NCT07447297 ↗ “Propafenone or Flecanide or Sotalol or Dofetilide or Dronedarone or Amiodarone.” NCT04037397 ↗ “Quinidine 600-900mg, Dronedarone 800mg” NCT00911508 ↗ |
| Known as | Dronedarona | ChEMBL registry synonym — accepted as the source's own label CHEMBL184412 ↗ |
| Known as | Dronedarone hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL184412 ↗ |
| Known as | DRONEDARONE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL184412 ↗ |
| Known as | Multaq | “dronedarone - Multaq™ OR flecainide - Tambocor™ OR propafenone - Rytmonorm™ OR sotalol - Sotacor™” NCT05939076 ↗ |
| Known as | SR-33598B | ChEMBL registry synonym — accepted as the source's own label CHEMBL184412 ↗ |
| Known as | SR33589 | “Drug: dronedarone (SR33589)” NCT00174785 ↗6“DRONEDARONE (SR33589)” NCT01213368 ↗ “Dronedarone (SR33589)” NCT00259376 ↗ “Dronedarone (SR33589)” NCT00696631 ↗ “dronedarone (SR33589)” NCT00489736 ↗ “Dronedarone (SR33589)” NCT00697086 ↗ “Dronedarone (SR33589)” NCT00259428 ↗ |
| Action | Inhibit | “Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 blocker” CHEMBL184412 ↗2“Inward rectifier potassium channel 2 blocker” CHEMBL184412 ↗ “Dronedarone is a new multichannel blocker” PMID 18760136 ↗ Sep 2008 |
| Modality | Small molecule | — CHEMBL184412 ↗ |
| Route | Oral | “oral administration (tablets)” NCT00174785 ↗ |
| Target | HCN4 | “Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 blocker” CHEMBL184412 ↗ |
| Target | KCNJ2 | “Inward rectifier potassium channel 2 blocker” CHEMBL184412 ↗ |