Overview
Carvedilol is a racemic mixture where the S(-) enantiomer is both a beta and alpha-1 adrenoceptor blocker, and the R(+) enantiomer is an alpha-1 adrenoceptor blocker. It is currently used to treat heart failure, left ventricular dysfunction, and hypertension. The dual action of carvedilol is advantageous in combination therapies as moderate doses of 2 drugs have a decreased incidence of adverse effects compared to high dose monotherapy in the treatment of moderate hypertension. Carvedilol was granted FDA approval on 14 September 1995.
Background
Carvedilol is a racemic mixture where the S(-) enantiomer is both a beta and alpha-1 adrenoceptor blocker, and the R(+) enantiomer is an alpha-1 adrenoceptor blocker. It is currently used to treat heart failure, left ventricular dysfunction, and hypertension. The dual action of carvedilol is advantageous in combination therapies as moderate doses of 2 drugs have a decreased incidence of adverse effects compared to high dose monotherapy in the treatment of moderate hypertension. Carvedilol was granted FDA approval on 14 September 1995.
Indication
Carvedilol is indicated to treat mild to severe heart failure, left ventricular dysfunction after myocardial infarction with ventricular ejection fraction ≤40%, or hypertension.
Associated Conditions
- Atrial Fibrillation
- Chronic Stable Angina Pectoris
- Hypertension
- LVEF ≤40% Left ventricular dysfunction
- NYHA Class I or II heart failure
- Chronic heart failure with reduced ejection fraction (NYHA Class III)
- Chronic heart failure with reduced ejection fraction (NYHA Class IV)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/09 | Phase 4 | Not yet recruiting | |||
2025/03/25 | Phase 1 | Recruiting | |||
2025/01/29 | Phase 2 | Recruiting | University Hospital Of Clermont-Ferrand | ||
2025/02/25 | Phase 2 | Recruiting | |||
2024/11/20 | Phase 2 | Not yet recruiting | |||
2024/10/16 | Early Phase 1 | Recruiting | |||
2024/09/19 | Phase 4 | Recruiting | |||
2024/09/19 | Phase 4 | Recruiting | |||
2024/08/22 | Not Applicable | Not yet recruiting | |||
2024/06/24 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Woodward Pharma Services LLC | 69784-713 | ORAL | 10 mg in 1 1 | 2/1/2022 | |
| Zydus Lifesciences Limited | 65841-619 | ORAL | 25 mg in 1 1 | 10/31/2022 | |
| Waylis Therapeutics LLC | 80725-388 | ORAL | 80 mg in 1 1 | 10/31/2023 | |
| Bayshore Pharmaceuticals LLC | 76385-110 | ORAL | 3.125 mg in 1 1 | 4/26/2019 | |
| Woodward Pharma Services LLC | 69784-385 | ORAL | 20 mg in 1 1 | 2/28/2022 | |
| Mylan Institutional Inc. | 51079-771 | ORAL | 3.125 mg in 1 1 | 12/20/2021 | |
| GlaxoSmithKline LLC | 0007-3387 | ORAL | 40 mg in 1 1 | 11/2/2020 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-133 | ORAL | 25 mg in 1 1 | 5/12/2014 | |
| Golden State Medical Supply, Inc. | 51407-051 | ORAL | 20 mg in 1 1 | 3/18/2024 | |
| RedPharm Drug, Inc. | 67296-1497 | ORAL | 12.5 mg in 1 1 | 2/2/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Vacodil 12.5 Film-coated Tablet 12.5 mg | SIN14643P | TABLET, FILM COATED | 12.500 mg | 10/2/2014 | |
| CARVEPEN tablet 25 mg | SIN13590P | TABLET | 25 mg | 1/7/2009 | |
| DILATREND TABLET 12.5 mg | SIN10335P | TABLET | 12.5 mg | 10/30/1998 | |
| Vacodil 25 Film-coated Tablet 25 mg | SIN14642P | TABLET, FILM COATED | 25.000 mg | 10/2/2014 | |
| Vacodil 6.25 Film-coated Tablet 6.25 mg | SIN14644P | TABLET, FILM COATED | 6.250 mg | 10/2/2014 | |
| DILATREND TABLET 25 mg | SIN07421P | TABLET | 25 mg | 5/5/1993 | |
| Carvepen tablet 6.25 mg | SIN13412P | TABLET | 6.25 mg | 2/25/2008 | |
| CARIVALAN FILM-COATED TABLET 6.25 MG/5 MG | SIN15624P | TABLET, FILM COATED | 6.25 mg | 2/12/2019 | |
| Carvedilol Sandoz 25mg | SIN13156P | TABLET | 25.0 mg | 11/7/2005 | |
| Carvedilol Sandoz 6.25mg | SIN13155P | TABLET | 6.25 mg | 11/7/2005 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Carvedilol Capsules | 国药准字H20000568 | 化学药品 | 胶囊剂 | 9/30/2020 | |
| Carvedilol Dispersible Tablets | 国药准字H20100084 | 化学药品 | 片剂 | 4/9/2020 | |
| Carvedilol Dispersible Tablets | 国药准字H20100083 | 化学药品 | 片剂 | 4/9/2020 | |
| Carvedilol Tablets | 国药准字H20051925 | 化学药品 | 片剂 | 3/5/2020 | |
| Carvedilol Tablets | 国药准字H20020219 | 化学药品 | 片剂 | 5/12/2020 | |
| Carvedilol Tablets | 国药准字H20093407 | 化学药品 | 片剂 | 3/17/2023 | |
| Carvedilol Tablets | 国药准字H20052426 | 化学药品 | 片剂 | 4/14/2020 | |
| Carvedilol Tablets | 国药准字H20083898 | 化学药品 | 片剂 | 3/17/2023 | |
| Carvedilol Tablets | 国药准字H20041516 | 化学药品 | 片剂 | 3/4/2020 | |
| Carvedilol Tablets | 国药准字H19991108 | 化学药品 | 片剂 | 7/31/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| APO-CARVEDILOL TAB 12.5MG | N/A | N/A | N/A | 4/28/2007 | |
| APO-CARVEDILOL TAB 25MG | N/A | N/A | N/A | 4/28/2007 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CARVEDILOL-WGR carvedilol 25 mg tablet blister pack | 332857 | Medicine | A | 4/21/2020 | |
| CARVIDOL carvedilol 6.25 mg tablet blister pack | 332855 | Medicine | A | 4/21/2020 | |
| CARVEDILOL SCP carvedilol 6.25 mg tablet blister pack | 194262 | Medicine | A | 10/22/2012 | |
| CARVEDILOL TIH carvedilol 12.5mg tablet blister pack | 383675 | Medicine | A | 4/14/2022 | |
| VOLIROP 25 carvedilol 25mg tablets Bottle | 174789 | Medicine | A | 11/11/2011 | |
| CARVEDILOL TIH carvedilol 25mg tablet blister pack | 383680 | Medicine | A | 4/14/2022 | |
| AURO-CARVEDILOL 3.125 carvedilol 3.125mg tablets Blister pack | 174793 | Medicine | A | 11/11/2011 | |
| DICARZ carvedilol 12.5 mg tablet blister pack | 124081 | Medicine | A | 4/24/2007 | |
| CARVEDILOL SANDOZ carvedilol 12.5 mg tablets blister pack | 104396 | Medicine | A | 5/31/2005 | |
| CARVEDILOL SCP carvedilol 12.5 mg tablet blister pack | 194263 | Medicine | A | 10/22/2012 |