Overview
Captopril is a potent, competitive inhibitor of angiotensin-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Captopril may be used in the treatment of hypertension.
Background
Captopril is a potent, competitive inhibitor of angiotensin-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Captopril may be used in the treatment of hypertension.
Indication
For the treatment of essential or renovascular hypertension (usually administered with other drugs, particularly thiazide diuretics). May be used to treat congestive heart failure in combination with other drugs (e.g. cardiac glycosides, diuretics, β-adrenergic blockers). May improve survival in patients with left ventricular dysfunction following myocardial infarction. May be used to treat nephropathy, including diabetic nephropathy.
Associated Conditions
- Aldosteronism
- Anatomic renal artery stenosis
- Congestive Heart Failure (CHF)
- Diabetic Nephropathy
- Heart Failure
- Hypertension
- Hypertensive crisis
- Non-STEMI Acute Coronary Syndrome
- Raynaud's Phenomenon
- Ejection fraction of 40% or less Left ventricular dysfunction
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/03 | Early Phase 1 | Recruiting | |||
2024/03/04 | Phase 1 | Completed | |||
2024/02/12 | Phase 3 | Recruiting | |||
2023/11/21 | Phase 3 | Not yet recruiting | Natural Wellness Egypt | ||
2023/09/15 | N/A | Recruiting | China National Center for Cardiovascular Diseases | ||
2023/09/15 | N/A | Recruiting | China National Center for Cardiovascular Diseases | ||
2023/09/14 | N/A | Recruiting | China National Center for Cardiovascular Diseases | ||
2022/07/05 | N/A | Recruiting | |||
2022/02/23 | Phase 2 | Recruiting | |||
2021/05/07 | Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Solco Healthcare US, LLC | 43547-364 | ORAL | 25 mg in 1 1 | 4/20/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0143-1173 | ORAL | 50 mg in 1 1 | 8/14/2021 | |
| DOH CENTRAL PHARMACY | 53808-0359 | ORAL | 100 mg in 1 1 | 1/23/2017 | |
| Legacy Pharmaceutical Packaging | 68645-162 | ORAL | 50 mg in 1 1 | 4/11/2011 | |
| Physicians Total Care, Inc. | 54868-3724 | ORAL | 25 mg in 1 1 | 10/1/2012 | |
| Major Pharmaceuticals | 0904-7105 | ORAL | 12.5 mg in 1 1 | 6/15/2021 | |
| AvKARE | 73190-027 | ORAL | 25 mg in 1 1 | 4/22/2025 | |
| Bryant Ranch Prepack | 63629-8728 | ORAL | 25 mg in 1 1 | 12/16/2019 | |
| Bryant Ranch Prepack | 71335-2358 | ORAL | 50 mg in 1 1 | 11/23/2021 | |
| Bryant Ranch Prepack | 63629-8727 | ORAL | 12.5 mg in 1 1 | 12/16/2019 |
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 |
|---|---|---|---|---|---|
| CATOPLIN-25 TABLETS 25 mg | SIN10401P | TABLET | 25mg | 11/11/1998 | |
| APO-CAPTO TABLET 12.5 mg | SIN06667P | TABLET | 12.5 mg | 11/14/1991 | |
| DEXACAP TABLET 25 mg | SIN08474P | TABLET | 25 mg | 12/13/1995 | |
| DEXACAP TABLET 12.5 mg | SIN08473P | TABLET | 12.5 mg | 12/13/1995 | |
| APO-CAPTO TABLET 50 mg | SIN06665P | TABLET | 50 mg | 11/14/1991 | |
| APO-CAPTO TABLET 25 mg | SIN06666P | TABLET | 25 mg | 11/14/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Captopril Capsules | 国药准字H46020595 | 化学药品 | 胶囊剂 | 5/18/2020 | |
| Captopril Injection | 国药准字H10970294 | 化学药品 | 注射剂 | 7/30/2020 | |
| Captopril Injection | 国药准字H10970293 | 化学药品 | 注射剂 | 7/30/2020 | |
| Captopril for Injection | 国药准字H20040202 | 化学药品 | 注射剂 | 12/22/2020 | |
| Captopril for Injection | 国药准字H20040204 | 化学药品 | 注射剂 | 12/22/2020 | |
| Captopril for Injection | 国药准字H20040203 | 化学药品 | 注射剂 | 12/22/2020 | |
| Captopril for Injection | 国药准字H20031166 | 化学药品 | 注射剂 | 3/6/2023 | |
| Captopril for Injection | 国药准字H20051389 | 化学药品 | 注射剂 | 9/12/2023 | |
| Captopril Pills | 国药准字H20061180 | 化学药品 | 滴丸剂 | 4/15/2021 | |
| Captopril Tablets | 国药准字H43021078 | 化学药品 | 片剂 | 1/16/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| EPSITRON 25 TAB 25MG | N/A | N/A | N/A | 12/21/1998 | |
| CAPTOPRIL STADA 25 TAB 25MG | N/A | N/A | N/A | 12/30/1997 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Capoten 25mg tablet blister pack | 19247 | Medicine | A | 9/30/1991 | |
| Capoten 50mg tablet blister pack | 19248 | Medicine | A | 9/30/1991 | |
| APO-CAPTOPRIL 50mg tablet blister pack | 74008 | Medicine | A | 6/8/2000 | |
| APO-CAPTOPRIL 12.5mg tablet blister pack | 74001 | Medicine | A | 6/8/2000 | |
| Capoten 12.5mg tablet blister pack | 60608 | Medicine | A | 7/28/1997 | |
| ZEDACE Captopril 25mg tablet blister pack | 57370 | Medicine | A | 10/10/1996 | |
| ZEDACE Captopril 50mg tablet blister pack | 57371 | Medicine | A | 10/10/1996 | |
| APO-CAPTOPRIL 25mg tablet blister pack | 74004 | Medicine | A | 6/8/2000 | |
| CAPOTEN captopril 5mg/mL oral liquid bottle | 68962 | Medicine | A | 6/23/1999 |