Overview
Candesartan is an angiotensin-receptor blocker (ARB) that may be used alone or with other agents to treat hypertension. It is available as a prodrug in the form of candesartan cilexetil.
Indication
May be used as a first line agent to treat uncomplicated hypertension, isolated systolic hypertension and left ventricular hypertrophy. May be used as a first line agent to delay progression of diabetic nephropathy. Candesartan may be also used as a second line agent in the treatment of congestive heart failure, systolic dysfunction, myocardial infarction and coronary artery disease in those intolerant of ACE inhibitors.
Associated Conditions
- Hypertension
- NYHA Functional Class II-IV Heart Failure
Research Report
Candesartan: A Comprehensive Pharmacological and Clinical Monograph
Section 1: Introduction and Physicochemical Profile
Candesartan is a potent, long-acting, and highly selective angiotensin II receptor blocker (ARB) that has become a cornerstone in the management of cardiovascular diseases, primarily hypertension and heart failure. As a member of the ARB class, its therapeutic efficacy is rooted in its ability to antagonize the physiological effects of angiotensin II, the principal pressor agent of the renin-angiotensin-aldosterone system (RAAS). Unlike its predecessors and some contemporaries in the class, candesartan possesses a unique pharmacological profile characterized by insurmountable antagonism and exceptionally high affinity for its target receptor, which translates into robust and sustained clinical effects. This monograph provides a comprehensive review of candesartan, encompassing its fundamental chemistry, detailed pharmacology, pharmacokinetics, pivotal clinical trial evidence, comparative efficacy, and safety profile.
1.1. Chemical Identity and Structure
Candesartan (DrugBank ID: DB13919) is a small molecule, nonpeptide drug belonging to the benzimidazolecarboxylic acid and biphenylyltetrazole chemical classes.[1] Its formal chemical name is 2-ethoxy-1-((2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl)methyl)-1H-benzimidazole-7-carboxylic acid.[1] The molecular formula of the active drug is
C24H20N6O3, corresponding to a molecular weight of approximately 440.45 g/mol.[2] It is uniquely identified by the Chemical Abstracts Service (CAS) Number 139481-59-7.[2] Common synonyms used in research and development include CV-11974, Candesartan M1, and Celexetil.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/06/27 | Phase 3 | Completed | |||
2023/04/24 | Phase 2 | ENROLLING_BY_INVITATION | |||
2022/04/14 | N/A | Completed | |||
2022/04/11 | Phase 3 | Recruiting | Cristina Avendaño Solá | ||
2021/11/16 | Phase 2 | Terminated | |||
2020/10/28 | Phase 3 | Terminated | |||
2020/10/05 | Phase 2 | Completed | St. Olavs Hospital | ||
2020/06/16 | Early Phase 1 | Withdrawn | |||
2020/06/12 | Not Applicable | UNKNOWN | |||
2020/04/17 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Alembic Pharmaceuticals Limited | 46708-060 | ORAL | 32 mg in 1 1 | 1/13/2023 | |
ANI Pharmaceuticals, Inc. | 62559-651 | ORAL | 32 mg in 1 1 | 10/25/2019 | |
Mylan Pharmaceuticals Inc. | 0378-3001 | ORAL | 16 mg in 1 1 | 8/15/2020 | |
Alembic Pharmaceuticals Limited | 46708-343 | ORAL | 16 mg in 1 1 | 10/9/2019 | |
Macleods Pharmaceuticals Limited | 33342-133 | ORAL | 32 mg in 1 1 | 10/17/2022 | |
Carilion Materials Management | 68151-4146 | ORAL | 8 mg in 1 1 | 7/5/2016 | |
Bryant Ranch Prepack | 72162-1510 | ORAL | 4 mg in 1 1 | 8/29/2023 | |
Solco Healthcare LLC | 43547-461 | ORAL | 32 mg in 1 1 | 11/4/2020 | |
Golden State Medical Supply, Inc. | 51407-882 | ORAL | 4 mg in 1 1 | 4/5/2024 | |
Zydus Lifesciences Limited | 70771-1207 | ORAL | 32 mg in 1 1 | 10/13/2022 |
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 |
---|---|---|---|---|---|
ATACAND TABLET 16 mg | SIN10880P | TABLET | 16 mg | 4/20/1999 | |
Candesartan Sandoz Tablet 16mg | SIN14301P | TABLET | 16mg | 1/29/2013 | |
ATACAND TABLET 8 mg | SIN10878P | TABLET | 8 mg | 4/20/1999 | |
ATACAND PLUS TABLET | SIN11383P | TABLET | 16 mg | 8/26/2000 | |
Candesartan Sandoz Tablet 8mg | SIN14302P | TABLET | 8mg | 1/29/2013 | |
ATACAND TABLET 4 mg | SIN10879P | TABLET | 4 mg | 4/20/1999 | |
CANDESARTAN HCT SANDOZ TABLET 16mg/12.5mg | SIN15503P | TABLET | 16mg | 6/7/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
KARBIS TABLETS 8MG | N/A | N/A | N/A | 8/15/2024 | |
PMS-CANDESARTAN TABLETS 16MG | N/A | N/A | N/A | 2/12/2016 | |
KARBIS TABLETS 16MG | N/A | N/A | N/A | 8/15/2024 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
MYLAN-CANDESARTAN HCTZ | Mylan Pharmaceuticals ULC | 02374897 | Tablet - Oral | 16.0 MG | 9/24/2012 |
ZINDA-CANDESARTAN/HYDROCHLOROTHIAZIDE | zinda pharma limited | 02434822 | Tablet - Oral | 32 MG | N/A |
ACCEL-CANDESARTAN/HCTZ | accel pharma inc | 02463865 | Tablet - Oral | 16 MG | 12/27/2017 |
CANDESARTAN-HCTZ | PRO DOC LIMITEE | 02392275 | Tablet - Oral | 16.0 MG | 10/17/2012 |
ACH-CANDESARTAN | 02379279 | Tablet - Oral | 8 MG | 2/16/2012 | |
CANDESARTAN | actavis pharma company | 02434520 | Tablet - Oral | 4 MG | N/A |
MAR-CANDESARTAN / HCTZ | marcan pharmaceuticals inc | 02432358 | Tablet - Oral | 32 MG | N/A |
CANDESARTAN | PRO DOC LIMITEE | 02377934 | Tablet - Oral | 8 MG | 2/2/2012 |
CANDESARTAN/HCTZ | sanis health inc | 02536072 | Tablet - Oral | 32 MG | N/A |
CANDESARTAN | sanis health inc | 02435845 | Tablet - Oral | 32 MG | 1/12/2015 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
CANDESARTAN HIDROCLOROTIAZIDA ALTER 32 MG/12,5 MG COMPRIMIDOS EFG | Laboratorios Alter S.A. | 78154 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
CANDESARTAN HIDROCLOROTIAZIDA ALTER 16 MG/12,5 MG COMPRIMIDOS EFG | Laboratorios Alter S.A. | 78153 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
CANDESARTAN HIDROCLOROTIAZIDA ALTER 32 MG/25 MG COMPRIMIDOS EFG | Laboratorios Alter S.A. | 78155 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
CANDESARTAN/HIDROCLOROTIAZIDA KRKA 32 MG/12,5 MG COMPRIMIDOS EFG | Krka D.D. Novo Mesto | 79668 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
BLOPRESS 16 mg COMPRIMIDOS | 61997 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
CANDESARTAN/HIDROCLOROTIAZIDA KRKA 32 MG/25 MG COMPRIMIDOS EFG | Krka D.D. Novo Mesto | 79669 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
CANDESARTAN/HIDROCLOROTIAZIDA KRKA 16 MG/12,5 MG COMPRIMIDOS EFG | Krka D.D. Novo Mesto | 79667 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
BLOPRESS PLUS 16/12,5 mg COMPRIMIDOS | 66050 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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