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Candesartan

Generic Name
Candesartan
Brand Names
Atacand, Atacand Hct
Drug Type
Small Molecule
Chemical Formula
C24H20N6O3
CAS Number
139481-59-7
Unique Ingredient Identifier
S8Q36MD2XX

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

Published: Jul 23, 2025

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

C24​H20​N6​O3​, 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]

Continue reading the full research report

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.

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

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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