Last reviewed 2026-04-20 · How we verify

Candesartan Cilexetil (CILEXETIL)

Candesartan cilexetil works by blocking the action of angiotensin II, a hormone that constricts blood vessels, to lower blood pressure and improve heart function.

Candesartan cilexetil is a small molecule drug developed by Alembic, targeting the angiotensin II receptor as an ACE inhibitor. It is used to treat hypertension and heart failure. The drug is currently owned by Alembic and was FDA-approved in 2021. Candesartan cilexetil is a patented medication with a half-life of 9 hours. It is essential to monitor patients for potential side effects, including dizziness and increased potassium levels.

At a glance

Mechanism of action

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Candesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is, therefore, independent of the pathways for angiotensin II synthesis. There is also an AT 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis. Candesartan has much greater affinity (>10,000-fold) for the AT 1 receptor than for the AT 2 receptor. Blockade of the renin-angiotensin system with ACE inhibitors, which inhib

Approved indications

• Hypertension
• Heart Failure

Boxed warnings

• WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible. (5.1, 8.1) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1, 8.1)

Common side effects

• Worsening renal disease
• Hypotension
• Abnormal renal function
• Hyperkalemia
• Headache
• Dizziness
• Back pain
• Upper respiratory tract infection
• Pharyngitis
• Rhinitis
• Neutropenia
• Leukopenia

Drug interactions

• Lithium
• NSAIDs
• Dual inhibition of the renin-angiotension system
• Potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes
• Lithium
• Non-Steroidal Anti-Inflammatory Agents
• NSAIDs
• Dual blockade of the RAS
• Triple combination of candesartan cilexetil with an ACE-inhibitor and a mineralocorticoid receptor antagonist
• Aliskiren
• Aliskiren
• Aliskiren

Key clinical trials

• Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects (PHASE1)
• Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury (PHASE2)
• Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension (PHASE3)
• EBA, Safety and Tolerability of Sanfetrinem Cilexetil (PHASE2)
• Adiposity and Endothelin Receptor Function (EARLY_PHASE1)
• Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19 (PHASE2)
• A Study to Evaluate the Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil in Essential Hypertension Patient Who Are Not Adequately Controlled With Amlodipine Besylate Monotherapy (PHASE3)
• A Study to Evaluate the Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil in Essential Hypertension Patient Who Are Not Adequately Controlled With Candesartan Cilexetil Monotherapy (PHASE3)

Primary sources

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Competitive intelligence

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