CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (candesartan cilexetil)
Candesartan cilexetil and hydrochlorothiazide treats high blood pressure to help reduce the risk of serious cardiovascular events like strokes and heart attacks. It is often used as part of a comprehensive management plan that includes lifestyle changes like exercise and diet to improve overall heart health. Because many patients require multiple medications to reach their goals, this combination helps manage blood pressure through two distinct pathways.
How CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE Works
Candesartan works by blocking the binding of angiotensin II to specific receptors, which prevents blood vessel constriction and the release of salt-retaining hormones. Hydrochlorothiazide acts as a diuretic that increases the excretion of sodium and chloride through the kidneys, further helping to lower blood pressure.
Details
- Status
- Discontinued
- First Approved
- 2012-12-04
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE Approval History
What CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE Treats
1 indicationsCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE Boxed Warning
FETAL TOXICITY • When pregnancy is detected, discontinue candesartan cilexetil and hydrochlorothiazide tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity...
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue candesartan cilexetil and hydrochlorothiazide tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05826912 APT-TBI-01 | APT-TBI-01 | Ph 2 | enrolling by invitation | Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury |
| NCT05122182 CLARITY 2 | CTC0312 | Ph 2 | terminated | Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19 |
| NCT03847506 REVERT-K | CJ_RVZ_401 | Ph 4 | completed | Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets |
| NCT02332824 results posted | TAK-272/CCT-101 JapicCTI-142658, U1111-1161-6858 | Ph 2 | completed | A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria |
| NCT01734096 | PZ00P3_121655 | Ph 4 | completed | Renal Response to Lower Body Negative Pressure in Pre-hypertensive States |
| NCT02047019 | 14727 2012-004493-26 | Ph 3 | withdrawn | Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil |
| NCT01611077 Sevicontrol-2 | Sevicontrol-2 | Ph 4 | completed | Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg |
| NCT02709187 | DP-CTR208-I-04 | Ph 1 | completed | DP-R208 Pharmacokinetic Study |
| NCT01613209 Sevicontrol1 | Sevicontrol-1 | Ph 3 | completed | Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine |
| NCT02707224 | DP-CTR208-I-02 | Ph 1 | completed | Clinical Trial to Compare the Pharmacokinetics of DP-R208 |
| NCT01135212 | A657-BR-CT-302 | Ph 3 | completed | The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension |
| NCT00905333 | D2452L00021 IMPACT 15381 | Ph 1 | completed | Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal |
| NCT00844324 | D2451C00007 | Ph 1 | completed | Bioequivalence Study in Healthy Subjects |
| NCT01012479 | BLO K027 DE-CAN-027, 2009-011776-30 | Ph 4 | completed | Efficacy and Safety of Candesartan Cilexetil Plus Hydrochlorothiazide in Subjects With Severe Hypertension |
| NCT00621153 CAESAR results posted | D2452L00016 | Ph 4 | completed | Candesartan Effect in Second Stage Arterial Hypertension |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE FDA Label Details
Indications & Usage
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE is indicated for the treatment of Hypertension.
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue candesartan cilexetil and hydrochlorothiazide tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.