ATACAND (candesartan cilexetil)
Atacand treats high blood pressure in adults and children as young as one year old. By lowering blood pressure, it helps patients reduce their risk of suffering from strokes or heart attacks. It is also used for patients with heart failure to help lower the chances of cardiovascular death and hospitalization.
How ATACAND Works
This drug works by selectively blocking the binding of angiotensin II to the AT1 receptor in tissues like vascular smooth muscle and the adrenal gland. By preventing this binding, it stops the hormone from causing vasoconstriction and releasing aldosterone, which results in lower blood pressure. Because it targets the receptor directly, it does not interfere with the breakdown of bradykinin.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-06-04
- Routes
- ORAL
- Dosage Forms
- TABLET
ATACAND Approval History
What ATACAND Treats
2 indicationsATACAND is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Heart Failure
ATACAND Boxed Warning
FETAL TOXICITY • When pregnancy is detected, discontinue ATACAND 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 ATACAND as soon as possib...
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ATACAND 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 ATACAND 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 )
ATACAND 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 ATACAND's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ATACAND treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ATACAND
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| 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 |
| NCT02254447 | 201713 | Ph 1 | completed | Relative Bioavailability Study of Candesartan Cilexetil Under Fasting Conditions |
| 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 |
| 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.
ATACAND FDA Label Details
Indications & Usage
FDA Label (PDF)ATACAND is indicated for the treatment of Hypertension; Heart Failure.
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ATACAND 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 Pr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment