TheraRadar
Data updated: May 26, 2026

ATACAND HCT (candesartan cilexetil)

Cardiovascular Approved 2000-09-05

ATACAND HCT is indicated for the treatment of Hypertension.

Source: FDA Label • ANI PHARMS • Thiazide Diuretic

How ATACAND HCT Works

Atacand HCT combines an angiotensin II receptor blocker (ARB

1
Indication
--
Phase 3 Trials
25
Years on Market

Details

Status
Prescription
First Approved
2000-09-05
Routes
ORAL
Dosage Forms
TABLET

Companies

ATACAND HCT Approval History

2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
39 FDA actions from 2000 to 2020
Aug 2020 SUPPL
Label · Labeling
Feb 2016 SUPPL
Label · Labeling
Feb 2015 SUPPL
Label · Labeling

What ATACAND HCT Treats

1 indications

ATACAND HCT is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
Source: FDA Label

ATACAND HCT Boxed Warning

FETAL TOXICITY • When pregnancy is detected, discontinue ATACAND HCT 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...

ATACAND HCT Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ATACAND HCT

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Clinical Trial Registry

14 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
NCT00621153 CAESAR results posted D2452L00016 Ph 4 completed Candesartan Effect in Second Stage Arterial Hypertension
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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 HCT FDA Label Details

Indications & Usage

FDA Label (PDF)

ATACAND HCT is indicated for the treatment of Hypertension.

⚠️ BOXED WARNING

WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ATACAND HCT 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.