TheraRadar
Data updated: Jul 17, 2026

CHLORTHALIDONE · IVAX PHARMS

Generic · see HEMICLOR
Cardiovascular Approved 1960-04-07

CHLORTHALIDONE is FDA-approved to treat 6 conditions (same as THALITONE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
36
Indications
--
Phase 3 Trials
66
Years on Market

Details

Status
Prescription
First Approved
1960-04-07
Routes
ORAL
Dosage Forms
TABLET

Companies

IVAX PHARMS ANI PHARMS ABBOTT Teva USL PHARMA INGENUS PHARMS LLC IPCA LABS LTD WATSON LABS INC SUPERPHARM WARNER CHILCOTT VANGARD ZYDUS PHARMS PUREPAC PHARM MUTUAL PHARM MACLEODS PHARMS LTD PHARMOBEDIENT Novartis DAVA PHARMS INC Sun Pharma PIONEER PHARMS APPCO ALEMBIC ASCOT CHARTWELL RX INVENTIA UNICHEM LABS LTD AJANTA PHARMA LTD MANKIND PHARMA AMNEAL PHARMS AIPING PHARM INC KV PHARM COSETTE PHARMS NC SUNNY Viatris UMEDICA ALKEM LABS LTD
Active Ingredient: CHLORTHALIDONE

CHLORTHALIDONE Approval History

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Original
New Indication
New Form
Label Update
389 FDA actions from 1981 to 2026
Jul 2026 ORIGINAL
Update
Nov 2024 ORIGINAL
Update
Oct 2022 SUPPL
Mfg · Manufacturing (CMC)

What CHLORTHALIDONE Treats

6 indications

CHLORTHALIDONE is approved for 6 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as THALITONE (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

17 trials
Trial Sponsor ID Phase Status Title
NCT05915286 DIURESED Pro00119451 Ph 4 terminated Diuretic Use in Hemodialysis Patients With Residual Renal Function
NCT05593055 2022P002126 Ph 4 recruiting Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension
NCT07225764 STUDY-25-00784 Ph 4 recruiting CaOx Stone Prevention
NCT05275907 STU00215781 1R56HL155093-01 Ph 4 withdrawn Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN)
NCT02841280 CLICK results posted 1507540384 Ph 2 completed Chlorthalidone in Chronic Kidney Disease
NCT04757532 ESPAMA IMIMFTCL/ESPAMA Ph 1 completed Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.
NCT03325114 results posted 66282 1K23DK114477-01 Ph 2 terminated Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
NCT03923933 results posted DI/19/105-B/03/018 Ph 2 completed Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial
NCT02236520 results posted 141382 Ph 2 completed Tissue Sodium in Pre-hypertensive Patients
NCT01203852 PEAR2 results posted IRB201700661-N U01GM074492-06 Ph 4 completed Pharmacogenomic Evaluation of Antihypertensive Responses 2
NCT01748123 PCORI-EGID 4231 00041242 Ph 4 withdrawn EBMtrialcentral- Comparing Initial Diuretic Therapies Using a Collaborative Network
NCT02644395 TT MEC-2012-417 Ph 3 completed Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus
NCT02030314 HM20002960 Ph 4 withdrawn The Management of Resistant Hypertension in Kidney Transplant Patients Using Chlorthalidone
NCT01750294 results posted 1206009002 1206009002 Ph 4 completed A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD
NCT02152969 YH22162-101 Ph 1 completed Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)
NCT01368536 VALENCIA results posted CSPV100AUS05 Ph 4 terminated Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes
NCT00847626 results posted TAK-491CLD_302 2008-004218-28, U1111-1113-8735 Ph 3 completed Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

CHLORTHALIDONE FDA Label Details

Indications & Usage

FDA Label (PDF)

CHLORTHALIDONE is FDA-approved to treat 6 conditions — same approved indications as THALITONE.

Looking for the branded version?

HEMICLOR

Full clinical data, patents, trials, and competitive landscape for chlorthalidone.

See HEMICLOR

Data Sources

FDA Approval: ANDA087176 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.