THALITONE (chlorthalidone)
Thalitone is a long-acting diuretic used to lower blood pressure in patients with hypertension. Lowering blood pressure with this medication helps patients reduce their risk of strokes and heart attacks. It also helps patients with edema by acting as an additional therapy for fluid retention associated with heart failure, liver cirrhosis, and kidney diseases.
How THALITONE Works
This medication works by targeting the distal convoluted tubule of the nephron in the kidneys. It promotes the depletion of sodium and water from the body, which serves as the basis for its blood-pressure-lowering effects.
Details
- Status
- Prescription
- First Approved
- 1984-07-13
- Routes
- ORAL
- Dosage Forms
- TABLET
THALITONE Approval History
What THALITONE Treats
6 indicationsTHALITONE is approved for 6 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Edema
- Heart Failure
- Cirrhosis
- Renal Disease
- Nephrotic Syndrome
THALITONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 THALITONE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications THALITONE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to THALITONE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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| NCT05275907 | STU00215781 1R56HL155093-01 | Ph 4 | withdrawn | Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN) |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 |
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.
THALITONE FDA Label Details
Indications & Usage
FDA Label (PDF)THALITONE is indicated for the treatment of Hypertension; Edema; Heart Failure; Cirrhosis; Renal Disease; Nephrotic Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.