NDAORALTABLET
Approved
Dec 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
4/8 — Partial
THALITONE (chlorthalidone) by R-Pharm US is clinical pharmacology: chlorthalidone is an oral diuretic with prolonged action (48–72 hours) and low toxicity. First approved in 1988.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
THALITONE (chlorthalidone) is an oral thiazide-like diuretic with prolonged action lasting 48–72 hours, used primarily for hypertension and edema management. It works by inhibiting sodium and chloride reabsorption at the cortical diluting segment of the ascending limb of Henle's loop, producing copious diuresis. The drug is approximately equivalent in diuretic efficacy to benzothiadiazine diuretics at comparable therapeutic doses.
$0.538MPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Medicare spending ($538K in 2023), indicating a mature, lower-priority brand requiring defensive positioning rather than growth investment.
Mechanism of Action
CLINICAL PHARMACOLOGY: Chlorthalidone is an oral diuretic with prolonged action (48–72 hours) and low toxicity. The major portion of the drug is excreted unchanged by the kidneys. The diuretic effect of the drug occurs in approximately 2.6 hours and continues for up to 72 hours. The mean half-life…
Pharmacologic Class:
Thiazide-like Diuretic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Efficacy and Safety of Candesartan Associated With Chlorthalidone Versus Losartan Associated With Hydrochlorothiazide (Hyzaar®) in Essential Hypertension Control
Started Nov 2016
0Essential Arterial Hypertension
Efficacy and Safety of Candesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control
Started Nov 2016
0Essential Arterial Hypertension
S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension
Started Dec 2015
170 enrolled
Essential Hypertension
A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone
Started Oct 2011
507 enrolled
Essential Hypertension
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
Started May 2011
975 enrolled
HypertensionStage 2 HypertensionDiabetes
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.