CLINICAL TRIALS PROFILE FOR CHLOROTHIAZIDE

All Clinical Trials for CHLOROTHIAZIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000484 ↗	Treatment of Hypertension	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1966-04-01	To determine whether the long-term treatment of essential hypertension without significant target organ disease materially influenced mortality and/or cardiovascular renal morbidity.
NCT00004360 ↗	Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus	Completed	Northwestern University		1995-09-01	OBJECTIVES: I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.
NCT00004360 ↗	Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus	Completed	National Center for Research Resources (NCRR)		1995-09-01	OBJECTIVES: I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.
NCT00281671 ↗	Nesiritide Use Following Cardiac Surgery in Infants	Terminated	Boston Children's Hospital	Phase 1/Phase 2	2006-04-08	The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.
NCT00281671 ↗	Nesiritide Use Following Cardiac Surgery in Infants	Terminated	Boston Children’s Hospital	Phase 1/Phase 2	2006-04-08	The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.
NCT01721655 ↗	Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease	Unknown status	West Virginia University Healthcare	Phase 2/Phase 3	2012-10-01	Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major complication of premature birth and is associated with a significant increased risk of complications including death. Diuretics have been used for decades in babies with BPD and are considered a standard of care. Patients receive electrolyte supplementation to replace the electrolytes removed by the diuretics. Spironolactone is not as good as other diuretics at removing extra fluid, but it is different from chlorothiazide and furosemide because instead of removing potassium, it actually can increase potassium levels in our body. Spironolactone is used with chlorothiazide to try to minimize the potassium lost; therefore, reduce the electrolyte supplementation needed. However, studies have suggested that preterm babies aren´t developed enough to appropriately respond to spironolactone. Also, one study has shown that adding spironolactone to chlorothiazide in patients with BPD has no effect on whether or not patients receive electrolyte supplementation. This study will examine whether there is a difference in the amount of electrolyte supplementation between patients receiving chlorothiazide only or chlorothiazide plus spironolactone. the investigators hypothesize there will be no difference in the amount of electrolyte supplementation between the two groups.
NCT02546583 ↗	Diagnosing and Targeting Mechanisms of Diuretic Resistance in Heart Failure	Active, not recruiting	National Heart, Lung, and Blood Institute (NHLBI)	Phase 1	2015-08-31	Effective diuresis is the primary goal of most acute decompensated heart failure hospitalizations, but diuretic resistance is common and our ability to detect it is limited. Further, there are therapeutically distinct groups of diuretic-resistant patients. These are not easily distinguished using currently available methods, leading to trial-and-error based treatment that promotes lengthy hospitalizations. The aims of this study are: 1. To develop inexpensive and efficient tools to predict diuretic response 2. To understand the prevalence of therapeutically targetable mechanisms of diuretic resistance using endogenous lithium clearance 3. To develop methodology to differentiate diuretic resistance mechanisms using common/inexpensive laboratory tests 4. To provide proof of concept that mechanistically tailored diuretic therapy can improve natriuresis

Clinical Trial Conditions for CHLOROTHIAZIDE

Condition Name

Condition Name for CHLOROTHIAZIDE
Intervention	Trials
Heart Failure	3
Cardiovascular Diseases	2
Diabetes Insipidus, Nephrogenic	1
Heart Defects, Congenital	1

Condition MeSH

Condition MeSH for CHLOROTHIAZIDE
Intervention	Trials
Heart Failure	4
Cardiovascular Diseases	2
Diabetes Insipidus	1
Vascular Diseases	1

Clinical Trial Locations for CHLOROTHIAZIDE

Trials by Country

Trials by Country for CHLOROTHIAZIDE
Location	Trials
United States	6

Trials by US State

Trials by US State for CHLOROTHIAZIDE
Location	Trials
Louisiana	1
Virginia	1
Tennessee	1
Connecticut	1
West Virginia	1

Clinical Trial Progress for CHLOROTHIAZIDE

Clinical Trial Phase

Clinical Trial Phase for CHLOROTHIAZIDE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CHLOROTHIAZIDE
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Unknown status	1

Clinical Trial Sponsors for CHLOROTHIAZIDE

Sponsor Name

Sponsor Name for CHLOROTHIAZIDE
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	2
Boston Children’s Hospital	1
West Virginia University Healthcare	1

Sponsor Type

Sponsor Type for CHLOROTHIAZIDE
Sponsor	Trials
Other	8
NIH	3

Chlorothiazide: Clinical Trial Update, Market Analysis, and Projection

Last updated: April 23, 2026

What does the current clinical trial landscape show for chlorothiazide?

Chlorothiazide is an established thiazide diuretic with a long commercial history. Clinical activity for the drug today is limited, with most contemporary work focused on comparative efficacy, dosing in specific populations, and formulation or combination studies rather than de novo, phase-advancing development.

Trial activity signals (public registries)

The practical picture from major clinical trial registries is that chlorothiazide’s presence is sporadic and not dominated by large, late-stage programs. Registrations typically skew toward older studies, with periodic updates that do not indicate a near-term wave of phase 3 readouts. The current state is consistent with a “mature asset” profile: clinical relevance remains, but the development pipeline is not expanding rapidly.

Where chlorothiazide is still studied

When chlorothiazide appears in more recent clinical work, it typically maps to these use-cases:

• Hypertension and blood pressure lowering in specific demographic subgroups
• Diuretic strategies in patients with edema or fluid retention where thiazide-class guidance applies
• Comparative evaluation against other thiazides or combination regimens
• Formulation and pharmacokinetic-focused work (including generic bioequivalence-era studies)

Implication for development ROI

Because the clinical trial footprint is not concentrated in late-stage, pivotal programs, the highest-value opportunities tend to be:

• Line-extension work with clear differentiation (fixed-dose combinations, targeted formulations)
• Geographic and regulatory lifecycle management for generic entrants
• Evidence generation for specific label-expansion niches rather than broad phase 3 campaigns

How does chlorothiazide’s market structure look today?

Chlorothiazide’s market is shaped by three forces: (1) off-patent status and wide generic availability, (2) strong class-level prescribing for hypertension and edema-related indications, and (3) pricing pressure that shifts revenue growth toward volume and low-cost distribution.

Market positioning

Chlorothiazide is a thiazide diuretic used as an antihypertensive and for diuretic indications consistent with class practice. In practice, clinicians choose among thiazide options based on dosing convenience, tolerability, availability, and payer preference.

Commercial economics: a mature, generic-dominated model

Market dynamics for chlorothiazide reflect:

• Low barrier to entry for generic manufacturers
• Competitive pricing tied to public and private tendering dynamics
• Revenue growth driven by incremental prescriptions, rather than therapy switching from branded competitors (few, if any, branded programs remain globally)

Competition set

The direct competitive set is the thiazide class:

• Thiazide diuretics (including hydrochlorothiazide and related agents) used for similar therapeutic roles
• Selected combination products that include a thiazide backbone (or thiazide-like components) in fixed-dose formats

Key demand drivers

• Chronic hypertension prevalence and long-term medication persistence
• Guideline adherence to thiazide-class diuretics for first-line or maintenance therapy in appropriate patients
• Hospital and outpatient formularies maintaining thiazides as cost-effective options

What is the basis for a chlorothiazide market projection?

A defensible projection for chlorothiazide rests on maturity assumptions: demand expands slowly with population and baseline hypertension burden, while revenue per unit declines under generic competition and price compression. The projection therefore hinges on volume vs. price and on whether a shift to combination products accelerates or dampens chlorothiazide-specific share.

Projection framework

• Volume trend: modest, tied to hypertension prevalence, adherence, and continued thiazide prescribing
• Price trend: persistent downward or stable-low pricing due to generic competition
• Share trend: risk that more prescriptions migrate from single-agent thiazides to fixed-dose combinations using other components, depending on formulary economics

Scenarios

A practical way to frame projection is to use three scenarios based on class share and pricing:

Scenario	Volume growth	Net price direction	Share dynamics	Revenue outlook
Base case	Low single-digit CAGR	Stable-to-downward	Mild erosion from combination regimens	Slow growth or flattish revenue
Bull case	Low-to-mid single-digit CAGR	Stable pricing	Better-than-expected persistence of chlorothiazide share	Modest value growth
Bear case	Low single-digit CAGR or flat	Downward	Faster shift to combination products and alternate thiazides	Revenue declines or stagnation

Output: what this means for business planning

• For manufacturers: the competitive edge is manufacturing scale, supply reliability, and cost positioning, not clinical differentiation
• For investors: upside comes from capacity economics, tender participation, and portfolio breadth across dosage forms and geographies
• For R&D: late-stage clinical innovation is not the dominant route; differentiation is more likely in formulation and combination strategies aligned with real-world prescribing

What regulatory and clinical constraints shape near-term prospects?

Chlorothiazide’s near-term strategic options are constrained by:

• Off-patent economics across major markets
• Limited room for new clinical endpoints that would drive premium pricing
• Emphasis in practice on class-level evidence and formulary stewardship

Practical constraints for new entrants

• Bioequivalence and manufacturing compliance drive timelines more than novel clinical development
• Any “value-add” strategy must compete with low-cost generics and class alternatives on both price and access

Clinical endpoints and evidence themes: what tends to matter in chlorothiazide-focused work?

Across thiazide-class development and comparative studies, the decision criteria in practice align with:

• Blood pressure reduction endpoints (systolic and diastolic change, responder rates)
• Tolerability (electrolyte changes such as potassium and sodium, renal function markers)
• Safety monitoring related to class effects
• Practical dosing and adherence attributes

Investment and operational takeaways

For chlorothiazide, the market is not a bet on breakthrough efficacy. It is a bet on supply-chain economics and formulary positioning in chronic care.

Where value can still be captured

• Dosage form and packaging optimization to reduce logistics cost and improve adoption
• Combination portfolio strategy (where allowed by formulation and regulatory scope)
• Geography-specific tender execution and contract manufacturing reliability
• Reduced manufacturing cost per unit while maintaining compliance and yield

Where value is structurally limited

• New phase 3 programs unless tied to a specific, differentiated combination or delivery strategy with distinct regulatory path
• Premium pricing strategies absent a differentiated dossier or exclusive access mechanism

Key Takeaways

• Chlorothiazide’s clinical trial presence is mature and not dominated by late-stage, pivotal development activity; most contemporary work aligns with comparative or population-specific evidence and formulation-era studies.
• Market economics are generic-driven, with stable demand tied to chronic hypertension prevalence and persistent pricing pressure from wide competition.
• Revenue outlook in base-case planning is typically flat to slow growth, with outcomes driven more by volume share and pricing than by clinical differentiation.
• Near-term strategic upside is operational: supply reliability, cost position, and portfolio execution, rather than costly late-stage R&D.

FAQs

1. Is chlorothiazide currently in active phase 3 development?
   Public registry visibility does not show a dominant, near-term phase 3 program trajectory for chlorothiazide; activity is sporadic and typically not characterized by large late-stage registration efforts.

2. What therapeutic areas drive chlorothiazide demand?
   Hypertension and thiazide-class diuretic use in edema or fluid retention settings drive demand through long-term chronic prescribing.

3. How does generic competition impact chlorothiazide pricing?
   Generic availability creates persistent price pressure, so revenue growth depends more on unit volume and formulary access than on price increases.

4. Do combination products affect chlorothiazide market share?
   Fixed-dose combinations can shift prescribing away from single-agent thiazides, depending on formulary and payer economics, which can pressure chlorothiazide-specific share.

5. What is the most realistic “value creation” pathway for new entrants?
   Manufacturing cost leadership, dosing/formulation packaging optimization, and geographic tender execution generally outperform novel clinical strategies for an established, off-patent molecule.

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References

[1] ClinicalTrials.gov. Chlorothiazide (search results). National Library of Medicine.
[2] FDA. Drug Trials Snapshots: Guidance and trial context for regulated clinical evidence (general framework). U.S. Food and Drug Administration.
[3] World Health Organization. Hypertension management guidance (thiazide diuretic role in chronic care). WHO.
[4] American Heart Association. Hypertension guideline summaries (thiazide diuretic class use). American Heart Association.