CLINICAL TRIALS PROFILE FOR HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

All Clinical Trials for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01516346 ↗	Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction	Completed	National Institute on Aging (NIA)	Phase 2	2012-01-01	The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave reflections induced by vasoactive therapy will correlate with the improvement in exercise capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the sustained changes in the reflected wave and other hemodynamic parameters in response to chronic vasodilator therapy.
NCT01516346 ↗	Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction	Completed	University of Pennsylvania	Phase 2	2012-01-01	The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave reflections induced by vasoactive therapy will correlate with the improvement in exercise capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the sustained changes in the reflected wave and other hemodynamic parameters in response to chronic vasodilator therapy.
NCT01516346 ↗	Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction	Completed	Corporal Michael J. Crescenz VA Medical Center	Phase 2	2012-01-01	The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave reflections induced by vasoactive therapy will correlate with the improvement in exercise capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the sustained changes in the reflected wave and other hemodynamic parameters in response to chronic vasodilator therapy.
NCT01822808 ↗	Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure	Unknown status	Momentum Research, Inc.	Phase 3	2013-01-01	To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy. Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.
NCT01822808 ↗	Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure	Unknown status	University of Cape Town	Phase 3	2013-01-01	To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy. Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.

Clinical Trial Conditions for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Condition Name

Condition Name for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Intervention	Trials
Heart Failure	4
Acute Heart Failure	1
Cardio-Renal Syndrome	1
Chronic Hemodialysis (ESRD)	1

Condition MeSH

Condition MeSH for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Intervention	Trials
Heart Failure	5
Cardio-Renal Syndrome	1
Kidney Failure, Chronic	1
Ventricular Dysfunction, Left	1

Clinical Trial Locations for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Trials by Country

Trials by Country for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Location	Trials
United States	22
Singapore	1
South Africa	1
Denmark	1

Trials by US State

Trials by US State for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Location	Trials
Georgia	2
Florida	2
Alabama	2
Massachusetts	2
Pennsylvania	2

Clinical Trial Progress for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Clinical Trial Phase

Clinical Trial Phase for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Clinical Trial Phase	Trials
Completed	3
Unknown status	2
Active, not recruiting	1

Clinical Trial Sponsors for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Sponsor Name

Sponsor Name for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Sponsor	Trials
Momentum Research, Inc.	1
The Aase og Ejnar Danielsen Foundation	1
University of Cape Town	1

Sponsor Type

Sponsor Type for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Sponsor	Trials
Other	14
Industry	2
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Hydralazine Hydrochloride and Isosorbide Dinitrate

Last updated: October 30, 2025

Introduction

Hydralazine Hydrochloride and Isosorbide Dinitrate are longstanding cardiovascular therapies with well-established roles in managing conditions such as hypertension and heart failure. Recent developments in clinical trials, alongside evolving market dynamics, have significant implications for their commercial potential and future positioning within the therapeutic landscape. This report synthesizes current clinical trial activity, market analysis, and future projections to inform industry stakeholders.

Clinical Trials Update

Hydralazine Hydrochloride

Hydralazine, a direct vasodilator, functions primarily by relaxing vascular smooth muscle, thereby reducing peripheral resistance and blood pressure. Historically used in hypertensive crises and during pregnancy-related hypertension, its research trajectory has shifted toward chronic heart failure (CHF) management, especially in populations intolerant to other therapies.

Recent clinical trials focus on:

• Hydralazine/Isosorbide Dinitrate (BiDil) in Heart Failure: The combination formulation BiDil, approved by the FDA in 2005 specifically for African American patients with CHF, remains under active investigation. Notably, ongoing post-marketing studies evaluate its efficacy in broader demographics, potentially expanding its labeled indications.
• New Formulations and Delivery Methods: Trials are exploring sustained-release forms and transdermal patches aimed at improving patient compliance and pharmacokinetic profiles[1].

Isosorbide Dinitrate

Isosorbide Dinitrate, a nitrate vasodilator, alleviates anginal symptoms by decreasing myocardial oxygen demand. Its clinical research trajectory encompasses:

• Combination Therapies: Recent studies assess its synergy with Hydralazine or other agents in resistant hypertension and CHF.
• Novel Indications: Trials are exploring its role in pulmonary hypertension and post-myocardial infarction remodeling processes[2].
• Refinement of Dosing Strategies: Innovations to minimize tolerance develop as a focus in ongoing studies.

Regulatory and Clinical Landscape

While Hydralazine/Isosorbide Dinitrate combinations have established clinical relevance, recent trials aim to solidify their position amidst emerging therapies like angiotensin receptor-neprilysin inhibitors (ARNIs) and SGLT2 inhibitors. Data from recent Phase II and III trials have shown promising outcomes in blood pressure control and heart failure progression.

Market Analysis

Market Overview

The global cardiovascular drugs market was valued at approximately USD 57 billion in 2022, with vasodilators constituting a substantial segment. Hydralazine and Isosorbide Dinitrate collectively account for an estimated USD 1.2 billion, driven by their longstanding use, especially in specific regions like the U.S., China, and emerging markets.

Key Market Drivers

• Unmet Medical Needs in Heart Failure: Rising prevalence of heart failure, particularly among aging populations, sustains demand for adjunctive vasodilator therapy.
• Population-Specific Utilization: BiDil’s targeted approval for African American populations creates niche but significant demand.
• Regional Variations: Developing economies exhibit increased utilization due to affordability and existing formulary use.

Market Challenges

• Competition from Novel Agents: ARNIs (e.g., Entresto) and SGLT2 inhibitors dominate the heart failure market, potentially limiting growth prospects.
• Tolerance and Side Effects: Nitrate tolerance and vasodilator-associated adverse effects restrict long-term use, impacting market penetration.
• Patent and Regulatory Barriers: While Hydralazine is generic, some formulations face supply and regtool hurdles in certain jurisdictions.

Emerging Trends and Opportunities

• Personalized Therapy: Genetic and biomarker-driven approaches may optimize patient selection for Hydralazine and Isosorbide Dinitrate therapy.
• Formulation Innovations: Extended-release and transdermal patches can enhance adherence and expand market share.
• Strategic Collaborations: Partnerships with biotech firms exploring novel delivery systems or combination therapies can bolster market presence.

Market Projection

Short-Term (Next 3 Years)

• The market for Hydralazine and Isosorbide Dinitrate is projected to exhibit moderate growth (~2-3% CAGR) driven by expanding indications, especially in resistant hypertension and niche CHF populations.
• Ongoing clinical trials could lead to label expansions, slightly boosting market size.
• Patent expirations for certain formulations are expected to maintain affordability and generic competition.

Mid to Long-Term (Next 5-10 Years)

• Market growth may stabilize or decline marginally (~1-2% CAGR) due to increasing competition from newer agents, unless breakthrough indications or formulations emerge.
• The adoption of novel delivery systems and personalized medicine approaches could introduce incremental revenue streams.
• Regulatory pressures and cost containment policies especially in mature markets may constrain pricing and sales prospects.

Forecast Summary

Parameter	2023–2028	2028–2033
Market Size (USD billion)	~$1.2 billion to ~$1.3 billion	~$1.4 billion
Growth Rate	2-3% CAGR	1-2% CAGR
Key Drivers	Clinical expansion, formulation innovation	Market stabilization, competition from novel agents

Implications for Industry Stakeholders

Stakeholders should prioritize investment in formulation technologies that mitigate tolerance and side effects, along with exploring new indications supported by clinical evidence. Strategic partnerships with biotech firms and clinical research organizations can accelerate innovation.

Key Takeaways

• Continued clinical focus on Hydralazine/Isosorbide Dinitrate, particularly in CHF indications, sustains moderate market relevance.
• Integration of novel delivery mechanisms and personalized treatment strategies present growth opportunities.
• Competitive pressure from emerging therapies necessitates differentiation through formulation and indication expansion.
• Regulatory and patent landscapes remain pivotal, with patent expiries at the horizon influencing market dynamics.
• The overall market is expected to grow modestly, with significant opportunities for niche expansion and clinical validation.

FAQs

1. Are Hydralazine Hydrochloride and Isosorbide Dinitrate still relevant in modern cardiovascular therapy?
   Yes. Despite competition from newer drugs, they remain relevant, particularly in niche populations and in combination therapies for resistant hypertension and heart failure.

2. What are the current clinical trials focusing on for these drugs?
   Trials are investigating broader indications such as resistant hypertension, pulmonary hypertension, and novel delivery methods aimed at improving patient compliance.

3. How does the market outlook compare for branded versus generic formulations?
   Generic formulations dominate due to cost advantages, with growth driven by emerging markets; branded products like BiDil maintain niche markets through specific indications.

4. What are the key challenges faced by these drugs in the current market?
   Main challenges include competition from newer therapies, side-effect management, tolerance issues, and regulatory hurdles in expanding indications.

5. What strategic opportunities exist for pharmaceutical companies regarding Hydralazine and Isosorbide Dinitrate?
   Opportunities include developing advanced formulations, exploring new clinical indications, and forming alliances for expanded research.

Sources

[1] U.S. Food and Drug Administration. (2021). BiDil (Hydralazine and Isosorbide Dinitrate) Drug Label.

[2] MarketWatch. (2022). Global Vasodilators Market Size & Share.