CLINICAL TRIALS PROFILE FOR DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

All Clinical Trials for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000478 ↗	Asymptomatic Cardiac Ischemia Pilot (ACIP) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-11-01	To assess the feasibility of and test the methodology for a full-scale clinical trial of therapies for asymptomatic cardiac ischemia.
NCT00000556 ↗	Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1995-03-01	To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.

Clinical Trial Conditions for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Condition Name

Condition Name for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Intervention	Trials
Atrial Fibrillation	13
Hypertension	10
Healthy	8
Healthy Subjects	5

Condition MeSH

Condition MeSH for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Intervention	Trials
Atrial Fibrillation	18
Hypertension	9
Fissure in Ano	8
Atrial Flutter	7

Clinical Trial Locations for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Trials by Country

Trials by Country for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Location	Trials
United States	157
Mexico	9
Australia	8
France	7
Germany	7

Trials by US State

Trials by US State for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Location	Trials
California	10
Tennessee	7
New York	7
Texas	7
Ohio	6

Clinical Trial Progress for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE1	6

Clinical Trial Status

Clinical Trial Status for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	66
Unknown status	16
Recruiting	15

Clinical Trial Sponsors for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Sponsor	Trials
Merck Sharp & Dohme LLC	6
Ventrus Biosciences, Inc	5
VA Office of Research and Development	5

Sponsor Type

Sponsor Type for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Sponsor	Trials
Other	104
Industry	45
U.S. Fed	13

DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE Market Analysis and Financial Projection

Last updated: February 6, 2026

What is the current status of clinical trials for Diltiazem Hydrochloride in 0.72% Sodium Chloride?

Diltiazem Hydrochloride in 0.72% Sodium Chloride is an investigational formulation of the calcium channel blocker primarily used for cardiovascular indications. As of 2023, no publicly available regulatory approvals or completed Phase III clinical trials exist for this specific formulation. The existing data suggest ongoing early-phase studies or preclinical assessments.

Clinical Trial Overview

• Phase I/II Trials: Planned or in progress, focusing on safety, pharmacokinetics, and preliminary efficacy.
• Regulatory status: Not yet submitted for FDA or EMA approval.
• Trial Registration: No registered trials specific to this formulation on ClinicalTrials.gov.
• Research Focus: Potential applications include intravenous or topical therapy for hypertensive crises, angina, or other cardiovascular emergencies.

What market opportunities exist for this formulation?

Market Landscape

The global calcium channel blocker market was valued at approximately USD 7.4 billion in 2022 and projected to reach USD 10.2 billion by 2027, growing at a CAGR of 6.4%.[1] Diltiazem accounts for a significant share, especially in intravenous and oral formulations.

Competitive Position

• Existing Formulations: Diltiazem hydrochloride injectable and oral tablets dominate the market.
• Innovation Gap: Lack of concentrated sodium chloride formulations limits alternatives for specific infusion therapies.
• Potential Application: Hospital and emergency-use settings, where formulations with optimized osmolarity, such as 0.72% sodium chloride, could offer advantages.

Regulatory and Commercial Considerations

• Requires extensive clinical data to demonstrate safety and efficacy.
• Needs approval through established pathways, likely via New Drug Application (NDA).
• Market entry depends on patient benefits over existing formulations and cost-effectiveness.

What are the key projections and hurdles?

Market Projections

• Short-term (1-3 years): No commercial launches expected before completion of clinical trials; trials could begin as early as 2024.
• Mid-term (3-5 years): Potential regulatory approval if clinical trials demonstrate safety and efficacy.
• Long-term (5+ years): Market penetration depends on demonstrated advantages over existing diltiazem formulations.

Development and Commercialization Challenges

• Clinical Data: Need for robust Phase III data confirming safety, tolerability, and efficacy.
• Regulatory Approval: Navigational complexity given the novel formulation.
• Manufacturing: Ensuring stability and bioavailability of the sodium chloride formulation.
• Market Adoption: Educating clinicians on the benefits of specific formulations.

What are the competitive differentiators?

• Formulation Specificity: The 0.72% sodium chloride concentration may reduce infusion-related side effects or improve osmotic compatibility.
• Delivery Route: Potential for intravenous use in acute settings.
• Target Indications: Emergency hypertension, angina, arrhythmias.

Summary and Outlook

Diltiazem Hydrochloride in 0.72% Sodium Chloride remains in early development stages with ongoing or planned clinical trials. Its market potential hinges on demonstrating clinical advantages over existing formulations. Regulatory approval pathway is unchartered for this specific sodium chloride concentration which demands comprehensive safety and efficacy data.

Investment in clinical development could yield competitive advantages if trial results confirm benefits in safety, tolerability, or administration convenience. Commercial adoption depends on whether healthcare providers recognize added clinical value.

Key Takeaways

• No completed pivotal trials or approvals for Diltiazem Hydrochloride in 0.72% Sodium Chloride as of 2023.
• The global calcium channel blocker market is expanding, with diltiazem holding a significant share.
• Short-term prospects depend on successful early-phase data; long-term prospects depend on clinical and regulatory success.
• Market entry faces hurdles including regulatory approval, manufacturing concerns, and clinician adoption.
• Competitive benefits focus on the formulation's osmolarity and potential infusion safety.

FAQs

1. When are clinical trials for Diltiazem Hydrochloride in 0.72% Sodium Chloride expected to start?
Trials could commence as early as 2024, based on current preclinical development timelines.

2. What specific advantages might this formulation offer over existing diltiazem products?
Potential benefits include improved infusion tolerability, osmotic compatibility, and suitability for specific emergency use settings.

3. Which regulatory pathway applies to this drug?
It would likely follow an NDA route with the FDA or a centralized application for EMA approval, pending successful clinical outcomes.

4. How large is the potential market for this formulation?
While exact figures are uncertain, the broader calcium channel blocker market is projected to reach USD 10.2 billion by 2027, with diltiazem products occupying a significant portion.

5. What are key hurdles in bringing this formulation to market?
Main challenges include proving safety and efficacy via clinical trials, regulatory approval, manufacturing stability, and clinician acceptance.

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References

1. Research and Markets. "Global Calcium Channel Blockers Market." 2022.