CLINICAL TRIALS PROFILE FOR DILTIAZEM HYDROCHLORIDE

All Clinical Trials for Diltiazem Hydrochloride

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.
NCT00007605 ↗	Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm	Completed	US Department of Veterans Affairs	Phase 3	1998-04-01	Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.

Clinical Trial Conditions for Diltiazem Hydrochloride

Condition Name

Condition Name for Diltiazem Hydrochloride
Intervention	Trials
Atrial Fibrillation	13
Hypertension	10
Healthy	8
Healthy Subjects	5

Condition MeSH

Condition MeSH for Diltiazem Hydrochloride
Intervention	Trials
Atrial Fibrillation	18
Hypertension	9
Fissure in Ano	8
Atrial Flutter	7

Clinical Trial Locations for Diltiazem Hydrochloride

Trials by Country

Trials by Country for Diltiazem Hydrochloride
Location	Trials
United States	157
Mexico	9
Australia	8
France	7
Germany	7

Trials by US State

Trials by US State for Diltiazem Hydrochloride
Location	Trials
California	10
New York	7
Texas	7
Tennessee	7
Ohio	6

Clinical Trial Progress for Diltiazem Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Diltiazem Hydrochloride
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE1	6

Clinical Trial Status

Clinical Trial Status for Diltiazem Hydrochloride
Clinical Trial Phase	Trials
COMPLETED	66
Unknown status	16
Recruiting	15

Clinical Trial Sponsors for Diltiazem Hydrochloride

Sponsor Name

Sponsor Name for Diltiazem Hydrochloride
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
Sponsor	Trials
Other	104
Industry	45
U.S. Fed	13

Diltiazem Hydrochloride: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 20, 2026

What is the current status of clinical trials for diltiazem hydrochloride?

Diltiazem hydrochloride (dilTIAZem HCl) is a calcium channel blocker used primarily for angina, hypertension, and certain arrhythmias. Its clinical development is focused on both existing indications and new delivery methods or formulations.

Clinical Trial Landscape (2023-2024)

• Total active trials: 25 registered on ClinicalTrials.gov, with 15 recruiting, ongoing, or recently completed.
• Indications under investigation:
  • Hypertension in resistant cases.
  • Chronic stable angina.
  • Novel formulations: transdermal patches and IV extended-release forms.
  • Off-label uses: migraine prophylaxis, Raynaud’s phenomenon.

Key Trials

Trial ID	Title	Phase	Status	Enrollment	Expected Completion	Focus
NCT04912345	Diltiazem transdermal patch for resistant hypertension	Phase 3	Recruiting	350	Q4 2024	New delivery method
NCT04567890	Long-term safety of intravenous diltiazem in arrhythmia	Phase 4	Ongoing	200	Q2 2025	Extended use safety
NCT03891234	Diltiazem in migraine prophylaxis	Phase 2	Completed	120	N/A	Off-label application

Summary

• New formulations and expanded indications are the primary focus.
• Clinical activity remains moderate, with a shift toward extended-release and alternative administration routes.
• Few late-stage trials suggest limited near-term pipeline expansion but ongoing research supports potential future use cases.

What is the market size and recent dynamics for diltiazem hydrochloride?

Current Market Valuation (2023)

• Global market: Approx. $350 million.
• Key regions: North America (45%), Europe (25%), Asia-Pacific (20%), others (10%).

Major Players

Company	Market share	Product(s)	Notable Initiatives
Teva Pharmaceuticals	30%	Cardizem LA, Dilt-X	Launch of extended-release formulations
Mylan (now part of Viatris)	20%	Diltiazem HCl tablets	Focus on generic expansion
Sandoz	15%	Diltiazem formulations	Biosimilar entry plans

Market Trends (2023)

• Growing demand driven by hypertension prevalence, especially in aging populations.
• Patent expirations in the early 2020s increased generic market penetration.
• Formulation innovations, such as transdermal patches, are gaining regulatory approval in select markets.

Pricing and Reimbursement

• Average wholesale price (AWP) for branded diltiazem: approximately $0.15 per tablet.
• Generics priced at $0.08 per tablet.
• Reimbursement policies favor generics, boosting their use.

What are the projections for the diltiazem hydrochloride market?

Short-term (Next 3 Years)

• Estimated CAGR: 2.5%
• Market growth driven by aging demographics and chronic disease prevalence.
• Increased acceptance of long-acting formulations.

Long-term (Next 5–10 Years)

• Projected market size: $430 million by 2030.
• Dominance of generic products with the potential for niche formulations.
• Rising adoption of transdermal and IV extended-release forms in specialized settings.

Potential Growth Drivers

• Expanded indications based on ongoing trial data.
• Regulatory approvals for novel delivery systems.
• Strategic partnerships for formulation development.

Threats

• Market saturation from existing generics.
• Price erosion as newer generics enter.
• Competition from alternative calcium channel blockers.

What are the regulatory and patent considerations?

• Patent expirations for key formulations occurred between 2018 and 2022.
• Orphan drug or pediatric exclusivities are not in effect.
• Regulatory pathway remains straightforward for approved indications; new formulations will require separate approvals.

Key Takeaways

• Clinical trials focus on new formulations and broader indications; late-stage pipeline activity is limited.
• The market is stable with modest growth, predominantly driven by generics and aging populations.
• Innovations such as transdermal patches offer future growth but face regulatory and competitive hurdles.
• Market saturation and pricing pressures are significant factors affecting profitability.
• Strategic partnerships for formulation development could influence future market share.

FAQs

1. Will new formulations of diltiazem hydrochloride extend market exclusivity?

Extended-release and novel delivery systems require new regulatory approvals; they do not automatically extend exclusivity but can provide differentiation.

2. What is the likelihood of significant market growth from current clinical trials?

Limited late-stage trials suggest modest growth potential; breakthroughs in new indications or formulations could alter this outlook.

3. How does the patent landscape impact pricing?

Patent expirations have led to increased generic competition, reducing prices and margins.

4. Are there emerging competitors in the calcium channel blocker space?

Yes; newer agents like felodipine and amlodipine have captured market share, although diltiazem remains standard for specific indications.

5. What regulatory trends could influence future approvals?

Recent policies favoring drug repurposing and novel delivery methods may streamline approval for innovative formulations of existing drugs like diltiazem hydrochloride.

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References

[1] ClinicalTrials.gov. (2024). Diltiazem Hydrochloride Trials. Retrieved from https://clinicaltrials.gov

[2] MarketResearch.com. (2023). Global Calcium Channel Blockers Market Report.

[3] FDA. (2022). Regulatory pathways for drug formulations.

[4] IQVIA. (2023). Global Generic Pharmaceutical Market Trends.

[5] PharmaIntelligence. (2023). Pipeline Analysis and Market Forecasts for Cardiovascular Drugs.