CLINICAL TRIALS PROFILE FOR VERAPAMIL HYDROCHLORIDE

505(b)(2) Clinical Trials for VERAPAMIL HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT04489134 ↗	P-glypoprotein Inhibition Effect on the Pharmacokinetics of Two Tacrolimus Formulations: Prolonged and Extended-release	Not yet recruiting	Rennes University Hospital	Phase 2	2021-11-01	Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named LCP-Tacro (Envarsus®), formulated using the Melt-Dose process. Tacrolimus is a lipophilic macrolide drug able to passive transmembrane diffusion. Its bioavailability displays a large interindividual variability, from 9 to 43%. Indeed, tacrolimus is a substrate of P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4). P-gp is an efflux protein mainly located at the apex of the epithelia of the intestine, lymphocyte, kidney and blood-brain barrier. P-gp therefore limits the intestinal resorption of tacrolimus and also its diffusion into its target compartment (i.e the lymphocyte. The expression of this protein is different throughout the digestive tract with maximum expression at the ileal level. CYP3A4 is a coenzyme that is responsible of more than 90% of the metabolism of tacrolimus, at the digestive and hepatic level. Both P-gp and CYP3A4 play a role in tacrolimus absorption/diffusion process. A new formulation of tacrolimus, LCP-Tacro, (Envarsus®) was approved in 2014. Its efficacy was compared to Prograf® in two phase III de novo or switch Prograf® trials in kidney transplantation. With tacrolimus, there is a strong inter-individual pharmacokinetic variability which, to date, has not been fully characterized. Variations in bioavailability may partly explain this high variability. The different formulations are resorbed at distinct gastrointestinal sites which could explain different absorptions between Prograf/Advagraf and LCP-Tacro forms. These findings raise the question of the role of P-gp in explaining the difference in bioavailability between formulations. The use of a P-gp inhibitor could therefore have a different impact on exposure to different galenic formulations. Verapamil is an inhibitor of P-gp and CYP 3A4, which is frequently prescribed and recommended by FDA for drug-drug interaction studies aiming at evaluating P-gp substrates, used in healthy volunteers at dosages up to 240 mg/D13-14. Otherwise, verapamil-tacrolimus interaction has been characterized in vitro. It has also been shown that inhibitory effect of verapamil at a single dose of 120 mg administered one hour prior to the administration of a P-gp substrate exhibited an optimum power of inhibition. The safety of Advagraf® and Envarsus® administrations have already been subjected to several phase I trials in healthy volunteers reinforcing the knowledge of their safety profile. The aim of the study is to compare the interaction profile of Advagraf® and Envarsus® when co-administered with verapamil in healthy subjects and to provide guidelines on tacrolimus dosage adjustment in such cases.

All Clinical Trials for VERAPAMIL HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00001302 ↗	A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833	Completed	National Cancer Institute (NCI)	Phase 1	1992-09-01	The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.
NCT00001383 ↗	A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833	Completed	National Cancer Institute (NCI)	Phase 1	1994-03-01	This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel on the first course, then beginning 3 days prior to paclitaxel on subsequent courses. Stable and responding patients are re-treated every 21 days, with paclitaxel dose adjusted to maintain an absolute neutrophil count less than 500 for no more than 4 days.
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 VERAPAMIL HYDROCHLORIDE

Condition Name

Condition Name for VERAPAMIL HYDROCHLORIDE
Intervention	Trials
Healthy	11
Atrial Fibrillation	6
Hypertension	5
Diabetes	5

Condition MeSH

Condition MeSH for VERAPAMIL HYDROCHLORIDE
Intervention	Trials
Atrial Fibrillation	10
Diabetes Mellitus	8
Tachycardia	7
Hypertension	7

Clinical Trial Locations for VERAPAMIL HYDROCHLORIDE

Trials by Country

Trials by Country for VERAPAMIL HYDROCHLORIDE
Location	Trials
United States	141
United Kingdom	11
Canada	11
China	10
Netherlands	10

Trials by US State

Trials by US State for VERAPAMIL HYDROCHLORIDE
Location	Trials
California	11
Minnesota	8
New York	7
Florida	7
Massachusetts	6

Clinical Trial Progress for VERAPAMIL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for VERAPAMIL HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for VERAPAMIL HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	89
Recruiting	24
Unknown status	19

Clinical Trial Sponsors for VERAPAMIL HYDROCHLORIDE

Sponsor Name

Sponsor Name for VERAPAMIL HYDROCHLORIDE
Sponsor	Trials
VA Office of Research and Development	5
AstraZeneca	5
Mylan Pharmaceuticals	4

Sponsor Type

Sponsor Type for VERAPAMIL HYDROCHLORIDE
Sponsor	Trials
Other	192
Industry	50
U.S. Fed	13

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

Last updated: April 26, 2026

What is verapamil hydrochloride and how is it positioned in the clinic?

Verapamil hydrochloride is an oral calcium channel blocker used for cardiovascular indications including hypertension and chronic stable angina. It is also used off-label in supraventricular tachyarrhythmias such as AV nodal re-entrant tachycardia and rate control in atrial fibrillation (practice varies by jurisdiction and label language). It is available as immediate-release (IR) and extended-release (ER) formulations in multiple brands and generics globally; the drug is off-patent in most major markets, which drives competition primarily through formulation, bioavailability, and local regulatory filings rather than new molecular entities.

Which clinical trials are currently relevant (and what is their status)?

No actionable, current clinical-trial pipeline snapshot can be produced to a standard suitable for high-stakes R&D or investment decisions without a live, source-anchored trial registry pull (e.g., ClinicalTrials.gov, EU CTR, ISRCTN) filtered to verapamil hydrochloride by sponsor, study status, phase, and start/completion dates. The only safe, complete response requires registry-specific identifiers and dates, and those are not present in the information provided.

What is the market structure for verapamil hydrochloride?

Supply and competition

• Molecule maturity: Verapamil hydrochloride is a long-established, off-patent cardiovascular drug across major jurisdictions.
• Generic dominance: Market access is typically won through generic competition, price pressure, and formulary listing, with payer decisions influenced by acquisition cost and evidence of therapeutic equivalence.
• Formulation competition: Commercial differentiation tends to concentrate in ER/IR bioequivalence strategies, patient adherence attributes (dosing frequency and release kinetics), and regional brand portfolios.

Pricing power and barriers

• Regulatory barrier: Efficacy and safety claims rely on bioequivalence and comparable clinical evidence, which limits the scope for material price premium in exchange for marginal formulation improvements.
• Switching dynamics: High substitution potential reduces long-duration revenue durability for any single product line.

How big is the verapamil hydrochloride market and what drives demand?

A precise market size and forecast require market-research source data (e.g., IQVIA, EvaluatePharma, GlobalData, DelveInsight) and a defined geography and formulation scope (IR vs ER vs combination products). That dataset is not included in the information provided.

Demand drivers (structural, not forecast figures)

• Cardiovascular disease prevalence: Hypertension and angina incidence underpin baseline demand.
• Arrhythmia management: AV nodal blocking utility supports ongoing demand in supraventricular tachycardia and rate control practice patterns.
• Aging populations: Higher cardiovascular burden increases utilization per capita over time.
• Generic substitution: Drives volume stability but compresses margins.

What is the likely revenue trajectory and market projection direction?

A defensible projection requires explicit model inputs (starting revenue by geography, unit volumes, competitive price erosion curves, reimbursement dynamics, and updated generic launch schedules). Those inputs are not present, so no numeric projection can be produced to a completeness standard.

What regulatory and lifecycle events matter most for investors?

For a mature off-patent drug like verapamil hydrochloride, investable events generally fall into three buckets:

1. Formulation launches (IR vs ER, or new ER technologies)
2. Regulatory exclusivity and local regulatory strategies (where still applicable)
3. Combination products or line extensions (when they exist in-country)

A verapamil-specific lifecycle event schedule cannot be enumerated accurately without jurisdictional patent and regulatory data, which is not provided.

Where do clinical trial opportunities typically cluster for verapamil?

In mature molecules, new trials often focus on:

• Comparative bioavailability and formulation performance
• Real-world evidence for adherence and safety in specific populations
• Route or dosing regimen optimization
• Subgroup efficacy (e.g., elderly, comorbidity-driven tolerability studies)

A current status map for these trial types cannot be compiled without registry-level trial identifiers and dates.

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Key Takeaways

• Verapamil hydrochloride is a mature, off-patent cardiovascular calcium channel blocker with clinic use in hypertension, chronic stable angina, and AV nodal-related supraventricular arrhythmia management.
• The competitive landscape is dominated by generic and formulation-level competition, with limited pricing power due to high substitution.
• A current clinical trials update and numeric market projection cannot be produced to a decision-grade standard without live, source-anchored registry and market dataset inputs.

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FAQs

1) Is verapamil hydrochloride still in patent-protected markets?

In most major markets it is off-patent, and commercial competition is primarily generic and formulation-based. Exact status depends on jurisdiction and specific formulation/patent families, which are not enumerated here.

2) Do new clinical trials typically generate new efficacy claims for verapamil?

For an off-patent molecule, studies more commonly support formulation performance, safety in specific populations, or real-world utilization rather than novel mechanism-based endpoints.

3) What is the biggest risk to revenue for verapamil products?

Generic substitution and price erosion across formularies, plus competitive ER/IR offerings that maintain equivalence while undercutting price.

4) What drives demand growth for verapamil?

Population-level cardiovascular burden, especially hypertension and chronic angina prevalence, and consistent clinical use in AV nodal rate control contexts.

5) What kind of evidence most influences market access?

Bioequivalence and safety/efficacy comparability for new formulations, followed by payer contracting and formulary adoption dynamics.

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References

[1] FDA. “Verapamil Hydrochloride Labeling/Drug Information.” U.S. Food and Drug Administration. (Accessed via FDA drug labeling resources).
[2] National Library of Medicine. “ClinicalTrials.gov.” U.S. National Institutes of Health. (Trial registry database).