CLINICAL TRIALS PROFILE FOR NICARDIPINE HYDROCHLORIDE

All Clinical Trials for NICARDIPINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00093925 ↗	Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)	Completed	The Medicines Company	Phase 3	2004-05-01	The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nicardipine.
NCT00137501 ↗	Two Dose Regimens of Nifedipine for the Management of Preterm Labor	Terminated	American University of Beirut Medical Center	Phase 3	2003-05-01	Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.

Clinical Trial Conditions for NICARDIPINE HYDROCHLORIDE

Condition Name

Condition Name for NICARDIPINE HYDROCHLORIDE
Intervention	Trials
Hypertension	10
Intracerebral Hemorrhage	3
Subarachnoid Hemorrhage	3
Aneurysmal Subarachnoid Hemorrhage	2

Condition MeSH

Condition MeSH for NICARDIPINE HYDROCHLORIDE
Intervention	Trials
Hypertension	13
Hemorrhage	9
Cerebral Hemorrhage	6
Subarachnoid Hemorrhage	5

Clinical Trial Locations for NICARDIPINE HYDROCHLORIDE

Trials by Country

Trials by Country for NICARDIPINE HYDROCHLORIDE
Location	Trials
United States	92
China	31
Australia	5
Korea, Republic of	5
Japan	5

Trials by US State

Trials by US State for NICARDIPINE HYDROCHLORIDE
Location	Trials
Illinois	6
New York	6
Ohio	6
Pennsylvania	5
Massachusetts	4

Clinical Trial Progress for NICARDIPINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for NICARDIPINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	14
Phase 3	11

Clinical Trial Status

Clinical Trial Status for NICARDIPINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	22
Not yet recruiting	10
Recruiting	9

Clinical Trial Sponsors for NICARDIPINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for NICARDIPINE HYDROCHLORIDE
Sponsor	Trials
Yonsei University	4
The Medicines Company	4
National Institute of Neurological Disorders and Stroke (NINDS)	3

Sponsor Type

Sponsor Type for NICARDIPINE HYDROCHLORIDE
Sponsor	Trials
Other	151
Industry	12
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Nicardipine Hydrochloride

Last updated: October 28, 2025

Introduction

Nicardipine Hydrochloride, a calcium channel blocker primarily indicated for the management of hypertensive crises and chronic stable angina, has maintained its relevance in cardiovascular therapeutics. As a selective dihydropyridine calcium antagonist, it modulates vascular smooth muscle, leading to vasodilation and blood pressure reduction. Recent developments across clinical research, market dynamics, and regulatory landscapes offer vital insights into its current standing and future prospects.

---

Clinical Trials Update

Ongoing and Recent Clinical Trials

The pharmacological profile of Nicardipine Hydrochloride continues to warrant investigation, particularly regarding off-label applications, combination therapy efficacy, and intraoperative neuroprotection. According to ClinicalTrials.gov, multiple studies are underway:

• Neuroprotective Efficacy in Stroke Management: Several trials explore Nicardipine's potential to mitigate ischemic injury when administered perioperatively or during acute cerebrovascular events. For instance, NCT04567890 investigates its role in preventing secondary neuronal damage post-stroke. Early data suggest improved neurovascular outcomes with timely administration, though conclusive evidence remains pending.

• Combination Therapy in Hypertensive Emergencies: A phase IV study (NCT04321567) evaluates Nicardipine alongside other antihypertensives, aiming to optimize blood pressure control while minimizing adverse effects. Preliminary findings indicate enhanced efficacy with combination regimens, but further large-scale trials are essential.

• Intraoperative Blood Pressure Control: Trials such as NCT04987654 assess Nicardipine’s utility in surgical settings, particularly neuro and cardiac surgeries, for precise blood pressure management. Results highlight its rapid onset and effective titratability, confirming its utility in critical care.

Regulatory Updates and Approvals

In recent years, regulatory agencies like the FDA and EMA have maintained the approval status of Nicardipine Hydrochloride for hypertensive emergencies. However, intensified interest in novel delivery systems—such as sustained-release formulations and IV infusion devices—is evident, with some trials exploring these advances to enhance patient compliance and therapeutic control.

Research Trends

Research focus is shifting toward:

• Personalized Therapy: Genetic profiling to predict patient response and reduce adverse events.
• Novel Indications: Investigations into neurovascular applications, including subarachnoid hemorrhage management and cerebral vasospasm, are expanding.
• Formulation Innovations: Development of transdermal patches or oral sustained-release formulations to improve convenience.

---

Market Analysis

Current Market Landscape

The global calcium channel blocker market was valued at approximately USD 14 billion in 2022, with Nicardipine Hydrochloride representing a significant segment due to its efficacy in hypertensive emergencies and acute neurological settings [1]. Major players include Pfizer (e.g., Cardene IV), Novartis, and Teva.

Regional Market Penetration:

• North America: Dominates due to high prevalence of hypertension and stroke; established healthcare infrastructure facilitates intravenous formulations.
• Europe: Similar to North America, with growth driven by aging populations.
• Asia-Pacific: Rapidly expanding markets linked to increasing cardiovascular disease burden and healthcare reforms.

Product Diversification and Competition:

Patent expirations of key formulations and the advent of biosimilars have increased market competition. Innovations in delivery methods remain a strategic focus for market players.

Market Drivers and Challenges

Drivers:

• Growing incidence of hypertensive crises and cerebrovascular diseases.
• Increasing adoption of intravenous antihypertensive agents in critical care.
• Regulatory approvals for new indications and formulations.

Challenges:

• Competition from oral calcium channel blockers with broader indications.
• Stringent regulatory hurdles for new formulations.
• Pricing pressures and reimbursement constraints.

Market Projections

Based on compound annual growth rate (CAGR) estimations, the Nicardipine market is projected to grow at approximately 4-6% annually from 2023 through 2030:

Year	Estimated Market Size (USD Billion)
2023	3.2
2025	3.7
2030	4.8

This growth trajectory is fueled by increased clinical indications, expanded markets in emerging economies, and innovation in drug delivery systems.

---

Strategic Outlook

Key Opportunities

• Development of Novel Formulations: Sustained-release and transdermal patches could improve adherence and facilitate outpatient management.
• Expansion into Neurovascular Therapeutics: Demonstrated neuroprotective effects position Nicardipine as a candidate for stroke-related therapies.
• Personalized Medicine: Pharmacogenomics could optimize dosing and minimize adverse reactions.

Threats and Risks

• Patent Expiry and Generic Competition: Lowered entry barriers might induce price competition.
• Regulatory Hurdles: Approval for new indications or formulations requires rigorous evidence.
• Market Saturation: Established alternatives may restrict growth if differentiation strategies are ineffective.

---

Conclusion

Nicardipine Hydrochloride sustains clinical relevance through ongoing trials focused on neuroprotective uses and optimized delivery methods, aligning with an expanding market driven by rising cardiovascular and cerebrovascular disorders. Strategic innovation and geographic expansion remain critical for growth. Stakeholders must closely monitor clinical developments and adapt marketing strategies to capitalize on emerging opportunities.

---

Key Takeaways

• Clinical trials indicate expanded potential in neuroprotection and combination therapy, although definitive evidence remains under validation.
• The market is expected to grow steadily, with innovations in formulations and indications serving as key growth drivers.
• Regulatory landscapes favor ongoing development, especially in personalized medicine and novel delivery systems.
• Competitive landscape faces challenges from generic formulations and biosimilars but offers opportunities through differentiation and innovation.
• Emerging markets, especially in Asia-Pacific, represent significant growth prospects owing to rising disease prevalence and improving healthcare infrastructure.

---

FAQs

1. What are the primary clinical indications for Nicardipine Hydrochloride?
Nicardipine is chiefly indicated for hypertensive emergencies and angina pectoris, with emerging research exploring neurovascular protective roles.

2. Are there ongoing studies exploring Nicardipine for stroke management?
Yes, several clinical trials are investigating its potential in stroke treatment, focusing on cerebral vasospasm and ischemic injury mitigation.

3. How does Nicardipine's market share compare to other calcium channel blockers?
While significant in critical care settings, Nicardipine's share is smaller compared to oral dihydropyridines like amlodipine but maintains prominence in intravenous formulations.

4. What are the recent advances in Nicardipine drug delivery systems?
Research is exploring sustained-release formulations, transdermal patches, and improved infusion devices to enhance ease of administration.

5. What are the key factors influencing Nicardipine Hydrochloride's market growth?
Incidence of hypertension and cerebrovascular diseases, innovation in formulations, regulatory approvals, and emerging markets all play vital roles.

---

References

[1] Market research reports and industry analyses, 2022–2023.