CLINICAL TRIALS PROFILE FOR AMLODIPINE BESYLATE; CELECOXIB

All Clinical Trials for amlodipine besylate; celecoxib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02172040 ↗	Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy	Completed	Kitov Pharmaceuticals, Ltd.	Phase 3	2014-06-26	The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate in subjects with newly diagnosed hypertension requiring antihypertensive therapy. This study was conducted to support a future marketing application for KIT-302. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib. The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study, two separate capsules were utilized: one containing a commercial celecoxib capsule (Celebrex®) or matched placebo capsule and one containing a commercial amlodipine besylate tablet (Norvasc®) or matched placebo tablet. The study hypothesis was that treatment with the amlodipine besylate containing capsule plus the celecoxib containing capsule would reduce blood pressure (BP) in subjects with hypertension with an efficacy that is not substantially inferior to the effect of amlodipine besylate alone (i.e., the amlodipine containing capsule plus the matched placebo for the celecoxib capsule). The United States (US) Food and Drug Administration (FDA) recently approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA) 210045] for the following indication: "patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions."
NCT02979197 ↗	Evaluation of Celecoxib Effects on Amlodipine in Subjects With Existing Hypertension Requiring Antihypertensives	Completed	Kitov Pharma Ltd	Phase 3	2016-11-03	The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate on renal and vascular function in subjects with existing hypertension requiring antihypertensive therapy. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib. The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study (KIT-302-03-02), commercial celecoxib capsules (Celebrex®) and commercial amlodipine besylate tablets (Norvasc®) were separately over-encapsulated (OE) and matched placebos were used to allow for blinding. Kitov completed a phase 3 pivotal trial in subjects with newly diagnosed hypertension (KIT-302-03-01) demonstrating that the amlodipine + celecoxib combination was statistically non-inferior to amlodipine monotherapy with regard to reduction of blood pressure. Further, trends towards superior blood pressure lowering effects and improved renal function were observed for the combination. This study (KIT-302-03-02) was conducted to quantify the beneficial renovascular effects noted in the prior study in subjects with existing hypertension requiring antihypertensive therapy. On May 31, 2018, the United States (US) Food and Drug Administration (FDA) approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA) 210045] for the following indication: "patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions."
NCT02979197 ↗	Evaluation of Celecoxib Effects on Amlodipine in Subjects With Existing Hypertension Requiring Antihypertensives	Completed	Kitov Pharmaceuticals, Ltd.	Phase 3	2016-11-03	The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate on renal and vascular function in subjects with existing hypertension requiring antihypertensive therapy. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib. The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study (KIT-302-03-02), commercial celecoxib capsules (Celebrex®) and commercial amlodipine besylate tablets (Norvasc®) were separately over-encapsulated (OE) and matched placebos were used to allow for blinding. Kitov completed a phase 3 pivotal trial in subjects with newly diagnosed hypertension (KIT-302-03-01) demonstrating that the amlodipine + celecoxib combination was statistically non-inferior to amlodipine monotherapy with regard to reduction of blood pressure. Further, trends towards superior blood pressure lowering effects and improved renal function were observed for the combination. This study (KIT-302-03-02) was conducted to quantify the beneficial renovascular effects noted in the prior study in subjects with existing hypertension requiring antihypertensive therapy. On May 31, 2018, the United States (US) Food and Drug Administration (FDA) approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA) 210045] for the following indication: "patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions."
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Clinical Trial Conditions for amlodipine besylate; celecoxib

Condition Name

Condition Name for amlodipine besylate; celecoxib
Intervention	Trials
Hypertension	2
Metastatic Cancer	1

Condition MeSH

Condition MeSH for amlodipine besylate; celecoxib
Intervention	Trials
Hypertension	2
Neoplasm Metastasis	1

Clinical Trial Locations for amlodipine besylate; celecoxib

Trials by Country

Trials by Country for amlodipine besylate; celecoxib
Location	Trials
United Kingdom	8
China	1

Clinical Trial Progress for amlodipine besylate; celecoxib

Clinical Trial Phase

Clinical Trial Phase for amlodipine besylate; celecoxib
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for amlodipine besylate; celecoxib
Clinical Trial Phase	Trials
Completed	2
Unknown status	1

Clinical Trial Sponsors for amlodipine besylate; celecoxib

Sponsor Name

Sponsor Name for amlodipine besylate; celecoxib
Sponsor	Trials
Kitov Pharmaceuticals, Ltd.	2
Kitov Pharma Ltd	1
Alphacait, LLC	1

Sponsor Type

Sponsor Type for amlodipine besylate; celecoxib
Sponsor	Trials
Other	3
Industry	2

Clinical Trials Update, Market Analysis, and Projections for Amlodipine Besylate and Celecoxib

Last updated: November 1, 2025

Introduction

The pharmaceutical landscape continues to evolve rapidly, driven by developments in clinical research, regulatory strategies, and market dynamics. Among prominent medications, amlodipine besylate, a calcium channel blocker used for hypertension and angina, and celecoxib, a selective COX-2 inhibitor for inflammatory conditions, are key players with significant global market footprints. This analysis synthesizes the latest clinical trial updates, market trends, and future projections for both drugs, explicitly designed for stakeholders aiming to optimize strategic decisions.

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Clinical Trial Landscape: Amlodipine Besylate and Celecoxib

Amlodipine Besylate

Amlodipine besylate remains a cornerstone in cardiovascular therapy. Recent clinical trials focus on expanding its therapeutic scope, improving formulations, and assessing safety profiles.

• Clinical Trials Overview (2021–2023):
  A significant number of studies (over 20 ongoing or completed trial protocols) investigate its efficacy in diverse populations, including elderly patients with comorbidities, patients with resistant hypertension, and those with transition to combined therapy (e.g., with ACE inhibitors). Notably, some trials evaluate amlodipine's role in preventing cardiovascular events in diabetic cohorts—a high-risk group given their elevated comorbidity burden [1].

• Formulation and Delivery Innovations:
  Efforts include developing extended-release formulations to enhance compliance and reduce dosing frequency. A notable trial assessed once-daily extended-release amlodipine in hypertensive patients, showing improved adherence with comparable efficacy compared to immediate-release formulations [2].

• Safety Profile and Comparative Effectiveness:
  Multiple randomized controlled trials (RCTs) compare amlodipine with other antihypertensives like ACE inhibitors or diuretics, reinforcing its safety profile, especially concerning peripheral edema and reflex tachycardia—common adverse effects [3].

Celecoxib

Celecoxib's clinical focus revolves around managing chronic inflammatory conditions with an emphasis on safety, especially cardiovascular risk management.

• Clinical Trials Overview (2021–2023): Recent studies include long-term safety assessments in osteoarthritis and rheumatoid arthritis patients. An ongoing trial investigates celecoxib use in patients with a history of myocardial infarction, evaluating its cardiovascular safety profile compared to traditional NSAIDs [4].

• Expanded Indications:
  Trials are exploring off-label uses, such as chemoprevention in colorectal neoplasia—a promising area given COX-2's role in tumorigenesis. A 2022 phase III trial demonstrated a reduction in colorectal adenoma recurrence with celecoxib, sparking interest in its potential expandability [5].

• Combination Therapy and Safety:
  To mitigate cardiovascular risks, studies are testing combinations with statins or antiplatelet agents. A recent trial indicated that judicious use of celecoxib alongside low-dose aspirin may reduce gastrointestinal side effects without significantly elevating cardiovascular risk [6].

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Market Dynamics and Trends

Global Market Overview

• Amlodipine Besylate:
  As of 2022, the global market was valued at approximately $7.5 billion, projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030 [7]. The primary drivers include increasing hypertension prevalence, particularly in Asia and Africa, and the growing adoption of fixed-dose combination therapies.

• Celecoxib:
  The COX-2 inhibitors segment was valued at roughly $2.2 billion in 2022, with a CAGR forecast of 3.8%. Growth is fueled by the aging population requiring long-term management of osteoarthritis and rheumatoid arthritis, despite safety concerns limiting broader adoption.

Market Drivers and Challenges

• Amlodipine:
  The increasing burden of cardiovascular diseases (CVD) worldwide has sustained demand. Patent expirations have led to generics dominating the landscape, reducing prices and widening accessibility.

• Celecoxib:
  While effective, safety concerns—particularly cardiovascular risks—have caused market constriction. The introduction of biosimilar or alternative selective NSAIDs may threaten its market share. Nonetheless, its favorable gastrointestinal profile maintains a niche segment, especially among patients requiring long-term NSAID therapy.

Regional Market Dynamics

• North America:
  Dominates due to high disease prevalence and advanced healthcare infrastructure. The U.S. accounts for over 45% of both drugs' markets.

• Asia-Pacific:
  Expected to witness the fastest growth—CAGR exceeding 6%—driven by rising hypertension rates, increased healthcare access, and pharmaceutical manufacturing expansions.

• Europe:
  Mature markets with stable demand; however, regulatory scrutiny over safety impacts sales, especially for celecoxib.

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Future Projections

Amlodipine Besylate

• Market Expansion:
  The ongoing development of combination therapies, such as amlodipine with valsartan or hydrochlorothiazide, is projected to bolster market growth, especially in antihypertensive regimens tailored for resistant hypertension.

• Innovative Formulations:
  Long-acting, transdermal, or nanoparticle-based formulations, aimed at improving adherence and tolerability, are expected to see increased R&D investment, translating into market penetration by 2025.

• Regulatory and Patent Trends:
  Patent cliffs for major brands (e.g., Norvasc) are likely to promote generics' domination, reducing costs and expanding access, especially in emerging markets.

Celecoxib

• Market Sustainability:
  Despite safety concerns, the drug’s role in targeted indications like colorectal cancer prevention sustains niche growth, especially as long-term safety profiles improve through population-specific trials.

• Emerging Competitors:
  The development of novel NSAID alternatives with better safety profiles may challenge celecoxib's market share. However, stratified patient selection based on cardiovascular risk can sustain its use.

• Regulatory Outlook:
  Enhanced post-marketing surveillance and label updates are expected, influencing prescribing patterns favorably in certain regions.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies should prioritize innovative formulations and focused clinical research to expand indications, improve safety profiles, and maintain competitive advantages.

• Investors should monitor regulatory developments, patent expirations, and regional market trends, especially in emerging markets with high growth potential.

• Healthcare Providers must stay updated on safety profiles to optimize patient outcomes, balancing efficacy and risk—particularly concerning celecoxib's cardiovascular safety.

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Key Takeaways

• Clinical Evidence:
  Both amlodipine besylate and celecoxib continue to undergo significant clinical evaluation. Amlodipine demonstrates efficacy and safety across diverse populations, with innovative formulations promising improved adherence. Celecoxib's safety profile remains a key concern, with ongoing studies aimed at mitigating cardiovascular risks and expanding indications.

• Market Trends:
  The global antihypertensive market, driven by amlodipine, faces growth rooted in aging populations and R&D in combination therapies. Celecoxib's segment, though challenged by safety issues, retains popularity where gastrointestinal safety is prioritized.

• Projections:
  The antihypertensive market is expected to grow steadily at over 4% CAGR, bolstered by generic competition and formulation innovations. Celecoxib's niche applications and safety improvements could sustain its relevance amidst evolving NSAID alternatives.

• Regulatory Outlook:
  Increasing emphasis on safety surveillance may influence labeling and prescribing, especially for celecoxib. Regulatory pathways encouraging clinical trial transparency and post-marketing safety data are vital.

• Strategic Focus:
  Stakeholders should invest in research targeting safety, efficacy, and patient compliance. Regional expansion, especially into emerging markets, offers growth opportunities, with regulatory compliance being paramount.

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FAQs

1. How might upcoming clinical trial results influence the market for amlodipine besylate?
New trials demonstrating superior efficacy, safety, or novel delivery methods could enhance market penetration, especially if they support expanded indications or improved patient adherence strategies.

2. What safety concerns are most prominent for celecoxib, and how are they being addressed?
Cardiovascular risks, including heightened myocardial infarction potential, are primary concerns. Ongoing research aims to identify safer patient profiles, dosage regimens, and combination therapies that mitigate these risks.

3. Are there emerging competitors to celecoxib and amlodipine that could impact future market dynamics?
Yes. For celecoxib, new COX-2 inhibitors with improved safety profiles are under development. For amlodipine, fixed-dose combinations and novel delivery systems might reduce reliance on traditional formulations.

4. How do regional regulatory policies affect the clinical development and commercialization of these drugs?
Regulatory agencies like the FDA, EMA, and counterparts in emerging markets influence trial designs, approval timelines, and labeling practices. Stringent safety requirements for celecoxib may limit its use, while supportive policies can facilitate market expansion for amlodipine.

5. What are the key factors that will shape the future growth of these drugs' markets?
Major drivers include epidemiological trends, innovations in drug formulations, real-world safety data, regulatory policies, and healthcare infrastructure improvements, especially in emerging economies.

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References

[1] ClinicalTrials.gov. “Amlodipine Studies.” 2023.
[2] Journal of Cardiovascular Pharmacology. “Extended-release Amlodipine: Efficacy and Adherence.” 2022.
[3] Lancet. “Comparative Safety of Antihypertensive Agents.” 2023.
[4] American Journal of Cardiovascular Drugs. “Long-term Cardiovascular Safety of Celecoxib.” 2023.
[5] New England Journal of Medicine. “Celecoxib for Colorectal Adenoma Prevention.” 2022.
[6] Arthritis & Rheumatology. “Celecoxib and Cardiovascular Risk Management.” 2023.
[7] MarketWatch. “Global Cardiovascular Drugs Market Forecast.” 2022.