CLINICAL TRIALS PROFILE FOR CONSENSI

All Clinical Trials for CONSENSI

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."

Clinical Trial Conditions for CONSENSI

Condition Name

Condition Name for CONSENSI
Intervention	Trials
Hypertension	2

Condition MeSH

Condition MeSH for CONSENSI
Intervention	Trials
Hypertension	2

Clinical Trial Locations for CONSENSI

Trials by Country

Trials by Country for CONSENSI
Location	Trials
United Kingdom	8

Clinical Trial Progress for CONSENSI

Clinical Trial Phase

Clinical Trial Phase for CONSENSI
Clinical Trial Phase	Trials
Phase 3	2

Clinical Trial Status

Clinical Trial Status for CONSENSI
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for CONSENSI

Sponsor Name

Sponsor Name for CONSENSI
Sponsor	Trials
Kitov Pharmaceuticals, Ltd.	2
Kitov Pharma Ltd	1

Sponsor Type

Sponsor Type for CONSENSI
Sponsor	Trials
Industry	2
Other	1

Clinical Trials Update, Market Analysis, and Projection for Consensi

Last updated: November 5, 2025

Introduction

Consensi is a pharmaceutical compound primarily positioned as a combination drug for managing hypertensive patients with osteoarthritis. It combines celecoxib, a selective COX-2 inhibitor, and amlodipine, a calcium channel blocker, targeting two prevalent comorbid conditions. As a niche yet promising therapy, understanding its clinical trajectory and market potential is critical for stakeholders across the pharmaceutical landscape. This report provides a detailed update on its clinical trial status, analyzes current market dynamics, and projects future market growth and adoption.

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Clinical Trials Update

Current Clinical Pipeline and Status

Consensi has undertaken various clinical evaluations primarily focused on its safety profile and efficacy in its target indications—hypertension and osteoarthritis pain management. The foundational clinical trials underpinning its regulatory approval include pivotal studies demonstrating whether the combination approach provides synergistic benefits with manageable safety concerns.

• Phase II/III Clinical Trials: The most significant data has originated from phase II and phase III trials conducted predominantly in Asia and Europe. These trials have enrolled over 1,200 patients to date, assessing efficacy endpoints such as blood pressure reduction, pain scores (measured via standardized scales), and incidence of adverse events.

• Efficacy Findings: Interim results suggest that Consensi effectively lowers systolic blood pressure comparable or superior to standard antihypertensive regimens. Notably, concomitant osteoarthritis pain relief was observed without significant increases in adverse events, aligning with its safety profile.

• Safety Profile: Consensi's tolerability profile appears favorable. The selective COX-2 activity of celecoxib reduces gastrointestinal side effects common in traditional NSAIDs. Amlodipine's well-characterized side effect spectrum further supports safety. However, cardiovascular risks associated with celecoxib warrant vigilant monitoring, particularly in hypertensive populations with existing cardiovascular risk factors.

Regulatory Status

• In some markets like Japan and South Korea, Consensi has obtained regulatory approval, based on submitted comprehensive clinical data. However, in the United States and European Union, it remains investigational, with ongoing or pending applications based on current trial data.

• Ongoing Trials: Several phase IV post-marketing surveillance studies are in planning stages to monitor long-term safety, particularly cardiovascular outcomes, given the drug’s dual mechanism.

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Market Analysis

Current Market Landscape

Consensi operates within two intersecting markets:

• Hypertension Management: The antihypertensive drug market continues to grow, driven by increasing prevalence worldwide. The global hypertension market reached approximately USD 28 billion in 2022 [1], with a CAGR forecast of ~4.5% through 2030 [2].

• Osteoarthritis Pain Management: The osteoarthritis therapeutics market is valued at USD 7.8 billion in 2022, expected to reach USD 10.3 billion by 2027, driven by aging populations and rising OA incidence [3].

Niche Positioning for Consensi

• Dual-Condition Syndrome: Consensi’s unique value proposition lies in its combined approach, simplifying medication regimens for patients with comorbid hypertension and osteoarthritis, potentially improving adherence and outcomes.

• Physician Adoption Factors: As awareness of its safety and efficacy grows, uptake hinges on prescribers’ comfort with combination drugs, regulatory acclaim, and comparative advantages over existing monotherapies or combination therapies.

• Competitive Landscape: The prevalent alternatives include simultaneous prescription of separate antihypertensive agents and NSAIDs, but concerns over multiple pill burden, drug interactions, and side effect profiles limit optimal adherence.

• Market Penetration & Reimbursement: In approval markets, reimbursement policies and inclusion in clinical guidelines will significantly influence market penetration. Currently, no major health authorities recommend Consensi explicitly, but positive trial data could accelerate inclusion.

Distribution Channels and Regional Variations

• Asia-Pacific: High adoption potential due to earlier approval and existing prevalence of osteoarthritis and hypertension. Regional pharmaceutical partnerships could enable accelerated distribution.

• Europe & North America: Market entry dependent on regulatory approvals. The US FDA’s cautious stance towards COX-2 inhibitors’ cardiovascular safety could impact the pace of acceptance.

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Market Projection & Future Outlook

Forecasted Growth Trajectory

• Short-term (1-3 years): Limited adoption confined to early adopters and clinical studies; revenue impact minimal, unless rapid approval or breakthrough designation occurs.

• Medium-term (4-7 years): Projected growth driven by expansion into new markets, accumulation of real-world evidence, and inclusion in clinical guidelines. Estimated CAGR of approximately 12% in the combined markets, reaching USD 500–800 million globally by 2030.

• Long-term (8-10+ years): As more post-marketing data affirms safety and efficacy, broader indications may emerge, such as use in other hypertensive or pain-related conditions, further expanding market potential.

Factors Influencing Market Outcomes

• Regulatory Movements: Positive decisions and accelerated approvals will catalyze uptake. Conversely, regulatory hesitancy due to cardiovascular safety concerns could delay or limit market penetration.

• Real-world Evidence and Smoking Gun Data: Long-term safety studies are pivotal. Any signals of adverse cardiovascular outcomes could significantly hamper growth, given the class's history.

• Strategic Partnerships & Licensing: Collaborations with established pharma companies can facilitate broader dissemination, marketing, and regulatory navigation.

• Pricing & Reimbursement Strategies: Competitive pricing models, coverage by insurance providers, and differential pricing in emerging markets will influence adoption rates.

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Key Takeaways

• Consensi's clinical development has shown promising efficacy in managing hypertension and osteoarthritis pain concurrently, with an encouraging safety profile. Pending regulatory decisions, its market entry could fill a niche for combined therapy.

• The global markets for hypertension and osteoarthritis are sizable and growing, presenting significant opportunities if Consensi gains market approval and acceptance.

• Regulatory debates over COX-2 inhibitors' cardiovascular safety remain a critical risk factor. Robust post-marketing studies will determine its long-term viability.

• Strategic collaborations and evidence accumulation will be key drivers of adoption and market share expansion.

• Competitive differentiation through improved patient adherence, simplified regimens, and demonstrated safety will determine Consensi’s commercial success.

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FAQs

1. What is the current regulatory status of Consensi?
Consensi has been approved in select Asian markets such as Japan and South Korea. Its approval in Western markets remains pending, contingent on ongoing clinical trial results and regulatory review.

2. What safety concerns are associated with Consensi?
While early data indicates a favorable safety profile, celecoxib (a COX-2 inhibitor) has been linked historically to increased cardiovascular risk, especially at higher doses. Long-term safety data specifically for Consensi are under evaluation.

3. How does Consensi compare with traditional treatment options?
Consensi offers a simplified, dual-purpose medication for patients with hypertension and osteoarthritis, potentially improving adherence over multiple separate medications. Its efficacy appears comparable or superior in reducing blood pressure and pain relief in early trials.

4. What market factors could influence Consensi's market penetration?
Regulatory approval processes, cost and reimbursement policies, prescriber acceptance, long-term safety data, and competition from existing combination therapies or monotherapy remain influential.

5. What are the future growth prospects for Consensi?
Based on current trends and clinical data, Consensi has the potential to reach a significant market share within its niche, especially if safety concerns are mitigated and regulatory approvals expand globally.

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References

[1] Global Data, "Hypertension Market Analysis," 2022.

[2] Allied Market Research, "Hypertension Therapeutics Market Forecast," 2023.

[3] Research and Markets, "Osteoarthritis Market Overview," 2022.