CLINICAL TRIALS PROFILE FOR CONSENSI

All Clinical Trials for CONSENSI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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."
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."

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

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−

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

Consensi: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Consensi

Consensi, a combination drug comprising amlodipine besylate, an antihypertensive calcium channel blocker, and celecoxib, a non-steroidal anti-inflammatory drug (NSAID), was approved by the U.S. Food and Drug Administration (FDA) on May 31, 2018. This approval marked a significant milestone for Kitov Pharma Ltd., the company behind the drug, as it offered a single-pill solution for treating both hypertension and osteoarthritis pain[1][2].

Clinical Trials and Approval

The FDA approval of Consensi was based on positive results from Kitov's Phase III clinical trials. These trials demonstrated that Consensi effectively lowered daytime systolic blood pressure and improved renal function. The primary endpoint of the study showed that Consensi reduced blood pressure by at least 50% of the reduction achieved with amlodipine besylate alone, with statistical significance (p=0.001). Additionally, the drug led to a statistically significant reduction in serum creatinine, a marker of renal function, from its baseline value (p=0.0005)[1].

Dosage and Administration

Consensi was approved in three dosage forms: 2.5 mg/200 mg, 5 mg/200 mg, and 10 mg/200 mg of amlodipine and celecoxib, respectively. The usual initial adult dose is 5 mg/200 mg once daily, with a maximum dose of 10 mg/200 mg once daily. For small, fragile, or elderly patients, or those with hepatic insufficiency, the starting dose can be 2.5 mg/200 mg orally daily[5].

Market Analysis

Despite its innovative combination and FDA approval, Consensi faced significant challenges in the market. The commercialization of Consensi was not as successful as anticipated, leading to the termination of the agreement with the U.S. distributor in February 2022. It was concluded that the drug was unlikely to generate significant revenue or achieve profitability in the near term, resulting in its discontinuation. The marketing end date for Consensi was set as July 27, 2022[2].

Reasons for Discontinuation

The discontinuation of Consensi can be attributed to several factors, including the competitive landscape of the pharmaceutical market and the high costs associated with maintaining the product. The market for hypertension and osteoarthritis treatments is highly saturated, making it challenging for new products to gain significant traction. Additionally, the costs of ongoing clinical trials and regulatory compliance can be prohibitive for smaller pharmaceutical companies[2].

Market Projections

While Consensi itself is no longer in the market, the broader pharmaceutical landscape continues to evolve. The global clinical trials market, for instance, is projected to grow from $61.58 billion in 2024 to $106.78 billion by 2032, at a Compound Annual Growth Rate (CAGR) of 7.1%. This growth is driven by the increasing demand for treatments for chronic diseases and the rising number of clinical trials globally[3].

Impact on Future Drug Development

The experience with Consensi highlights the importance of thorough market analysis and financial planning in drug development. Companies like Kitov Pharma Ltd. and its successor, Purple Biotech Ltd., are now focusing on other promising candidates, such as NT219 and CM24, which are in various stages of clinical trials for oncology indications. These efforts reflect a strategic shift towards areas with higher potential for market impact and profitability[1][4].

Key Takeaways

• Clinical Trials Success: Consensi demonstrated significant efficacy in clinical trials, meeting primary endpoints for blood pressure reduction and renal function improvement.
• Market Challenges: Despite FDA approval, Consensi faced significant market challenges, leading to its discontinuation.
• Broader Market Trends: The global clinical trials market is expected to grow substantially, driven by the need for chronic disease treatments.
• Strategic Shifts: Pharmaceutical companies are focusing on high-potential areas like oncology to maximize market impact and profitability.

FAQs

What is Consensi, and what was it approved for?

Consensi is a combination drug containing amlodipine besylate and celecoxib, approved for the treatment of hypertension and osteoarthritis pain.

Why was Consensi discontinued?

Consensi was discontinued due to the conclusion that it was unlikely to generate significant revenue or achieve profitability in the near term.

What were the key findings from the clinical trials of Consensi?

The clinical trials showed that Consensi effectively reduced daytime systolic blood pressure and improved renal function, meeting its primary endpoints with statistical significance.

What is the current focus of the company behind Consensi?

The company, now known as Purple Biotech Ltd., is focusing on advancing other promising drug candidates, such as NT219 and CM24, for oncology indications.

How does the discontinuation of Consensi impact the broader pharmaceutical market?

The discontinuation of Consensi highlights the challenges in the pharmaceutical market and the need for thorough market analysis and financial planning in drug development. It also underscores the strategic importance of focusing on high-potential therapeutic areas.

Sources

1. GlobeNewswire: FDA Approves Kitov's Consensi™ for Treatment of Osteoarthritis Pain and Hypertension.
2. Drugs.com: Consensi (amlodipine and celecoxib) FDA Approval History.
3. Fortune Business Insights: Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032].
4. Biospace: Purple Biotech Reports Second Half and Full-Year 2021 Financial Results.
5. FDA: 210045Orig1s000 - Consensi (amlodipine and celecoxib) Product Information.