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Last Updated: March 26, 2025

CLINICAL TRIALS PROFILE FOR XENICAL


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All Clinical Trials for XENICAL

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00152360 ↗ The Effect of Xenical on Weight and Risk Factors Completed University of British Columbia Phase 4 2005-06-01 The purpose of this study is to determine the effect of using the weight loss medication Xenical (generic name - orlistat) on weight loss and change in heart disease risk factors in patients of the Healthy Heart Program Lipid Clinic at St. Paul's Hospital over a three month period. Xenical works by blocking the body's absorption of dietary fat in the gut, allowing it to pass through to be excreted, therefore reducing the intake of fat and calories. This is a pilot study supported by Hoffmann-La Roche Limited which produces Xenical. The aim is to investigate whether weight loss will also result in reductions in heart disease risk factors that may allow for less of a need for medications controlling lipid levels, hypertension and plasma glucose.
NCT00108524 ↗ A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss Completed US Department of Veterans Affairs N/A 2004-07-01 This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
NCT00108524 ↗ A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss Completed VA Office of Research and Development N/A 2004-07-01 This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
NCT00160407 ↗ Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH) Completed Hoffmann-La Roche Phase 4 2003-10-01 The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH.
NCT00001723 ↗ Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1998-05-01 Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life. African American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents. One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults. Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).
NCT00001723 ↗ Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Completed Roche Pharma AG Phase 2 1998-05-01 Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life. African American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents. One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults. Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).
NCT00001723 ↗ Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Completed Jack Yanovski Phase 2 1998-05-01 Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life. African American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents. One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults. Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for XENICAL

Condition Name

1522200246810121416ObesityHepatitis CDiabetes MellitusFatty Liver[disabled in preview]
Condition Name for XENICAL
Intervention Trials
Obesity 15
Hepatitis C 2
Diabetes Mellitus 2
Fatty Liver 2
[disabled in preview] 0
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Condition MeSH

114430-10123456789101112ObesityWeight LossOverweightDiabetes Mellitus[disabled in preview]
Condition MeSH for XENICAL
Intervention Trials
Obesity 11
Weight Loss 4
Overweight 4
Diabetes Mellitus 3
[disabled in preview] 0
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Clinical Trial Locations for XENICAL

Trials by Country

+
Trials by Country for XENICAL
Location Trials
United States 26
Canada 1
Brazil 1
Switzerland 1
Iran, Islamic Republic of 1
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Trials by US State

+
Trials by US State for XENICAL
Location Trials
Texas 3
Ohio 2
Connecticut 2
Missouri 2
North Carolina 2
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Clinical Trial Progress for XENICAL

Clinical Trial Phase

55.6%5.6%16.7%22.2%012345678910Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for XENICAL
Clinical Trial Phase Trials
Phase 4 10
Phase 3 1
Phase 2 3
[disabled in preview] 4
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Clinical Trial Status

65.0%10.0%10.0%15.0%01234567891011121314CompletedActive, not recruitingUnknown status[disabled in preview]
Clinical Trial Status for XENICAL
Clinical Trial Phase Trials
Completed 13
Active, not recruiting 2
Unknown status 2
[disabled in preview] 3
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Clinical Trial Sponsors for XENICAL

Sponsor Name

trials011223344Hoffmann-La RocheDonaghue Medical Research FoundationPennington Biomedical Research Center[disabled in preview]
Sponsor Name for XENICAL
Sponsor Trials
Hoffmann-La Roche 4
Donaghue Medical Research Foundation 1
Pennington Biomedical Research Center 1
[disabled in preview] 4
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Sponsor Type

46.7%36.7%10.0%6.7%02468101214OtherIndustryU.S. Fed[disabled in preview]
Sponsor Type for XENICAL
Sponsor Trials
Other 14
Industry 11
U.S. Fed 3
[disabled in preview] 2
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Xenical (Orlistat): Clinical Trials, Market Analysis, and Projections

Introduction to Xenical (Orlistat)

Xenical, also known as orlistat, is a gastrointestinal lipase inhibitor used for the treatment of obesity. It works by reducing the absorption of dietary fats, which helps in weight loss and the management of weight-related health issues.

Clinical Trials Overview

XENDOS Study

One of the significant clinical trials involving Xenical is the XENDOS (XENical in the prevention of Diabetes in Obese Subjects) study. This was a 4-year, double-blind, randomized, placebo-controlled prospective study conducted at 22 Swedish medical centers between 1997 and 2002. The study aimed to determine the long-term effect of orlistat, in combination with lifestyle changes, in reducing the progression to type 2 diabetes and body weight in obese, nondiabetic patients with either normal glucose tolerance (NGT) or impaired glucose tolerance (IGT)[4].

  • Key Findings: The XENDOS study showed that orlistat, combined with lifestyle changes, significantly reduced the risk of developing type 2 diabetes and helped in achieving and maintaining weight loss over the 4-year period. The study also highlighted the safety and tolerability of orlistat over an extended period.

Current Market Analysis

Global Market Size and Growth

The global market for Xenical (orlistat) is substantial and growing. As of 2024, the global Orlistat market size is estimated to be USD 3152.2 million, with a projected compound annual growth rate (CAGR) of 6.10% from 2024 to 2031[5].

  • Regional Breakdown: North America holds a significant share of the global Orlistat market, accounting for more than 40% of the global revenue, with a market size of USD 1260.88 million in 2024. The Asia Pacific region also exhibits strong growth, with a market size of USD 725.01 million in 2024 and a CAGR of 8.1% from 2024 to 2031[5].

Market Drivers

The growth of the Orlistat market is driven by several factors:

  • Increasing Prevalence of Obesity: The rising prevalence of obesity and related health concerns globally is a major driver. Regions such as North America and the Asia Pacific are experiencing high rates of obesity, leading to a substantial demand for weight management solutions like Orlistat[5].
  • Effective Distribution Channels: The availability of Orlistat through both prescription and over-the-counter channels enhances its market reach and accessibility.
  • Robust Pipeline and New Product Launches: The anti-obesity drugs market, including Orlistat, is expected to benefit from new product launches and a promising pipeline of treatments, which will further propel market growth[2].

Market Projections

Forecasted Market Size

The global Orlistat market is expected to expand significantly over the forecast period. Here are some key projections:

  • Global Market Size: The market is projected to grow at a CAGR of 6.10% from 2024 to 2031, reaching a substantial size by the end of the forecast period[5].
  • Regional Growth: North America and the Asia Pacific are expected to continue as major contributors to the global market, driven by increasing obesity rates and supportive regulatory frameworks[5].

Competitive Landscape

The anti-obesity drugs market, where Orlistat is a key player, is highly competitive. Other major players include Novo Nordisk A/S, Lilly, GlaxoSmithKline plc, and Currax Pharmaceuticals LLC. The market is expected to see significant competition from emerging therapies and new product launches[2].

Emerging Therapies and Competition

Late-Stage Emerging Therapies

The market for obesity treatments is witnessing the development of several late-stage emerging therapies. These new treatments focus on novel approaches to obesity management, which could potentially challenge the dominance of existing drugs like Orlistat. For instance, enobosarm, a selective androgen receptor modulator (SARM), is being developed for treating sarcopenic obesity and has shown promising results in clinical trials[1].

Impact on Xenical Market

The launch of these emerging therapies is expected to impact the market for Xenical. However, Orlistat's established presence, efficacy, and safety profile, as demonstrated in studies like XENDOS, will likely help it maintain a significant market share despite the competition[4].

Regulatory and Development Activities

Regulatory Milestones

Orlistat has undergone extensive regulatory scrutiny and has been approved in many regions. The drug's regulatory milestones, including its approval and any subsequent updates, are crucial for its market presence. Detailed reports on Orlistat provide insights into its regulatory status and developmental activities across different regions[3].

Conclusion

Xenical (orlistat) remains a significant player in the anti-obesity drugs market, supported by its proven efficacy and safety profile. The global market for Orlistat is expected to grow substantially, driven by increasing obesity rates and robust distribution channels. However, the market will also face competition from emerging therapies, which could influence its market share in the future.

Key Takeaways

  • Clinical Efficacy: Xenical has been shown to be effective in reducing weight and preventing the progression to type 2 diabetes in clinical trials like XENDOS.
  • Market Growth: The global Orlistat market is projected to grow at a CAGR of 6.10% from 2024 to 2031.
  • Regional Dominance: North America and the Asia Pacific are key regions driving the market growth.
  • Competitive Landscape: The market is competitive, with emerging therapies potentially challenging Orlistat's dominance.
  • Regulatory Status: Orlistat has a well-established regulatory profile, which supports its market presence.

FAQs

What is the primary mechanism of action of Xenical (orlistat)?

Xenical works by inhibiting gastrointestinal lipase, thereby reducing the absorption of dietary fats.

What was the main objective of the XENDOS study?

The XENDOS study aimed to determine the long-term effect of orlistat in reducing the progression to type 2 diabetes and body weight in obese, nondiabetic patients.

What is the projected global market size for Orlistat by 2031?

The global Orlistat market is expected to grow at a CAGR of 6.10% from 2024 to 2031, but the exact size by 2031 is not specified in the sources provided.

Which regions are expected to drive the growth of the Orlistat market?

North America and the Asia Pacific are expected to be the key drivers of the Orlistat market growth.

How does the emergence of new therapies impact the market for Xenical?

The emergence of new therapies could challenge Xenical's market share, but its established efficacy and safety profile are likely to help it maintain a significant market presence.

What are some of the major drivers of the Orlistat market?

The increasing prevalence of obesity, effective distribution channels, and robust pipeline of new treatments are major drivers of the Orlistat market.

Sources

  1. Veru to Present at ObesityWeek: Meta-Analysis of 4 Previous Randomized Clinical Trials... - BioSpace
  2. Anti-obesity Drugs Market Size & Share | Global Report [2032] - Fortune Business Insights
  3. XENICAL (Orlistat), Drug Insight and Market Forecast - 2032 - Research and Markets
  4. XENical in the Prevention of Diabetes in Obese Subjects (XENDOS... - Diabetes Journals
  5. Orlistat Market will grow at a CAGR of 6.10% from 2024 to 2031. - Cognitive Market Research

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