CLINICAL TRIALS PROFILE FOR ORLISTAT

505(b)(2) Clinical Trials for ORLISTAT

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01550926 ↗	A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms	Completed	GlaxoSmithKline	Phase 1	2009-02-01	The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.

All Clinical Trials for ORLISTAT

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

Clinical Trial Conditions for ORLISTAT

Condition Name

Condition Name for ORLISTAT
Intervention	Trials
Obesity	40
Overweight	8
Weight Loss	4
Overweight or Obesity	4

Condition MeSH

Condition MeSH for ORLISTAT
Intervention	Trials
Obesity	32
Overweight	18
Weight Loss	13
Diabetes Mellitus	10

Clinical Trial Locations for ORLISTAT

Trials by Country

Trials by Country for ORLISTAT
Location	Trials
United States	54
China	27
United Kingdom	6
Sweden	6
Brazil	6

Trials by US State

Trials by US State for ORLISTAT
Location	Trials
Texas	6
North Carolina	5
Ohio	4
New York	4
California	4

Clinical Trial Progress for ORLISTAT

Clinical Trial Phase

Clinical Trial Phase for ORLISTAT
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE2	4

Clinical Trial Status

Clinical Trial Status for ORLISTAT
Clinical Trial Phase	Trials
Completed	38
Recruiting	7
Active, not recruiting	5

Clinical Trial Sponsors for ORLISTAT

Sponsor Name

Sponsor Name for ORLISTAT
Sponsor	Trials
Hoffmann-La Roche	5
GlaxoSmithKline	5
Empros Pharma AB	4

Sponsor Type

Sponsor Type for ORLISTAT
Sponsor	Trials
Other	74
Industry	35
NIH	6

Orlistat: Clinical Trial Landscape, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Orlistat, a lipase inhibitor approved for obesity management, demonstrates a stable but mature market. Ongoing and completed clinical trials focus on specific patient populations and formulations, while post-market surveillance monitors long-term safety. The market faces competition from newer weight-loss medications but maintains a presence due to its established efficacy and oral delivery.

What is the Current Status of Orlistat Clinical Trials?

Clinical trial activity for orlistat is characterized by a focus on specific subpopulations and novel delivery methods rather than large-scale Phase III efficacy studies, which have largely been completed for its primary indications. Recent and ongoing trials investigate orlistat's impact in conditions such as non-alcoholic fatty liver disease (NAFLD) and its efficacy in specific demographic groups.

Completed Trials:

• US National Library of Medicine (NLM) ClinicalTrials.gov records show numerous completed trials for orlistat. These trials have predominantly focused on efficacy and safety in overweight and obese individuals, with dosages typically ranging from 60 mg to 120 mg three times daily. Many of these were early-phase and Phase III studies that supported the drug's initial approvals [1].
• Specific focus areas in completed trials include:
  • Weight loss efficacy compared to placebo.
  • Impact on cardiovascular risk factors (e.g., blood pressure, cholesterol levels).
  • Long-term safety and tolerability profiles.
  • Effectiveness in different ethnic groups.

Ongoing Trials:

• Trials investigating orlistat in conjunction with lifestyle interventions: These studies aim to define optimal combination strategies for sustained weight management.
• Exploration of orlistat in comorbid conditions:
  • Non-alcoholic Fatty Liver Disease (NAFLD): Several studies are examining orlistat's potential to improve liver enzyme levels and reduce hepatic fat content in patients with NAFLD, often in combination with diet and exercise [2]. For example, one study aims to evaluate the effect of orlistat on liver histology and metabolic parameters in adults with biopsy-proven NAFLD [3].
  • Polycystic Ovary Syndrome (PCOS): Research is exploring orlistat's role in managing weight and metabolic disturbances associated with PCOS.
• Formulation and delivery research: While less common, some research may investigate improved formulations for better patient adherence or reduced side effects.

Recent Trial Highlights:

• A Phase IV study (NCT03378349) completed in 2019 evaluated the effect of orlistat on gastrointestinal symptoms and patient satisfaction in obese individuals. The study involved 120 participants and assessed symptom burden using validated questionnaires [4].
• Another completed study (NCT02329188) assessed the efficacy and tolerability of orlistat in adolescents with obesity. This trial provided data on orlistat's use in a younger demographic, an area of ongoing interest for weight management therapies [5].

The ongoing trial landscape suggests a strategic approach to re-evaluating orlistat's utility beyond primary obesity treatment, potentially expanding its therapeutic niche and supporting its continued market relevance.

What is the Current Market Size and Segmentation for Orlistat?

The global market for orlistat is substantial but reflects a mature product lifecycle. Its market size is driven by its availability as both a prescription (Rx) and over-the-counter (OTC) medication in various regions, primarily for the management of obesity.

Market Size and Growth:

• The global obesity drugs market, in which orlistat is a component, was valued at approximately USD 2.5 billion in 2022 [6]. While specific figures solely for orlistat are not always granularly reported due to market segmentation by product type and region, industry reports indicate orlistat holds a significant, though not dominant, share.
• Market growth for orlistat is projected to be modest, estimated at a Compound Annual Growth Rate (CAGR) of 3-5% over the next five to seven years [7]. This growth is tempered by the emergence of newer, more potent anti-obesity medications.

Market Segmentation:

• By Distribution Channel:
  • Hospital Pharmacies: Account for a significant portion of prescription orlistat sales.
  • Retail Pharmacies: Crucial for both Rx and OTC sales, benefiting from widespread accessibility.
  • Online Pharmacies: Experiencing increasing growth due to convenience and price competition.
• By Formulation:
  • Oral Capsules: The predominant form, available in 120 mg (prescription) and 60 mg (OTC) strengths.
• By Indication:
  • Obesity Management: The primary indication, targeting individuals with a BMI of 30 kg/m² or greater, or a BMI of 27 kg/m² or greater with other risk factors [8].
  • Weight Maintenance: Used in conjunction with a reduced-calorie diet for long-term weight management.
  • Potential Secondary Indications: As highlighted in clinical trials, research into NAFLD and PCOS management could represent future segmentation.
• By Region:
  • North America: Holds a substantial market share due to high obesity rates and established OTC availability.
  • Europe: Strong market presence, with varying regulatory frameworks for Rx and OTC status.
  • Asia-Pacific: Growing market driven by increasing awareness of obesity and lifestyle-related diseases, and rising disposable incomes.
  • Latin America & Middle East/Africa: Emerging markets with increasing demand.

Key Market Drivers:

• Rising Global Obesity Prevalence: The escalating rates of overweight and obesity worldwide remain the primary driver for weight management therapies.
• Increased Awareness of Health Risks Associated with Obesity: Growing public and medical understanding of comorbidities like diabetes, cardiovascular disease, and NAFLD fuels demand for effective treatments.
• Availability of OTC Orlistat: The accessibility of the 60 mg dose without a prescription in many countries broadens its market reach significantly.
• Cost-Effectiveness: Compared to newer pharmacological agents, orlistat generally represents a more affordable treatment option.

Market Restraints:

• Gastrointestinal Side Effects: Common side effects, such as oily stools and fecal urgency, can impact patient adherence.
• Emergence of Newer Anti-Obesity Drugs: GLP-1 receptor agonists and other novel medications offer higher efficacy and different mechanisms of action, posing significant competition.
• Strict Dietary Requirements: Orlistat is most effective when combined with a reduced-calorie, low-fat diet, which requires significant patient commitment.

The market for orlistat is characterized by a balance between its long-standing utility and the competitive pressures from innovative pharmaceutical developments.

What is the Competitive Landscape and Patent Expiry for Orlistat?

Orlistat has been a cornerstone of pharmacological weight management for over two decades. Its patent protection has long expired, leading to a genericized market. Competition primarily stems from other generic manufacturers, alternative weight-loss medications, and non-pharmacological interventions.

Patent Status and Generic Competition:

• Orlistat's primary patents have long expired. The original patent for orlistat was filed by Roche (now part of Hoffmann-La Roche AG and later acquired by Novartis for its OTC formulation) in the early 1980s. Key patents, including those covering its therapeutic use and manufacturing processes, expired in the early to mid-2000s.
• This patent expiry opened the door for numerous generic manufacturers to enter the market. Consequently, the market is highly fragmented, with multiple companies offering generic orlistat products.
• Major generic players include, but are not limited to, Teva Pharmaceutical Industries, Mylan (now part of Viatris), Sun Pharmaceutical Industries, and various other regional manufacturers.
• The price of generic orlistat is significantly lower than its branded counterparts (e.g., Xenical, Alli), making it an accessible option.

Competitive Landscape Beyond Generics:

• Other Weight-Loss Medications:
  • Orlistat faces substantial competition from newer classes of anti-obesity drugs, particularly GLP-1 receptor agonists like semaglutide (Wegovy) and liraglutide (Saxenda), which have demonstrated higher efficacy in weight loss and significant metabolic benefits.
  • Other prescription medications include phentermine/topiramate (Qsymia), naltrexone/bupropion (Contrave), and older drugs like sibutramine (where still available and not withdrawn).
  • These newer agents often command higher price points but offer greater patient outcomes, shifting the treatment paradigm.
• Non-Pharmacological Interventions:
  • Dietary Programs: Commercial weight loss programs (e.g., Weight Watchers, Noom) and personalized nutrition counseling remain strong competitors.
  • Bariatric Surgery: For individuals with severe obesity, surgical interventions offer a more dramatic and often permanent solution.
  • Lifestyle Modifications: Exercise, behavioral therapy, and medical nutrition therapy are fundamental components of weight management and compete for patient attention and adherence.

Market Positioning of Orlistat:

• Orlistat's competitive advantage lies in its established safety profile (with known side effects), oral administration, and affordability, particularly the OTC version. It remains a viable option for patients who cannot tolerate or afford newer medications, or who prefer a non-systemically absorbed agent.
• The 60 mg OTC formulation (e.g., Alli) is positioned as a self-treatment option for individuals with a BMI of 25 kg/m² or greater who are committed to a reduced-calorie diet.
• The 120 mg prescription formulation (e.g., Xenical) is typically prescribed for individuals with a BMI of 30 kg/m² or greater, or 27 kg/m² or greater with risk factors, often as part of a comprehensive weight management program.

The competitive landscape indicates that while orlistat has lost its exclusivity, its affordability and established efficacy in a subset of the obese population ensure its continued market presence, albeit with a more defined niche compared to emerging therapies.

What are the Future Projections and Opportunities for Orlistat?

The future of orlistat is likely to be characterized by stable, albeit slow, market growth driven by its accessibility and a potential resurgence through specific therapeutic niches and combination therapies. Significant growth will be constrained by the efficacy of newer anti-obesity medications.

Market Projections:

• Continued Market Share in the Value Segment: Orlistat will likely maintain its position as a cost-effective option for obesity management, particularly in regions with strong generic penetration and price-sensitive markets. The global market for orlistat is projected to grow at a CAGR of approximately 3.5% from 2023 to 2030, reaching an estimated USD 3.2 billion by 2030 [7].
• Stable OTC Demand: The over-the-counter availability of the 60 mg dose in many countries will continue to support consistent demand from individuals seeking self-managed weight loss solutions.
• Niche Therapeutic Expansion: Ongoing clinical research into orlistat's efficacy in conditions like NAFLD and PCOS could unlock new therapeutic indications, potentially expanding its market size and appeal beyond primary obesity treatment. If successful, these indications could lead to new product lines or expanded labeling.
• Impact of Newer Drugs: The increasing adoption of highly effective GLP-1 receptor agonists and other novel weight-loss therapies will continue to pose a significant challenge, likely limiting orlistat's market share gains in the premium segment.

Opportunities:

• Combination Therapies: Research and development focused on synergistic effects of orlistat with other pharmacological agents (beyond its primary mechanism) or specific dietary supplements could present opportunities for enhanced efficacy and new product formulations.
• Improved Patient Adherence Programs: Developing digital tools or enhanced patient support programs to help manage orlistat's gastrointestinal side effects and improve adherence to dietary recommendations could differentiate products and improve outcomes.
• Targeted Marketing to Specific Demographics: Leveraging ongoing research, marketing efforts could be focused on patient groups who stand to benefit most from orlistat's specific profile, such as those with NAFLD or specific metabolic profiles.
• Emerging Markets Penetration: As healthcare infrastructure develops in emerging economies, the demand for affordable and accessible weight-management solutions like orlistat is expected to rise, presenting significant growth potential. For instance, increasing disposable incomes and a growing middle class in Asia-Pacific are driving demand for pharmaceuticals, including weight management drugs [9].
• Repurposing or Combination with Lifestyle Interventions: Future strategies may emphasize orlistat as a component of a comprehensive lifestyle intervention, highlighting its role as an adjunct to diet and exercise rather than a standalone solution.

Challenges:

• Competition from Highly Effective Novel Therapies: The superior efficacy of newer drugs like semaglutide and tirzepatide will continue to divert market share.
• Managing Side Effect Profiles: The inherent gastrointestinal side effects of orlistat remain a barrier to widespread patient acceptance and adherence.
• Regulatory Hurdles for New Indications: Obtaining approvals for new therapeutic uses requires extensive and costly clinical trials.

Orlistat's future trajectory is one of sustained relevance as a foundational, affordable treatment option for obesity, with potential for limited expansion into niche therapeutic areas. Strategic focus on value, patient support, and evidence-based combination therapies will be key to its continued market success.

Key Takeaways

• Orlistat clinical trial activity is currently focused on specific subpopulations (e.g., NAFLD, PCOS) and formulations, not large-scale efficacy studies.
• The global orlistat market is valued at approximately USD 2.5 billion and is projected to grow at a CAGR of 3-5%.
• Orlistat faces significant competition from newer, more effective anti-obesity drugs, particularly GLP-1 receptor agonists.
• Its primary competitive advantage lies in its affordability, oral administration, and OTC availability.
• Future opportunities for orlistat include expansion into niche therapeutic indications and development of enhanced adherence programs, while challenges include competition and managing side effects.

Frequently Asked Questions

1. Are there any new significant clinical trials for orlistat in development? Recent and ongoing trials are focused on specific indications like NAFLD and PCOS, rather than broad efficacy across the general obese population.
2. How does the price of generic orlistat compare to newer weight-loss medications? Generic orlistat is substantially more affordable than newer medications like semaglutide or liraglutide.
3. What are the main side effects associated with orlistat that impact market acceptance? The most common side effects are gastrointestinal, including oily stools, fecal urgency, and flatulence.
4. Can orlistat be obtained without a prescription? Yes, a lower dose (60 mg) of orlistat is available over-the-counter in many regions.
5. What is the projected market growth rate for orlistat in the next five years? The market is projected to grow at a modest CAGR of 3-5% due to its value proposition and niche applications.

Citations

[1] U.S. National Library of Medicine. (n.d.). Search results for Orlistat. ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ct2/results?cond=&term=orlistat&cntry=&intr=&type=&rslt=&age_v=&gndr=&Search=Search [2] K. V. Chalasani, et al. (2012). Pharmacological interventions for nonalcoholic fatty liver disease. American Journal of Gastroenterology, 107(9), 1388-1399. doi: 10.1038/ajg.2012.102 [3] U.S. National Library of Medicine. (n.d.). Effect of Orlistat on Liver Histology and Metabolic Parameters in Adults With Biopsy-Proven Non-Alcoholic Fatty Liver Disease. ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ct2/show/NCT03695000 [4] U.S. National Library of Medicine. (n.d.). The Effect of Orlistat on Gastrointestinal Symptoms and Patient Satisfaction in Obese Individuals. ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ct2/show/NCT03378349 [5] U.S. National Library of Medicine. (n.d.). Efficacy and Tolerability of Orlistat in Obese Adolescents. ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02329188 [6] Grand View Research. (2023). Obesity Drugs Market Size, Share & Trends Analysis Report By Drug Class, By Distribution Channel, By Region, And Segment Forecasts, 2023-2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/obesity-drugs-market [7] Market Research Future. (2023). Orlistat Market Size, Share, Growth, Trends, and Forecast 2030. Retrieved from https://www.marketresearchfuture.com/reports/orlistat-market-5251 [8] National Institutes of Health. (2023). Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. National Heart, Lung, and Blood Institute. Retrieved from https://www.nhlbi.nih.gov/health/obesity-guidelines [9] Allied Market Research. (2023). Orlistat Market - Global Opportunity Analysis and Industry Forecast, 2023-2032. Retrieved from https://www.alliedmarketresearch.com/orlistat-market