XENICAL (orlistat)
Xenical helps patients with obesity management, supporting both initial weight loss and long-term weight maintenance when combined with a reduced-calorie diet. It is used for individuals with a body mass index (BMI) of 30 or greater, or those with a BMI of at least 27 who have additional risk factors such as hypertension, diabetes, or dyslipidemia. The medication also helps reduce the risk of regaining weight after a previous weight loss.
How XENICAL Works
This medication works by targeting and inhibiting lipase enzymes in the stomach and small intestine. By binding to these enzymes, it prevents them from breaking down dietary fats into smaller, absorbable molecules. As a result, these undigested fats pass through the system without being absorbed, creating a caloric deficit that supports weight control.
Details
- Status
- Prescription
- First Approved
- 1999-04-23
- Routes
- ORAL
- Dosage Forms
- CAPSULE
XENICAL Approval History
What XENICAL Treats
1 indicationsXENICAL is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Obesity
XENICAL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to XENICAL
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01351753 REVIVE results posted | 201012738 | Ph 2 | terminated | Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity |
| NCT05579249 results posted | NN9536-4741 U1111-1263-7301 | Ph 4 | completed | A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America |
| NCT06854614 STAY-LEAN | 24-695 | Ph 4 | active not recruiting | Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial) |
| NCT05816343 | STU-2019-0776 | Ph 2 | recruiting | Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia |
| NCT04531176 EMPOWER-T2D results posted | 20-648 | Ph 4 | terminated | EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial |
| NCT03582722 results posted | IRB00099231 R01ES025775 | Ph 4 | completed | Weight Loss Aid in an Exposed Population |
| NCT05496075 | orlistat reduces UA | Ph 4 | completed | Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia |
| NCT02767531 T1HLP results posted | 012013-042 | Ph 2 | completed | Orlistat for the Treatment of Type I Hyperlipoproteinemia |
| NCT02041234 | Bariatric Surgery RCT | Ph 4 | completed | Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment |
| NCT02432209 FIT-PLESE results posted | FIT-Plese | Ph 3 | completed | Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility |
| NCT01675154 results posted | 3940 FD-R-003940 | Ph 2 | terminated | Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia |
| NCT01003483 | 616 | Ph 2 | completed | Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients |
| NCT01597531 | ECDOI-D71 | Ph 4 | terminated | Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding |
| NCT01035333 results posted | 09-016 | Ph 4 | completed | A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery. |
| NCT00752726 results posted | W3600586 | Ph 4 | completed | Effect of Orlistat in Body Composition |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XENICAL FDA Label Details
Indications & Usage
FDA Label (PDF)XENICAL is indicated for the treatment of Obesity.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.