Overview
The global prevalence of obesity is increasing rapidly. Obesity-related complications lead to significant personal and economic burden by reducing quality of life and increasing the cost of healthcare. In some individuals, diet and exercise are insufficient to maintain weight loss, and pharmacological or surgical intervention is required. Orlistat is a lipase inhibitor used in the treatment of obesity that works by inhibiting fat-metabolizing enzymes. It was approved by the FDA for use in combination with a reduced-calorie diet in 1999. This drug is a generally well-tolerated and effective weight-loss aid and is now available in both over-the-counter and prescription preparations, depending on the dosage quantity.
Background
The global prevalence of obesity is increasing rapidly. Obesity-related complications lead to significant personal and economic burden by reducing quality of life and increasing the cost of healthcare. In some individuals, diet and exercise are insufficient to maintain weight loss, and pharmacological or surgical intervention is required. Orlistat is a lipase inhibitor used in the treatment of obesity that works by inhibiting fat-metabolizing enzymes. It was approved by the FDA for use in combination with a reduced-calorie diet in 1999. This drug is a generally well-tolerated and effective weight-loss aid and is now available in both over-the-counter and prescription preparations, depending on the dosage quantity.
Indication
Orlistat is indicated for obesity management including weight loss and weight maintenance when used in combination with calorie reduction in overweight and obese adults; this indication applies to both the prescription formulation of 120 mg and the over-the-counter formulation of 60 mg. Orlistat in the 120 mg prescription formulation is also indicated to reduce the risk of weight regain following weight loss.
Associated Conditions
- Weight Gain
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2011/07/04 | N/A | Completed | |||
2011/05/11 | Phase 2 | Terminated | |||
2011/04/11 | N/A | Completed | |||
2010/08/19 | Not Applicable | Completed | |||
2010/07/27 | Not Applicable | Completed | University of Campinas, Brazil | ||
2010/05/20 | Phase 2 | Completed | |||
2009/12/18 | Phase 4 | Completed | |||
2009/10/28 | Phase 2 | Completed | Yazd Research & Clinical Center for Infertility | ||
2009/10/08 | N/A | Completed | Federico II University | ||
2009/07/16 | Phase 3 | Completed |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||