Orlistat

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.

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

Title	Posted	Study ID	Phase	Status	Sponsor
A Trial With EMP16 in Preparation for Late Phase Studies	2025/05/28	NCT06993428	Phase 2	Not yet recruiting	Empros Pharma AB
Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)	2025/03/03	NCT06854614	Phase 4	Recruiting	The Cleveland Clinic
Orlistat Overcoming Third-generation EGFR-TKI Resistance	2025/02/11	NCT06818955	Phase 2	Not yet recruiting	Ping Peng
Anti-obesity Effects of Dandelion (Taraxacum Officinale L.)	2024/10/03	NCT06625736	Not Applicable	Completed	October 6 University
Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease	2024/07/15	NCT06501326	Phase 4	Recruiting	Affiliated Hospital of Nantong University
A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers	2023/08/28	NCT06013163	Phase 1	Recruiting	Empros Pharma AB
Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia	2023/04/18	NCT05816343	Phase 2	Recruiting	University of Texas Southwestern Medical Center
A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America	2022/10/13	NCT05579249	Phase 4	Completed	Novo Nordisk A/S
Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia	2022/08/11	NCT05496075	Phase 4	Completed	Shanghai 10th People's Hospital
Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg	2021/10/13	NCT05076474	Not Applicable	Completed	Shandong New Time Pharmaceutical Co., LTD

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ORLISTAT	H2-Pharma LLC	61269-565	ORAL	120 mg in 1 1	6/1/2022
Xenical	H2-Pharma LLC	61269-460	ORAL	120 mg in 1 1	11/25/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Alli (previously Orlistat GSK)	Haleon Ireland Dungarvan Limited,Knockbrack,Dungarvan,Co. Waterford,IRELAND	Authorised	7/22/2007
Xenical	CHEPLAPHARM Arzneimittel GmbH,Ziegelhof 24,17489 Greifswald,Germany	Authorised	7/29/1998

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
OBELIT 120 CAPSULE 120MG	Intas pharmaceuticals Limited	SIN15312P	CAPSULE, GELATIN COATED	120.00 mg	8/4/2017
XENICAL CAPSULE 120MG	F. Hoffman-La Roche Ltd, Delpharm Milano S.R.L.	SIN13046P	CAPSULE	120MG	1/31/2005

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ODISTAD 120 CAPSULES 120MG	N/A	HONG KONG MEDICAL SUPPLIES LIMITED	N/A	N/A	3/17/2021

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ORLIZEN Orlistat 120 mg capsule blister pack	453806	Accord Healthcare Pty Ltd	Medicine	A	6/27/2024
XENICAL orlistat 120mg capsule blister pack	61598	Pharmaco Australia Ltd	Medicine	A	4/11/2000
ORLISTAT GPPL orlistat 120 mg capsules blister pack	309908	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/1/2018
XENISTAT orlistat 120 mg capsules blister pack	309910	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/1/2018
PROLISTAT orlistat 120 mg capsule blister pack	268252	Boucher & Muir Pty Ltd	Medicine	A	1/29/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
XENICAL	Cheplapharm Arzneimittel Gmbh	02240325	Capsule - Oral	120 MG	6/3/1999

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
XENICAL 120 mg CAPSULAS DURAS	Cheplapharm Arzneimittel Gmbh	98071003IP8	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
XENICAL 120 mg CAPSULAS DURAS	Roche Registration Limited	98071003IP6	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
XENICAL 120 MG CAPSULAS DURAS	Cheplapharm Arzneimittel Gmbh	98071003IP7	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
XENICAL 120 mg capsulas duras	Cheplapharm Arzneimittel Gmbh	98071003IP5	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
NORMOFIT 60 MG CAPSULAS DURAS	Laboratorios Normon S.A.	83538	CÁPSULA DURA	Sin Receta	Commercialized
XENICAL 120 mg capsulas duras	Cheplapharm Arzneimittel Gmbh	98071002IP1	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ORLISTAT AUROVITAS 120 MG CAPSULAS DURAS	Aurovitas Spain, S.A.U.	78603	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ALLI 60 MG CAPSULAS DURAS	Haleon Ireland Dungarvan Limited	07401009	CÁPSULA DURA	Sin Receta	Commercialized
XENICAL 120mg capsulas duras	Cheplapharm Arzneimittel Gmbh	98071003IP4	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ORLISTAT ARISTO 120 MG CÁPSULAS DURAS	Aristo Pharma Iberia S.L.	81194	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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