Alli

(Orlistat)

ApprovedSmall molecule

Alli is a small molecule that works as a Gastric Lipase Inhibitor; Pancreatic Lipase Inhibitor.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Alli is one of 322 small molecule programs targeting Metabolic Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

321

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Metabolic SyndromeApproved

HyperlipidemiaActive, not recruiting

HyperuricemiaActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Weight LossActive, not recruiting

Crigler-Najjar SyndromeActive, not recruiting

Hyperlipoproteinemia Type 1Approved

Fatty Liver DiseaseActive, not recruiting

Polycystic Ovary SyndromeApproved

Type 2 DiabetesActive, not recruiting

Metabolic SyndromeApproved

Approved

HyperlipidemiaPreclinical

Active, not recruiting

HyperuricemiaApproved

Active, not recruiting

Type 2 Diabetes MellitusPhase 2

Active, not recruiting

Weight LossApproved

Active, not recruiting

Crigler-Najjar SyndromePreclinical

Active, not recruiting

Hyperlipoproteinemia Type 1Approved

Approved

Fatty Liver DiseaseApproved

Active, not recruiting

Polycystic Ovary SyndromeApproved

Approved

Type 2 DiabetesApproved

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Alli

EEngelhard Arzneimittel GmbH & Co.KG

Approved

2 2

Byetta

AstraZeneca

Preclinical

55 3

Jardiance

Boehringer Ingelheim

Preclinical

31 4

NOVOLIN R

Novo Nordisk

Preclinical

5 5

Glargine

Eli Lilly

Preclinical

8 6

Inspra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 7

Aurlumyn

BBTG International Inc.

Preclinical

1 8

Nexium

DDexcel Pharma Technologies Ltd.

Preclinical

1 9

Inderal

WWyeth-Lederle Vaccines

Preclinical

1 10

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

N/ANot yet recruiting

Weight Management

NCT07326839

Q2 2028

Post-ApprovalActive, not recruiting

Weight Loss

NCT06854614

Q2 2029

Phase 2Recruiting

Long Term Efficacy and Safety

NCT05816343

Clinical

Trials by Indication[1]

Weight loss7 trials

Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

Terminated·UUniversity of Iowa·Phase 2·NCT01351753·128 enrolled

Weight Loss Aid in an Exposed Population

Completed·EEmory University·Phase 4·NCT03582722·100 enrolled

A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.

Completed·—·Phase 4·NCT01035333·19 enrolled

Show 4 more trials

A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

Completed·UUS Department of Veterans Affairs·N/A·NCT00108524·146 enrolled

Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

Completed·GGachon University Gil Medical Center·N/A·NCT01184560·174 enrolled

Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults

Completed· Roche logo

Roche·Phase 4·NCT02706067·50 enrolled

Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)

Active, not recruiting·TThe Cleveland Clinic·Phase 4·NCT06854614·150 enrolled

Overweight4 trials

The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects

Withdrawn·PPennington Biomedical Research Center·N/A·NCT01719419

A Study of Xenical (Orlistat) in Overweight and Obese Adolescents

Completed· Roche logo

Roche·Phase 3·NCT00940628·60 enrolled

RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity

Completed·CCertmedica International GmbH·N/A·NCT02529631·64 enrolled

Show 1 more trial

Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)

Completed·SSt. Louis University·Phase 4·NCT00160407·50 enrolled

Obesity3 trials

Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases

Completed·JJack Yanovski·Phase 2·NCT00001723·200 enrolled

Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

Completed·EEMS·Phase 3·NCT01755676·638 enrolled

A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT05579249·500 enrolled

Treatment3 trials

Orlistat Treatment of Crigler-Najjar Disease

Completed·UUniversity Medical Center Groningen·N/A·NCT00461799·16 enrolled

Orlistat for the Treatment of Type I Hyperlipoproteinemia

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT02767531·2 enrolled

Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT01675154·5 enrolled

Weight Management2 trials

Effectiveness of Brief Counseling for Weight Management

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 4·NCT00212199·246 enrolled

Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT

Not yet recruiting·XXueMei Guo·N/A·NCT07326839·120 enrolled

19 more indications

Type 2 Diabetes2 trials

EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

Terminated·TThe Cleveland Clinic·Phase 4·NCT04531176·74 enrolled

Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

Terminated·—·Phase 4·NCT01597531·1 enrolled

Efficacy and Safety2 trials

Double-Blind, Multi-Center, Randomized Study to Assess the Efficacy and Safety of Velneperit (S-2367) and Orlistat Administered Individually or Combined With a Reduced Calorie Diet (RCD) in Obese Subjects

Completed· Shionogi logo

Shionogi·Phase 2·NCT01126970·486 enrolled

Efficacy and Safety of ATL-962 in Obese Diabetics

Completed·AAlizyme·Phase 2·NCT00156897·600 enrolled

Polycystic Ovary Syndrome2 trials

Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients

Completed·YYazd Research & Clinical Center for Infertility·Phase 2·NCT01003483·80 enrolled

The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)

Unknown status·—·Phase 4·NCT01475019·200 enrolled

Female1 trial

Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

Completed·UUniversity of Campinas, Brazil·N/A·NCT01414465·17 enrolled

Hyperuricemia1 trial

Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia

Completed·SShanghai 10th People's Hospital·Phase 4·NCT05496075·72 enrolled

Pregnancy1 trial

Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

Unknown status·RRenJi Hospital·Phase 4·NCT03383068·160 enrolled

Efficacy1 trial

Comparison of MAG and Fish Oil Efficacy

Completed·SSociété des Produits Nestlé (SPN)·N/A·NCT01797757·46 enrolled

Age1 trial

A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms

Completed· GSK logo

GSK·Phase 1·NCT01550926·48 enrolled

Hyperlipidemia1 trial

Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.

Unknown status·FFifth Affiliated Hospital of Xinjiang Medical University··NCT03884127·58 enrolled

Resistance1 trial

Orlistat Overcoming Third-generation EGFR-TKI Resistance

Not yet recruiting·PPing Peng·Phase 2·NCT06818955·36 enrolled

Liraglutide1 trial

The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 2·NCT00422058·564 enrolled

Growth1 trial

Growth Factor/Insulin-like Growth Factor (GH/IGF)-1 Axis in Obese Subjects in Treatment With Orlistat

Completed·FFederico II University··NCT00991926·20 enrolled

Acute Lymphoblastic Leukemia1 trial

Survey on the Pharmacy Follow-up of Alli Purchasers

Completed· GSK logo

GSK··NCT01387243·80 enrolled

Fatty Liver Disease1 trial

Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease

Unknown status·—·Phase 4·NCT06501326·102 enrolled

Absorption1 trial

Study of Fat Malabsorption by Lipiblock Versus Xenical

Completed·UUniversity of Campinas, Brazil·N/A·NCT01170806·20 enrolled

Long Term Efficacy and Safety1 trial

Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT05816343·28 enrolled

Infertility1 trial

Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

Completed·YYale University·Phase 3·NCT02432209·379 enrolled

Type 2 Diabetes Mellitus1 trial

Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea

Unknown status·MMid-Atlantic Epilepsy and Sleep Center, LLC·Phase 2·NCT02069197·150 enrolled

Unspecified2 trials

Effect of Orlistat in Body Composition

Completed· GSK logo

GSK·Phase 4·NCT00752726·131 enrolled

The Effect of Xenical on Weight and Risk Factors

Completed·UUniversity of British Columbia·Phase 4·NCT00152360·25 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 23, 1999

XENICAL

NDA NDA020766

Feb 7, 2007

ALLI

NDA NDA021887

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Orlistat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Orlistat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Orlistat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021887). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Engelhard Arzneimittel GmbH & Co.KG company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Gastric Lipase Inhibitor; Pancreatic Lipase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: EEngelhard Arzneimittel GmbH & Co.KG

Alli

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2028

Q2 2029

Trials by Indication[1]

Weight loss7 trials

Overweight4 trials

Obesity3 trials

Treatment3 trials

Weight Management2 trials

Type 2 Diabetes2 trials

Efficacy and Safety2 trials

Polycystic Ovary Syndrome2 trials

Female1 trial

Hyperuricemia1 trial

Pregnancy1 trial

Efficacy1 trial

Age1 trial

Hyperlipidemia1 trial

Resistance1 trial

Liraglutide1 trial

Growth1 trial

Acute Lymphoblastic Leukemia1 trial

Fatty Liver Disease1 trial

Absorption1 trial

Long Term Efficacy and Safety1 trial

Infertility1 trial

Type 2 Diabetes Mellitus1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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