Drugs / Orlistat
Orlistat
also known as
Xenical · Alli · Alli (previously orlistat gsk) · Beacita · EMP22 · NSC-758881 · Orlipastat · RO 18-0647/002 · +3 more
Small molecule targets LIPF, PNLIP via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | XENICAL | — | 2003-12-12 – 2004-10-22 | fda.gov ↗ |
| Approved | US (FDA) | XENICAL | — | 1999-04-23 | fda.gov ↗ |
| Approved | EU (EMA) | Xenical | — | 1998-07-29 | europa.eu ↗ |
Trials 40
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04521751 | May 2020 → Aug 2021 | obesity disorder | Empros Pharma AB | Completed | No outcome recorded |
| Phase 211 trials · 2 met primary | ||||||
| Phase 2 | NCT07714070 | Jul 2026 → Sep 2027 expected | atypical endometrial hyperplasia, endometrial cancer, progesterone resistance | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06993428 | May → Jul 2025 overdue | obesity disorder | Empros Pharma AB | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06818955 | Feb → May 2025 overdue | lung adenocarcinoma | Ping Peng | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05934110 | Apr → Nov 2023 | obesity disorder | Empros Pharma AB | Unknown | No outcome recorded |
| Phase 2 | NCT02767531 | Dec 2015 → May 2018 | hypertriglyceridemia 1 | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01675154 | Nov 2015 → Jun 2020 | hyperlipoproteinemia, type 1D | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT01351753 | Mar 2011 → Jan 2014 | metabolic syndrome X, obesity disorder | University of Iowa | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01126970 | Apr 2010 → Jan 2011 | obesity disorder | Shionogi | Completed | No outcome recorded |
| Phase 2 | NCT01003483 | Dec 2008 → Aug 2009 | obesity disorder | Yazd Research & Clinical Center for Infertility | Completed | No outcome recorded |
| Phase 2 | NCT00156897 | Dec 2004 → Oct 2005 | obesity disorder, type 2 diabetes mellitus | Alizyme | Completed | Met primary |
| Phase 2 | NCT00001723 | May 1998 → Oct 2011 | diabetes mellitus, hypertensive disorder, obesity disorder, sleep apnea syndrome | Jack Yanovski | Completed | Met primary |
| Phase 33 trials | ||||||
| Phase 3 | NCT01755676 | Sep 2016 → Dec 2017 | obesity disorder | EMS | Completed | No outcome recorded |
| Phase 3 | NCT03336086 | Mar → Nov 2012 | lymphoid hemopathy, viral infectious disease | Shiraz University of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00940628 | Apr 2008 → Sep 2010 | obesity disorder | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 415 trials · 2 met primary · 2 missed | ||||||
| Phase 4 | NCT07301437 | May 2026 → Aug 2027 expected | — | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06501326 | Nov 2023 → Oct 2024 | NAFLD1, obesity disorder | Affiliated Hospital of Nantong University | Unknown | No outcome recorded |
| Phase 4 | NCT05496075 | Aug 2022 → Dec 2023 | — | Shanghai 10th People's Hospital | Completed | Mixed |
| Phase 4 | NCT04531176 | Sep 2020 → Aug 2022 | obesity disorder, type 2 diabetes mellitus | The Cleveland Clinic | Terminated | Mixed |
| Phase 4 | NCT03799198 | Jan 2019 → May 2020 | obesity disorder | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT03582722 | Sep 2018 → Jun 2022 | poisoning | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT03383068 | Jan → Dec 2018 | glucose intolerance, polycystic ovary syndrome | RenJi Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01035333 | Nov 2009 → Apr 2011 | obesity disorder | Albany College of Pharmacy and Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00516919 | Aug 2007 → Dec 2010 | binge eating disorder, obesity disorder | Yale University | Completed | Missed primary |
| Phase 4 | NCT00115063 | Jul 2005 → Dec 2007 | obesity disorder | Pennington Biomedical Research Center | Terminated | Met primary |
| Phase 4 | NCT00152360 | Jun 2005 → Mar 2013 | heart disorder, obesity disorder | University of British Columbia | Completed | No outcome recorded |
| Phase 4 | NCT01475019 | Jan 2004 → Jan 2010 | obesity disorder, polycystic ovary syndrome | Aristotle University Of Thessaloniki | Unknown | No outcome recorded |
| Phase 4 | NCT00160407 | Oct 2003 → Dec 2006 | fatty liver disease, hepatitis | St. Louis University | Completed | Missed primary |
| Phase 4 | NCT02706067 | Jul 2002 → Mar 2009 | obesity disorder | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00212199 | Jan 2002 → Aug 2004 | obesity disorder | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase not applicable10 trials · 1 met primary · 1 missed | ||||||
| — | NCT07326839 | Dec 2025 → Nov 2027 expected | gout, obesity disorder | XueMei Guo | Not yet recruiting | No outcome recorded |
| — | NCT05076474 | Oct 2020 → Mar 2021 | — | Shandong New Time Pharmaceutical Co., LTD | Completed | No outcome recorded |
| — | NCT03675191 | Oct 2018 → Jul 2019 | obesity disorder | Gangnam Severance Hospital | Completed | Met primary |
| — | NCT01719419 | Mar → Sep 2012 | obesity disorder | Pennington Biomedical Research Center | Withdrawn | No outcome recorded |
| — | NCT01184560 | Feb → Jul 2010 | obesity disorder | Gachon University Gil Medical Center | Completed | No outcome recorded |
| — | NCT01414465 | Oct 2009 → Mar 2010 | obesity disorder | University of Campinas, Brazil | Completed | No outcome recorded |
| — | NCT00829283 | Nov 2008 → Nov 2013 | binge eating disorder, obesity disorder | Yale University | Completed | No outcome recorded |
| — | NCT00794963 | Nov 2008 → May 2010 | metabolic syndrome X | Northwell Health | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00292799 | Feb 2006 → Feb 2008 | anovulation, obesity disorder | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | Missed primary |
| — | NCT00461799 | Sep 2003 → Jan 2004 | Crigler-Najjar syndrome | University Medical Center Groningen | Completed | No outcome recorded |
| Comparator or background therapy23 trials | ||||||
| Phase 1 | NCT06013163 Comparator | Sep 2023 → Dec 2024 | obesity disorder | Empros Pharma AB | Unknown | No outcome recorded |
| Phase 1 | NCT05760677 Background | Oct 2022 → Sep 2023 | polycystic ovary syndrome, type 2 diabetes mellitus | Affiliated Hospital of Nantong University | Unknown | No outcome recorded |
| Phase 1 | NCT01550926 Comparator | Feb → Mar 2009 | obesity disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT02503865 Comparator | Jan 2003 → Dec 2008 | metabolic syndrome X | Nazarbayev University | Completed | No outcome recorded |
| Phase 2 | NCT05816343 Comparator | Jan 2024 → Aug 2027 expected | hypertriglyceridemia 1 | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT02069197 Comparator | Jan 2014 → Aug 2020 | obesity disorder, obstructive sleep apnea syndrome, type 2 diabetes mellitus | Mid-Atlantic Epilepsy and Sleep Center, LLC | Unknown | No outcome recorded |
| Phase 2 | NCT00704912 Comparator | Sep 2008 → Mar 2014 | polycystic ovary syndrome | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00422058 Comparator | Jan → Sep 2007 | metabolic disease, obesity disorder | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT02432209 Comparator | Aug 2015 → Nov 2019 | female infertility | Yale University | Completed | No outcome recorded |
| Phase 4 | NCT05812183 Background | Jul 2023 → Feb 2025 | — | University of California, Los Angeles | Withdrawn | No outcome recorded |
| Phase 4 | NCT05579249 Comparator | Jan 2023 → Nov 2024 | obesity disorder | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT02041234 Comparator | Feb 2014 → Dec 2020 | type 2 diabetes mellitus | Khoo Teck Puat Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01597531 Comparator | Jun 2012 → Jun 2014 | type 2 diabetes mellitus | East Carolina University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00752726 Comparator | Sep 2008 → Jul 2009 | obesity disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00207311 Comparator | Aug 2005 → May 2009 | fatty liver disease, hepatitis C virus infection | Brooke Army Medical Center | Completed | No outcome recorded |
| — | NCT07437001 Background | Mar → Jun 2026 overdue | — | Cairo University | Not yet recruiting | No outcome recorded |
| — | NCT06625736 Comparator | Jan → Sep 2024 | morbid obesity, premature menopause | October 6 University | Completed | No outcome recorded |
| — | NCT02141230 Background | Dec 2015 → Feb 2016 | — | GlaxoSmithKline | Withdrawn | No outcome recorded |
| — | NCT01797757 Comparator | Jan → Sep 2012 | obesity disorder | Nestlé | Completed | No outcome recorded |
| — | NCT02529631 Comparator | Nov 2009 → Jun 2010 | obesity disorder | Certmedica International GmbH | Completed | No outcome recorded |
| — | NCT01170806 Comparator | Oct 2009 → Mar 2010 | obesity disorder | University of Campinas, Brazil | Completed | No outcome recorded |
| — | NCT00601354 Background | Sep 2007 → Nov 2008 | eating disorder, obesity disorder | Stanford University | Completed | No outcome recorded |
| — | NCT00108524 Comparator | Jul 2004 → Dec 2007 | diabetes mellitus, obesity disorder | US Department of Veterans Affairs | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-11-03 | Empros Pharma AB | Results Topline POEM Study Results Position EMP16 as a Promising Oral Weight-Loss Maintenance Therapy emprospharma.com ↗
Empros Pharma AB, a Stockholm-based biopharmaceutical company developing EMP16, an investigational oral fixed dose combination of orlistat and acarbose for obesity and long-term weight-loss maintenance, is pleased to announce positive topline results from its Phase 2 POEM study. |
| 2017-09-11 | Empros Pharma AB | Results Pressrelease phase 2A trial emprospharma.com ↗
The trials show best-in class safety and indicates stronger appetite suppressing effect and improved glycaemic control compared to existing alternatives like Xenical ® . |
| 2017-08-13 | Empros Pharma AB | Results Phase 2A trial concluded emprospharma.com ↗
The results clearly indicate that EMP16-01 has a stronger appetite suppressing effect as compared to Xenical®, see figure, which is expected reduce the BMI more than Xenical®. |
| 2009-04-19 | GlaxoSmithKline | Regulatory GlaxoSmithKline launches alli® (orlistat 60 mg) gsk.com ↗
GSK has received a non-prescription licence for alli (orlistat 60mg); the first time the European Commission has approved a non-prescription product for weight loss. |
| 2009-01-20 | GlaxoSmithKline | Regulatory GlaxoSmithKline receives European Commission approval to market alli® (orlistat 60mg) gsk.com ↗
GlaxoSmithKline (GSK) has received a non-prescription licence for alli (orlistat 60mg); the first time the European Commission has approved a non-prescription product for weight loss. |
| 2008-06-16 | Novo Nordisk A/S | Results Signifikant vægttab fastholdes hos svært overvægtige efter behandling med liraglutide i et år novonordisk.com ↗
Deltagere, der blev behandlet med open-label orlistat, tabte sig 3,5-4,0 kg i forhold til udgangspunktet, og omkring 45% og omkring 15% opnåede et vægttab på henholdsvis over 5% og 10% efter 52 ugers behandling. |
| 2008-06-16 | Novo Nordisk A/S | Results Significant weight loss sustained in obese people treated with liraglutide for one year novonordisk.com ↗
The people treated with open-label orlistat lost 3.5-4.0 kg from baseline and around 45% and around 15% achieved a weight loss larger than 5% and 10% after 52 weeks of treatment, respectively. |
| 2007-11-20 | Novo Nordisk A/S | Results Nyt fase 2-studie viser, at liraglutide medfører signifikant vægttab hos svært overvægtige novonordisk.com ↗
Novo Nordisk har i dag offentliggjort kliniske resultater fra et dobbeltblindt, placebokontrolleret fase 2-studie, der har sammenlignet liraglutide, den humane GLP-1-analog til dosering én gang dagligt, med lipasehæmmeren orlistat ved behandling af fedme hos personer uden diabetes. |
All press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-03 | Empros Pharma AB | Topline POEM Study Results Position EMP16 as a Promising Oral Weight-Loss Maintenance Therapy emprospharma.com ↗ |
| 2017-09-11 | Empros Pharma AB | Pressrelease phase 2A trial emprospharma.com ↗ |
| 2017-08-13 | Empros Pharma AB | Phase 2A trial concluded emprospharma.com ↗ |
| 2009-04-19 | GlaxoSmithKline | GlaxoSmithKline launches alli® (orlistat 60 mg) gsk.com ↗ |
| 2009-01-20 | GlaxoSmithKline | GlaxoSmithKline receives European Commission approval to market alli® (orlistat 60mg) gsk.com ↗ |
| 2008-06-16 | Novo Nordisk A/S | Signifikant vægttab fastholdes hos svært overvægtige efter behandling med liraglutide i et år novonordisk.com ↗ |
| 2008-06-16 | Novo Nordisk A/S | Significant weight loss sustained in obese people treated with liraglutide for one year novonordisk.com ↗ |
| 2007-11-20 | Novo Nordisk A/S | Nyt fase 2-studie viser, at liraglutide medfører signifikant vægttab hos svært overvægtige novonordisk.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 66 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Orlistat | “Orlistat : A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing...” NCT01184560 ↗59“Xenical (Orlistat) - 120 mg/day in integration of Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin...” NCT02503865 ↗ “All women in both groups will adhere to the same medication (orlistat) as prescribed by the gynecologist for 12 weeks.” NCT07437001 ↗ “MR orlistat 120 mg is the same as EMP16-120/40 but without the acarbose component in matching oral capsules.” NCT05934110 ↗ “Xenical® (120 mg orlistat) will be taken together with breakfast during one PK study day.” NCT06013163 ↗ “A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity” NCT03336086 ↗ “Orlistat (Xenical® pills, per os \[p.o.; by mouth\])” NCT03799198 ↗ “Orlistat (Xenical, Alli)” NCT05812183 ↗ “Alli® (orlistat 60 mg)” NCT02141230 ↗ “Orlistat” NCT02041234 ↗ |
| Known as | Alli | “Orlistat in its conventional form will be Alli® 60 mg during week 1 to 4 and Xenical® 120 mg from week 5 and onwards in matching oral capsules.” NCT05934110 ↗4“the drug orlistat (Alli, Xenical) decreases the taste for fat in humans.” NCT01719419 ↗ “Orlistat in its conventional form will be Alli® 60 mg.” NCT06993428 ↗ “Orlistat (Xenical, Alli)” NCT05812183 ↗ |
| Known as | Alli (previously orlistat gsk) | ChEMBL registry synonym — accepted as the source's own label CHEMBL175247 ↗ |
| Known as | Beacita | ChEMBL registry synonym — accepted as the source's own label CHEMBL175247 ↗ |
| Known as | EMP22 | “EMP22 (also referred to as MR orlistat) has the same MR properties as EMP16 but lacks the acarbose component.” NCT06013163 ↗ |
| Known as | NSC-758881 | ChEMBL registry synonym — accepted as the source's own label CHEMBL175247 ↗ |
| Known as | Orlipastat | ChEMBL registry synonym — accepted as the source's own label CHEMBL175247 ↗ |
| Known as | RO 18-0647/002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL175247 ↗ |
| Known as | tetrahydrolipstatin | “Orlistat (tetrahydrolipstatin or THL) inhibits gastrointestinal lipase and reduces the absorption of dietary fat.” NCT00752726 ↗ |
| Known as | THL | “Orlistat (tetrahydrolipstatin or THL) inhibits gastrointestinal lipase and reduces the absorption of dietary fat.” NCT00752726 ↗ |
| Known as | Xenical | “Xenical (Orlistat) - 120 mg/day in integration of Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin...” NCT02503865 ↗14“In addition, orlistat (Xenical, Roche S.A., Greece; 120 mg, 3 times per day) was administered before each meal, for 24 weeks.” NCT01475019 ↗ “One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche).” NCT00001723 ↗ “Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)” NCT00160407 ↗ “Xenical® (120 mg orlistat) will be taken together with breakfast during one PK study day.” NCT06013163 ↗ “the drug orlistat (Alli, Xenical) decreases the taste for fat in humans.” NCT01719419 ↗ “weight loss medication Xenical (generic name - orlistat)” NCT00152360 ↗ “Orlistat (Xenical® pills, per os \[p.o.; by mouth\])” NCT03799198 ↗ “comparison with orlistat (Xenical).” PMID 19461584 ↗ May 2009 “Orlistat (Xenical, Alli)” NCT05812183 ↗ “orlistat [Xenical]” NCT00940628 ↗ |
| Known as | Xenical (orlistat) | “Xenical (orlistat)” NCT00207311 ↗ |
| Action | Inhibit | “Orlistat acts by inhibiting gastrointestinal lipases” NCT00001723 ↗ |
| Modality | Small molecule | — CHEMBL175247 ↗ |
| Route | Oral | “120 mg orally 3 times daily” PMID 20101008 ↗ Jan 2010 |
| Target | LIPF | “Gastric lipase inhibitor” CHEMBL175247 ↗ |
| Target | PNLIP | “Pancreatic lipase inhibitor” CHEMBL175247 ↗ |