For obesity. Sold as Xenical, Alli. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 2 applications for Orlistat (sold as Xenical, Alli), first approved Apr 23, 1999, with 2 new uses approved and 0 published complete response letters.
| Orlistat | Part D | $236K | +7% | 121 |
| Xenical | Part D | $142K | -22% | 70 |
| Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical TrialPolycystic Ovary Syndrome · Khyber Medical University Peshawar | Not applicable | Recruiting | Aug 5, 2026 |
| Orlistat Plus Progestin for Fertility-Sparing Treatment of Endometrial Cancer or Atypical HyperplasiaEndometrial Neoplasms, Endometrial Cancer · Peking University People's Hospital | Phase 2 | Not yet recruiting | Jul 20, 2026 |
| Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCTGout, Obesity · XueMei Guo | Not applicable | Not yet recruiting | Jan 8, 2026 |
| RWS of of Liraglutide Alone and in Combination With Orlistat for Weight Loss in Overweight/Obese Patients.Overweight and Obese Adults · The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Phase 4 | Not yet recruiting | Dec 24, 2025 |
| Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)Cardiovascular Kidney Metabolic Syndrome · Ohio State University | — | Active, not recruiting | Sep 23, 2025 |
| A Trial With EMP16 in Preparation for Late Phase StudiesOverweight or Obese, Obesity and Overweight · Empros Pharma AB | Phase 2 | Not yet recruiting | May 28, 2025 |
| Weight Loss Management in Endometrial Cancer SurvivorsEndometrial Cancer Survivors, Weight Management · University of Kansas Medical Center | — | Active, not recruiting | Mar 14, 2025 |
| Orlistat Overcoming Third-generation EGFR-TKI ResistanceLung Adenocarcinoma, Osimertinib · Ping Peng | Phase 2 | Not yet recruiting | Feb 11, 2025 |
| Apr 23, 1999 | XenicalNDA 20766 · New molecular entity | Cheplapharm | 29 | Marketed |
| Feb 7, 2007 | AlliNDA 21887 · New formulation or manufacturer | Haleon US Holdings | 7 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA