FDA · United States
orlistat — FDA regulatory status
orlistat (XENICAL) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- XENICAL
- Originator
- Lacuna Pharma Pty Ltd
- Mechanism
- Pancreatic lipase inhibitor
- Target
- Gastric triacylglycerol lipase
- Structured fields
- 8
Sponsor / originator context: Lacuna Pharma Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Pancreatic lipase inhibitor. Target: Gastric triacylglycerol lipase. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 30 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 116130 | Phase 3 | Disc Medicine | 2024-516756-18-00 |
| Crystalline cellulose simple occlusive dressing | Phase 3 | First People's Hospital | NCT01512017 |
| GSK 2132231A | Phase 3 | GSK Glaxo Smith | NCT00796445 |
| GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) | Phase 3 | GSK Glaxo Smith | NCT01051661 |
| LBS-008-CT05 | Phase 3 | ELITE PHARMACEUTICALS INC | 2023-503931-17-00 |
| NICOTINAMIDE, cellulose microcristalline | Phase 3 | Ishita Pharma - | 2023-508664-30-00 |
| NOE-TGN-201 | Phase 3 | Anaxis Pharma | 2024-514497-41-00 |
| Nano-crystalline Megestrol Acetate Oral Suspension | Phase 3 | Chinese Academy of | NCT06961201 |
| Palliative Chemotherapy | Phase 3 | Sun Yat-sen University | NCT06208371 |
| Placebo | Phase 3 | Jazz Pharmaceuticals Ireland | NCT00674609 |
| Recombinant human tissue kallikrein | Phase 3 | DiaMedica Therapeutics | NCT05065216 |
| AMBROXOL , Microcrystalline cellulose | Phase 2 | Disc Medicine | 2024-514976-41-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026047022 | FORME POSOLOGIQUE PHARMACEUTIQUE SOLIDE ET STABLE COMPRENANT UNE FORME CRISTALLINE D'UN INHIBITEUR DE HER2/MUTEGFR ET SA MÉTHODE DE PRÉPARATION | WO |
| 2026047020 | FORMES CRISTALLINES D'INHIBITEURS DE HER2/MUTEGFR ET LEUR PROCÉDÉ DE PRÉPARATION | WO |
| 2025242585 | FORMES CRISTALLINES DE SELS D'ÉLINZANÉTANT ET COMPOSITIONS CONTENANT DES SELS D'ÉLINZANÉTANT | WO |
| 12410184 | Crystalline forms of a menin inhibitor | US |
| 12384854 | Plasma kallikrein binding proteins and uses thereof in treating hereditary angioedema | US |
| 12378245 | Crystalline forms of an RSK inhibitor | US |
| 12344585 | Crystalline salts of a plasma kallikrein inhibitor | US |
| 12338249 | Crystalline forms of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea | US |
| 12329805 | Dosage forms of tissue kallikrein 1 | US |
| 12319657 | Solid state crystalline forms of a selective potassium channel modulator | US |
| 12319651 | Crystalline forms and methods of producing crystalline forms of a compound | US |
| 12319693 | Crystalline forms of CFTR modulators | US |
Related hubs
FAQ
What is the FDA approval status of orlistat?
orlistat currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get orlistat regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to orlistat?
This spoke lists 30 published programs associated with orlistat in our pipeline index.