Orlistat
As of the edition of 20 October 2026, Orlistat is a small molecule: marketed, first approved in 1972 (CH); acts on LIPF and PNLIP.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Xenical
- First approved
- 14 July 1972 (CH)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Aurovitas Spain, S.A.U.; 5 holders in all
- Registered trials
- 45, 7 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Cancer; Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Orlistat.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 17 | 11 | 2 | 3 |
| Phase 1 | 2 | 1 | 0 | 0 |
| Phase 2 | 9 | 5 | 2 | 2 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 15 | 8 | 2 | 2 |
| All trials | 45 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cheplapharm Arzneimittel | Applicant | 1998 to now |
| Roche | Applicant and Lead sponsor of trials | 1999 to now |
| GSK | Later holder and Lead sponsor of trials | 2007 to now |
| Haleon | Acquired holder and Later holder | 2007 to now |