Tibolone
As of the edition of 20 October 2026, Tibolone is a small molecule: marketed, first approved in 1994 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2006
- Kind
- Small molecule
- Brand name
- Boltin
- First approved
- 1 December 1994 (ES)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- ORGANON FARMACÊUTICA LTDA.; 5 holders in all
- Registered trials
- 14, 2 stopped early
- Disease areas
- Bones, joints and muscles; Nutrition and metabolism; Cancer; Urinary and reproductive; Mental health; Nervous system
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 3 | 1 | 1 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 6 | 4 | 0 | 1 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Applicant and Lead sponsor of trials | 1998 to now |
| Libbs Farmacêutica LTDA | Applicant | 2006 to now |