| Drug Name |
Tibolone |
| Drug ID |
BADD_D02213 |
| Description |
Tibolone is a synthetic steroid hormone drug, which is mainly non-selective in its binding profile, acting as an agonist primarily at estrogen receptors (ER), with a preference for ER alpha [L1874].
Tibolone (Livial, Org OD 14), produced by Organon (West Orange, NJ), is a synthetic steroid that possesses estrogenic, androgenic and progestogenic properties. It has been used in Europe for almost 2 decades, primarily for the prevention of postmenopausal osteoporosis and the treatment of post-menopausal symptoms [L1720]. Tibolone is approved in 90 countries to manage menopausal symptoms and in 45 countries to prevent the development of osteoporosis [L1876].
In June 2006, Organon Pharmaceuticals announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for tibolone had not been approved [L1722].
Interestingly, the use of tibolone in the treatment cardiovascular disease has been studied with inconclusive results [A32164]. Tibolone has been to have anti-resorptive effects on bone [L1874]. |
| Indications and Usage |
For the relief of post-menopausal symptoms and for the prevention of osteoporosis [L1724]. |
| Marketing Status |
approved; investigational |
| ATC Code |
G03CX01 |
| DrugBank ID |
DB09070
|
| KEGG ID |
D01639
|
| MeSH ID |
C027385
|
| PubChem ID |
444008
|
| TTD Drug ID |
D0W3OS
|
| NDC Product Code |
51508-010; 73774-006; 24002-0033 |
| UNII |
FF9X0205V2
|
| Synonyms |
tibolone | tibilone | Org OD 14 | Org OD14 | Livial | Liviella | Boltin |
