Overview
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 . 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 . Tibolone is approved in 90 countries to manage menopausal symptoms and in 45 countries to prevent the development of osteoporosis . 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 . Interestingly, the use of tibolone in the treatment cardiovascular disease has been studied with inconclusive results . Tibolone has been to have anti-resorptive effects on bone .
Background
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 . 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 . Tibolone is approved in 90 countries to manage menopausal symptoms and in 45 countries to prevent the development of osteoporosis . 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 . Interestingly, the use of tibolone in the treatment cardiovascular disease has been studied with inconclusive results . Tibolone has been to have anti-resorptive effects on bone .
Indication
For the relief of post-menopausal symptoms and for the prevention of osteoporosis .
Associated Conditions
- Vasomotor Symptoms Associated With Menopause
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/11/07 | Phase 4 | Not yet recruiting | |||
2023/05/06 | N/A | Completed | Guoqing Zhou | ||
2022/10/06 | N/A | Withdrawn | McGill University Health Centre/Research Institute of the McGill University Health Centre | ||
2022/03/15 | N/A | Recruiting | |||
2013/04/02 | Phase 4 | Completed | |||
2012/09/06 | Not Applicable | Completed | Federal University of Minas Gerais | ||
2012/03/05 | Not Applicable | Completed | Selmo Geber | ||
2011/11/11 | Phase 4 | Completed | The Alfred | ||
2011/06/07 | Phase 4 | Terminated | The Alfred | ||
2008/12/16 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LIVIAL TABLET 2.5 mg | SIN05423P | TABLET | 2.5 mg | 2/18/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tibolone Tablets | 国药准字H20020198 | 化学药品 | 片剂 | 7/22/2024 | |
| Tibolone Tablets | 国药准字HJ20160575 | 化学药品 | 片剂 | 7/29/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TIBOLONE LUPIN tibolone 2.5 mg tablet blister pack | 286595 | Medicine | A | 4/4/2018 | |
| TIBOGEN tibolone 2.5 mg tablet blister pack | 220602 | Medicine | A | 2/9/2015 | |
| TIBOLONE SCP tibolone 2.5 mg tablet blister pack | 286597 | Medicine | A | 4/4/2018 | |
| TIBOLONE GPPL tibolone 2.5 mg tablet blister pack | 283951 | Medicine | A | 3/28/2018 | |
| LIVILAN tibolone 2.5 mg tablet blister pack | 283947 | Medicine | A | 3/28/2018 | |
| APO-TIBOLONE tibolone 2.5 mg tablet blister pack | 283952 | Medicine | A | 3/28/2018 | |
| CHEMMART TIBOLONE tibolone 2.5 mg tablet blister pack | 283954 | Medicine | A | 3/28/2018 | |
| TERRY WHITE CHEMISTS TIBOLONE tibolone 2.5 mg tablet blister pack | 283953 | Medicine | A | 3/28/2018 | |
| TIBOLONE SANDOZ tibolone 2.5 mg tablet blister pack | 286596 | Medicine | A | 4/4/2018 | |
| TIBOLONE-WGR tibolone 2.5 mg tablet blister pack | 282315 | Medicine | A | 3/28/2018 |