Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tibolone · 5 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | tibolone |
| 2 | ACTIVE_COMPARATOR | transdermal continuous combined E2-NETA (estradiol-norethisterone) |
| Arm 1 | ACTIVE_COMPARATOR | Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with tibolone |
| Arm 2 | PLACEBO_COMPARATOR | Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with placebo |
| Tibolone | ACTIVE_COMPARATOR | Tibolone 2.5 mg/day |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Tibolone 1.25 mg | EXPERIMENTAL | - |
| Tibolone 2.5 mg | EXPERIMENTAL | - |
| CE/MPA | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| tibolone | DRUG | tibolone (2.5 mg) over 24 weeks |
| estradiol-norethisterone | DRUG | transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks |
| placebo | DRUG | Subjects were to take one tablet of tibolone-matched placebo, per day, every day, for 14 ± 2 days (until the day before surgery). |
| Tibolone 2.5 mg | DRUG | oral 2.5 mg tablet, once daily, for 2 years |
| CE/MPA | DRUG | oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years |
Inclusion Criteria: * Physically and mentally healthy postmenopausal women, \>=48 and \<=68 years of age, with an intact uterus. * Women were to suffer from decreased satisfactory sexual activity compared to younger age and sexual problems were not to be considered caused by relationship/partner pr...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
Tibolone is a small molecule in development for postmenopausal women, sexual dysfunction, osteoporosis, and breast cancer. It has been studied in postmenopausal women with breast cancer and climacteric symptoms, as well as in the treatment of osteoporosis. It is an investigational drug and has not been approved by the FDA.
Tibolone is being developed by Organon & Co., a company traded on the New York Stock Exchange under the ticker symbol OGN. Organon has conducted clinical trials evaluating Tibolone for conditions including breast cancer and osteoporosis.
Tibolone is in Phase 3 clinical development. Multiple Phase 3 trials have been completed, including studies in breast cancer, osteoporosis, and postmenopausal women. As an investigational drug, it remains in clinical development and is not yet approved for any indication.
Tibolone has been studied in several completed Phase 3 trials. These include NCT00408863, a study in breast cancer and climacteric symptoms with 3,148 participants; NCT00519857, a trial in osteoporosis with 4,534 participants; NCT00725374, a study on breast tissue in postmenopausal women with breast cancer; and NCT00745108, an endometrium study in postmenopausal women.
Yes, Tibolone is also known as Livial. Clinical trials have referred to the drug as Livial, including a study investigating its effects on breast tissue in postmenopausal women with breast cancer. The drug is being developed by Organon & Co. under the brand name Livial.