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Tibolone (Livial)
Tibolone is a synthetic steroid that acts as a selective tissue estrogenic activity regulator (STEAR), providing estrogenic, progestagenic, and androgenic effects to alleviate menopausal symptoms.
Tibolone is a synthetic steroid that acts as a selective tissue estrogenic activity regulator (STEAR), providing estrogenic, progestagenic, and androgenic effects to alleviate menopausal symptoms. Used for Vasomotor symptoms of menopause (hot flushes, night sweats), Mood disturbances associated with menopause, Vaginal atrophy and sexual dysfunction in postmenopausal women.
At a glance
| Generic name | Tibolone (Livial) |
|---|---|
| Also known as | Livial |
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Drug class | Selective tissue estrogenic activity regulator (STEAR); synthetic steroid |
| Target | Estrogen receptor, progesterone receptor, androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Menopause |
| Phase | FDA-approved |
Mechanism of action
Tibolone is metabolized into three active metabolites that selectively bind to estrogen, progesterone, and androgen receptors in different tissues. This tissue-selective action allows it to provide symptom relief in some tissues (brain, bone, vagina) while minimizing proliferative effects in others (breast, endometrium), making it distinct from conventional hormone replacement therapy.
Approved indications
- Vasomotor symptoms of menopause (hot flushes, night sweats)
- Mood disturbances associated with menopause
- Vaginal atrophy and sexual dysfunction in postmenopausal women
- Bone loss prevention in postmenopausal women
Common side effects
- Vaginal bleeding or spotting
- Breast tenderness
- Headache
- Abdominal pain or bloating
- Nausea
Key clinical trials
- A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469) (PHASE3)
- Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090) (PHASE4)
- HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness
- Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
- the Effects of Different Therapy Regimens on Menopausal Sleep Disorders (PHASE4)
- The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill
- The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder (PHASE4)
- Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tibolone (Livial) CI brief — competitive landscape report
- Tibolone (Livial) updates RSS · CI watch RSS
- Wyeth is now a wholly owned subsidiary of Pfizer portfolio CI