Livial

(Tibolone)

ApprovedSmall molecule

Tibolone is used to treat symptoms of menopause in women, such as hot flashes, night sweats, and mood changes. It also helps prevent bone loss that can occur after menopause.[2] Livial is currently approved and in use across 7 indications[4].[1]

Livial is one of 178 small molecule programs targeting Bone Density. It is currently in Approved.

Indications

Total Trials

Active Trials

177

Competitors

Pipeline

Status by Indication[4][1]

Indication

Bone DensityActive, not recruiting

Lower Urinary Tract SymptomActive, not recruiting

Sleep DisorderActive, not recruiting

Breast CancerActive, not recruiting

OsteoporosisActive, not recruiting

Overactive BladderActive, not recruiting

EndometriosisActive, not recruiting

Bone DensityPhase 2

Active, not recruiting

Lower Urinary Tract SymptomApproved

Active, not recruiting

Sleep DisorderApproved

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

OsteoporosisPhase 3

Active, not recruiting

Overactive BladderPreclinical

Active, not recruiting

EndometriosisPreclinical

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Livial

Pfizer

Approved

2 2

MS Contin

Merck & Co.

Preclinical

2 3

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 4

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 5

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 6

Avastin

Roche

Preclinical

4 7

Nubain

AAultman Health Foundation

Preclinical

1 8

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—9

QS21

MMemorial Sloan Kettering Cancer Center

Preclinical

3 10

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Recruiting

Overactive Bladder

NCT05280028

Clinical

Trials by Indication[1]

Postmenopausal Women3 trials

Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)

Completed·OOrganon and Co·Phase 3·NCT00413764·358 enrolled

Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)

Completed·OOrganon and Co·Phase 4·NCT00431431·324 enrolled

Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women

Completed· Pfizer logo

Pfizer·Phase 4·NCT00472004·204 enrolled

Breast Cancer2 trials

Livial Intervention Following Breast Cancer; Efficacy, Recurrence and Tolerability Endpoints (LIBERATE)(COMPLETED)(P05885)

Completed·OOrganon and Co·Phase 3·NCT00408863·3,148 enrolled

A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469)

Completed·OOrganon and Co·Phase 3·NCT00725374·102 enrolled

ART2 trials

Vascular Effect of Tibolone in the Brachial Artery

Completed·SSelmo Geber·N/A·NCT01543399·60 enrolled

Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

Completed·FFederal University of Minas Gerais·N/A·NCT01679795·60 enrolled

Depression2 trials

Investigation of Tibolone and Escitalopram in Perimenopausal Depression

Terminated·TThe Alfred·Phase 4·NCT01368068·2 enrolled

Tibolone and Placebo in Adjunct to Antidepressant Medication for Women With Menopausal Depression

Completed·TThe Alfred·Phase 4·NCT01470092·120 enrolled

Treatment1 trial

Effects of Tibolone Treatment on the Endometrium

Completed·EErasmus Medical Center·Phase 4·NCT00294463·35 enrolled

10 more indications

Bone Density1 trial

Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy

Completed·—·Phase 2·NCT00165204·50 enrolled

Osteoporosis1 trial

Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)

Completed·OOrganon and Co·Phase 3·NCT00519857·4,534 enrolled

Lower Urinary Tract Symptom1 trial

The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder

Completed·FFar Eastern Memorial Hospital·Phase 4·NCT01822288·125 enrolled

Hormone Replacement Therapy1 trial

Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women

Completed·SSolvay Pharmaceuticals·Phase 4·NCT00145522·135 enrolled

Trial1 trial

Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)

Completed·OOrganon and Co·Phase 4·NCT00431093·570 enrolled

Sleep Disorder1 trial

the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT06117969·180 enrolled

Overactive Bladder1 trial

HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness

Recruiting·FFar Eastern Memorial Hospital··NCT05280028·100 enrolled

Endometriosis1 trial

Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids

Withdrawn·MMcGill University Health Centre/Research Institute of the McGill University Health Centre··NCT05568940

Cholesterol1 trial

High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone

Completed·KKeogh Institute for Medical Research·Phase 4·NCT00809068·20 enrolled

Unspecified2 trials

The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill

Completed·GGuoqing Zhou··NCT05846698·276 enrolled

Tibolone Endometrium Study (Study 32972)(P06470)

Completed·OOrganon and Co·Phase 3·NCT00745108·32 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Tibolone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Livial drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tibolone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tibolone. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Livial

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Postmenopausal Women3 trials

Breast Cancer2 trials

ART2 trials

Depression2 trials

Treatment1 trial

Bone Density1 trial

Osteoporosis1 trial

Lower Urinary Tract Symptom1 trial

Hormone Replacement Therapy1 trial

Trial1 trial

Sleep Disorder1 trial

Overactive Bladder1 trial

Endometriosis1 trial

Cholesterol1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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