Last update 25 Mar 2025

Tibolone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
17-hydroxy-7alpha-methyl-19-nor-17alpha-pregn-5(10)-en-20-yn-3-one, Boltin, Livial
+ [14]
Target
Action
agonists
Mechanism
ERs agonists(Estrogen receptors agonists)
Originator Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC21H28O2
InChIKeyWZDGZWOAQTVYBX-XOINTXKNSA-N
CAS Registry5630-53-5

External Link

KEGGWikiATCDrug Bank
D01639Tibolone

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Osteoporosis, Postmenopausal
Argentina
-16 Feb 2006
Menopausal syndrome
Australia
19 May 2000
Oestrogen deficiency
China
26 Nov 1990
Endocrine System Diseases--01 Jan 1988
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Sexual DysfunctionPhase 3-23 Mar 2004
Sexual Dysfunction, PhysiologicalPhase 3-23 Mar 2004
Breast CancerPhase 3-01 May 2002
Early Stage Breast CarcinomaPhase 3-01 May 2002
Menopausal symptomsPhase 3-01 Oct 2001
OsteoporosisPhase 3-01 Jul 2001
Spinal FracturesPhase 3-01 Jul 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
3,148
sapsbbjwyr(cswyywnlta) = fagcstntbk sqqvamjjhp (hsgxzdyonw )
-
01 Dec 2011
Placebo
sapsbbjwyr(cswyywnlta) = vxqynwigbo sqqvamjjhp (hsgxzdyonw )
Phase 3
3,148
yjkufyvdog(hwsmlgmhqy): HR = 1.4 (95% CI, 1.14 - 1.7), P-Value = 0.001
Negative
01 Feb 2009
Placebo
Phase 3
-
4,538
wewuxfouvs(ymoeicldzk): relative hazard = 0.31 (95% CI, 0.1 - 0.96), P-Value = 0.04
-
14 Aug 2008
Placebo
Phase 4
570
qehxosriqb(lxmairawtz) = tkdgdkeejp zdlcrwgyab (ixdclwrahf )
-
01 Dec 2007
17beta estradiol plus 0.5 mg norethisterone acetate (E2/NETA) 1 mg
qehxosriqb(lxmairawtz) = phmtglwree zdlcrwgyab (ixdclwrahf )
Phase 3
-
102
Tibolone 2.5 mg/d
xexvbvftom(ywriklipph) = nlaoidxens vyqdwtalny (sqcmnokgxu )
Negative
15 Jul 2007
Placebo
xexvbvftom(ywriklipph) = dulppzesxy vyqdwtalny (sqcmnokgxu )
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Regulation

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