Last update 11 Jul 2024

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
+ [13]
Target
Mechanism
ERs agonists(Estrogen receptors agonists)
Originator Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure

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
AR
-16 Feb 2006
Menopausal syndrome
AU
19 May 2000
Oestrogen deficiency
CN
26 Nov 1990
Endocrine System Diseases--01 Jan 1988
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 2-01 May 2002
Menopausal symptomsPhase 2-01 Oct 2001
OsteoporosisPhase 2-01 Jul 2001
Spinal FracturesPhase 2-01 Jul 2001
Menopausal syndromePhase 2
CA
-
Menopausal syndromePhase 2
US
--
Osteoporosis, PostmenopausalPhase 2
JP
--
Osteoporosis, PostmenopausalPhase 2
CA
--
Osteoporosis, PostmenopausalPhase 2
JP
--
Osteoporosis, PostmenopausalDiscovery
CA
--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
3,148
herwjwbtdg(hhrvtsplhw) = oumsowaoif wcaueldkyf (hdxwrbznah )
-
01 Dec 2011
Placebo
herwjwbtdg(hhrvtsplhw) = toxzjfamik wcaueldkyf (hdxwrbznah )
Phase 3
3,148
rvyonrueyb(lfvcgkpzuh): HR = 1.4 (95% CI, 1.14 - 1.7), P-Value = 0.001
Negative
01 Feb 2009
Placebo
Phase 3
-
4,538
tnumbwbkdn(ayesftnyrv): relative hazard = 0.31 (95% CI, 0.1 - 0.96), P-Value = 0.04
-
14 Aug 2008
Placebo
Phase 3
-
102
zienvifuca(cweykbxfwk) = tbrfazfnsv xvigehycws (xdlchvokzv )
Negative
15 Jul 2007
Placebo
zienvifuca(cweykbxfwk) = qafvgfhlum xvigehycws (xdlchvokzv )
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Approval

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Regulation

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