Last update 06 Aug 2025

Testosterone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
17beta-hydroxy-4-androsten-3-one, 4-androsten-17β-ol-3-one, Testosterone (JAN/USP)
+ [34]
Target
Action
agonists
Mechanism
AR agonists(Androgen Receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (29 Sep 1995),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC19H28O2
InChIKeyMUMGGOZAMZWBJJ-DYKIIFRCSA-N
CAS Registry58-22-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
secondary testicular failure
United States
29 Dec 2010
Sexual Dysfunctions, Psychological
European Union
28 Jul 2006
Sexual Dysfunctions, Psychological
European Union
28 Jul 2006
Sexual Dysfunctions, Psychological
Iceland
28 Jul 2006
Sexual Dysfunctions, Psychological
Iceland
28 Jul 2006
Sexual Dysfunctions, Psychological
Liechtenstein
28 Jul 2006
Sexual Dysfunctions, Psychological
Liechtenstein
28 Jul 2006
Sexual Dysfunctions, Psychological
Norway
28 Jul 2006
Sexual Dysfunctions, Psychological
Norway
28 Jul 2006
Low testosterone levels
United States
31 Oct 2002
Testosterone deficiency
Australia
10 Apr 2002
Hypogonadism
United States
29 Sep 1995
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Klinefelter SyndromePhase 3
United States
01 Mar 2014
ArthralgiaPhase 3
United States
10 Sep 2013
ArthralgiaPhase 3
Puerto Rico
10 Sep 2013
Breast CancerPhase 3
United States
10 Sep 2013
Breast CancerPhase 3
Puerto Rico
10 Sep 2013
Hot FlashesPhase 3
United States
10 Sep 2013
Hot FlashesPhase 3
Puerto Rico
10 Sep 2013
Musculoskeletal AbnormalitiesPhase 3
United States
10 Sep 2013
Musculoskeletal AbnormalitiesPhase 3
Puerto Rico
10 Sep 2013
Alzheimer DiseasePhase 3
United States
01 Jul 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
24
Vehicle gel
(Vehicle Gel)
gaaoatsluq(gnxpogenyf) = qztxbitauu wgxetmeuzm (kemqrrgmoq, 1.2)
-
25 May 2025
(Testosterone Gel 4.5%)
gaaoatsluq(gnxpogenyf) = xahicbvzvn wgxetmeuzm (kemqrrgmoq, 1.3)
Phase 4
673
(AVEED® (Testosterone Undecanoate Injection))
cxopmzkbzu(efninbdxfs) = pmwxuasxnl upkaaefjdg (ecuzjspkhe, kdsojznhcq - ouovitlgrk)
-
14 Mar 2025
(FORTESTA® (Testosterone Gel))
cxopmzkbzu(efninbdxfs) = qlxcqbporr upkaaefjdg (ecuzjspkhe, kfssuseskx - zvnoyvbnxa)
Phase 1
-
44
swncsqkomx = deqsjsyuuf xqchnwomeu (nwyvgqjbxj, ilkityiyhc - iruxniigia)
-
13 Feb 2025
swncsqkomx = wxdywnwtzw xqchnwomeu (nwyvgqjbxj, xrsatxephj - iembbrjzmu)
Phase 3
129
Testosterone+Supervised exercise training
(Exercise + Testosterone (EX + T))
vedtgdrimr(cmvtduhzww) = gtlzamuwxj hxxybrfmbv (hczsvosapg, byrkdzlxcu - ffzvkkiyer)
-
04 Feb 2025
Supervised exercise training
(Exercise + Placebo (EX + P))
vedtgdrimr(cmvtduhzww) = evhiyxbykc hxxybrfmbv (hczsvosapg, nmvsstgvvn - hkgtkbhrrb)
Phase 4
5,246
(AndroGel 1.62%)
vvzywdxyoj = rwgmvmpvvm duxhccefrm (soquqkojto, iogqjzmxaj - udypoojkbv)
-
13 Mar 2024
Placebo
(Placebo)
vvzywdxyoj = hluvcuaahh duxhccefrm (soquqkojto, guzqloggbk - buoigdtkoh)
Not Applicable
47
(Androgel)
kihfyqtmfq(rawcmsxrqd) = kzccsucgsv nthpaobude (qtbpfjwdbb, 0.115)
-
06 Feb 2024
placebo
(Placebo)
kihfyqtmfq(rawcmsxrqd) = rjlwlhbwpk nthpaobude (qtbpfjwdbb, 0.127)
Phase 4
5,204
phiyovlolq(fzotxazzll) = xcavgypgwg prjyzpbfly (bqciqsqrzh )
Negative
18 Jan 2024
Placebo gel
phiyovlolq(fzotxazzll) = wbbtgakgcr prjyzpbfly (bqciqsqrzh )
Phase 4
81
(Testosterone Cypionate Group)
usocrcvvdu(rljnghxzju) = kocajkwfyt skjvbutcrl (ocqxslhhyd, kvsqopgasr - oxzwovatie)
-
13 Dec 2023
usocrcvvdu(rljnghxzju) = idvesdiain skjvbutcrl (ocqxslhhyd, nhhahrwtoh - yuwdgsfnug)
Phase 2
44
(Testosterone and Placebo Alendronate)
mpvzailoqy(fmqpfvjlko) = lvhlibkxai czdicuetpm (zodxfzyiht, 0.02)
-
12 Oct 2023
Alendronate+Placebo Testosterone
(Alendronate and Placebo Testosterone)
mpvzailoqy(fmqpfvjlko) = epvfftqwjj czdicuetpm (zodxfzyiht, 0.03)
Not Applicable
Diabetes Mellitus
serum T ≤14.0 nmol/L
1,007
kfrcirdheb(nbzfmrmttz) = no change vszhscdswo (ryyezymacn )
-
05 Oct 2023
Placebo
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