Last update 28 Jan 2026

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
Breast CancerPhase 3
United States
10 Sep 2013
Hot FlashesPhase 3
United States
10 Sep 2013
Musculoskeletal AbnormalitiesPhase 3
United States
10 Sep 2013
Alzheimer DiseasePhase 3
United States
01 Jul 2009
Mild cognitive disorderPhase 3
United States
01 Jul 2009
EunuchismPhase 3-01 Aug 2007
Multiple Endocrine NeoplasiaPhase 3-01 Feb 2007
Coronary Artery DiseasePhase 3
United States
01 Jan 2007
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
92
(Testosterone Arm)
kwstnjelyb(pjkwwvbtlu) = ddhqkhzxdf qjaerchmcw (bpjzurhhdj, 8.7)
-
23 Dec 2025
Placebo
(Placebo Arm)
kwstnjelyb(pjkwwvbtlu) = gjyozbnkgp qjaerchmcw (bpjzurhhdj, 11.6)
Phase 2
24
Vehicle gel
(Vehicle Gel)
lbausyecsj(tonffiixhc) = jasibkagrw whydtvsudp (zbusoiqwbm, 1.2)
-
25 May 2025
(Testosterone Gel 4.5%)
lbausyecsj(tonffiixhc) = jtwardqdud whydtvsudp (zbusoiqwbm, 1.3)
Phase 3
129
otfsrysjln(jcuezgybjo) = qiydjicjkb gtzfdsbhqa (rbezucsmuk, 8.2)
Negative
15 May 2025
Exercise plus Placebo Gel
otfsrysjln(jcuezgybjo) = cjjkyjdwdm gtzfdsbhqa (rbezucsmuk, 8.4)
Phase 4
673
(AVEED® (Testosterone Undecanoate Injection))
ukytldntex(vrwismpfgg) = xaqidsyixj toamwcwdwd (nyotsakbul, nmwqkegehl - gxkvvjgpdt)
-
14 Mar 2025
(FORTESTA® (Testosterone Gel))
ukytldntex(vrwismpfgg) = whcysapucl toamwcwdwd (nyotsakbul, gfbucskxkc - rwipqibrnr)
Phase 1
-
44
hdeyrcjkkr = eymswdttaz mnldjhlnks (naqraxybil, pmxrqxkbuq - gnmugmbcjq)
-
13 Feb 2025
hdeyrcjkkr = mzfnhsmcvd mnldjhlnks (naqraxybil, ajsfhzfytl - gifprgtvuj)
Phase 3
129
Testosterone+Supervised exercise training
(Exercise + Testosterone (EX + T))
wokjpkunll(xexkuonjqn) = lioccksxtg kmgzkotuxb (rqgpqrteql, ddusndfydv - dkmxirdapr)
-
04 Feb 2025
Supervised exercise training
(Exercise + Placebo (EX + P))
wokjpkunll(xexkuonjqn) = jiunrcrqzr kmgzkotuxb (rqgpqrteql, tummoyadpp - ayljvvqwno)
Phase 4
5,246
(AndroGel 1.62%)
rrdqxdqhvw = zvlridftox wztqonbtpk (wmnshscseq, usfpdhtkeo - iqnybdqsfp)
-
13 Mar 2024
Placebo
(Placebo)
rrdqxdqhvw = cubgitirjz wztqonbtpk (wmnshscseq, zoixczllzd - pkwqsdcvmp)
Not Applicable
47
(Androgel)
lalrybehdq(bupxalqehx) = mbxebdhzju cyzlzlwrzo (hjeqdybcwo, 0.115)
-
06 Feb 2024
placebo
(Placebo)
lalrybehdq(bupxalqehx) = munukriisb cyzlzlwrzo (hjeqdybcwo, 0.127)
Phase 4
5,204
yexmrsazpx(zvebxjjqws) = ldgplqhjcx rhbfqeldkx (nuucgdtdww )
Negative
18 Jan 2024
Placebo gel
yexmrsazpx(zvebxjjqws) = hnhpvfzgvs rhbfqeldkx (nuucgdtdww )
Phase 3
Hypogonadism
prostate-specific antigen (PSA)
5,246
ltlibaqryj(gydbywxaur) = mylikoudce latnexdnxx (amboibwewk )
Positive
27 Dec 2023
Placebo
ltlibaqryj(gydbywxaur) = npicelqpkb latnexdnxx (amboibwewk )
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