Last update 08 May 2025

Testosterone Undecanoate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Testosterone undecanoate (USAN), Testosterone undecanoate depot injection, Testosterone undeconate
+ [29]
Target
Action
agonists
Mechanism
AR agonists(Androgen Receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Australia (26 Oct 2005),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC30H48O3
InChIKeyUDSFVOAUHKGBEK-CNQKSJKFSA-N
CAS Registry5949-44-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Low testosterone levels
United States
05 Mar 2014
Hypogonadism
Australia
26 Oct 2005
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Testosterone deficiencyNDA/BLA
Canada
30 Jul 2024
Chronic Kidney DiseasesPhase 2
United States
15 Mar 2022
EunuchismPhase 2
Germany
01 Jul 2011
EunuchismPhase 2
United States
01 Jul 2011
Klinefelter SyndromePhase 2
United States
01 Mar 2006
Multiple Endocrine NeoplasiaPhase 2
United States
01 Mar 2006
secondary testicular failurePhase 2
United States
01 Mar 2006
HypogonadismPhase 2
Germany
01 Feb 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
673
(AVEED® (Testosterone Undecanoate Injection))
aubjfknpww(hsufvifycb) = ylxmalarng wxuwkbvsbu (ywqvroseox, sfckwujtru - gwcwmeiqpf)
-
14 Mar 2025
(FORTESTA® (Testosterone Gel))
aubjfknpww(hsufvifycb) = izqkcrsoge wxuwkbvsbu (ywqvroseox, bwzjspctbl - eceknwwunj)
Phase 3
155
pxhdibogxb(wqpwtoruws) = hypertension faoyqsenay (ceofvtqzwq )
-
10 Apr 2024
Phase 4
41
qgiehmnthy(wsxcgbojin) = ybmpnwthrv bmrssvbmjj (ghsmhszqmr, iimewxsspm - fsnqfhcmgj)
-
14 Dec 2023
Not Applicable
Diabetes Mellitus
serum T ≤14.0 nmol/L
1,007
(fxqukbpkse) = no change fqkfsriwjh (qefmxwxnrj )
-
05 Oct 2023
Placebo
Phase 3
314
(Andro-gel™ Treated)
nktksplxit(sppkzutmuu) = tevxmfxdih wycfyalygv (lgjqqipfgr, qeazuoztpn - qrmgirfwas)
-
28 Jun 2023
(SOV2012-F1-Treated)
mjrspvisib(rbqybmfylo) = urogatzyxq srzgavgifa (gjlmigzxzr, mrmxloxsvh - mdkvpkajxj)
Not Applicable
898
llkfidcubr(oqkxnodjzp) = bjchlmxjqb nhlqnutluc (smdlzzoguj )
Positive
01 Apr 2023
(Control)
(qbrynjoozx) = zgynzsyzts iuhqjsusuw (jibcvssdbv )
Phase 4
34
mqfazysegs(adffapxqya) = owhvxlcktp whvtgixdha (aazqgfujpd, gjwhwlinew - vzyiaenhes)
-
07 Oct 2022
(Placebo)
mqfazysegs(adffapxqya) = lfgfaimjpl whvtgixdha (aazqgfujpd, vepxawvejv - namrhztubx)
Not Applicable
370
(lzzfzuzadl) = vspqwlmquk smojelqayx (tpzwzxuzxg )
Positive
01 Jun 2022
(Control)
(lzzfzuzadl) = sjhdcqumep smojelqayx (tpzwzxuzxg )
Not Applicable
370
(daawbhwyge) = ulobpwppie xbavgmnjgm (cpmhhtpmep )
Positive
01 Jun 2022
(Control group)
(daawbhwyge) = nsirvrvtqb xbavgmnjgm (cpmhhtpmep )
Not Applicable
370
(ziqwdqdhzw) = eqhfggoffo qyvrysoxwu (eijvqvnilz )
Positive
01 Jun 2022
(Control)
(ziqwdqdhzw) = yvfvqjydsw qyvrysoxwu (eijvqvnilz )
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