testosterone

Trade name: delatestryl

Small moleculeapproved

Approved

Dec 24, 1953

Testosterone is a steroid sex hormone found in both men and women. In men, testosterone is produced primarily by the Leydig (interstitial) cells of the testes when stimulated by luteinizing hormone (LH). It functions to stimulate spermatogenesis, promote physical and functional maturation of spermatozoa, maintain accessory organs of the male reproductive tract, support development of secondary sexual characteristics, stimulate growth and metabolism throughout the body and influence brain development by stimulating sexual behaviors and sexual drive. In women, testosterone is produced by the ovaries (25%), adrenals (25%) and via peripheral conversion from androstenedione (50%). Testerone in women functions to maintain libido and general wellbeing. Testosterone exerts a negative feedback mechanism on pituitary release of LH and follicle-stimulating hormone (FSH). Testosterone may be further converted to dihydrotestosterone or estradiol depending on the tissue. The effects of testosterone in humans and other vertebrates occur by way of two main mechanisms: by activation of the androgen receptor (directly or as DHT), and by conversion to estradiol and activation of certain estrogen receptors. Free testosterone (T) is transported into the cytoplasm of target tissue cells, where it can bind to the androgen receptor, or can be reduced to 5α-dihydrotestosterone (DHT) by the cytoplasmic enzyme 5α-reductase. DHT binds to the same androgen receptor even more strongly than T, so that its androgenic potency is about 2.5 times that of T. The T-receptor or DHT-receptor complex undergoes a structural change that allows it to move into the cell nucleus and bind directly to specific nucleotide sequences of the chromosomal DNA. The areas of binding are called hormone response elements (HREs), and influence transcriptional activity of certain genes, producing the androgen effects. Testosterone is used as hormone replacement or substitution of diminished or absent endogenous testosterone. Use in males: For management of congenital or acquired hypogonadism, hypogonadism associated with HIV infection, and male climacteric (andopause). Use in females: For palliative treatment of androgen-responsive, advanced, inoperable, metastatis (skeletal) carcinoma of the breast in women who are 1-5 years postmenopausal; testosterone esters may be used in combination with estrogens in the management of moderate to severe vasomotor symptoms associated with menopause in women who do not respond to adequately to estrogen therapy alone. — NCATS

Clinical trial activity

453 trials · 332 clinical orgs · 58 marketing orgs

Phase 1

Phase 2

227

Phase 3

103

Phase 4

Earliest trial started Oct 1, 1992 (NCT00004771)

Timeline

1950s

Dec 24, 1953
Endo Pharmaceuticals — Earliest FDA Approval
Dec 24, 1953
Endo Pharmaceuticals — NDA Secondary Org
Dec 24, 1953
Endo Pharmaceuticals — NDA Organization

1970s

Jul 13, 1972
Auxillium — Marketing Organization
Dec 3, 1973
Belmar Pharmacy — Marketing Organization
Jun 23, 1978
Watson Pharmaceuticals — Marketing Organization
Jul 25, 1979
Pharmacia & Upjohn — Marketing Organization
Jul 25, 1979
Pfizer — Marketing Organization

1980s

Jun 13, 1980
Pharmacia & Upjohn — NDA Secondary Org
Jun 29, 1982
Savage Labs — Marketing Organization

1990s

Jan 1, 1992
Earliest Phase 2 Sponsor(trial)
Jan 1, 1992
Earliest Phase 3 Sponsor(trial)
Oct 12, 1993
Alza — NDA Secondary Org
Sep 29, 1995
Allergan — NDA Secondary Org
Sep 29, 1995
Allergan — Marketing Organization

2000s

Jan 1, 2000
Earliest Phase 1 Sponsor(trial)
Feb 28, 2000
AbbVie — NDA Secondary Org
Feb 28, 2000
Besins Healthcare — Marketing Organization
Feb 28, 2000
Besins Healthcare — NDA Secondary Org
Oct 31, 2002
Auxillium — NDA Secondary Org
Jan 31, 2005
Paddock Laboratories — Marketing Organization
Jan 31, 2005
Padagis Us — Marketing Organization
Jan 27, 2006
Actavis — Marketing Organization
Jun 14, 2006
Nexus Pharmaceuticals — Marketing Organization
Aug 10, 2006
Sandoz — Marketing Organization
Aug 10, 2006
Novartis — Marketing Organization
Dec 11, 2006
Mylan — Marketing Organization
Dec 11, 2006
Rising Pharmaceuticals — Marketing Organization
May 23, 2007
Par Pharmaceuticals — Marketing Organization
May 23, 2007
Strides Pharma Science — Marketing Organization

2010s

Jul 15, 2010
Hikma — Marketing Organization
Jul 15, 2010
West-Ward Pharmaceutical — Marketing Organization
Nov 23, 2010
Eli Lilly — NDA Secondary Org
Dec 29, 2010
Bristol-Myers Squibb — NDA Secondary Org
Feb 14, 2012
Ani Pharmaceuticals — NDA Secondary Org
Jan 31, 2013
Perrigo — NDA Secondary Org
Jun 3, 2013
Sun Pharmaceuticals — Marketing Organization
Mar 5, 2014
Endo Pharmaceuticals — Marketing Organization
May 28, 2014
AYTU BioScience — NDA Secondary Org
May 28, 2014
Acerus Pharmaceuticals Corporation — Marketing Organization
May 28, 2014
Bausch Health Companies — NDA Secondary Org
Jun 4, 2014
Upsher-Smith Laboratories — NDA Secondary Org
Aug 5, 2015
Allergan PLC (2015) — Marketing Organization
Jun 16, 2017
Lutipold — Marketing Organization
Jun 16, 2017
Sankyo — Marketing Organization
Jun 16, 2017
Daiichi Sankyo — Marketing Organization
Jul 12, 2017
Perrigo — Marketing Organization
Oct 23, 2017
Lupin — Marketing Organization
Jan 29, 2018
Cipla — Marketing Organization
Sep 28, 2018
Antares Pharma Inc. — NDA Secondary Org
Mar 27, 2019
Clarus Therapeutics, Inc. — NDA Secondary Org
Mar 27, 2019
Clarus Therapeutics, Inc. — Marketing Organization
Mar 27, 2019
Tolmar Inc. — Marketing Organization
Mar 27, 2019
Tolmar Inc. — NDA Secondary Org
Apr 10, 2019
Amneal Pharmaceuticals — Marketing Organization
Apr 10, 2019
Dr. Reddy's Laboratories — Marketing Organization
Apr 24, 2019
Wilshire Pharmaceuticals — Marketing Organization
Sep 23, 2019
TWi Biotechnology, Inc. — Marketing Organization

2020s

Apr 16, 2020
Exeltis — Marketing Organization
Nov 25, 2020
Apotex — Marketing Organization
Dec 8, 2020
Lipocine Inc. — Marketing Organization
Jan 11, 2021
Dash Pharms — Marketing Organization
Mar 3, 2021
Alembic — Marketing Organization
Nov 9, 2021
Encube Ethicals Pvt. Ltd. — Marketing Organization
Mar 28, 2022
Verity Pharmaceuticals — Marketing Organization
Jun 2, 2022
Azurity — Marketing Organization
Jun 2, 2022
Slayback Pharma Llc — Marketing Organization
Jun 2, 2022
Slayback Pharma Llc — NDA Secondary Org
Jul 27, 2022
MARIUS PHARMS LLC — Marketing Organization
Jul 27, 2022
MARIUS PHARMS LLC — NDA Secondary Org
Oct 20, 2023
Eugia Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Androgen ReceptorAGONIST
AR agonist
- Androgen receptor (AR) ↗

Combination products

depo-testadiol
with estradiol
Also known as ditate-ds, testosterone cypionate-estradiol cypionate

Approval history

approvedPriority reviewDec 24, 1953

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CC[C@H]3[C@@H](CCC4=CC(=O)CC[C@]34C)[C@@H]1CC[C@@H]2O

Mol. weight: 288.4244 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Discontinued

Oral

Parenteral

Yes

Topical

Prodrug

Sources

Also known as

17beta-hydroxy-4-androsten-3-one
17beta-hydroxy-4-androsten-3-one
17beta-testosterone
4-androsten-17β-ol-3-one
4-androsten-17β-ol-3-one
abt-slv176
abt-slv361
andriol
andriol
andriol
andro-cyp
andro-cyp
androderm
androderm
androderm
androgel
androgel
androgel 1%
androgel 1%
andronate
andropatch
andropatch
andropository
androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17-beta)
androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17-beta)-
ard-0403
axiron
axiron
btg brand of testosterone enanthate
delatestryl
delatestryl
delatestryl
delatestryl
depandro
depandro
deposteron
depostomead
depotest
depotest
depo-testadiol
depo-testadiol
depo-testosterone
depo-testosterone
depo-testosterone
depo-testosterone cypionate
duratest
durathate
eifelfango brand of testosterone enanthate
fortesta
fortesta
intrinsa
intrinsa
jenapharm brand of testosterone enanthate
mertestate
mertestate
nebido
nebido
nebido
org-538
org-538
organon brand of testosterone undecanoate
pantestone
pasadena brand of testosterone enanthate
primoteston depot
primoteston depot
primoteston depot
restandol
restandol
restandol
restandol testocap
roberts brand of testosterone enanthate
rotexmedica brand of testosterone enanthate
rugby brand of testosterone enanthate
schering brand of testosterone enanthate
striant
striant
striant sr
testa-c
testex
testex
testex elmu
testim
testim
testim
testim 1%
testoderm
testoderm
testoderm tts
testoderm tts
testogel
testogel
testopatch
testopel
testopel
testoral
testoral
testosteron
testosteron
testosterona
testosterona
testosteron-depot eifelfango
testosteron-depot jenapharm
testosteron depot-rotexmedica
testosterone
testosterone
testosterone
testosterone
testosterone
testosterone
testosterone
testosterone
testosterone
testosterone
testosterone
testosterone
testosterone
testostérone
testostérone
testosterone 17 beta-cyclopentanepropionate
testosterone 17 beta-cyclopentylpropionate
testosterone 17 beta-cypionate
testosterone cyclopentylpropionate
testosterone cyclopentylpropionate
testosterone cyclopentylpropionate
testosterone cyclopentylpropionate
testosterone cypionate
testosterone cypionate
testosterone cypionate
testosterone cypionate
testosterone cypionate
testosterone cypionate
testosterone cypionate
testosterone cypionate
testosterone enantate
testosterone enantate
testosterone enantate
testosterone enantate
testosterone enanthate
testosterone enanthate
testosterone enanthate
testosterone enanthate
testosterone enanthate
testosterone enanthate
testosterone enanthate
testosterone heptanoate
testosterone heptanoate
testosterone heptanoate
testosterone heptylate
testosterone heptylate
testosterone oenanthate
testosterone propionate
testosterone propionate
testosterone propionate
testosterone propionate
testosterone propionate
testosterone propionate
testosterone propionate
testosterone propionate
testosterone undecanoate
testosterone undecanoate
testosterone undecanoate
testosterone undecanoate
testosterone undecanoate
testosterone undecanoate
testosterone undecanoate
testosterone undecanoate
testosterone undeconate
testosterone undeconate
testosterone undecylate
testosterone undecylate
testosteronum
testosteronum
testoviron
testoviron
testrin p.a.
theramed brand of testosterone enanthate
theramex
tostran
tsx-002
undestor
undestor
undestor
virormone
virormone
virormone
virormone
virormone
virormone
virosterone
virosterone

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07212712	N/A	Mar 1, 2026	University of British Columbia
NCT07278362	Phase 4	Feb 28, 2026	University of Miami
NCT07260825	Phase 2/Phase 3 (Phase 3)	Dec 31, 2025	TriHealth
NCT07142551	Phase 2	Dec 30, 2025	Bayer, Johns Hopkins University
NCT07092527	Phase 4	Dec 1, 2025	National Institutes of Health (NIH), University of California, San Diego
NCT07254429	Phase 2	Oct 2, 2025	University of Copenhagen
NCT06922318	Phase 2	Aug 19, 2025	Johns Hopkins University, National Cancer Institute (NCI), Zenith Epigenetics
NCT07028255	N/A	Jul 1, 2025	Qualia Life Sciences
NCT07287800	Phase 1/Phase 2 (Phase 2)	Jul 1, 2025	University of California, Los Angeles
NCT06720597	N/A	Jan 31, 2025	University of California, Irvine
NCT06689085	Phase 3	Jan 31, 2025	Halozyme Therapeutics
NCT06733350	Phase 4	Jan 1, 2025	State University of New York, Buffalo
NCT06305598	Phase 1	Dec 15, 2024	State University of New York, Buffalo
NCT06450405	Phase 4	Nov 15, 2024	National Institutes of Health (NIH), University of California, San Diego
NCT06592144	Phase 4	Sep 9, 2024	University of Sao Paulo
NCT06188767	N/A	Sep 1, 2024	University of Copenhagen
NCT06294990	N/A	Aug 15, 2024	University of Copenhagen
NCT06594926	Phase 2	Aug 14, 2024	Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, University of New South Wales
NCT06455969	Phase 4	Jul 15, 2024	United States Army, University of Pittsburgh
NCT06351501	Phase 3	Jun 6, 2024	Assistance Publique - Hôpitaux de Paris

Showing 20 of 453 trials

Page 1 / 23

Organizations

Research & Development (332)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Institutes of Health (NIH)	Government	30	5	5	1999
University of Washington	Academic/Hospital	26	24	5	2002
Harvard University	Academic/Hospital	25	18	5	1998
Solvay	For profit	21	4	5	2002
Department of Veteran Affairs	Government	20	14	5	1999
Johns Hopkins University	Academic/Hospital	16	15	5	2008
Bayer	For profit	14	4	3	2003
Clarus Therapeutics, Inc.	For profit	14	11	4	2007
National Institute on Aging (NIA)	Government	12	4	4	1999
Acerus Pharmaceuticals Corporation	For profit	11	8	4	2009
National Cancer Institute (NCI)	Government	10	2	4	2000
University of California, Los Angeles	Academic/Hospital	10	4	4	2002
Merck	For profit	9	7	2	2001
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Government	9	4	5	1998
University of Colorado, Denver	Academic/Hospital	9	7	5	2005
Warner Chilcott	For profit	9	9	3	2002
Abbott	For profit	8	4	3	2007
Boston University	Academic/Hospital	8	4	4	2002
Eli Lilly	For profit	8	8	4	2007
Endo Pharmaceuticals	For profit	8	4	3	2006

332 organizations

Page 1 / 17

Marketing (85)

Organization	Org type	Relationship	Date
AYTU BioScience	For profit	NDA2	May 28, 2014
AbbVie	For profit	NDA2	Feb 28, 2000
Acerus Pharmaceuticals Corporation	For profit	MKTG	May 28, 2014
Actavis	For profit	MKTG	Jan 27, 2006
Alembic	For profit	MKTG	Mar 3, 2021
Alembic	For profit	SYN	Mar 3, 2021
Allergan	For profit	NDA2	Sep 29, 1995
Allergan	For profit	MKTG	Sep 29, 1995
Allergan PLC (2015)	For profit	MKTG	Aug 5, 2015
Alza	For profit	NDA2	Oct 12, 1993
Amneal Pharmaceuticals	For profit	MKTG	Apr 10, 2019
Amneal Pharmaceuticals	For profit	SYN	Apr 10, 2019
Ani Pharmaceuticals	For profit	NDA2	Feb 14, 2012
Ani Pharmaceuticals	For profit	SYN	Feb 14, 2012
Antares Pharma Inc.	For profit	NDA2	Sep 28, 2018
Apotex	For profit	MKTG	Nov 25, 2020
Athenex, Inc.	For profit	MKTG	—
Auxillium	For profit	NDA2	Oct 31, 2002
Auxillium	For profit	MKTG	Jul 13, 1972
Azurity	For profit	MKTG	Jun 2, 2022
Bausch Health Companies	For profit	NDA2	May 28, 2014
Belmar Pharmacy	For profit	MKTG	Dec 3, 1973
Besins Healthcare	For profit	MKTG	Feb 28, 2000
Besins Healthcare	For profit	NDA2	Feb 28, 2000
Bristol-Myers Squibb	For profit	NDA2	Dec 29, 2010
Cipla	For profit	MKTG	Jan 29, 2018
Clarus Therapeutics, Inc.	For profit	NDA2	Mar 27, 2019
Clarus Therapeutics, Inc.	For profit	MKTG	Mar 27, 2019
Daiichi Sankyo	For profit	MKTG	Jun 16, 2017
Dash Pharms	For profit	MKTG	Jan 11, 2021
Dr. Reddy's Laboratories	For profit	SYN	Jul 7, 1983
Dr. Reddy's Laboratories	For profit	MKTG	Apr 10, 2019
Eli Lilly	For profit	NDA2	Nov 23, 2010
Eli Lilly	For profit	MKTG	—
Elkins Sinn	For profit	MKTG	—
Encube Ethicals Pvt. Ltd.	For profit	MKTG	Nov 9, 2021
Endo Pharmaceuticals	For profit	NDA2	Dec 24, 1953
Endo Pharmaceuticals	For profit	NDA	Dec 24, 1953
Endo Pharmaceuticals	For profit	MKTG	Mar 5, 2014
Endo Pharmaceuticals	For profit	SYN	Jul 13, 1972
Eugia Pharma	For profit	MKTG	Oct 20, 2023
Exeltis	For profit	MKTG	Apr 16, 2020
Hikma	For profit	MKTG	May 1, 2012
Hikma	For profit	MKTG	Jul 15, 2010
Hikma	For profit	MKTG	Jul 15, 2010
Lipocine Inc.	For profit	MKTG	Dec 8, 2020
Lupin	For profit	SYN	Apr 13, 2018
Lupin	For profit	MKTG	Oct 23, 2017
Lupin	For profit	SYN	Apr 10, 2019
Lutipold	For profit	MKTG	Jun 16, 2017
MARIUS PHARMS LLC	For profit	MKTG	Jul 27, 2022
MARIUS PHARMS LLC	For profit	NDA2	Jul 27, 2022
Mylan	For profit	MKTG	Dec 11, 2006
Nexus Pharmaceuticals	For profit	MKTG	Jun 14, 2006
Nexus Pharmaceuticals	For profit	SYN	Jun 14, 2006
Novartis	For profit	MKTG	Aug 10, 2006
Padagis Us	For profit	MKTG	Aug 4, 2015
Padagis Us	For profit	MKTG	Jan 31, 2005
Paddock Laboratories	For profit	MKTG	Jan 31, 2005
Paddock Laboratories	For profit	SYN	Dec 9, 2016
Par Pharmaceuticals	For profit	MKTG	May 23, 2007
Perrigo	For profit	NDA2	Jan 31, 2013
Perrigo	For profit	MKTG	Jul 12, 2017
Pfizer	For profit	MKTG	Jul 25, 1979
Pharmacia & Upjohn	For profit	MKTG	Jul 25, 1979
Pharmacia & Upjohn	For profit	NDA2	Jun 13, 1980
Rising Pharmaceuticals	For profit	MKTG	Dec 11, 2006
Rising Pharmaceuticals	For profit	SYN	Dec 11, 2006
Sandoz	For profit	MKTG	Aug 10, 2006
Sandoz	For profit	SYN	Aug 10, 2006
Sankyo	For profit	MKTG	Jun 16, 2017
Savage Labs	For profit	MKTG	Jun 29, 1982
Slayback Pharma Llc	For profit	MKTG	Jun 2, 2022
Slayback Pharma Llc	For profit	NDA2	Jun 2, 2022
Strides Pharma Science	For profit	MKTG	May 23, 2007
Sun Pharmaceuticals	For profit	MKTG	Jun 3, 2013
TWi Biotechnology, Inc.	For profit	MKTG	Sep 23, 2019
Tolmar Inc.	For profit	MKTG	Mar 27, 2019
Tolmar Inc.	For profit	NDA2	Mar 27, 2019
Upsher-Smith Laboratories	For profit	NDA2	Jun 4, 2014
Verity Pharmaceuticals	For profit	MKTG	Mar 28, 2022
Watson Pharmaceuticals	For profit	MKTG	Jun 23, 1978
Watson Pharmaceuticals	For profit	SYN	Dec 10, 1980
West-Ward Pharmaceutical	For profit	MKTG	Jul 15, 2010
Wilshire Pharmaceuticals	For profit	MKTG	Apr 24, 2019