Testosterone Undecanoate

Summary

Testosterone Undecanoate (CHEMBL2107067) is an approved small molecule; indicated across 13 conditions including hypogonadism and neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• Indications: 13 conditions
• Clinical trials: 47
• Chemistry: 456.7 Da · C30H48O3

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2107067
Name	Testosterone Undecanoate
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	65157
Molecular formula	C30H48O3
Molecular weight	456.7
InChIKey	UDSFVOAUHKGBEK-CNQKSJKFSA-N

SMILES: CCCCCCCCCCC(=O)O[C@H]1CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CCC4=CC(=O)CC[C@]34C)C

IUPAC name: [(8R,9S,10R,13S,14S,17S)-10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] undecanoate

Also known as: Andriol, Aveed, Jatenzo, Kyzatrex, MK-3033, Nebido, ORG 538, ORG-538, Restandol, Restandol testocap, Testosterone 17.beta.-undecylate, Testosterone undecanoate

Patent coverage: 743 distinct patent families (2,662 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

4 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
hypogonadism	4	MONDO:0002146	MONDO:0002146
neoplasm	4	MONDO:0005070	EFO:0000616
Klinefelter syndrome	4	MONDO:0006823	EFO:1001006
orchitis	4	MONDO:0006882	EFO:1001078

5 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
respiratory failure	3	MONDO:0021113	EFO:0009686
physiological sexual disorder	2	MONDO:0002134	EFO:0004714
renal cell carcinoma	2	MONDO:0005086	EFO:0000681
coronary artery disorder	2	MONDO:0005010	EFO:0001645
spinal cord injury	2	MONDO:0043797	EFO:1001919

4 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 47.

Phase distribution

Phase	Trials
PHASE2	14
PHASE4	12
PHASE3	10
Not specified	5
PHASE2/PHASE3	2
PHASE1/PHASE2	2
PHASE1	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03721497	PHASE4	ACTIVE_NOT_RECRUITING	Testosterone in Bariatric Patients
NCT03851627	PHASE4	RECRUITING	Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism
NCT06385509	PHASE4	ACTIVE_NOT_RECRUITING	A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months
NCT00131183	PHASE4	COMPLETED	Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
NCT00710827	PHASE4	WITHDRAWN	Nebido Versus Placebo in Elderly Men With Typical Symptoms of Late Onset Hypogonadism Over a Period of 54 Weeks
NCT01510847	PHASE4	TERMINATED	The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)
NCT01813201	PHASE4	COMPLETED	Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects
NCT03126656	PHASE4	COMPLETED	Effects of Testosterone on Myocardial Repolarization
NCT03792321	PHASE4	COMPLETED	Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients (SETH2)
NCT03815331	PHASE4	COMPLETED	Xiaflex® Plus Testosterone Treatment Pilot Study Protocol
NCT04120363	PHASE4	COMPLETED	Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
NCT04983940	PHASE4	COMPLETED	Patient Satisfaction After Switching to Oral Testosterone Undecanoate
NCT00117000	PHASE3	UNKNOWN	The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
NCT00467870	PHASE3	COMPLETED	Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
NCT01206270	PHASE2/PHASE3	COMPLETED	Androgen for Leydig Cell Proliferation
NCT01403116	PHASE3	COMPLETED	Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
NCT01699178	PHASE3	COMPLETED	Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
NCT01765179	PHASE3	COMPLETED	Safety and Efficacy Trial of Testosterone Undecanoate
NCT02081300	PHASE3	COMPLETED	Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
NCT02514629	PHASE3	COMPLETED	Testosterone, Metformin, or Both, for Hypogonadism in Obese Males
NCT02722278	PHASE3	COMPLETED	A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
NCT04545450	PHASE3	COMPLETED	Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen
NCT05964920	PHASE2/PHASE3	COMPLETED	Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?
NCT06489457	PHASE3	COMPLETED	The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity
NCT04049331	PHASE2	ACTIVE_NOT_RECRUITING	Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
NCT04798469	PHASE2	RECRUITING	Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
NCT05249634	PHASE2	RECRUITING	Testosterone Treatment in Men With Chronic Kidney Disease
NCT06082817	PHASE2	NOT_YET_RECRUITING	An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
NCT00239590	PHASE2	COMPLETED	Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)
NCT00911586	PHASE2	COMPLETED	Pharmacokinetic Study to Determine Time to Steady-state
NCT01516554	PHASE2	TERMINATED	Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients
NCT01724658	PHASE2	COMPLETED	Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
NCT01919294	PHASE2	COMPLETED	Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)
NCT02670343	PHASE1/PHASE2	COMPLETED	Phlebotomy Study of Testosterone Undecanoate
NCT02697188	PHASE2	COMPLETED	Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
NCT02921386	PHASE2	COMPLETED	The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
NCT03335254	PHASE1/PHASE2	TERMINATED	A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males
NCT03379012	PHASE2	COMPLETED	Testosterone in Metastatic Renal Cell Carcinoma Patients
NCT03576001	PHASE2	COMPLETED	Multimodality Intervention for Function and Metabolism in SCI
NCT05081193	PHASE2	COMPLETED	Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer
NCT02966652	PHASE1	COMPLETED	Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
NCT03973840	PHASE1	COMPLETED	Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes
NCT06188767	Not specified	RECRUITING	Testosterone-induced Muscle Memory and Underlying Mechanisms
NCT01758029	Not specified	UNKNOWN	Testosterone Undecanoate and Quality of Life of Men and Spouses
NCT04134130	Not specified	COMPLETED	The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer
NCT05417035	Not specified	COMPLETED	Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment
NCT05541172	Not specified	UNKNOWN	Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).