Jatenzo

(Testosterone undecanoate)

ApprovedSmall molecule

GGrupo Espanol de Tumores Neuroendocrinos

Jatenzo is a small molecule that works as Androgen Receptor Agonist.[2] It is being used across 17 indications, with its most advanced program in Approved.[1]

Jatenzo is one of 300 small molecule programs targeting Bariatric Surgery Candidate. It is currently in Approved.

Indications

Total Trials

Active Trials

299

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Bariatric Surgery CandidateCompleted

OrchitisActive, not recruiting

Delayed PubertyActive, not recruiting

Respiratory FailureApproved

Coronary Artery DiseaseApproved

Klinefelter's SyndromeActive, not recruiting

Renal Cell CarcinomaApproved

ContraceptionApproved

Spinal Cord InjuryApproved

Hypogonadotropic HypogonadismApproved

Bariatric Surgery CandidateApproved

Completed

OrchitisApproved

Active, not recruiting

Delayed PubertyPreclinical

Active, not recruiting

Respiratory FailureApproved

Approved

Coronary Artery DiseaseApproved

Approved

Klinefelter's SyndromeApproved

Active, not recruiting

Renal Cell CarcinomaApproved

Approved

ContraceptionApproved

Approved

Spinal Cord InjuryApproved

Approved

Hypogonadotropic HypogonadismApproved

Approved

Showing 10 of 17 indications

Competition

Competitive Landscape

206 competitors in Heart Failure

#DrugCompanyPhaseTrials

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Approved

1 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Medrol

Pfizer

Preclinical

1 5

Amidate

Pfizer

Preclinical

1 6

Activase

Zemplar

Adriamycin

Savaysa

Xifaxan

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Hypogonadism, Male

NCT04049331

Q4 2028

N/ARecruiting

Memory

NCT06188767

Post-ApprovalRecruiting

Hypogonadism

NCT03851627

Clinical

Trials by Indication[1]

Testosterone13 trials

The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

Unknown status·UUniversity of Adelaide·Phase 3·NCT00117000·200 enrolled

Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

Completed·CClarus Therapeutics, Inc.·Phase 3·NCT01699178·182 enrolled

Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17

Not yet recruiting·UUniversity of Washington·Phase 1/2·NCT06312761·10 enrolled

Show 10 more trials

A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Completed·CClarus Therapeutics, Inc.·Phase 3·NCT02722278·222 enrolled

Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

Completed·CClarus Therapeutics, Inc.·Phase 2·NCT00695110·29 enrolled

Phlebotomy Study of Testosterone Undecanoate

Completed·CClarus Therapeutics, Inc.·Phase 1/2·NCT02670343·8 enrolled

Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Completed·CClarus Therapeutics, Inc.·Phase 2·NCT02697188·12 enrolled

Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

Completed·CClarus Therapeutics, Inc.·Phase 2·NCT00924612·16 enrolled

Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men

Completed· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 3·NCT00467870·531 enrolled

The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate

Completed·CClarus Therapeutics, Inc.·Phase 2·NCT02921386·18 enrolled

Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations

Completed·PPennington Biomedical Research Center·Phase 4·NCT04120363·34 enrolled

Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen

Completed·UUnita Complessa di Ostetricia e Ginecologia·Phase 3·NCT04545450·16 enrolled

Effects of Testosterone on Myocardial Repolarization

Completed·UUniversity of Roma La Sapienza·Phase 4·NCT03126656·123 enrolled

Hypogonadism4 trials

Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism

Unknown status·—··NCT05541172·27 enrolled

Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00434824·322 enrolled

Testosterone, Metformin, or Both, for Hypogonadism in Obese Males

Completed·FFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud·Phase 3·NCT02514629·107 enrolled

Show 1 more trial

Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism

Recruiting·AAlexandra Kautzky-Willer·Phase 4·NCT03851627·32 enrolled

Memory2 trials

Testosterone-induced Muscle Memory and Underlying Mechanisms

Recruiting·MMorten Hostrup, PhD·N/A·NCT06188767·30 enrolled

Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?

Completed·NNorwegian School of Sport Sciences·Phase 2/3·NCT05964920·45 enrolled

Prostate Cancer2 trials

Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT05081193·15 enrolled

The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

Completed·LLund University·N/A·NCT04134130·33 enrolled

Safety and Efficacy2 trials

Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Completed·CClarus Therapeutics, Inc.·Phase 3·NCT01403116·325 enrolled

Safety and Efficacy Trial of Testosterone Undecanoate

Completed·CClarus Therapeutics, Inc.·Phase 3·NCT01765179·144 enrolled

17 more indications

Heart Disease1 trial

Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)

Completed·IImperial College London·Phase 2·NCT00239590·28 enrolled

Heart Failure1 trial

Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects

Completed·FFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia·Phase 4·NCT01813201·14 enrolled

Testosterone Replacement Therapy1 trial

Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)

Completed·UUniversity Medical Centre Ljubljana·Phase 4·NCT03792321·55 enrolled

Treatment Outcome1 trial

Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice

Completed· Bayer logo

Bayer··NCT00410306·1,493 enrolled

Menopausal Women1 trial

An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD

Not yet recruiting·SSan Diego Sexual Medicine·Phase 2·NCT06082817·30 enrolled

Erectile Dysfunction1 trial

The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction

Completed·—·Phase 4·NCT00421460·30 enrolled

Multiple Sclerosis1 trial

Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients

Terminated·HHealth Sciences Centre, Winnipeg, Manitoba·Phase 2·NCT01516554·3 enrolled

Metabolism1 trial

Multimodality Intervention for Function and Metabolism in SCI

Completed·—·Phase 2·NCT03576001·84 enrolled

Postmenopausal Women1 trial

Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Completed·—·Phase 2·NCT01724658·70 enrolled

Quality of Life1 trial

Testosterone Undecanoate and Quality of Life of Men and Spouses

Unknown status·MMeir Medical Center··NCT01758029·80 enrolled

Type 2 Diabetes Mellitus1 trial

The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity

Completed·UUniversity Medical Centre Ljubljana·Phase 3·NCT06489457·25 enrolled

Oral1 trial

Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes

Completed·CClarus Therapeutics, Inc.·Phase 1·NCT03973840·13 enrolled

Non-Alcoholic Steatohepatitis1 trial

Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)

Completed·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 2·NCT01919294·3 enrolled

Male Hypogonadism1 trial

A Phase 1, Randomised, Open-label, 2-cohort, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Native Oral Testosterone Formulation (DITEST) in the Fed and Fasted State and Compared to Testosterone Undecanoate in Adult Men With Primary or Secondary Hypogonadism

Completed·NNeurocrine UK Limited·Phase 1·NCT02966652·25 enrolled

Completed·CClarus Therapeutics, Inc.·Phase 2·NCT00911586·15 enrolled

Androgen for Leydig Cell Proliferation

Completed·UUniversity of Roma La Sapienza·Phase 2/3·NCT01206270·56 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 5, 2014

AVEED

NDA NDA022219

Mar 27, 2019

JATENZO

NDA NDA206089

Mar 28, 2022

TLANDO

NDA NDA208088

Jul 27, 2022

KYZATREX

NDA NDA213953

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for Testosterone undecanoate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Testosterone undecanoate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Testosterone undecanoate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213953). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Jatenzo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Grupo Espanol de Tumores Neuroendocrinos company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Androgen Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: GGrupo Espanol de Tumores Neuroendocrinos

Patent Landscape[5]

Patent Cliff

Jan 6, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11179402Apr 14, 2026

11331325Jan 6, 2027

7718640Mar 14, 2027

8338395May 8, 2027

11304960Jan 8, 2029

29 more patents

8778922Jan 8, 2029

8865695Jan 8, 2029

8241664Mar 29, 2029

11426416Apr 12, 2030

10543219Apr 12, 2030

8778916Apr 12, 2030

10617696Apr 12, 2030

11179403Apr 12, 2030

11364249Nov 30, 2030

9943527Nov 30, 2030

10716794Nov 30, 2030

9949985Nov 30, 2030

11311555Nov 30, 2030

10226473Nov 30, 2030

11433083Nov 30, 2030

8492369Dec 20, 2030

10576090Dec 31, 2030

10576089Dec 31, 2030

11590146Dec 31, 2030

12357643Mar 15, 2033

11617758Mar 15, 2033

11559530Nov 28, 2037

12310978Feb 21, 2039

11564933Apr 12, 2039

12605391Apr 12, 2039

12011503Oct 16, 2040

12403146Mar 29, 2041

12691057Apr 28, 2041

11464735Apr 28, 2041

Jatenzo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2028

Trials by Indication[1]

Testosterone13 trials

Hypogonadism4 trials

Memory2 trials

Prostate Cancer2 trials

Safety and Efficacy2 trials

Heart Disease1 trial

Heart Failure1 trial

Testosterone Replacement Therapy1 trial

Treatment Outcome1 trial

Menopausal Women1 trial

Erectile Dysfunction1 trial

Multiple Sclerosis1 trial

Metabolism1 trial

Postmenopausal Women1 trial

Quality of Life1 trial

Type 2 Diabetes Mellitus1 trial

Oral1 trial

Non-Alcoholic Steatohepatitis1 trial

Male Hypogonadism1 trial

Bariatric Surgery Candidate1 trial

Hypogonadism, Male1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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