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Depo-Testosterone

(Testosterone Cypionate)

ApprovedSmall molecule

AAzurity Pharmaceuticals

Testosterone Cypionate is used to treat low testosterone levels in men, helping restore normal male characteristics and function. It may also be used in hormone therapy for transgender individuals.[2] Depo-Testosterone is currently approved and in use across 16 indications[4].[1]

Depo-Testosterone is one of 295 small molecule programs targeting Hypogonadism. It is currently in Approved.

16

Indications

30

Total Trials

14

Active Trials

294

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[4][1]

Indication

HypogonadismActive, not recruiting

OrchitisActive, not recruiting

Metastatic Prostate CancerApproved

Testosterone Replacement TherapyActive, not recruiting

Diabetic NeuropathyApproved

Sexual DysfunctionApproved

Rotator Cuff TearApproved

Postmenopausal WomenActive, not recruiting

Castration-Resistant Prostate CancerRecruiting

Castration-Resistant Prostate CarcinomaRecruiting

HypogonadismApproved

Active, not recruiting

OrchitisApproved

Active, not recruiting

Metastatic Prostate CancerApproved

Approved

Testosterone Replacement TherapyPhase 1

Active, not recruiting

Diabetic NeuropathyApproved

Approved

Sexual DysfunctionApproved

Approved

Rotator Cuff TearApproved

Approved

Postmenopausal WomenPhase 2

Active, not recruiting

Castration-Resistant Prostate CancerPhase 2

Recruiting

Castration-Resistant Prostate CarcinomaPhase 2

Recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Depo-Testosterone

AAzurity Pharmaceuticals

Nizoral

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Docetaxel /m²

Piflufolastat F 18

Trexall

Jazz Pharmaceuticals

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Duragesic

Ranexa

MMenarini International Operations Luxembourg SA

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalActive, not recruiting

Critically Ill Patients

NCT06592144

Phase 1Active, not recruiting

Testosterone Replacement Therapy

NCT04731376

Q3 2027

Phase 2Recruiting

Testosterone

NCT07476001

Q4 2027

Phase 2Active, not recruiting

Stress Urinary Incontinence

NCT06111209

Q1 2028

Phase 2Recruiting

Metastatic Castration-Resistant Prostate Cancer

NCT06100705

Phase 1Active, not recruiting

Castration-Resistant Prostate Carcinoma

NCT06305598

Clinical

Trials by Indication[1]

Testosterone7 trials

Long-term Lifestyle Change and Testosterone Replacement

Completed·—··NCT03256292·38 enrolled

Testosterone Replacement for Male Opioid Agonist Maintained Patients

Completed·YYale University·Phase 1/2·NCT01873989·15 enrolled

CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy

Completed·VVA Office of Research and Development·Phase 1·NCT01378299·105 enrolled

Show 4 more trials

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT07476001·12 enrolled

RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02090114·112 enrolled

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT07142551·60 enrolled

Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02286921·222 enrolled

Prostate Cancer6 trials

Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer

Completed·UUniversity of Washington·Phase 2·NCT03516812·36 enrolled

Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT06059118·50 enrolled

Bipolar Androgen-based Therapy for Prostate Cancer (BAT)

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01750398·33 enrolled

Show 3 more trials

Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Bipolar Androgen Therapy

Completed·HHospital Sirio-Libanes·Phase 2·NCT04424654·20 enrolled

Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)

Completed·LLatin American Cooperative Oncology Group·Phase 2·NCT04558866·51 enrolled

Safety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance

Not yet recruiting·UUniversity of Miami·Approved·NCT07278362·35 enrolled

Castration-Resistant Prostate Carcinoma2 trials

Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Active, not recruiting·RRoswell Park Cancer Institute·Phase 1·NCT06305598·3 enrolled

SPECTRA: Supraphysiological Androgen to Enhance Treatment Activity

Recruiting·UUniversity of Washington·Phase 2·NCT06039371·69 enrolled

Heart Failure1 trial

Exercise Training and Testosterone Replacement in Heart Failure Patients

Completed·UUniversity of Sao Paulo General Hospital·Phase 4·NCT01852994·39 enrolled

CLE1 trial

Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors

Terminated·SSt. Louis University··NCT04551144·4 enrolled

13 more indications

Injury1 trial

Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

Withdrawn·OOrthopedic Institute, Sioux Falls, SD·Phase 2/3·NCT04345666

Trial1 trial

The COSMYC Trial (COmbined Suppression of MYC)

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT06922318·50 enrolled

Bone Marrow Transplantation1 trial

Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02995330·3 enrolled

Critically Ill Patients1 trial

TESTO-TRIAL: Use of Testosterone in Critically Ill Patients

Active, not recruiting·LLeticia Maria Defendi Barboza Marson·Phase 4·NCT06592144·94 enrolled

Postmenopausal Women1 trial

Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)

Active, not recruiting·—·Phase 2·NCT04895306·40 enrolled

Anorexia Nervosa1 trial

The Effect of Testosterone Replacement on Bone Mineral Density in Boys and Men With Anorexia Nervosa

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT00853502

Testosterone Replacement Therapy1 trial

Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone

Active, not recruiting·EEmory University·Phase 1·NCT04731376·56 enrolled

Nivolumab1 trial

COMbination of Bipolar Androgen Therapy and Nivolumab

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03554317·45 enrolled

Intensive Care Unit1 trial

Role of Anabolic Steroids on Intensive Care Unit-Acquired Weakness

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 2/3·NCT03038919·30 enrolled

Metastatic Castration-Resistant Prostate Cancer1 trial

A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Recruiting·YYale University·Phase 2·NCT06100705·26 enrolled

Spinal Cord Injury1 trial

A Multisite, Double-blind, Randomized Controlled Trial Comparing Body Composition, Muscle, and Bone Changes to TestosteRone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial

Not yet recruiting·VVA Office of Research and Development·Preclinical·NCT07742553·300 enrolled

Castration-resistant Prostate Cancer1 trial

A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04363164·150 enrolled

Stress urinary incontinence1 trial

A Pilot Study to Evaluate the Anabolic Effect of Testosterone on Muscles of the Pelvic Floor in Older Women With Stress Urinary Incontinence

Active, not recruiting·BBrigham and Women's Hospital·Phase 2·NCT06111209·30 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 2, 2022

AZMIRO

NDA NDA216318

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Testosterone Cypionate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Depo-Testosterone drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Testosterone Cypionate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Testosterone Cypionate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216318). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Depo-Testosterone. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Androgen Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAzurity Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Mar 25, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12138271Mar 25, 2039

11642355Mar 25, 2039

11311554Mar 25, 2039

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