Depo-Testosterone
(Testosterone Cypionate)ApprovedSmall molecule
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 249 small molecule programs targeting Hypogonadism. It is currently in Approved.
16
Indications
32
Total Trials
16
Active Trials
248
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
3
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 16 indications
Competition
Competitive Landscape
312 competitors in Prostate Cancer
#DrugCompanyPhaseTrials
1Opdivo
Bristol-Myers SquibbPhase 3
Yervoy
Bristol-Myers SquibbPhase 3
Depo-Testosterone
AAzurity Pharmaceuticals
Approved
Lupron
EEastern Cooperative Oncology Group
Phase 3
Androgen Deprivation Therapy
Johnson & JohnsonPhase 3
Cortef
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase 3
INR101
YYunhe Pharmaceutical (Tianjin) Co., Ltd
Phase 3
Trexall
Jazz PharmaceuticalsPreclinical
Jatenzo
GGrupo Espanol de Tumores Neuroendocrinos
Preclinical
Botox
VVitae Pharmaceuticals Inc., an Allergan affiliate
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Testosterone7 trials
Long-term Lifestyle Change and Testosterone Replacement
Completed·—··NCT03256292·38 enrolled
Show 4 more trials
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT07142551·60 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
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
Show 3 more trials
Metastatic Castration-Resistant Prostate Cancer2 trials
A Phase II Study of Sequential Bipolar Androgen Therapy and ZEN-3694 in Sequence With Enzalutamide + ZEN-3694 in Asymptomatic Patients With Metastatic CRPC: The COSMYC Trial (COmbined Suppression of MYC)
Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT06922318·50 enrolled
Castration-Resistant Prostate Carcinoma2 trials
14 more indications
Postmenopausal Women1 trial
Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)
Active, not recruiting·—·Phase 2·NCT04895306·40 enrolled
Anorexia Nervosa1 trial
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
Testosterone Replacement Therapy1 trial
Nivolumab1 trial
COMbination of Bipolar Androgen Therapy and Nivolumab
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03554317·45 enrolled
Male Hypogonadism1 trial
Prostate Adenocarcinoma1 trial
Spinal Cord Injury1 trial
Regulatory
FDA Approval Timeline[5]
Jun 2, 2022
AZMIRO
NDA NDA216318
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Depo-Testosterone drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Testosterone Cypionate. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Androgen Receptor Agonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- AAzurity Pharmaceuticals