Delatestryl
(Testosterone enanthate)ApprovedSmall molecule
Testosterone enanthate is used to treat low testosterone levels in men and to help transgender men achieve male characteristics. It's a hormone replacement therapy that works by replacing or supplementing the body's natural testosterone.[2] Delatestryl is currently approved and in use across 10 indications[4].[1]
Delatestryl is one of 208 small molecule programs targeting Prostate Carcinoma. It is currently in Approved.
10
Indications
24
Total Trials
3
Active Trials
207
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
18
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
120 competitors in Chronic Obstructive Pulmonary Disease
#DrugCompanyPhaseTrials
1Delatestryl
AAntares Pharma Inc.
Approved
EXDENSUR
GGlaxo Dba Glaxosmithkline
Phase 3
Lunsekimig
SanofiPhase 3
Tozorakimab
AstraZenecaPhase 3
CM310
KKeymed Biosciences Co.Ltd
Phase 3
Astegolimab
RochePhase 3
CM512
KKeymed Biosciences Co.Ltd
Phase 2
Titrated Oxygen
RRigshospitalet, Denmark
Phase 3
HSK39004
Haisco Pharmaceutical Group Co., Ltd.Phase 2
RLS-0071
RReAlta Life Sciences, Inc.
Phase 2
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Testosterone11 trials
Testosterone Effects on Pelvic Floor Muscles
Withdrawn·—·Phase 3·NCT04026880
Show 8 more trials
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 and Physical Function in HIV+ Men
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00260143·61 enrolled
The Effect of 5-Alpha Reductase on Testosterone in Men
Unknown status·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00070733·184 enrolled
The Role of 5-alpha Reductase in Mediating Testosterone Actions
Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 4·NCT00493987·184 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
Spinal Cord Injury2 trials
CLE1 trial
Mobility Limitation1 trial
Optimizing Protein Intake in Older Americans With Mobility Limitations
Completed·—·Phase 3·NCT01275365·92 enrolled
8 more indications
Prostate Cancer1 trial
Weight loss1 trial
Testosterone Replacement Therapy1 trial
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
Completed·—·Phase 2/3·NCT00161304·44 enrolled
Rehabilitation1 trial
Unspecified1 trial
Working Out M0 Bipolar Androgen Therapy
Recruiting·AAustralian and New Zealand Urogenital and Prostate Cancer Trials Group·Phase 2·NCT06594926·69 enrolled
Regulatory
FDA Approval Timeline[5]
Jan 1, 1982
DELATESTRYL
NDA NDA009165
Sep 28, 2018
XYOSTED (AUTOINJECTOR)
NDA NDA209863
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Delatestryl drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Testosterone enanthate. 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
- AAntares Pharma Inc.