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 243 small molecule programs targeting Glioma. It is currently in Approved.
10
Indications
24
Total Trials
3
Active Trials
242
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
18
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
1399 competitors in Prostate Cancer
#DrugCompanyPhaseTrials
1Delatestryl
AAntares Pharma Inc.
Approved
Novantrone
PfizerPreclinical
Mekinist
NovartisPreclinical
Trexall
Alnylam PharmaceuticalsPreclinical
Jatenzo
GGrupo Espanol de Tumores Neuroendocrinos
Preclinical
Viagra
VViatris Specialty LLC
Preclinical
Duragesic
CCephalon
Preclinical
Ranexa
MMenarini International Operations Luxembourg SA
Preclinical
Triptorelin Pamoate
IpsenPreclinical
Osmitrol
BB. Braun Medical Inc.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Testosterone12 trials
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
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
Show 9 more trials
Testosterone and Physical Function in HIV+ Men
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00260143·61 enrolled
Testosterone Effects on Pelvic Floor Muscles
Withdrawn·—·Phase 3·NCT04026880
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
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04363164·150 enrolled
Spinal Cord Injury2 trials
Mobility Limitation1 trial
Optimizing Protein Intake in Older Americans With Mobility Limitations
Completed·—·Phase 3·NCT01275365·92 enrolled
7 more indications
Rehabilitation1 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
Prostate Cancer1 trial
Weight loss1 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.