XYOSTED (AUTOINJECTOR) (testosterone enanthate)
XYOSTED (AUTOINJECTOR) is indicated for the treatment of Hypogonadism; Cryptorchidism; Torsion; Orchitis; Vanishing Testis Syndrome; Delayed Puberty.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-09-28
- Patent Cliff
- 2038
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
XYOSTED (AUTOINJECTOR) Approval History
What XYOSTED (AUTOINJECTOR) Treats
6 indicationsXYOSTED (AUTOINJECTOR) is approved for 6 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypogonadism
- Cryptorchidism
- Torsion
- Orchitis
- Vanishing Testis Syndrome
- Delayed Puberty
XYOSTED (AUTOINJECTOR) Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to XYOSTED (AUTOINJECTOR)
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06594926 WOMBAT | ANZUP 2201 | Ph 2 | recruiting | Working Out M0 Bipolar Androgen Therapy |
| NCT04363164 | J2060sIRB IRB00312725 | Ph 2 | recruiting | Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression |
| NCT03516812 results posted | 9984 NCI-2018-00542, 9984 | Ph 2 | completed | Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer |
| NCT04460872 | 649726 | Ph 2 | recruiting | Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury |
| NCT02248701 results posted | B1449-R 1I01RX001449-01A1 | Ph 2 | terminated | Testosterone Plus Finasteride Treatment After Spinal Cord Injury |
| NCT03123913 STARFISH results posted | 1R01NS095813-01 | Ph 1 | completed | Study of Testosterone and rHGH in FSHD |
| NCT04026880 TPELVIC | 2018P000248 | Ph 3 | withdrawn | Testosterone Effects on Pelvic Floor Muscles |
| NCT02090114 Restore results posted | J1416 NA_00093344, 1R01CA184012-01 | Ph 2 | completed | RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study) |
| NCT03674320 | 18-0202 | Ph 2, Ph 3 | withdrawn | Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD |
| NCT01275365 OPTIMen results posted | 2012P001321 7R01AG037547 | Ph 3 | completed | Optimizing Protein Intake in Older Americans With Mobility Limitations |
| NCT02286921 Transformer results posted | J14146 IRB00046414, W81XWH-14-2-0189 | Ph 2 | completed | Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance |
| NCT02734238 OPS results posted | PBRC 2015-063 | Ph 4 | completed | Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery |
| NCT01962454 | 200030 | Ph 1 | completed | A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers |
| NCT01417364 | 11-132 | Ph 4 | withdrawn | The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XYOSTED (AUTOINJECTOR) FDA Label Details
Indications & Usage
FDA Label (PDF)XYOSTED (AUTOINJECTOR) is indicated for the treatment of Hypogonadism; Cryptorchidism; Torsion; Orchitis; Vanishing Testis Syndrome; Delayed Puberty.
XYOSTED (AUTOINJECTOR) Patents & Exclusivity
Patents (23 active)
Pro Intelligence Preview
Deep insights for XYOSTED (AUTOINJECTOR)
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 207 active patents
Trial Analysis
- • 16 total trials
- • Stage: Declining
Competitive Landscape
- • 16 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment