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Testosterone enanthate

Phase 3

Hypogonadism, Male | Small molecule | Endocrine |Halozyme Therapeutics, Inc.|Last Updated: Feb 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT0668908552 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With HypogonadismPHASE3 RECRUITING 100 — — Mar 7, 2025Mar 1, 2030Feb 18, 202620 United States
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Study Endpoints
Primary Endpoints
Increase in testosterone, as evaluated using PK parameters
From Enrollment through End of Study Assessments at Week 53
Secondary Endpoints
Percentage of participants demonstrating either progression through Tanner Stages of puberty or attainment of Tanner Stage 5 by the end of the study
End of Study Assessment at Week 53
• Percentage of patients that had an increase in stretched penile length
End of Study Assessment at Week 53
Change from Screening or Baseline in DEXA bone density for total body less head (TBLH) and PA spine
End of Study Assessment at Week 53
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ParticipantsEXPERIMENTALXYOSTED Injection (Testosterone enanthate) 25 mg / 0.5 mL, 50 mg / 0.5 mL, 75 mg / 0.5 mL, 100 mg / 0.5 mL
Interventions
NameTypeDescription
Testosterone enanthateCOMBINATION_PRODUCTXYOSTED 25 mg / 0.5 mL; XYOSTED 50 mg / 0.5 mL; XYOSTED 75 mg / 0.5 mL; XYOSTED 100 mg / 0.5 mL
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Eligibility Criteria
Age Range12 Years — 17 Years
SexMALE
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Diagnosed with a deficiency or absence of endogenous testosterone due to primary or secondary hypogonadism of a known etiology. Children with combined hormone deficiencies are permitted to enroll (but the child must already be receiving treatment for concomitant hormonal defi...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06689085primaryCompletionDate: changed
LOWMay 24, 2026NCT06689085studyFirstPostDate: changed