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Xyosted

Phase 3

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

Target and mechanism

ModalitySmall molecule

Also known as Testosterone enanthate

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Xyosted · 1 trial · 1 indication

Phase 3 1
NCT0668908552 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With HypogonadismHypogonadism, Male
RECRUITING100 Analytics
PHASE3RECRUITING
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
NCT06689085100
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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 to 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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