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Xyosted

Phase 3FDA approved

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

Xyosted development status

FDA approval on record Approved
Highest phase Phase 3

Xyosted 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

Xyosted clinical trials

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, MaleUnlock trial analytics

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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Frequently asked questions about Xyosted

What is Xyosted used for?

Xyosted is being studied for testosterone replacement in male adolescents with hypogonadism. The Phase 3 trial enrolls males aged 12 years and older in the United States. Xyosted is a small molecule therapy in the endocrine therapeutic area.

Who is developing Xyosted?

Xyosted is being developed by Halozyme Therapeutics, Inc., which trades under the ticker HALO. The company is running a Phase 3 study of the drug for testosterone replacement in male adolescents with hypogonadism.

What phase is Xyosted in?

Xyosted is in Phase 3 clinical development. The ongoing trial is a 52-week study with a 24-month long-term extension evaluating safety, pharmacokinetics, and efficacy for testosterone replacement in male adolescents with hypogonadism.

What clinical trials is Xyosted in?

Xyosted is being evaluated in the Phase 3 trial NCT06689085, titled a 52-week study plus 24-month long-term extension of safety, PK, and efficacy of XYOSTED for testosterone replacement in male adolescents with hypogonadism. The trial is recruiting in the United States and plans to enroll 100 participants.

Is Xyosted the same as testosterone enanthate?

Yes, Xyosted is also known as testosterone enanthate. It is a small molecule therapy being studied for testosterone replacement in male adolescents with hypogonadism.