Recent Updates
Recently added Catalysts

Testosterone enanthate auto-injector

Phase 3

Hypogonadism | Small molecule | Endocrine |Halozyme Therapeutics, Inc.|Last Updated: Apr 19, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials4
Total Enrollment361
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02504541Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With HypogonadismPHASE3 COMPLETED 133Jul 1, 2015Jun 1, 2016Mar 30, 201820 United States
NCT02159469Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With HypogonadismPHASE3 COMPLETED 150Jul 1, 2014Nov 1, 2015Feb 7, 201828 United States
NCT02777242Safety of Subcutaneous Testosterone Enanthate in Adult Male HypogonadismPHASE2 COMPLETED 66Jun 1, 2016Aug 1, 2016Mar 22, 20183 United States
NCT02233751Pharmacokinetic Study of Subcutaneous Testosterone EnanthatePHASE1 COMPLETED 12Sep 1, 2014Oct 1, 2014Apr 19, 20191 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
26 weeks

Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population. Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)

Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
12 weeks

The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.

Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
3 weeks

Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.

Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate
Maximum serum concentrations occurring during an 8 days study window

Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate

Area Under the Concentration-time Curve From Time Zero to Time t
168 hrs

AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);

Area Under the Concentration-time Curve From Time Zero to Infinity
time zero to infinity

AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity

Secondary Endpoints
Safety and Tolerability
52 weeks
Time to Maximum Concentration (Tmax)(hr)
The sample time of Cmax during a 168 hour sampling interval
Half-life (t 1/2)(hr)
168 hours
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Testosterone enanthate auto-injectorEXPERIMENTALTestosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
Testosterone enanthate auto-injector - 50 mgEXPERIMENTALTestosterone enanthate auto-injector - 50 mg (SC injection)
Testosterone enanthate auto-injector - 200 mgEXPERIMENTALTestosterone enanthate auto-injector- 200 mg (SC injection)
Interventions
NameTypeDescription
Testosterone enanthate auto-injectorCOMBINATION_PRODUCTDose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexMALE
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Adult men ≥18 and ≤75 years of age with a documented history of hypogonadism * Total testosterone levels \< 300 ng/dL at two qualification visits * Patients in good general health Exclusion Criteria: * Allergy to sesame or testosterone products * BMI ≥ 40 kg/m2 * Hematocrit ...

Countries:United States
Unlock Eligibility Criteria