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Danavorexton

Phase 1

Sleep Apnea | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Dec 2, 2022

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05180890A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep ApneaPHASE1 COMPLETED 13 — — Mar 10, 2022Nov 23, 2022Dec 2, 20221 Australia
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Study Endpoints
Primary Endpoints
Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE)
From the first dose of danavorexton in Treatment Period 1 up to approximately 7 days after the last dose of danavorexton in Treatment Period 3 (up to 41 days)
Secondary Endpoints
Change From Baseline in Upper Airway Collapsibility Index (UACI)
Baseline (-15 minutes from the start of infusion [first UACI]), and at 20 minutes (second UACI), and 55 minutes (third UACI) on Day 1 of each Treatment Period
Apnea-Hypopnea Index (AHI) Observed During Overnight Polysomnographys (PSGs)
Day 1 up to Day 2 of each Treatment Period
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.
Danavorexton LDEXPERIMENTALDanavorexton LD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.
Danavorexton HDEXPERIMENTALDanavorexton HD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.
Interventions
NameTypeDescription
DanavorextonDRUGDanavorexton intravenous infusion.
PlaceboDRUGPlacebo intravenous infusion.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Has OSA diagnosed according to the International Classification of Sleep Disorders-3 (ICSD-3) criteria and an AHI of 12-50 events/hour sleep (documented by an in-clinic PSG or at-home sleep test within the last 12 months). Participants who do not have PSG results from within ...

Countries:Australia
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