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480 Mometasone Furoate Sinus Drug Depot

Phase 1

Chronic Sinusitis | Small molecule | ENT |Lyra Therapeutics, Inc.|Last Updated: Aug 25, 2021

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 Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02967731480 Biomedical Sinus Drug DepotPHASE1 COMPLETED 20Jun 6, 2017May 18, 2018Aug 25, 20214 Australia, New Zealand
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Study Endpoints
Primary Endpoints
Product related serious adverse events from baseline visit to 4 weeks post procedure
4 weeks post procedure
Secondary Endpoints
Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
Up to 24 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
480 Mometasone Furoate Sinus Drug DepotEXPERIMENTAL480 Mometasone Furoate Sinus Drug Depot
Interventions
NameTypeDescription
480 Mometasone Furoate Sinus Drug DepotDRUGManagement of Chronic Sinusitis
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Diagnosis of CS. * Female study subjects of child-bearing potential must have a negative pregnancy test and must agree to not become pregnant during the course of the study. * The study subject has been informed of the nature of the study, agrees to its provisions and has prov...

Countries:AustraliaNew Zealand
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Competitive Landscape -Chronic Rhinosinusitis 12 trials