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Tasipimidine

Phase 2

Insomnia | Small molecule | Other |Icon Plc|Last Updated: Oct 22, 2025

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment190
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06956495Efficacy and Tolerability of Tasipimidine in Sleepless PatientsPHASE2 COMPLETED 190Aug 20, 2023Sep 24, 2025Oct 22, 20251 Finland
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Study Endpoints
Primary Endpoints
Wake after sleep onset (WASO) combined from Part 1 and Part 2
Treatment Day 1 and 2

Assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2

Latency to persistent sleep (LPS) combined from Part 1 and Part 2
Treatment Day 1 and 2

Assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Tasipimidine Dose level 1EXPERIMENTALDose level 1
Tasipimidine Dose level 2EXPERIMENTALDose level 2
Tasipimidine Dose level 3EXPERIMENTALDose level 3
PlaceboPLACEBO_COMPARATORTasipimidine Placebo
Tasipimidine Dose level 4EXPERIMENTALDose level 4
Interventions
NameTypeDescription
TasipimidineDRUGTasipimidine solution
Tasipimidine placeboDRUGTasipimidine placebo solution
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Signed informed consent (IC) for participation in the study. * Male or female subjects with age between 18 and 65 years. * Insomnia disorder * Self-reported history of the following on at least 3 nights per week and for at least 3 months prior to the screening: ≥ 30 minutes to...

Countries:Finland
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