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ONO-1110

Phase 2

Fibromyalgia | Small molecule | Musculoskeletal |Co-Diagnostics, Inc.|Last Updated: Jul 8, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment175
FDA Designations
No designations recorded
Clinical trial landscape

ONO-1110 · 4 trials · 4 indications

Phase 2 4
NCT06805565A Study of ONO-1110 in Patients With Social Anxiety DisorderSocial Anxiety Disorder (SAD)
ACTIVE NOT_RECRUITING100 Analytics
NCT06752603A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial CystitisHunner Type Interstitial Cystitis
COMPLETED57 Analytics
NCT06752590A Clinical Study of ONO-1110 in Patients With FibromyalgiaFibromyalgia
COMPLETED175 Analytics
NCT06792136A Study of ONO-1110 in Patients With Major Depressive DisorderMajor Depressive Disorder (MDD
COMPLETED103 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of ONO-1110 in Patients With Social Anxiety Disorder
Social Anxiety Disorder (SAD)
NCT06805565100
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PHASE2COMPLETED
A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial Cystitis
Hunner Type Interstitial Cystitis
NCT0675260357
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PHASE2COMPLETED
A Clinical Study of ONO-1110 in Patients With Fibromyalgia
Fibromyalgia
NCT06752590175
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PHASE2COMPLETED
A Study of ONO-1110 in Patients With Major Depressive Disorder
Major Depressive Disorder (MDD
NCT06792136103
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Study Endpoints
Primary Endpoints
Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period
Up to 19 weeks
Change in weekly mean of average pain score from baseline to Week 12 of the treatment period
Up to 20 weeks
Adverse events
Up to 20 weeks
Change in weekly mean of average pain score from baseline to Week 8 of the treatment period
Up to 16 weeks
Change in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period
Up to 16 weeks
Secondary Endpoints
The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 8 of the treatment period
Up to 19 weeks
The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Fear or Anxiety score from baseline to Week 8 of the treatment period
Up to 19 weeks
The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Avoidance score from baseline to Week 8 of the treatment period
Up to 19 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ONO-1110EXPERIMENTAL -
PlaceoPLACEBO_COMPARATOR -
PlaceboPLACEBO_COMPARATORPlacebo tablets once daily
Interventions
NameTypeDescription
ONO-1110DRUGONO-1110 tablets once a day
PlaceboDRUGPlacebo tablets once daily
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: 1. Japanese participants (sex not specified) 2. Participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements 3. Participants diagnosed with social anxiety disorder base...

Countries:Japan
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Competitive Landscape -Fibromyalgia 5 trials
CompanyTickerTrialsLead PhaseDrugs
Axsome Therapeutics, Inc.AXSM1PHASE3AXS-14
Grace Therapeutics, Inc.GRCE1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06805565studyFirstPostDate: changed