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TD-9855 Group 1

Phase 2

Fibromyalgia | Small molecule | Musculoskeletal |Theravance Biopharma, Inc.|Last Updated: Mar 4, 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 Enrollment392
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01693692Phase 2 Study of TD-9855 to Treat FibromyalgiaPHASE2 COMPLETED 392Nov 1, 2012Apr 1, 2014Mar 4, 202234 United States
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Study Endpoints
Primary Endpoints
Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries
Baseline and Week 6

Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.

Secondary Endpoints
Fibromyalgia Impact Questionnaire (FIQ)
Day 43 (End of study treatment)
Patient Global Impression of Change (PGIC)
Day 43 (End of study treatment)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TD-9855 Group 1EXPERIMENTALGroup 1 to be dosed with TD-9855
TD-9855 Group 2EXPERIMENTALGroup 2 to be dosed with TD-9855
PlaceboPLACEBO_COMPARATORGroup to be dosed with Placebo
Interventions
NameTypeDescription
TD-9855 Group 1DRUG -
TD-9855 Group 2DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM) * Informed consent * 18 to 65 years of age * Discontinue therapy with adrenergic-acting drugs, and certain other medications * Only acetaminophen or NSAID as rescue pain medication ...

Countries:United States
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Competitive Landscape -Fibromyalgia 5 trials
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