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TD-9855 Group 1

Phase 2

Fibromyalgia | Small molecule | Musculoskeletal |Theravance Biopharma, Inc.|Last Updated: Mar 4, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment392

FDA Designations

No designations recorded

Clinical trial landscape

TD-9855 Group 1 · 1 trial · 1 indication

Phase 2 1
NCT01693692Phase 2 Study of TD-9855 to Treat FibromyalgiaFibromyalgia
COMPLETED392 Analytics
PHASE2COMPLETED
Phase 2 Study of TD-9855 to Treat Fibromyalgia
FibromyalgiaUnlock trial analytics

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 to 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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Frequently asked questions about TD-9855 Group 1

What is TD-9855 used for?

TD-9855 is an investigational small molecule being studied for the treatment of fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain. It is being developed by Theravance Biopharma, Inc. and is currently in clinical development, though it is not approved for any use.

What does TD-9855 target?

The specific molecular target of TD-9855 has not been disclosed in available information. It is a small molecule being evaluated for its potential to treat fibromyalgia, but its mechanism of action is not publicly detailed.

Who is developing TD-9855?

TD-9855 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol TBPH. The company is conducting clinical trials to evaluate the drug's safety and efficacy for fibromyalgia.

What phase is TD-9855 in?

TD-9855 is in Phase 2 clinical development. A Phase 2 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities, and its development status is subject to ongoing clinical evaluation.

What clinical trials is TD-9855 in?

TD-9855 has been studied in a completed Phase 2 clinical trial registered as NCT01693692, titled 'Phase 2 Study of TD-9855 to Treat Fibromyalgia.' The trial enrolled 392 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is TD-9855 the same as any other drug?

No alternative names for TD-9855 have been identified in available information. It is referred to solely as TD-9855 in clinical trial records and by its developer, Theravance Biopharma, Inc.