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TD-4208 700 μg

Phase 2

Chronic Obstructive Pulmonary Disease, COPD | Small molecule | Respiratory |Viatris Inc.|Last Updated: Feb 24, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03064113Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)PHASE2 COMPLETED 32May 1, 2011Oct 1, 2011Feb 24, 20221 New Zealand
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Study Endpoints
Primary Endpoints
Peak Forced Expiratory Volume in One Second (FEV1) Relative to Baseline
From predose to 25 hours postdose
Secondary Endpoints
Area Under the FEV1 vs. Time Curve, Time-matched Difference From Placebo
12 hr and 24 hr
Area Under the FEV1 vs. Peak FEV1, Time-matched Difference From Placebo
12 hr and 24 hr
Peak Expiratory Flow Rate (PEFR) From 25% to 75% of Vital Capacity (FEF25-75), as Related to FEV1
12hr and 24hr
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTALPeriod 1 = Placebo; Period 2 = TD-4208 700 μg; Period 3 = TD-4208 350 μg; Period 4 = Ipratropium 500 μg
Sequence 2EXPERIMENTALPeriod 1 = TD-4208 700 μg; Period 2 = Ipratropium 500 μg; Period 3 = Placebo; Period 4 = TD-4208 350 μg
Sequence 3EXPERIMENTALPeriod 1 = TD-4208 350 μg; Period 2 = Placebo; Period 3 = Ipratropium 500 μg; Period 4 = TD-4208 700 μg
Sequence 4EXPERIMENTALPeriod 1 = Ipratropium 500 μg; Period 2 = TD-4208 350 μg; Period 3 = TD-4208 700 μg; Period 4 = Placebo
Interventions
NameTypeDescription
PlaceboDRUG -
TD-4208 700 μgDRUG -
TD-4208 350 μgDRUG -
Ipratropium 500 μgDRUG -
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Eligibility Criteria
Age Range40 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of moderate stable Chronic Obstructive Pulmonary. * Disease with FEV1/FVC \<0.7 at screening. * Woman of non-childbearing potential. * Female participants of childbearing potential must test negative for pregnancy and must be using a highly effective method of birth ...

Countries:New Zealand
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