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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

TD-4208 700 μg · 1 trial · 1 indication

Phase 2 1
NCT03064113Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease, COPD
COMPLETED32 Analytics
PHASE2COMPLETED
Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease, COPDUnlock trial analytics

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 to 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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Frequently asked questions about TD-4208 700 μg

What is TD-4208 700 μg used for?

TD-4208 700 μg is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes TD-4208 700 μg?

TD-4208 700 μg is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol VTRS. The drug is in Phase 2 clinical development for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

What phase is TD-4208 700 μg in?

TD-4208 700 μg is in Phase 2 clinical development. It is an investigational drug for the treatment of Chronic Obstructive Pulmonary Disease (COPD) and has not yet been approved by regulatory authorities.

What clinical trials is TD-4208 700 μg in?

TD-4208 700 μg has one completed Phase 2 clinical trial, identified as NCT03064113, titled 'Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)'. The trial enrolled 32 participants in New Zealand and was randomized, double-blind, and controlled.

Is TD-4208 700 μg the same as TD-4208?

TD-4208 700 μg is a specific dose of the drug TD-4208, which is being developed by Viatris Inc. for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The 700 μg dose was studied in a Phase 2 clinical trial.