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Tofimilast

Phase 2

Asthma | Small molecule | Respiratory |Pfizer, Inc.|Trials Updated: Nov 7, 2012

Tofimilast development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Sep 2005

Tofimilast target and mechanism

Molecular targetPDE4A, PDE4D, PDE4B, PDE4C
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment412

FDA Designations

No designations recorded

Tofimilast clinical trials

Tofimilast · 2 trials · 2 indications

Phase 2 2
NCT00150397A Study of the Safety and Efficacy of Tofimilast in Adult AsthmaticsAsthma
COMPLETED112 Analytics
NCT00219622A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic Obstructive
COMPLETED300 Analytics
PHASE2COMPLETED
A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics
AsthmaUnlock trial analytics
PHASE2COMPLETED
A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in FEV1 compared to placebo

Secondary Endpoints

Change from baseline in other lung function parameters, disease control and quality of life compared to placebo
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
TofimilastDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Mild to moderate persistent asthma (NAEPP/GINA Step 2-3) * Reversibility to albuterol at least 12% and 200 mL Exclusion Criteria: * Any significant co-morbid disease, particularly cardiovascular * Use of any maintenance therapy except short acting bronchodilators * Smoking h...

Countries:United StatesCosta RicaIndiaArgentinaBrazilChileMexico
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Frequently asked questions about Tofimilast

What is Tofimilast?

Tofimilast is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for respiratory conditions. It has been studied in adults with asthma and chronic obstructive pulmonary disease (COPD). It is a Phase 2 drug and has not been approved by the FDA.

What is Tofimilast used for?

Tofimilast has been studied for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Clinical trials enrolled adults aged 18 and older with asthma and adults aged 40 and older with COPD. It remains an investigational therapy and is not approved for any indication.

What does Tofimilast target?

Tofimilast is a phosphodiesterase 4 (PDE4) inhibitor. It targets the PDE4 enzyme subtypes PDE4A, PDE4B, PDE4C, and PDE4D. Inhibiting these enzymes is the intended mechanism of action for this small molecule in respiratory disease.

Who makes Tofimilast?

Tofimilast is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 2 clinical trials of the drug in asthma and chronic obstructive pulmonary disease.

What phase is Tofimilast in?

Tofimilast is in Phase 2 development. It is an investigational drug and is not FDA approved. Both of its recorded Phase 2 trials have been completed, and no trials are currently active.

What clinical trials is Tofimilast in?

Tofimilast has been evaluated in two completed Phase 2 trials. NCT00219622 studied it in 300 adults with chronic obstructive pulmonary disease across the United States, Argentina, Brazil, Chile, Costa Rica, and Mexico. NCT00150397 studied it in 112 adult asthmatics in the United States, Costa Rica, and India.