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tofimilast

Phase 2

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 7, 2012

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00219622A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary DiseasePHASE2 COMPLETED 300May 1, 2004Jul 1, 2005Nov 7, 201240 United States, Argentina +4
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Study Endpoints
Primary Endpoints
Change from baseline in FEV1 compared to placebo
Secondary Endpoints
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 Range40 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Moderate-severe COPD (GOLD 2003 definition) * Smoking history of at least 10 pack-years Exclusion Criteria: * Any significant co-morbid disease, particularly cardiovascular * Use of any maintenance therapy except short acting bronchodilators

Countries:United StatesArgentinaBrazilChileCosta RicaMexico
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