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PF-03654764

Phase 2

Allergic Rhinitis | Small molecule | Respiratory |Pfizer, Inc.|Trials Updated: Aug 17, 2010

PF-03654764 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Oct 2009

PF-03654764 target and mechanism

Molecular targetHRH3
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

PF-03654764 clinical trials

PF-03654764 · 1 trial · 1 indication

Phase 2 1
NCT01033396The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic RhinitisAllergic Rhinitis
COMPLETED64 Analytics
PHASE2COMPLETED
The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Congestion scores
6 hours
Other allergic rhinitis symptoms
6 hours

Secondary Endpoints

Pharmacokinetics
6 hours
Blood pressure/pulse rate
6 hours
Adverse event reporting
2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-03654764 + AllegraEXPERIMENTAL -
PF-03654764EXPERIMENTAL -
Allegra-DACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-03654764DRUGPF-03654764 single dose 5 mg
AllegraDRUGFexofenadine single dose 60 mg
Allegra-DDRUGFexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
PlaceboDRUGPlacebo single dose
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female subjects 18-60 years allergic to ragweed pollen. * Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit. Exclusion Criteria: * Subjects with significant diseases other than allergic rhinitis that may interfe...

Countries:Canada
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Competitive Landscape -Allergic Rhinitis 8 trials

Top 1 of 3 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY1PHASE3LY3650150
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Frequently asked questions about PF-03654764

What is PF-03654764 used for?

PF-03654764 was developed for the treatment of allergic rhinitis. It is an investigational small molecule studied by Pfizer as a potential therapy for nasal allergy symptoms, including in combination with the antihistamine Allegra (fexofenadine). It has not been approved for any indication.

What does PF-03654764 target?

PF-03654764 targets HRH3, the histamine H3 receptor, acting as an antagonist. By blocking this receptor, the drug was designed to modulate histamine signaling relevant to allergic rhinitis symptoms. HRH3 antagonism was the intended mechanism explored in its clinical program.

Who makes PF-03654764?

PF-03654764 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical research evaluating the compound in allergic rhinitis.

What phase is PF-03654764 in?

PF-03654764 reached Phase 2 clinical development for allergic rhinitis. It is an investigational drug and has not been approved by the FDA. Its single recorded Phase 2 trial has been completed, and no active trials are currently listed.

What clinical trials is PF-03654764 in?

PF-03654764 was evaluated in one Phase 2 trial, NCT01033396, titled "The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis." The completed trial enrolled 64 participants in Canada, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.