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esreboxetine

Phase 3

Fibromyalgia | Small molecule | Musculoskeletal |Pfizer, Inc.|Trials Updated: Dec 4, 2018

esreboxetine development status

Highest phase Phase 3 (NCT00796601)
Phase scored for PFEPhase 2
Registered trials 3 across 1 sponsor since Sep 2008

esreboxetine target and mechanism

Molecular targetSLC6A2
Target classInhibitor
ModalitySmall molecule

Also known as [14C]-esreboxetine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment129

FDA Designations

No designations recorded

esreboxetine clinical trials

esreboxetine · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00752505A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.Fibromyalgia
COMPLETED89 Analytics
PHASE2COMPLETED
A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.
FibromyalgiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Computer based psychometric tests
11 week
To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers
Up to 24 hours

Secondary Endpoints

A questionnaire to evaluate the subjects cognitive status
Once at randomisatoin
A questionnaire to assess the subjects mood
11 weeks
A question to assess the subjects pain at visits
11 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
OneEXPERIMENTAL -
TwoPLACEBO_COMPARATOR -
ThreeACTIVE_COMPARATORAdministration of a single oral dse of 400mg moxifloxacin

Interventions

NameTypeDescription
EsreboxetineDRUGTablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing
placeboDRUGOnce daily administration of placebo for 9 days. Placebo will be administered double blind
moxifloxacinDRUGOnce daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: * Subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. Control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender Exclusion Criteria: * Other confound...

Countries:United StatesBelgium
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Competitive Landscape -Fibromyalgia 10 trials

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Axsome Therapeutics, Inc.AXSM2PHASE3AXS-14
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Frequently asked questions about esreboxetine

What is esreboxetine used for?

Esreboxetine has been studied as a treatment for fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain. It was developed by Pfizer, Inc. and reached Phase 2 clinical development for this indication. It is an investigational drug and is not approved for any use.

What does esreboxetine target?

Esreboxetine targets SLC6A2, also known as the norepinephrine transporter. It acts as an inhibitor of this transporter. By inhibiting SLC6A2, esreboxetine increases norepinephrine levels in the synaptic cleft, which may help modulate pain signaling in fibromyalgia.

Who is developing esreboxetine?

Esreboxetine is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer conducted the clinical trials for esreboxetine in fibromyalgia.

What phase is esreboxetine in?

Esreboxetine is in Phase 2 clinical development for fibromyalgia. It is an investigational small molecule and has not been approved by the FDA or any regulatory agency for any indication. The completed trials include one Phase 1 and one Phase 2 study.

What clinical trials is esreboxetine in?

Esreboxetine has been evaluated in two completed clinical trials. NCT00809289 was a Phase 1 thorough QT study in 40 healthy volunteers in Belgium. NCT00752505 was a Phase 2 study assessing esreboxetine's effects on concentration, memory, decision making, and problem solving in 89 patients with fibromyalgia in the United States.

Is esreboxetine the same as [14C]-esreboxetine?

Yes, [14C]-esreboxetine is an alternative name for esreboxetine. The [14C] designation indicates a carbon-14 radiolabeled form of the same molecule, often used in clinical pharmacology studies to track the drug's absorption, distribution, metabolism, and excretion.