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AGG-523

Phase 1

Osteoarthritis | Small molecule | Musculoskeletal |Pfizer, Inc.|Trials Updated: Jul 29, 2009

AGG-523 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Sep 2006

AGG-523 target and mechanism

ModalitySmall molecule

Also known as AGG-523 (Aggrecanase Inhibitor)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment2

FDA Designations

No designations recorded

AGG-523 clinical trials

AGG-523 · 3 trials · 2 indications

Phase 1 3
NCT00454298Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee ReplacementOsteoarthritis
COMPLETED2 Analytics
NCT00427687Study Evaluating AGG-523 in Subjects With OsteoarthritisOsteoarthritis
COMPLETED- Analytics
NCT00380900Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in HealthyHealthy Subjects
COMPLETED- Analytics
PHASE1COMPLETED
Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement
OsteoarthritisUnlock trial analytics
PHASE1COMPLETED
Study Evaluating AGG-523 in Subjects With Osteoarthritis
OsteoarthritisUnlock trial analytics
PHASE1COMPLETED
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in Healthy
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Using parts of the knee joint and the surrounding fluid that is taken out at the time of knee replacement, measure 1) the activity of aggrecansase (an enzyme that breaks down cartilage) and 2) the amount of study drug using lab tests.
4 weeks
The effect of AGG-523 on biomarkers related to osteoarthritis.
Assess the safety of multiple doses of AGG-523 administered to subjects.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATORAGG-523 1800 mg QD PO (12 capsules) for 28 days
BACTIVE_COMPARATORAGG-523 900 mg BID PO (12 capsules) for 28 days
CPLACEBO_COMPARATORPlacebo QD PO (12 capsules) for 28 days
DPLACEBO_COMPARATORPlacebo BID PO (12 capsules) for 28 days

Interventions

NameTypeDescription
AGG-523 (Aggrecanase Inhibitor)DRUG -
AGG-523DRUG -
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Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Generally healthy, men or women, at least 55 years old * Osteoarthritis of the knee requiring total knee replacement surgery Exclusion Criteria: * Other types of arthritis, like rheumatoid arthritis * Recent major surgery (in past 3 months) * Recent knee injections (in past ...

Countries:United States
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Competitive Landscape -Osteoarthritis 143 trials

Frequently asked questions about AGG-523

What is AGG-523?

AGG-523 is an investigational small molecule developed by Pfizer, Inc. (ticker: PFE) for osteoarthritis, a musculoskeletal condition. It is also referred to as AGG-523 (Aggrecanase Inhibitor). The drug has been studied in Phase 1 clinical trials and has not been approved for any use.

What is AGG-523 used for in osteoarthritis?

AGG-523 was studied for the treatment of osteoarthritis. Its Phase 1 trials enrolled adults with osteoarthritis, including one study in subjects with severe osteoarthritis requiring total knee replacement. The program remains investigational and the drug is not approved for treating osteoarthritis or any other condition.

Who makes AGG-523?

Pfizer, Inc. (ticker: PFE) is the developer of AGG-523. Pfizer sponsored the Phase 1 clinical studies of the drug in osteoarthritis, all of which were conducted in the United States.

What phase is AGG-523 in?

AGG-523 is in Phase 1 development. All three of its recorded clinical trials were Phase 1 studies, and all three are completed, with no active trials ongoing. The drug is investigational and has not received FDA approval.

What clinical trials is AGG-523 in?

AGG-523 has been evaluated in three completed Phase 1 trials: NCT00454298 in severe osteoarthritis requiring total knee replacement, NCT00427687 in osteoarthritis, and NCT00380900, a multiple ascending dose study of safety, tolerability, pharmacokinetics and pharmacodynamics in healthy subjects. All were conducted in the United States.

Is AGG-523 the same as an aggrecanase inhibitor?

Yes. AGG-523 is also known as AGG-523 (Aggrecanase Inhibitor), so searches for the aggrecanase inhibitor AGG-523 refer to the same Pfizer compound. It is a small molecule studied in Phase 1 trials for osteoarthritis.