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FX006

Aliases
FX006 10 mg, FX006 16 mg, FX006 32 mg, FX006 40 mg (2 other aliases)
Name
Zilretta
INN Name
triamcinolone acetonide extended-release injectable suspension
FDA Approved
Yes

17 clinical trials

1 organization

16 indications

1 document

Indication
Osteoarthritis of the Shoulder
Indication
Frozen Shoulder
Indication
Osteoarthritis of the Hip
Indication
Osteoarthritis of the Knee
Indication
Knee Osteoarthritis
Indication
Osteoarthritis
Indication
hip
Indication
Post-traumatic Osteoarthritis of the Knee
Indication
Type 2 Diabetes Mellitus
Indication
Knee
Indication
Trochanteric Bursitis
Indication
Rotator Cuff Tears
Indication
Rotator Cuff Tendinitis
Indication
Rotator Cuff Impingement
Indication
Injectables
Indication
Glucocorticoids
Clinical trial
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis (RANGE)
Status: Terminated, Estimated PCD: 2020-06-15
Clinical trial
A Randomized, Open-label Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension) in Patients With Osteoarthritis of the Shoulder (Glenohumeral Joint) or Hip
Status: Completed, Estimated PCD: 2018-10-09
Clinical trial
An Open-label, Single Administration Study to Characterize the Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee
Status: Completed, Estimated PCD: 2014-04-01
Clinical trial
A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)
Status: Completed, Estimated PCD: 2018-03-14
Clinical trial
An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee
Status: Completed, Estimated PCD: 2016-09-01
Clinical trial
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
Status: Terminated, Estimated PCD: 2019-08-07
Clinical trial
A Single-arm, Open-label Study to Evaluate a Procedure for Intra-articular (IA) Injection of FX006 in Patients With Osteoarthritis (OA) of the Hip
Status: Completed, Estimated PCD: 2019-10-11
Clinical trial
A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Status: Completed, Estimated PCD: 2015-11-01
Clinical trial
An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee
Status: Completed, Estimated PCD: 2018-07-19
Clinical trial
A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
Status: Terminated, Estimated PCD: 2016-07-01
Clinical trial
A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee
Status: Completed, Estimated PCD: 2013-04-01
Clinical trial
A Double-Blind, Randomized, Parallel Group Comparison of the Effects of FX006 and TCA IR (Triamcinolone Acetonide Suspension) on Blood Glucose in Patients With Osteoarthritis of the Knee and Type 2 Diabetes Mellitus
Status: Completed, Estimated PCD: 2016-10-01
Clinical trial
A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Status: Completed, Estimated PCD: 2016-01-01
Clinical trial
A Double-Blind, Randomized, Parallel Group, Active Comparator Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects (HPA Axis) of FX006 in Patients With Osteoarthritis of the Knee
Status: Completed, Estimated PCD: 2012-11-01
Clinical trial
An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Status: Completed, Estimated PCD: 2019-11-08
Clinical trial
Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis
Status: Completed, Estimated PCD: 2022-12-14
Clinical trial
Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease
Status: Recruiting, Estimated PCD: 2024-12-01
Document
DailyMed Label: Zilretta
Organization
Pacira Pharmaceuticals, Inc.