CLINICAL TRIALS PROFILE FOR ZILRETTA

All Clinical Trials for Zilretta

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02116972 ↗	Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee	Completed	Flexion Therapeutics, Inc.	Phase 2	2014-04-01	The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).
NCT02357459 ↗	Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee	Completed	Flexion Therapeutics, Inc.	Phase 3	2015-01-01	The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.
NCT02468583 ↗	Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee	Terminated	Flexion Therapeutics, Inc.	Phase 2	2015-02-01	This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.
NCT02637323 ↗	Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee	Completed	Flexion Therapeutics, Inc.	Phase 2	2015-11-01	The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
NCT02762370 ↗	Study to Assess the Effects of FX006 on Blood Glucose in Patients With OA of the Knee and Type 2 Diabetes	Completed	Flexion Therapeutics, Inc.	Phase 2	2016-04-01	The purpose of this study was to compare the effects of FX006 and Triamcinolone Acetonide Injectable Suspension, United States Pharmacopeia (USP) (referred to as TCA IR in the protocol) on blood glucose (BG) in patients with osteoarthritis (OA) of the knee and Type 2 diabetes mellitus (DM).
NCT03378076 ↗	Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA	Completed	Flexion Therapeutics, Inc.	Phase 2	2017-12-06	This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.

Clinical Trial Conditions for Zilretta

Condition Name

Condition Name for Zilretta
Intervention	Trials
Osteoarthritis, Knee	5
Osteoarthritis of the Knee	4
Osteoarthritis of the Shoulder	2
Adhesive Capsulitis	2

Condition MeSH

Condition MeSH for Zilretta
Intervention	Trials
Osteoarthritis, Knee	12
Osteoarthritis	12
Bursitis	3
Wounds and Injuries	1

Clinical Trial Locations for Zilretta

Trials by Country

Trials by Country for Zilretta
Location	Trials
United States	75
Australia	3
Canada	3
Hong Kong	1
Estonia	1

Trials by US State

Trials by US State for Zilretta
Location	Trials
California	8
Pennsylvania	8
Texas	6
Florida	5
North Carolina	5

Clinical Trial Progress for Zilretta

Clinical Trial Phase

Clinical Trial Phase for Zilretta
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	10

Clinical Trial Status

Clinical Trial Status for Zilretta
Clinical Trial Phase	Trials
Completed	8
Recruiting	5
Terminated	2

Clinical Trial Sponsors for Zilretta

Sponsor Name

Sponsor Name for Zilretta
Sponsor	Trials
Flexion Therapeutics, Inc.	11
Sorrento Therapeutics, Inc.	1
ROC Foundation	1

Sponsor Type

Sponsor Type for Zilretta
Sponsor	Trials
Industry	13
Other	7