Trial Profile
An Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of FX201 in Patients With Osteoarthritis of the Knee
Status:
Active, no longer recruiting
Phase of Trial:
Phase I
Latest Information Update: 15 Mar 2024
Price :
$35
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At a glance
- Drugs Humantakinogene hadenovec (Primary)
- Indications Musculoskeletal pain; Osteoarthritis
- Focus Adverse reactions; First in man
- Sponsors Flexion Therapeutics; Pacira BioSciences
- 13 Mar 2024 According to a Flexion Therapeutics media release, the 52-week data have been accepted for presentation at OARSI 2024 taking place in Vienna, Austria in April 2024 and the company expects to present 104-week efficacy and safety data later this year.
- 13 Mar 2024 According to a Flexion Therapeutics media release, based on preliminary results from this trial, the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PCRX-201 (enekinragene inzadenovec), for the treatment of osteoarthritis of the knee.
- 31 Jan 2024 Planned End Date changed from 30 Nov 2026 to 28 Nov 2026.