Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FX201 · 1 trial · 1 indication
Incidence of treatment emergent adverse events after a single intra-articular (IA) injection of FX201
| Arm | Type | Description |
|---|---|---|
| Low Dose FX201 | EXPERIMENTAL | Single low dose FX201 injection |
| Mid Dose FX201 | EXPERIMENTAL | Single mid dose FX201 injection |
| High Dose FX201 | EXPERIMENTAL | Single high dose FX201 injection |
| Name | Type | Description |
|---|---|---|
| FX201 | BIOLOGICAL | FX201, humantakinogene hadenovec, is a novel interleukin-1 receptor antagonist (IL-1Ra) gene therapy for IA administration that is being developed for the treatment of patients with OAK. |
Inclusion Criteria: * Written consent to participate in the study * Male or female 30 to 80 years of age, inclusive, on the day of enrollment (Day 1) * Body mass index (BMI) ≤ 40 kilograms per meters squared (kg/m2) * Clinical diagnosis of OA of the knee on the American College of Rheumatology crit...
FX201 is an investigational monoclonal antibody being developed for the treatment of osteoarthritis of the knee. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with this condition to evaluate its safety and tolerability.
FX201 is being developed by Pacira BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PCRX. The company is conducting clinical trials to evaluate the safety and tolerability of FX201 in patients with osteoarthritis of the knee.
FX201 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to evaluate the safety and tolerability of FX201 in patients with osteoarthritis of the knee.
FX201 is being studied in a Phase 1 clinical trial with the identifier NCT04119687, titled 'Study to Evaluate the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee.' This trial is active but not recruiting, with an enrollment of 72 participants in the United States.
Yes, FX201 is a monoclonal antibody. It is being developed as a potential treatment for osteoarthritis of the knee. The drug is currently in Phase 1 clinical trials to assess its safety and tolerability in patients with this condition.