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...
Top 5 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
FX201 is an investigational gene therapy being developed for the treatment of osteoarthritis of the knee. It is designed to be given as a single intra-articular injection into the knee joint, where it aims to provide sustained production of an anti-inflammatory protein to reduce pain and inflammation associated with knee osteoarthritis.
FX201 targets the interleukin-1 receptor antagonist, or IL1RA. By delivering genetic material that codes for IL1RA, FX201 is intended to increase local production of this natural anti-inflammatory protein within the knee joint, thereby blocking interleukin-1 signaling and reducing inflammation and cartilage degradation in osteoarthritis.
FX201 is being developed by Pacira BioSciences, Inc., which trades on the Nasdaq under the ticker symbol PCRX. Pacira is a specialty pharmaceutical company focused on non-opioid pain management and regenerative health products.
FX201 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. The Phase 1 program is evaluating its safety and tolerability in patients with osteoarthritis of the knee.
FX201 is being studied in a single Phase 1 clinical trial, NCT04119687, titled "Study to Evaluate the Safety and Tolerability of FX201 in Patients With Osteoarthritis of the Knee." The trial has an estimated enrollment of 72 participants, is controlled, and is currently active but not recruiting. It is being conducted in the United States.
FX201 is a gene therapy that targets IL1RA, but it is a specific investigational product developed by Pacira BioSciences. It is not simply interchangeable with other IL1RA-targeting therapies; FX201 refers to this particular agent and its clinical program.