Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FX005 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| FX005 | EXPERIMENTAL | - |
| Placebo 1 (Carrier) | PLACEBO_COMPARATOR | - |
| Placebo 2 (Diluent) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| FX005 | DRUG | Single Ascending Dose (SAD) Phase Cohorts: 1, 10 or 45 mg intra-articular injection; Proof of Concept Phase: Maximum, well-tolerated dose intra-articular injection (determined during SAD Phase) |
| Placebo 1 (Carrier) | DRUG | Single intra-articular injection |
| Placebo 2 (Diluent) | DRUG | Single intra-articular injection |
Inclusion Criteria: * Male or female ≥40 years of age * Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological) * Kellgren-Lawrence grades II or III * Mea...
FX005 is an investigational small molecule being studied for the treatment of pain in patients with osteoarthritis of the knee. It is in Phase 1 clinical development and has not been approved by regulatory authorities. A completed trial evaluated its safety and efficacy in 140 patients with knee osteoarthritis.
FX005 is being developed by Pacira BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PCRX. The company is conducting clinical research to evaluate the drug's potential as a treatment for pain associated with osteoarthritis of the knee.
FX005 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. One Phase 1 trial has been completed, and the drug remains under clinical investigation for the treatment of knee osteoarthritis pain.
FX005 has one completed clinical trial, NCT01291914, titled 'Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee.' This Phase 1 study enrolled 140 participants and was conducted in Austria, Canada, Spain, and the United Kingdom.
Yes, the completed Phase 1 trial of FX005 was a randomized, double-blind, placebo-controlled study. This design was used to evaluate the drug's effects on pain in patients with osteoarthritis of the knee, comparing FX005 against a placebo control group.