Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as REGN475
Fasinumab AI · 4 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Group A will receive REGN475 dosing regimen 1 |
| Group B | EXPERIMENTAL | Group B will receive REGN475 dosing regimen 2 |
| Group C | EXPERIMENTAL | Group C will receive REGN475 dosing regimen 3 |
| Group D | EXPERIMENTAL | Group D will receive REGN475 dosing regimen 4 |
| Group E | EXPERIMENTAL | Group E will receive matching placebo |
| placebo injection | PLACEBO_COMPARATOR | - |
| active | EXPERIMENTAL | subcutaneous injection of REGN475 |
| active 2 | EXPERIMENTAL | subcutaneous injection of REGN475 |
| Auto-injector (AI) | EXPERIMENTAL | - |
| Prefilled syringe (PFS) | EXPERIMENTAL | - |
| Dose 1 | EXPERIMENTAL | - |
| Dose 2 | EXPERIMENTAL | - |
| Dose 3 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| REGN475 | DRUG | - |
| Placebo | DRUG | - |
| Placebo Injection | DRUG | Placebo Subcutaneous injection |
| Fasinumab AI | DRUG | Self-administered with auto injector |
| Fasinumab PFS | DRUG | Prefilled syringe administered by study staff |
Key Inclusion Criteria: 1. Body mass index ≤39 2. Clinical diagnosis of OA of the knee or hip 3. History of inadequate pain relief or intolerance to analgesics used for OA 4. Moderate to severe pain in the index joint 5. History of regular use of analgesic medications for OA pain 6. Willing to disc...
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 |
Fasinumab AI is being developed for knee osteoarthritis, a musculoskeletal condition. It is an investigational monoclonal antibody and has not been approved for any use. Regeneron Pharmaceuticals is studying it in a Phase 1 program, so its clinical role in treating osteoarthritis remains under evaluation.
Fasinumab AI targets nerve growth factor, or NGF. It is an inhibitor of NGF, meaning it binds and blocks the activity of this target. NGF is a signaling protein involved in pain and nerve function, and inhibiting it is the intended mechanism for addressing osteoarthritis pain.
Fasinumab AI is developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the company responsible for the clinical development of this monoclonal antibody candidate.
Fasinumab AI is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The Phase 1 program includes one completed trial, and no active trials are currently listed for this asset.
Fasinumab AI has been studied in one completed Phase 1 trial, NCT03491904, titled "To Assess the Patients' Ability to Self-Administer Fasinumab." The trial enrolled 100 participants with knee or hip osteoarthritis in the United States and was randomized and controlled.