Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M6495 · 1 trial · 1 indication
Number of participants with clinically significant change from baseline will be reported.
| Arm | Type | Description |
|---|---|---|
| M6495 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| M6495 | DRUG | Participants will receive escalated dose of M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4. |
| Placebo | DRUG | Participants will receive placebo matched to M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4. |
Inclusion Criteria: * Kellgren Lawrence (KL) radiological Grade of 2 to 4 in the target knee * Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore of greater than or equal to (\>=) 40 out of 100 in the target knee at screening * Primary or post-traumatic femorotibia...
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 |
M6495 is an investigational small molecule being developed by Merck KGaA for knee osteoarthritis. It was studied in a Phase 1 clinical trial in participants with knee osteoarthritis. M6495 has not been approved and remains in clinical development.
M6495 is being developed for the treatment of knee osteoarthritis, a musculoskeletal condition. It was evaluated in a Phase 1 multiple ascending dose study in participants with knee osteoarthritis. The drug is investigational and has not been approved for any use.
M6495 is developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the Phase 1 clinical trial of M6495 in knee osteoarthritis.
M6495 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
M6495 was studied in one Phase 1 trial, NCT03583346, titled a multiple ascending dose study of an anti-ADAMTS-5 nanobody in participants with knee osteoarthritis. The trial enrolled 32 participants in Denmark, was randomized, double-blind, and placebo-controlled, and is now completed.
M6495 is described as an anti-ADAMTS-5 nanobody. ADAMTS-5 is a molecular target associated with cartilage degradation in osteoarthritis. The Phase 1 trial evaluated multiple ascending doses of M6495 in participants with knee osteoarthritis.