Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AS902330 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| AS902330 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AS902330 | BIOLOGICAL | 10, 30 or 100 µg intra-articular injection per subject in the Single Ascending Dose (SAD) cohorts and 10, 30 or 100 µg intra-articular injection per week for three weeks per subject in the Multiple Ascending Dose (MAD) cohorts. |
| Placebo | DRUG | Placebo or, 3, 10, 30, 100 or 300 µg intra-articular injection per subject in SAD cohorts and placebo or, 10, 30, 100, 300 µg or highest tolerated dose of AS902330 intra-articular injection per week for three weeks per subject in MAD cohorts. |
Inclusion Criteria: 1. Male or female \>= 40 years of age; females must be postmenopausal or surgically sterile 2. Established diagnosis of primary femoro-tibial OA of the target knee by standard American College of Rheumatology Criteria for at least six months (clinical AND radiological criteria) ...
AS902330 is an investigational small molecule being developed for knee osteoarthritis, a degenerative joint disease. It is administered intra-articularly, meaning directly into the knee joint. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AS902330 is being developed by Merck KGaA, a German multinational pharmaceutical company. The company's stock is traded over-the-counter under the ticker MKGAF. Merck KGaA is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for knee osteoarthritis.
AS902330 is in Phase 1 clinical development. Two Phase 1 trials have been completed, involving a total of 265 participants with knee osteoarthritis. The drug remains investigational and has not received regulatory approval for any indication.
AS902330 has completed two Phase 1 clinical trials. The first, NCT00911469, enrolled 73 patients with knee osteoarthritis who were candidates for total knee replacement. The second, NCT01033994, enrolled 192 patients with knee osteoarthritis not requiring surgery. Both trials were randomized, double-blind, and placebo-controlled.
Yes, AS902330 is also known as rhFGF-18, which stands for recombinant human fibroblast growth factor 18. Both names refer to the same investigational drug being developed by Merck KGaA for the treatment of knee osteoarthritis.