Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RHH646 · 1 trial · 1 indication
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in the volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
| Arm | Type | Description |
|---|---|---|
| RHH646 75 mg | EXPERIMENTAL | RHH646 was administered orally once per day for a year. |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo was administered orally once per day for a year. |
| Name | Type | Description |
|---|---|---|
| RHH646 | DRUG | RHH646 capsule for oral use |
| Placebo | DRUG | RHH646 placebo capsule for oral use |
Inclusion Criteria: * Participant is ≥35 and ≤75 years old, at time of screening * Participants must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) ≤35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2 * Diagnosis of tibiofemoral OA in at least one knee by stan...
RHH646 is an investigational small molecule being developed for the treatment of osteoarthritis of the knee. It is intended to address pain and functional limitations associated with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
RHH646 is a small molecule therapeutic, but its specific molecular target has not been disclosed in available information. The drug is being studied for its effects on knee osteoarthritis, a degenerative joint disease, though the precise biological pathway it modulates remains unspecified.
RHH646 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical research to evaluate the safety and efficacy of this investigational drug for knee osteoarthritis.
RHH646 is in Phase 2 clinical development. A Phase 2 trial has been completed, evaluating the drug's safety and efficacy in patients with knee osteoarthritis. The drug remains investigational and has not received regulatory approval for any indication.
RHH646 has been studied in one completed Phase 2 clinical trial registered as NCT05816395, titled 'Safety and Efficacy of RHH646 for Knee Osteoarthritis.' The trial enrolled 82 participants across the United States, Argentina, Denmark, Poland, and Spain, and was randomized, double-blind, and placebo-controlled.
RHH646 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for knee osteoarthritis. The completed Phase 2 trial assessed its safety and efficacy, but the drug has not yet received marketing authorization from the FDA or any other regulatory body.