Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Experimental: Group 1- RZ402 · 1 trial · 1 indication
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Change from baseline in Central Subfield Thickness (CST), as measured by Spectral Domain Ocular Coherence Tomography (SD-OCT), compared to placebo.
| Arm | Type | Description |
|---|---|---|
| Group 1 - 50 mg RZ402 | EXPERIMENTAL | RZ402 50mg oral tablet, once daily for 3 months |
| Group 2 - 200 mg RZ402 | EXPERIMENTAL | RZ402 200mg oral tablet, once daily for 3 months |
| Group 3 - 400 mg RZ402 | EXPERIMENTAL | RZ402 400mg oral tablet, once daily for 3 months |
| Group 4 - Placebo | PLACEBO_COMPARATOR | placebo oral tablet, once daily for 3 months |
| Name | Type | Description |
|---|---|---|
| Experimental: Group 1 - 50mg RZ402 | DRUG | RZ402 50 mg oral tablet, once daily for 3 months |
| Experimental: Group 2 - 200mg RZ402 | DRUG | RZ402 200mg oral tablet, once daily for 3 months |
| Experimental: Group 3 - 400mg RZ402 | DRUG | RZ402 400mg oral tablet, once daily for 3 months |
| Placebo: Group 4 - Placebo | OTHER | Placebo oral tablet, once daily for 3 months |
Inclusion Criteria: General Inclusion Criteria: 1. Confirmed diabetes mellitus Type 1 or Type 2 2. Stable glycemic control Study Eye Inclusion Criteria: 3. Mild to moderate non-proliferative diabetic retinopathy (NPDR) with retinal thickening due to CI-DME as determined by the Investigator. 4....
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
RZ402 is an investigational small molecule being studied for the treatment of Diabetic Macular Edema (DME). It is designed to address the condition through a mechanism that has not been publicly detailed. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
RZ402 is being developed by Rezolute, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol RZLT. The company is conducting clinical research to evaluate the efficacy and safety of RZ402 in patients with Diabetic Macular Edema.
RZ402 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed to evaluate the drug's efficacy and safety in patients with Diabetic Macular Edema. RZ402 remains an investigational drug and has not received FDA approval.
RZ402 has been studied in a Phase 2 clinical trial identified as NCT05712720, titled "Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)." This trial enrolled 94 participants in the United States and has been completed.
RZ402 is the primary name used for this investigational drug in clinical research. No alternative names have been reported in the available clinical trial information. The drug is being studied solely under the designation RZ402 by its developer, Rezolute, Inc.