Drugs / RZ402
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05712720 | Feb 2023 → Apr 2024 | diabetic macular edema | Rezolute | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-05-21 | Rezolute | Results Rezolute Reports Positive Topline Results from Phase 2 Proof of Concept Study of RZ402 in Patients with Diabetic Macular Edema (DME) rezolutebio.com ↗ |
| 2022-02-22 | Rezolute | Results Rezolute Announces Positive Study Results for RZ402, an oral PKI being developed for DME rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced topline data from its Phase 1b multiple-ascending dose (MAD) study of RZ402, a plasma kallikrein inhibitor (PKI) being developed as an oral therapy for the treatment of diabetic macular edema (DME). |
| 2021-05-04 | Rezolute | Results Rezolute Announces Positive RZ402 Study Results Demonstrating Potential for Once Daily Dosing of an Oral Plasma Kallikrein Inhibitor for Diabetic Macular Edema rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance, today announced positive topline results from its first-in-human Phase 1a clinical study of RZ402, the Company’s investigational oral plasma kallikrein inhibitor (PKI), for the treatment of diabetic macular edema (DME). |
| 2020-12-03 | Rezolute | Regulatory FDA Clears Rezolute’s IND Application for RZ402 rezolutebio.com ↗
Rezolute, Inc. (Nasdaq:RZLT), focused on advancing therapies for rare, metabolic and life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for RZ402, an orally available plasma kallikrein inhibitor, which is in development for the treatment of diabetic macular edema (DME). |
| 2020-06-15 | Rezolute | Results Rezolute Announces Publication of RZ402 Data in Diabetic Macular Edema (DME) in Investigative Ophthalmology & Visual Science rezolutebio.com ↗
We have found in relevant animal models that RZ402 demonstrates an excellent safety profile in both single- and repeat-dosing settings at a range of doses. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RZ402 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05712720 ↗ |
| Action | Inhibit | “potent and selective plasma kallikrein inhibitor (PKI)” NCT05712720 ↗ |
| Route | Oral | “RZ402 50 mg oral tablet, once daily for 3 months” NCT05712720 ↗ |