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Also known as Runcaciguat (BAY1101042)
runcaciguat · 2 trials · 2 indications
DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
| Arm | Type | Description |
|---|---|---|
| Runcaciguat (BAY1101042) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| runcaciguat | EXPERIMENTAL | Participant randomized to this arm will be up-titrated. A 30-day safety follow up will be performed after end of treatment or after early discontinuation from the study. |
| Name | Type | Description |
|---|---|---|
| Runcaciguat (BAY1101042) | DRUG | Oral dose of runcaciguat |
| Placebo | OTHER | Oral dose of matching placebo |
| runcaciguat | DRUG | Titrated dose of active dose 1, dose 2, dose 3, dose 4 of runcaciguat will be administered orally once a day. |
Main Inclusion Criteria: * Moderately severe to severe NPDR in the study eye: Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53 * Diabetes type 1 or 2 * Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (appr...
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Runcaciguat is an investigational small molecule developed by Bayer AG under the code BAY1101042. It is being studied in Phase 2 clinical trials for chronic kidney disease and diabetic retinopathy. It is a soluble guanylate cyclase activator and has not been approved for any indication.
Runcaciguat is being evaluated for chronic kidney disease and non-proliferative diabetic retinopathy. Both are Phase 2 investigational uses, and no regulatory approval has been granted. One completed trial enrolled patients with chronic kidney disease plus high blood sugar, high blood pressure, or cardiovascular disease, and another studied non-proliferative diabetic retinopathy.
Runcaciguat targets the soluble guanylate cyclase subunits GUCY1B1, GUCY1A2, and GUCY1A1. It acts as an activator of these subunits, a mechanism intended to stimulate cyclic GMP signaling. This target class distinguishes it from soluble guanylate cyclase stimulators.
Runcaciguat is developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer is the sponsor of the clinical program studying the drug in chronic kidney disease and diabetic retinopathy.
Runcaciguat is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulator. The program includes completed Phase 2 trials, and no active trials are currently listed.
Runcaciguat has been studied in two completed Phase 2 trials. NCT04507061 evaluated the drug in chronic kidney disease with 243 patients, and NCT04722991 studied non-proliferative diabetic retinopathy with 109 patients across 14 countries. Both were randomized, double-blind, and placebo-controlled.
Yes, runcaciguat is also known as BAY1101042. BAY1101042 is Bayer's internal development code for the same small molecule, so searches for either name refer to the identical investigational compound being studied in chronic kidney disease and diabetic retinopathy.