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Runcaciguat

Phase 2

Diabetic Retinopathy | Small molecule | Ophthalmology |Bayer AG|Last Updated: Apr 8, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment109

FDA Designations

No designations recorded

Clinical trial landscape

Runcaciguat · 2 trials · 2 indications

Phase 2 2
NCT04722991Non-proliferative Diabetic Retinopathy Treated With RuncaciguatDiabetic Retinopathy
COMPLETED109 Analytics
NCT04507061Study on the Safety of the Drug Runcaciguat and How Well it Works When Given at the Highest Dose as Tolerated by Individual Patient Whose Kidneys Are Not Working Properly and Suffering at the Same Time From High Blood Sugar and/or High Blood Pressure and a Disease of the Heart and the Blood Vessels.Chronic Kidney Disease
COMPLETED243 Analytics
PHASE2COMPLETED
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
Diabetic Retinopathy
NCT04722991109
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PHASE2COMPLETED
Study on the Safety of the Drug Runcaciguat and How Well it Works When Given at the Highest Dose as Tolerated by Individual Patient Whose Kidneys Are Not Working Properly and Suffering at the Same Time From High Blood Sugar and/or High Blood Pressure and a Disease of the Heart and the Blood Vessels.
Chronic Kidney Disease
NCT04507061243
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Study Endpoints

Primary Endpoints

Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye
At 48 weeks of treatment

DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.

Mean change in urinary albumin-to-creatinine ratio (UACR) from baseline to the average of multiple time points during treatment
From baseline up to day 57 (± 3)

Secondary Endpoints

Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye
At 48 weeks
Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye
At 24 weeks of treatment
Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale
At 48 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Runcaciguat (BAY1101042)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
runcaciguatEXPERIMENTALParticipant 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.

Interventions

NameTypeDescription
Runcaciguat (BAY1101042)DRUGOral dose of runcaciguat
PlaceboOTHEROral dose of matching placebo
runcaciguatDRUGTitrated dose of active dose 1, dose 2, dose 3, dose 4 of runcaciguat will be administered orally once a day.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites55

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...

Countries:United StatesBulgariaCzechiaDenmarkGermanyLatviaNetherlandsPolandPortugalRomaniaSlovakiaSpainSwitzerlandUnited KingdomAustriaBelgiumFinlandIsraelItalySwedenUkraine
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Competitive Landscape -Diabetic Retinopathy 7 trials

CompanyTickerTrialsLead PhaseDrugs
Ocular Therapeutix IncOCUL1PHASE3Single intravitreal of axitinib hydrogel followed by a mock procedure at Week 24, Intravitreal of axitinib hydrogel followed by a second intravitreal of the axitinib at Week 24
AbbVie, Inc.ABBV3PHASE2ABBV-RGX-314 Dose 1, Steroid, Aflibercept
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-150 IVT, Aflibercept IVT
Rhythm Pharmaceuticals, Inc.RYTM1 - Undisclosed
Adverum Biotechnologies, Inc.ADVM1 - ADVM-022
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Frequently asked questions about Runcaciguat

What is Runcaciguat used for?

Runcaciguat is an investigational small molecule being studied for diabetic retinopathy and chronic kidney disease. It is in Phase 2 clinical development and is not approved by the FDA. The drug is being developed by Bayer AG.

What does Runcaciguat target?

Runcaciguat is a soluble guanylate cyclase (sGC) stimulator, a class of drugs that enhance the nitric oxide signaling pathway. This mechanism is being investigated for potential benefits in conditions like diabetic retinopathy and chronic kidney disease.

Who makes Runcaciguat?

Runcaciguat is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY.

What phase is Runcaciguat in?

Runcaciguat is in Phase 2 clinical development. It has completed two Phase 2 trials, one in chronic kidney disease and one in diabetic retinopathy. The drug is still investigational and has not received FDA approval.

What clinical trials is Runcaciguat in?

Runcaciguat has completed two Phase 2 trials. NCT04507061 studied the drug in 243 patients with chronic kidney disease across Europe. NCT04722991 studied the drug in 109 patients with non-proliferative diabetic retinopathy in the US and Europe.

Is Runcaciguat the same as BAY 1101042?

Runcaciguat is also known by the development code BAY 1101042. Both names refer to the same investigational drug being developed by Bayer AG for diabetic retinopathy and chronic kidney disease.