Investigation of the Pharmacokinetics, Safety and Tolerability of Runcaciguat in Participants With Hepatic Impairment (Classified as Child Pugh A or B) and in a Control Group of Age-, Weight-, and Gender-matched Participants Following a Single Oral 15 mg Modified Release (MR) Tablet Dose in a Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification

Researchers are looking for a better way to treat people with chronic kidney diseases. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the drug in the body.
In this study researchers will investigate how the liver function influences blood concentrations of runcaciguat in participants with different degrees of liver impairment compared to participants with normal liver function.
The participants will all take one tablet with 15 mg runcaciguat by mouth. Prior to inclusion into the study, all participants will have a screening examination within 21 to 2 days prior to dosing to check eligibility for study participation.
During the study, all of the participants will stay at the study site for up to 8 days (from Day -1 to Day 7), whereby Day 6 and 7 might also be performed in an ambulatory setting. Blood and urine samples will be collected. The physician will check the participants' heart health using an electrocardiogram (ECG) and by measuring blood pressure and heart rate. The participants will answer questions about their wellbeing and taken medications.
The participants will have a follow-up examination 7 to 11 days after dosing to follow-up their health.
Each participant will be in the study for approximately 5 weeks. The entire study will last about 9 months.

Start Date07 Apr 2021

Sponsor / Collaborator

Bayer AG

NCT04722991

/ CompletedPhase 2

A Phase 2 Randomized, Placebo-controlled, Double-masked Proof-of-concept Study to Investigate the Efficacy and Safety of Runcaciguat (BAY 1101042) in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography for central assessment of the diabetic retinopathy severity score, or DRSS. Two-step DRSS improvement at 24 weeks of treatment will be the primary efficacy endpoint. DRSS assessments are repeated after completion of 48 weeks of treatment. In addition, vision threatening complications will be recorded throughout the study and assessed as secondary efficacy endpoint.

Start Date17 Mar 2021

Sponsor / Collaborator

Bayer AG

CTR20202670

/ TerminatedPhase 1

在中国健康受试者中评估BAY 1101042单次和多次给药的药代动力学、安全性、耐受性和药效学的I期研究

[Translation] A Phase I study to evaluate the pharmacokinetics, safety, tolerability, and pharmacodynamics of single and multiple doses of BAY 1101042 in healthy Chinese subjects

在中国健康男性受试者中单次和多次给药后，评价BAY 1101042的药代动力学、安全性、耐受性和药效学

[Translation]

To evaluate the pharmacokinetics, safety, tolerability, and pharmacodynamics of BAY 1101042 in healthy Chinese male subjects after single and multiple doses

Start Date17 Mar 2021

Sponsor / Collaborator

Bayer AG

[+1]

100 Clinical Results associated with Runcaciguat

100 Translational Medicine associated with Runcaciguat

100 Patents (Medical) associated with Runcaciguat

Literatures (Medical) associated with Runcaciguat

01 Jul 2025·CURRENT PHARMACEUTICAL DESIGN

Potential New Treatments for Chronic Kidney Diseases: A Concise Review

Article

Author: Al-Horani, Rami A.

Chronic Kidney Disease (CKD) affects about 37 million Americans. Approximately 20% of patients with high blood pressure and 33% of patients with diabetes have kidney disease. CKD is most common among people aged 65 or older and is slightly more common in women. It substantially impacts certain ethnic groups more than others and is associated with a huge financial burden. End-Stage Kidney Disease (ESKD) is treated with dialysis or a kidney transplantation. CKD and ESKD are very detrimental and expensive illnesses, demanding creative therapeutic interventions to enable better management and enhanced clinical outcomes. Toward this goal, agents from various novel drug classes showed promising safety and efficacy in patients with varying severity of CKD in several phase 2 studies. This concise review will shed light on the clinical trials of runcaciguat, cotadutide, osocimab, and Endothelin Receptor Antagonists (ERAs) in patients with CKD and/or ESKD. These drugs were retrieved following surveying the Clinical Trial database as well as the Pubmed database, both maintained by the US National Library of Medicine.

01 Jun 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Discovery of the first isoform-specific sGC activator: Selective activation of GC-1 by runcaciguat

Article

Author: Rühle, Anne ; Sandner, Peter ; Behrends, Sönke ; Stomberg, Svenja ; Wittrien, Theresa

Drug research and development programmes targeting soluble guanylyl cyclase (sGC) have been highly successful, leading to the launch of the sGC stimulators riociguat for pulmonary hypertension (2013) and vericiguat for chronic heart failure (2021). As the main receptor for nitric oxide, sGC plays a vital role in various physiological processes. It consists of an alpha and a beta subunit, with two distinct isoforms identified in humans: GC-1 (α₁/β₁) and GC-2 (α₂/β₁). Growing evidence indicates that these isoforms engage in different downstream signalling pathways, indicating that isoform-specific approaches could lead to novel therapeutic opportunities and reduce potential side effects. In this study, we performed concentration-response measurements with the sGC activators BAY 60-2770, BI 703704 and runcaciguat (BAY 1101042) in cell systems expressing each isoform and in purified enzymes. We found that runcaciguat selectively activated GC-1, while acting as a competitive antagonist to other activators in GC-2, without interfering with nitric oxide. BAY 60-2770 and BI 703704 activated both isoforms, albeit with varying efficacy. Our findings challenge the historical view that the two sGC isoforms are functionally indistinguishable. In fact, we demonstrate that the isoforms can be activated independently, highlighting their distinct functional profiles. Notably, runcaciguat is the first sGC activator identified to selectively target GC-1 at therapeutic concentrations. This selective targeting of isoforms not only opens avenues for new therapeutic strategies but also provides an alternative to knockout animal models for investigating isoform-specific functions.

01 Feb 2025·BIOCHEMICAL PHARMACOLOGY

Runcaciguat activates soluble guanylyl cyclase via the histidine essential for heme binding and nitric oxide activation

Article

Author: Rühle, Anne ; Elgert, Christin ; Mathar, Ilka ; Behrends, Sönke ; Wittrien, Theresa ; Sandner, Peter

Soluble guanylyl cyclase (sGC) is a well-established pharmacological target for the treatment of acute angina pectoris, pulmonary hypertension and heart failure. Histidine 105 in the heme binding pocket of sGC is a crucial residue for heme binding and natural enzyme activation by NO. It was assumed that the heme-free sGC mutants α₁/β₁H105F and α₁/β₁H105A were valuable research tools for studying NO independent sGC activators. These mutants have been used in drug screening and animal models. We confirm that the first generation of sGC activators cinaciguat and BAY 60-2770 activate the α₁/β₁H105F and α₁/β₁H105A mutants. In contrast, we show that the second generation sGC activators runcaciguat and BAY 543 only activate heme-free sGC when the β₁H105 residue is present. By testing runcaciguat in β₁ H105F knock-in mice, we confirm this histidine-dependency in vivo. We propose a novel classification of sGC activators, distinguishing between the histidine-dependent activators runcaciguat and BAY 543 and the histidine-independent activators cinaciguat, BAY 60-2770 and BI703704. The histidine-dependency of some of the sGC activators provides a compelling rationale for a re-evaluation of previous research and drug development programs based on sGC histidine mutants. Whether the classification of sGC activators based on the activation mechanism also makes a therapeutic difference needs to be clarified in the future.

News (Medical) associated with Runcaciguat

08 Aug 2023

·www.fiercebiotech.com

Bayer ends respiratory distress drug development in latest phase 2 cleanout

It was not until May that Bayer decided “not to pursue further development activities” for adrenomedullin pegol. Bayer has dropped an acute respiratory distress syndrome drug in phase 2 development for “scientific reasons,” the German pharma giant revealed in its latest earnings results. The company “decided not to pursue further development activities” for the drug, called adrenomedullin pegol, in May, Bayer said in this morning’s second-quarter earnings release (PDF). Adrenomedullin is a human hormone that is involved in vasodilation, among other activities. A phase 2 trial of the inhaled formulation wrapped up at the end of last year, according to ClinicalTrials.gov. While Bayer only alluded to “scientific reasons” as the cause of its decision, a note attached to the trials register said the study was terminated due to the results of part A of the trial and “not due to any safety data.” It was not until May that the company decided “not to pursue further development activities” for adrenomedullin pegol, Bayer added. Picking out some other notable pipeline developments over the first half of the year, Bayer used the same document to reaffirm two previously disclosed phase 2 pipeline culls. The company explained that a decision was made in April to halt work on runcaciguat, a soluble guanylate cyclase (sGC) activator that was being developed for chronic kidney disease (CKD). Bayer didn’t give a reason for the decision, but did point out that it hasn’t given up on its sGC program entirely. The company is still pushing ahead with another sGC activator called BAY3283142. The oral therapy, which is currently in a phase 1 trial for CKD, is considered by Bayer to be a “follow-up” therapy to runcaciguat, with the added benefit of an “improved pharmacokinetic/pharmacodynamic profile.” Finally, the company explained that a BDKRB1 receptor antagonist was benched because of the results of a phase 2a trial in neuropathic pain.

Phase 2Phase 3Clinical Trial FailurePhase 1

29 May 2023

·www.prnewswire.com

Diabetic Retinopathy Clinical Trial Pipeline Space Brims With Novel Emerging Therapies with Over 50 Key Companies Working in the Domain | DelveInsight

The prevalence of diabetic retinopathy has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of diabetic retinopathy and the growing research and development activities to develop novel therapies to treat diabetic retinopathy to drive the market. The companies developing the potential therapies in the last stage of development include Roche, Kodiak Sciences, Novartis, and several others. LAS VEGAS, May 29, 2023 /PRNewswire/ -- DelveInsight's ' Diabetic Retinopathy Pipeline Insight – 2023 ' report provides comprehensive global coverage of pipeline diabetic retinopathy therapies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space and future growth potential of the diabetic retinopathy pipeline domain. Key Takeaways from the Diabetic Retinopathy Pipeline Report DelveInsight's diabetic retinopathy pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for diabetic retinopathy treatment. Key diabetic retinopathy companies such as Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, Palatin Technologies, Valo Health, EyePoint Pharmaceuticals, Kubota Vision, MingSight Pharmaceuticals, Oxurion, Aerie Pharmaceuticals, AsclepiX Therapeutics, Ocugen, Ashvattha Therapeutics, Stealth BioTherapeutics, and others are evaluating new diabetic retinopathy drugs to improve the treatment landscape. Promising diabetic retinopathy pipeline therapies in various stages of development include KSI-301, Brolucizumab, RGX 314, OTT-166, OTX-TKI, Runcaciguat, RC 28 E, RG7774, APX3330, ADVM-022, Faricimab, BI 764524, PL8331, OPL-0401, EYP-1901, emixustat hydrochloride, MS-553, THR-149, AR-13503, AXT107, OCU200, D 4517.2, Elamipretide, and others. In May 2023, Oculic Holding AG announced positive top-line results from Stage 1 of its Phase III DIAMOND trial of OCS-01 eye drops in diabetic macular edema (DME). According to the company, the DIAMOND trial in diabetic macular edema with topical OCS-01 met its stage 1 objective of validating the loading and maintenance dosing regimen designed to optimize OCS-01 efficacy potential with robust statistical significance. In April 2023, Palatin Technologies announced The International Journal of Molecular Sciences published a manuscript, "Stimulating the Melanocortin System in Uveitis and Diabetes Preserves the Structure and Anti-Inflammatory Activity of the Retina" by Tat Fong Ng and Andrew W. Taylor from Department of Ophthalmology, Boston University Chobanian and Avedisian School of Medicine, in Boston, Massachusetts. The manuscript summarizes data demonstrating the effects of PL8331 in two mouse models of retinal disease, experimental autoimmune uveoretinitis (EAU) and diabetic retinopathy (DR). Palatin and the National Institute of Health (NIH) and the Massachusetts Lions Eye Research Foundation provided funding for the study. In February 2023, Ocugen announced that it had submitted an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of OCU200, a fusion protein with a distinct mechanism of action (MOA), for the treatment of diabetic macular edema (DME). This regulatory milestone fulfills the Company's commitment to file the IND for OCU200 within the first quarter of 2023. In January 2023, Ocuphire Pharma announced topline efficacy and safety results from its ZETA-1 Phase II trial evaluating oral APX3330 for the treatment of diabetic retinopathy (DR). Oral APX3330 demonstrated favorable safety and tolerability allowing for a potential attractive non-invasive option for protection of vision in both eyes in DR patients. In May 2022, EyePoint Pharmaceuticals announced the EYP-1901 license to Betta Pharmaceuticals, to develop and commercialize EYP-1901 in China, Hong Kong, Macau, and Taiwan. EyePoint retains all rights for EYP-1901 in the rest of the world and expands its exclusive rights to local delivery of vorolanib for the treatment of all ophthalmic diseases, including diabetic macular edema (DME). Request a sample and discover the recent advances in diabetic retinopathy drug treatment @ Diabetic Retinopathy Pipeline Report The diabetic retinopathy pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage diabetic retinopathy drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the diabetic retinopathy clinical trial landscape. Diabetic Retinopathy Overview Diabetic retinopathy is a microvascular condition caused by diabetes mellitus's long-term effects. Diabetic retinopathy can cause vision-threatening retinal damage, eventually leading to blindness. It is found in one-third of patients with diabetes and is linked to an increased risk of life-threatening systemic vascular consequences such as stroke, coronary heart disease, and heart failure. Diabetic retinopathy affects an estimated 40% (8% for vision-threatening retinopathy) of people with type 2 diabetes and 86% (42%) of people with type 1 diabetes in the United States. The keys to avoiding diabetic retinopathy blindness are early detection and appropriate intervention. Several large studies have found that the onset of diabetic retinopathy does not usually occur within the first 5 years of type 1 diabetes diagnosis. In contrast, the onset of type 2 diabetes is frequently more subtle, and as a result, retinal damage may be evident at the time of diagnosis. As a result, screening for diabetic retinopathy is advised in type 2 diabetics at the time of diagnosis. Find out more about drugs for diabetic retinopathy @ New Diabetic Retinopathy Drugs A snapshot of the Diabetic Retinopathy Pipeline Drugs mentioned in the report: Learn more about the emerging diabetic retinopathy pipeline therapies @ Diabetic Retinopathy Clinical Trials Diabetic Retinopathy Therapeutics Assessment The diabetic retinopathy pipeline report proffers an integral view of diabetic retinopathy emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Diabetic Retinopathy Pipeline Report Coverage: Global Diabetic Retinopathy Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Diabetic Retinopathy Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Diabetic Retinopathy Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Diabetic Retinopathy Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Diabetic Retinopathy Therapeutics Assessment By Mechanism of Action: Vascular endothelial growth factors inhibitors, Angiogenesis inhibitors, Vascular endothelial growth factor A inhibitors, Gene transference, Integrin alphaVbeta3 antagonists, Integrin alphaVbeta6 inhibitors, Integrin alphavbeta8 inhibitors, Platelet-derived growth factor beta receptor antagonists, Protein tyrosine kinase inhibitors, Proto oncogene protein c-kit inhibitors, Vascular endothelial growth factor receptor 3 antagonists, Vascular endothelial growth factor receptor-1 antagonists, Vascular endothelial growth factor receptor-2 antagonists, Guanylate cyclase stimulants, APEX1 protein inhibitors, DNA apurinic apyrimidinic site lyase inhibitors Key Diabetic Retinopathy Companies: Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, Palatin Technologies, Valo Health, EyePoint Pharmaceuticals, Kubota Vision, MingSight Pharmaceuticals, Oxurion, Aerie Pharmaceuticals, AsclepiX Therapeutics, Ocugen, Ashvattha Therapeutics, Stealth BioTherapeutics, and others. Key Diabetic Retinopathy Pipeline Therapies: KSI-301, Brolucizumab, RGX 314, OTT-166, OTX-TKI, Runcaciguat, RC 28 E, RG7774, APX3330, ADVM-022, Faricimab, BI 764524, PL8331, OPL-0401, EYP-1901, emixustat hydrochloride, MS-553, THR-149, AR-13503, AXT107, OCU200, D 4517.2, Elamipretide, and others. Dive deep into rich insights for new drugs for diabetic retinopathy treatment; visit @ Diabetic Retinopathy Medications Table of Contents For further information on the diabetic retinopathy pipeline therapeutics, reach out @ Diabetic Retinopathy Drug Treatment Related Reports Diabetic Retinopathy Market Diabetic Retinopathy Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic retinopathy companies, including Genentech, Inc., Regeneron Pharmaceuticals, Roche, Opthea Limited, Regenxbio, Kodiak Sciences Inc, Ocuphire Pharma, Eisai Co Ltd, Apexian Pharmaceuticals, Oculis, among others. Diabetic Retinopathy Epidemiology Forecast Diabetic Retinopathy Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and diabetic retinopathy epidemiology trends. Proliferative Diabetic Retinopathy Pipeline Proliferative Diabetic Retinopathy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key proliferative diabetic retinopathy companies, including Kubota Vision, among others. Diabetic Neuropathy Pipeline Diabetic Neuropathy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic neuropathy companies, including Goldfinch Bio, Novartis, Serodus, CURACLE, Daiichi Sankyo, NeuroBo Pharmaceuticals, Dong-A Pharmaceutical, among others. Diabetic Neuropathy Market Diabetic Neuropathy Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic neuropathy companies, including Goldfinch Bio, Novartis, Serodus, CURACLE, Daiichi Sankyo, NeuroBo Pharmaceuticals, Dong-A Pharmaceutical, among others. Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Clinical ResultPhase 1Phase 3

15 May 2023

·endpts.com

Bayer cuts four programs amid a 'slow start' to the year

Bayer announced a handful of pipeline cuts in its quarterly earnings report last week, as CEO Werner Baumann revealed the quarter “came in soft” compared to last year’s performance. The culls include two Phase II programs, a BDKRB1 receptor antagonist for neuropathic pain, and runcaciguat, in development for chronic kidney disease. The BDKRB1 receptor plays a role in pain perception, and Bayer’s candidate, BAY 2395840, came out of a research alliance with Evotec. The company also said it’s discontinuing a Phase I program studying BAY 2395840 in endometriosis. Unlock this story instantly and join 168,600+ biopharma pros reading Endpoints daily — and it's free.

Phase 2Phase 1Financial Statement

100 Deals associated with Runcaciguat

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonproliferative diabetic retinopathy	Phase 2	United States	Bayer AG	17 Mar 2021
Nonproliferative diabetic retinopathy	Phase 2	Bulgaria	Bayer AG	17 Mar 2021
Nonproliferative diabetic retinopathy	Phase 2	Czechia	Bayer AG	17 Mar 2021
Nonproliferative diabetic retinopathy	Phase 2	Denmark	Bayer AG	17 Mar 2021
Nonproliferative diabetic retinopathy	Phase 2	Germany	Bayer AG	17 Mar 2021
Nonproliferative diabetic retinopathy	Phase 2	Latvia	Bayer AG	17 Mar 2021
Nonproliferative diabetic retinopathy	Phase 2	Netherlands	Bayer AG	17 Mar 2021
Nonproliferative diabetic retinopathy	Phase 2	Poland	Bayer AG	17 Mar 2021
Nonproliferative diabetic retinopathy	Phase 2	Portugal	Bayer AG	17 Mar 2021
Nonproliferative diabetic retinopathy	Phase 2	Romania	Bayer AG	17 Mar 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04722991 (NEON-NPDR, CTgov)	Phase 2	Nonproliferative diabetic retinopathy	109	Placebo (Placebo)	ovsupeushx = myelstymtb ovmvpullfy (tfyeqzmjao, owixyeukdg - vffmzgqdya) View more	-	08 Apr 2025
				Runcaciguat (BAY1101042) (Runcaciguat (BAY1101042))	pbfgipcrhh(vhzramwdiy) = drdmzojfen vcfprdfbva (tzjxcddcav, eftbpskbqf - hijeofdnja) View more
NCT04507061 (Pubmed \| Int J Mol Sci)	Phase 2	-	-	Runcaciguat 1 mg/kg/bid	alxsoykulf(hxndrbjmyk) = xnunysrhxr lyyuklxawi (vrrjhjqkrw ) View more	-	25 Aug 2023
				Runcaciguat 3 mg/kg/bid	alxsoykulf(hxndrbjmyk) = lvjlomvmuz lyyuklxawi (vrrjhjqkrw ) View more
ARVO2021	Not Applicable	Retinal Diseases	-	Runcaciguat	rhtmiptzmk(smzebpbxop) = hxdvyfpcsg sotuzfrlmq (pqugbeurgb ) View more	-	01 Jun 2021
				Vehicle	rhtmiptzmk(smzebpbxop) = qtehpcckfx sotuzfrlmq (pqugbeurgb ) View more
ARVO2021	Not Applicable	Retinal Vascular Disorder	-	Runcaciguat	xoamftauua(nvecucbsyo) = a trend of increased cpRNFL thickness was detected in rat STZ model anuepgqaui (xfyymjpilk ) View more	-	01 Jun 2021

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