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.

开始日期2021-04-07

申办/合作机构

Bayer AG

NCT04722991 / Active, not recruiting临床2期

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.

开始日期2021-03-17

申办/合作机构

Bayer AG

CTR20202670 / Terminated临床1期

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

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

开始日期2021-03-17

申办/合作机构

拜耳医药保健有限公司

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100 项与 Runcaciguat 相关的转化医学

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100 项与 Runcaciguat 相关的专利（医药）

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项与 Runcaciguat 相关的文献（医药）

2023-08-25·International journal of molecular sciences

The sGC Activator Runcaciguat Has Kidney Protective Effects and Prevents a Decline of Kidney Function in ZSF1 Rats.

Article

作者: Hartmann, Elke ; Kraehling, Jan R ; Benardeau, Agnes ; Schomber, Tibor ; Vienenkoetter, Julia ; Hagelschuer, Ina ; Siudak, Krystyna ; Mathar, Ilka ; Ellinger-Ziegelbauer, Heidrun ; Sandner, Peter ; Pavkovic, Mira ; Eitner, Frank ; Popp, Laura ; Hahn, Michael G ; Hueser, Joerg ; Freyberger, Alexius ; Geiss, Volker

Chronic kidney disease (CKD) progression is associated with persisting oxidative stress, which impairs the NO-sGC-cGMP signaling cascade through the formation of oxidized and heme-free apo-sGC that cannot be activated by NO. Runcaciguat (BAY 1101042) is a novel, potent, and selective sGC activator that binds and activates oxidized and heme-free sGC and thereby restores NO-sGC-cGMP signaling under oxidative stress. Therefore, runcaciguat might represent a very effective treatment option for CKD/DKD. The potential kidney-protective effects of runcaciguat were investigated in ZSF1 rats as a model of CKD/DKD, characterized by hypertension, hyperglycemia, obesity, and insulin resistance. ZSF1 rats were treated daily orally for up to 12 weeks with runcaciguat (1, 3, 10 mg/kg/bid) or placebo. The study endpoints were proteinuria, kidney histopathology, plasma, urinary biomarkers of kidney damage, and gene expression profiling to gain information about relevant pathways affected by runcaciguat. Furthermore, oxidative stress was compared in the ZSF1 rat kidney with kidney samples from DKD patients. Within the duration of the 12-week treatment study, kidney function was significantly decreased in obese ZSF1 rats, indicated by a 20-fold increase in proteinuria, compared to lean ZSF1 rats. Runcaciguat dose-dependently and significantly attenuated the development of proteinuria in ZSF1 rats with reduced uPCR at the end of the study by -19%, -54%, and -70% at 1, 3, and 10 mg/kg/bid, respectively, compared to placebo treatment. Additionally, average blood glucose levels measured as HbA1C, triglycerides, and cholesterol were increased by five times, twenty times, and four times, respectively, in obese ZSF1 compared to lean rats. In obese ZSF1 rats, runcaciguat reduced HbA1c levels by -8%, -34%, and -76%, triglycerides by -42%, -55%, and -71%, and cholesterol by -16%, -17%, and -34%, at 1, 3, and 10 mg/kg/bid, respectively, compared to placebo. Concomitantly, runcaciguat also reduced kidney weights, morphological kidney damage, and urinary and plasma biomarkers of kidney damage. Beneficial effects were accompanied by changes in gene expression that indicate reduced fibrosis and inflammation and suggest improved endothelial stabilization. In summary, the sGC activator runcaciguat significantly prevented a decline in kidney function in a DKD rat model that mimics common comorbidities and conditions of oxidative stress of CKD patients. Thus, runcaciguat represents a promising treatment option for CKD patients, which is in line with recent phase 2 clinical study data, where runcaciguat showed promising efficacy in CKD patients (NCT04507061).

2023-01-01·Nephron

Responses in Blood Pressure and Kidney Function to Soluble Guanylyl Cyclase Stimulation or Activation in Normal and Diabetic Rats

Article

作者: Patel, Rohit ; Thomson, Scott C ; Fu, Yiling ; Benardeau, Agnes M ; Vallon, Volker ; Khang, Ser

Introduction: Agonists of soluble guanylate cyclase (sGC) are being developed as treatment for cardiovascular disease. Most effects of nitric oxide (NO) on glomerular and tubular function are mediated through sGC, but whether sGC agonists mimic these effects is unknown. Methods: Renal clearance and micropuncture studies were performed in Wistar-Froemter rats (WF), with or without streptozotocin diabetes (STZ-WF), and in Goto-Kakizaki rats (GK) with mild type 2 diabetes to test for acute effects of the sGC “stimulator” BAY 41-2272, which synergizes with endogenous NO, and the “activator” runcaciguat, which generates cGMP independent of NO. Results: Both sGC agonists reduced arterial blood pressure (MAP). For MAP reductions <10%, the drugs increased GFR in WF and STZ-WF but not in GK. Larger MAP reductions outweighed this effect and GFR declined, with better preserved GFR in STZ-WF. Changes in GFR could not be accounted for by changes in RBF, suggesting parallel changes in ultrafiltration pressure and/or ultrafiltration coefficient. The doses chosen for micropuncture in WF and GK reduced MAP by 2–10%, and the net effect on single nephron GFR and ultrafiltration pressure was neutral. The effects of the drugs on tubular reabsorption were dominated by declining MAP, and no natriuretic effect was observed at any dose. Discussion/Conclusion: sGC agonists impact kidney function directly and because they reduce MAP. The direct tendency to increase GFR is most apparent for MAP reductions <10%. The direct effect is otherwise subtle and overridden when MAP declines more. Effects of sGC agonists on tubular reabsorption are dominated by the effects on MAP.

2022-06-01·British Journal of Pharmacology

Novel soluble guanylyl cyclase activators increase glomerular cGMP, induce vasodilation and improve blood flow in the murine kidney

Article

作者: Hahn, Michael G. ; Sandner, Peter ; Bénardeau, Agnès ; Eitner, Frank ; Xu, Min Ze ; Schweda, Frank ; Kraehling, Jan R. ; Stehle, Daniel ; Feil, Robert ; Feil, Susanne ; Schomber, Tibor ; Patzak, Andreas

Background and PurposeGeneration of cGMP via NO‐sensitive soluble guanylyl cyclase (sGC) has been implicated in the regulation of renal functions. Chronic kidney disease (CKD) is associated with decreased NO bioavailability, increased oxidative stress and oxidation of sGC to its haem‐free form, apo‐sGC. Apo‐sGC cannot be activated by NO, resulting in impaired cGMP signalling that is associated with chronic kidney disease progression. We hypothesised that sGC activators, which activate apo‐sGC independently of NO, increase renal cGMP production under conditions of oxidative stress, thereby improving renal blood flow (RBF) and kidney function.Experimental ApproachTwo novel sGC activators, runcaciguat and BAY‐543, were tested on murine kidney. We measured cGMP levels in real time in kidney slices of cGMP sensor mice, vasodilation of pre‐constricted glomerular arterioles and RBF in isolated perfused kidneys. Experiments were performed at baseline conditions, under L‐NAME‐induced NO deficiency, and in the presence of oxidative stress induced by ODQ.Key ResultsMouse glomeruli showed NO‐induced cGMP increases. Under baseline conditions, sGC activator did not alter glomerular cGMP concentration or NO‐induced cGMP generation. In the presence of ODQ, NO‐induced glomerular cGMP signals were markedly reduced, whereas sGC activator induced strong cGMP increases. L‐NAME and ODQ pretreated isolated glomerular arterioles were strongly dilated by sGC activator. sGC activator also increased cGMP and RBF in ODQ‐perfused kidneys.Conclusion and ImplicationsGC activators increase glomerular cGMP, dilate glomerular arterioles and improve RBF under disease‐relevant oxidative stress conditions. Therefore, sGC activators represent a promising class of drugs for chronic kidney disease treatment.LINKED ARTICLESThis article is part of a themed issue on cGMP Signalling in Cell Growth and Survival. To view the other articles in this section visithttp://onlinelibrary.wiley.com/doi/10.1111/bph.v179.11/issuetoc

项与 Runcaciguat 相关的新闻（医药）

2023-08-08

·FierceBiotech

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.

临床2期临床3期临床失败临床1期

2023-05-29

·PRNewswire

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

临床结果临床1期临床3期

2023-05-21

·药时代

一季度，15家跨国药企终止超40条管线，都有啥特点？

编者按：2023 Q1，多家药企接连终止在研管线，例如，GSK结束对细胞基因疗法领域的投入、诺华削减10%非核心管线、武田放弃AAV基因疗法和罕见血液学领域……当然，也有例外，例如诺和诺德。在糖尿病与肥胖领域，其司美格鲁肽很有可能成为今年“药王”的有力竞争者。关于诺和诺德的研发之道，药时代有幸采访到了诺和诺德全球药物发现负责人，相信对致力于研发FIC药物的企业们会有帮助。百年药企诺和诺德如何「以慢制快」？对话诺和诺德全球药物发现高级副总裁 Karin Conde-Knape博士药时代对强生、礼来、艾伯维、罗氏、阿斯利康、辉瑞、BMS、赛诺菲、安进、再生元、拜耳、第一三共、渤健、GSK的四十多条终止管线进行了汇总梳理，在此与大家分享。小分子药物被砍掉最多小分子药物是被砍掉最多的类型，有20条管线。辉瑞一共终止了6条管线，其中5条为小分子药物，分别是：用于急性心力衰竭的APD418、用于血管阻塞的Temanogre、用于治疗雷诺氏综合征的Temanogrel、用于掌跖脓疱病和化脓性汗腺炎两种适应症的RIST4721。（图源：辉瑞官网）拜耳的4项终止均为小分子药物，分别为：用于糖尿病神经性疼痛的BDKRB1 受体拮抗剂、用于慢性肾病的Runcaciguat、用于子宫内膜异位症的BAY 2395840和P2X4拮抗剂。礼来终止TRPA1 拮抗剂在镇痛领域的研究；艾伯维终止ABBV-154在囊性纤维化上的研究；阿斯利康终止ALXN1840在威尔逊病领域的研究；BMS终止iberdomide在淋巴瘤上的研究；赛诺菲终止Tolebrutinib和atuzabrutinib在自身免疫病相关研究；渤健终止BIIB093在脑挫伤和大脑半球梗塞领域的研究，及BIIB131在急性缺血性中风上的研究；GSK停止了Zejula在乳腺癌领域的研究。（图源：Lilly官网）（图源：百时美施贵宝官网）单抗类药物次于小分子药物，被砍掉逾10条管线。罗氏一共终止了3条单抗类药物管线，均为Tecentrig组合药物，分别为：用于一线转移性尿路上皮癌的Tecentrig+chemo、用于二线非小细胞肺癌的Tecentriq+Cabometyx、用于二线her2阳性、PD-L1阳性转移性乳腺癌的Tecentriq +Kadcyla。赛诺菲和再生元均分别终止了Dupixent的一条管线，分别为过敏性真菌性鼻炎和无鼻息肉慢性鼻窦炎、慢性寒冷引起的荨麻疹。阿斯利康终止了用于实体瘤的AZD8853和用于一线转移性非小细胞肺癌的Imfinzi。礼来终止用于阿尔兹海默症的solanezumab；辉瑞终止用于溃疡性结肠炎的PF-06480605；BMS终止用于黑色素瘤的nivolumab +rHuPH20；第一三共终止用于进行性骨化性纤维发育不良的DS-6016。疫苗终止了两条管线，均为强生的药物，分别是成人RSV疫苗和HIV疫苗。反义寡核苷酸类药物共有两个，分别是第一三共用于杜氏进行性肌营养不良的DS-5141和渤健用于脊髓小脑性共济失调3型的BIIB132。融合蛋白类有两个，分别为礼来和安进用于系统性红斑狼疮的Rezpegaldesleukin和efavaleukin alfa。剩下的为阿斯利康用于NASH领域的合成多肽类药物cotadutide、罗氏用于骨髓纤维化的重组蛋白类药物zinpentraxin alfa、安进用于系统性红斑狼疮的双特异性抗体药物Rozibafusp alfa。免疫和肿瘤领域依然占大头被砍掉的自免型疾病管线占大头，有11条。其次是肿瘤类管线，有8条。再就是罕见病领域，有4条管线被终止。渤健终止的几条管线均为脑血管疾病领域。II期项目“夭折”最多根据统计，除去部分临床阶段不明的管线，在II期被终止的管线有19条：在III期被终止的管线有11条：在I期被终止的管线有6条：II期试验也称为疗效试验或临床效能试验。主要目的是评估新药在特定疾病人群中的治疗效果和安全性。如果在这个阶段没有足够的证据表明新药对疾病有明显的疗效，或者新药的效果与已有治疗方案相比没有显著优势，试验可能会被终止。同时，临床II期试验是在相对较大规模的患者群体中进行的，这时候药物的潜在安全性问题更容易被发现。如果药物出现了严重的安全问题，试验可能会被终止以保护患者安全。而III期实验的终止，可能是因为前两期的实验过程出现了问题，而导致潜在安全问题没有被发现。且即使是到了申报上市的阶段，也有可能管线被终止，而无法上市。只过了2个月，就从「即将获批」变成了「管线终止」......这款药，是从一开始就做错了吗？封面图来源：123rf2023年1月1日至今，~20笔中国新药出海交易横空出世，总金额高达上百亿美元！一时间，喜讯频传，令行业、企业和每一位同药振奋！曾经提出“百靶竞技，百炼创新，百家上市，百药争先”的药时代团队再一次真切感受到：中国新药研发正当时！中国新药出海正当时！中国新药BD正当时！在这个BD如火如的好时代里，企业对于BD的要求不断提高，如何与时俱进，学习最新BD知识，掌握最新BD技能，成为摆在每一位BD同药面前的一个实际而迫切的问题。为了帮助企业培养优秀的BD高级人才，为了帮助BD人才成长进步，药时代学苑全力打造创新药BD高级研讨会，致力于成为中国制药界ZUI有实力和活力的学习平台。点击这里，报名参加，一起快乐学习！

基因疗法细胞疗法

100 项与 Runcaciguat 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
心脏病	临床3期	斯洛伐克	Bayer AG	2020-09-01
心脏病	临床2期	德国	Bayer AG	2020-09-01
心脏病	临床2期	以色列	Bayer AG	2020-09-01
心脏病	临床2期	西班牙	Bayer AG	2020-09-01
心脏病	临床2期	芬兰	Bayer AG	2020-09-01
心脏病	临床2期	意大利	Bayer AG	2020-09-01
心脏病	临床2期	瑞典	Bayer AG	2020-09-01
心脏病	临床1期	保加利亚	Bayer AG	2020-09-01
心脏病	药物发现	丹麦	Bayer AG	2020-09-01
心脏病	药物发现	波兰	Bayer AG	2020-09-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ARVO2021	N/A	视网膜血管疾病	-	Runcaciguat	(願淵構糧選觸範襯鹽積) = a trend of increased cpRNFL thickness was detected in rat STZ model 築獵醖壓壓遞廠鹹餘顧 (醖窪糧範遞網顧廠糧壓 ) 更多	-	2021-06-01
ARVO2021	N/A	视网膜疾患	-	Runcaciguat	憲製簾觸願積夢壓簾蓋(範繭觸襯蓋壓製壓鹹築) = 繭艱築積餘廠遞遞齋鑰網鹽齋鑰顧鹹鬱襯鹹醖 (壓壓夢夢淵積築鑰獵範 ) 更多	-	2021-06-01
ARVO2021	N/A	视网膜疾患	-	Vehicle	憲製簾觸願積夢壓簾蓋(範繭觸襯蓋壓製壓鹹築) = 淵觸築遞構餘鏇構鏇獵網鹽齋鑰顧鹹鬱襯鹹醖 (壓壓夢夢淵積築鑰獵範 ) 更多	-	2021-06-01