Discontinuation Versus Continuation of Riociguat Monotherapy in Chronic Thromboembolic Pulmonary Hypertension Successfully Treated With Balloon Pulmonary Angioplasty

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but severe complication of acute pulmonary embolism, characterized by persistent obstruction of the pulmonary arteries by organized thrombi and secondary microvasculopathy. International guidelines recommend a multimodal approach combining pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA), and medical treatment with riociguat, to address the full spectrum of CTEPH lesions. BPA and riociguat are recommended for symptomatic patients with inoperable CTEPH or persistent pulmonary hypertension after PEA. Riociguat is administered before BPA to reduce periprocedural complications by improving pulmonary hemodynamics. While this pre-BPA strategy is well established, post-BPA management is poorly studied, especially in patients achieving therapeutic goals, defined as WHO functional class I or II and near-normal resting pulmonary hemodynamics (70 to 80% of cases). In such cases, riociguat monotherapy is often continued long-term, despite its cost, burden, and potential side effects, which may negatively impact patients' quality of life. Retrospective single-center studies suggest that discontinuation of medical treatment does not lead to significant clinical deterioration. Therefore, we propose conducting a multicenter trial using a PROBE (prospective, randomized, open-label, blinded endpoint) design and a Bayesian approach to test if stopping riociguat monotherapy after successful BPA is associated with an acceptably low risk of clinical worsening over a follow-up period of at least one year compared to continuation. The trial will also assess the cost-effectiveness of riociguat discontinuation.

Start Date01 Nov 2026

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

CTRI/2026/01/102198

/ Not yet recruitingNot Applicable

An open label, randomized, balanced, two treatment, two sequence, two period, two-way crossover, single-dose, oral bioequivalence study of Riociguat 2.5 mg tablets (T) manufactured by Zenara Pharma Pvt. Ltd., Plot No: 83/B, 84 & 87-96, Phase III, IDA Cherlapally, Hyderabad-500051, India with ADEMPAS (riociguat) 2.5 mg tablets (R) manufactured for Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981, United states in normal healthy, adult male subjects under fasting condition. - NIL

Start Date10 Feb 2026

Sponsor / Collaborator

Zenara Pharma Pvt Ltd.

CTIS2024-519225-38-00

/ RecruitingPhase 4IIT

STOP-RIO: A randomized controlled non-inferiority trial to test the safety of discontinuation of riociguat after balloon pulmonary angioplasty in Chronic Thrombo-embolic Pulmonary Hypertension

Start Date28 Oct 2025

Sponsor / Collaborator-

100 Clinical Results associated with Riociguat

100 Translational Medicine associated with Riociguat

100 Patents (Medical) associated with Riociguat

601

Literatures (Medical) associated with Riociguat

01 Dec 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Soluble guanylate cyclase stimulators and activators: Chemistry, biology, and therapeutic advances

Review

Author: Chen, Mao ; Yang, Haoran ; Zuo, Zeping ; Feng, Qipu ; Ran, Junpeng

The discovery of soluble guanylate cyclase (sGC) stimulators and activators has provided invaluable tools for elucidating nitric oxide (NO)-sGC signaling and has opened up novel therapeutic opportunities for cardiovascular diseases and beyond. In recent years, sGC modulators have garnered widespread attention as promising agents for diseases such as pulmonary hypertension, heart failure, chronic kidney disease, and diabetic retinopathy-with sGC stimulators and sGC activators emerging as key research focuses in this field. Although first-in-class sGC stimulators (e.g., riociguat, vericiguat) and activators (e.g., cinaciguat) have advanced into clinical use or development, most subsequent candidates continue to be refined to optimize efficacy, safety, and target selectivity. This review provides a comprehensive and systematic exploration of sGC stimulators and sGC activators in the context of disease therapy. Specifically, these small molecules are classified and elaborated based on their mechanisms of action, structural characteristics, and development trajectories; for each category, the binding modes, structural features, and pharmacological activities of representative compounds are analyzed in detail, while their inherent advantages and limitations are critically evaluated. Collectively, this review offers valuable insights and guidance for the future research and development of safer, more effective, and more precisely targeted sGC modulators.

01 Dec 2026·JOURNAL OF MOLECULAR MEDICINE-JMM

TGF-β-induced autophagy in pulmonary artery endothelial cells associated with chronic thromboembolic pulmonary hypertension

Article

Author: Hsu, Hsao-Hsun ; Yeh, Yung-Hsin ; Tsai, Ching-Yen ; Lai, Ying-Ju ; Chang, Chi-Jen ; Chen, Po-Ru ; Huang, Yen-Lin ; De Almeida, Celina

Chronic thromboembolic pulmonary hypertension (CTEPH) is a progressive vascular disorder characterized by persistent thromboembolic obstruction and fibrotic remodeling of the pulmonary arteries. Although autophagy has been implicated in various forms of pulmonary hypertension, its specific role in CTEPH pathogenesis remains unclear. In this study, histological, immunohistochemical, and molecular analyses of pulmonary artery lesions from CTEPH patients revealed increased collagen deposition and elevated expression of autophagy markers beclin-1 and microtubule-associated protein 1A/1B-light chain 3 (LC3) compared to non-CTEPH controls. Primary pulmonary artery endothelial cells (PAECs) derived from CTEPH patients exhibited dysregulated autophagy-related protein expression. Mechanistically, TGF-β stimulation induced autophagy via the Smad3 signaling pathway. Notably, riociguat, a soluble guanylate cyclase stimulator approved for CTEPH, modulated autophagy-related proteins in vitro. In hypoxia- and TGF-β-induced pulmonary hypertension mouse models, riociguat attenuated LC3 but not beclin-1 expression and significantly reduced right ventricular systolic pressure. These findings suggest that LC3 may be a key autophagy marker in CTEPH. These findings identify the TGF-β/Smad3-LC3 axis as a critical mechanism driving CTEPH and suggest that pharmacological modulation of autophagy, particularly via riociguat, offers a promising therapeutic opportunity, especially for patients ineligible for surgical intervention. KEY MESSAGES: Beclin-1 and LC3, key autophagy markers, are upregulated in thrombofibrotic pulmonary arteries from patients with CTEPH. TGF-β activates autophagy in pulmonary artery endothelial cells through the Smad3 signaling pathway. Riociguat treatment downregulates LC3 expression, improves pulmonary hemodynamics, and reduces vascular remodeling in experimental PH models. LC3 as a potential biomarker and therapeutic target in the progression of CTEPH driven by autophagy.

01 Oct 2026·KAOHSIUNG JOURNAL OF MEDICAL SCIENCES

Protective Effects of Riociguat Against Contrast‐Induced Nephropathy: An Experimental and Machine Learning‐Based Study in Rats

Article

Author: Koyuncu, İsmail ; Sarıısık, Gencay ; Toprak, Kenan ; Demirbag, Recep ; Fedai, Halil ; Bicer, Asuman ; Tascanov, Mustafa Begenc ; Dedeoglu, Necip Fazıl ; Turedi, Sibel ; Tanrıverdi, Zulkif ; Altıparmak, İbrahim Halil

ABSTRACT:

Contrast‐induced nephropathy (CIN) is an important cause of acute kidney injury following exposure to iodinated contrast media, and effective preventive strategies remain limited. This study investigated the renoprotective effects of riociguat, a soluble guanylate cyclase stimulator, in an experimental rat model of CIN and explored machine‐learning‐based prediction of renal injury using histopathological, biochemical, and inflammatory markers. Thirty‐six female Wistar albino rats were randomized into control, riociguat, CIN model, and CIN + riociguat groups. CIN was induced by iohexol after dehydration, and riociguat was administered orally for 5 days. Renal injury was assessed by histopathological scoring, TUNEL assay, and biochemical parameters including serum creatinine, urea, tumor necrosis factor‐alpha, nitric oxide, neutrophil gelatinase‐associated lipocalin, and advanced oxidation protein products. Riociguat significantly decreased serum creatinine, urea, apoptotic index, and histopathological injury scores, reduced inflammatory and oxidative stress markers, and increased nitric oxide levels compared with untreated CIN animals ( p < 0.05). Machine learning models (Random Forest, CatBoost, AdaBoost, and XGBoost) were applied for exploratory prediction and feature importance analysis. The apoptotic index and nitric oxide were identified as dominant predictors, indicating mechanistic relevance but limited clinical screening utility because these predictors require histological assessment. Overall, riociguat demonstrated significant renoprotective effects through anti‐apoptotic, anti‐inflammatory, and antioxidative mechanisms, and machine learning provided hypothesis‐generating insight rather than a clinically deployable predictive model.

News (Medical) associated with Riociguat

15 Oct 2026

·www.prnewswire.com

Roxus® ED Nasal Spray Now Available in the U.S.: Peak Blood Levels in About 10 Minutes, Not an Hour

Available by prescription through telemedicine partner Mavrox.com/Roxus. MINNEAPOLIS, Oct. 15, 2026 /PRNewswire/ -- LTR Pharma Limited (ASX: LTP), the Australian pharmaceutical company, today announced that Roxus® is now available to men across the U.S. Roxus is a prescription nasal spray for erectile dysfunction (ED) that delivers vardenafil, the same type of ED medicine as Viagra®, used in tablets for more than 20 years, through LTR's proprietary intranasal spray technology. Roxus uses the same intranasal vardenafil formulation as SPONTAN®, LTR Pharma's nasal spray prescribed in Australia for the past two years. In clinical studies, including a peer-reviewed Phase 1 study, the spray reached peak blood levels in a median of about 10 minutes, compared with 45 to 60 minutes for vardenafil tablets.¹ Men 65 and older reached peak levels just as quickly, and the spray did it with a quarter of the tablet dose. Because it's absorbed through the nose rather than the stomach, it's designed to avoid the delays a heavy meal can cause with pills. "For twenty years, ED treatment has meant taking a pill, waiting an hour, and hoping dinner doesn't get in the way. Roxus delivers vardenafil through the nose instead of the stomach, and in our clinical studies, our nasal spray reached peak blood levels in about ten minutes instead of an hour. That changes the experience for men and their partners, as it's effective within 5-10 minutes," said Lee Rodne, Executive Chairman, LTR Pharma. "In sexual medicine, convenience is clinical. Roxus gives us an opportunity to rethink delivery of a familiar PDE5 mechanism around the patient experience: speed, discretion and spontaneity," said Dr. Amy Pearlman, urologist and member of LTR Pharma's Scientific Advisory Board. How to get Roxus LTR Pharma has partnered with Shed, whose men's health telemedicine platform Mavrox brings Roxus to men nationwide. To obtain a prescription, men complete a short online health assessment at Mavrox.com/Roxus. A licensed U.S. provider reviews it, and if Roxus is appropriate, Strive Pharmacy fills the prescription and ships it discreetly to their door. Men who prefer an in-person visit can ask their healthcare provider about Roxus. To learn more, visit Roxus.com. IMPORTANT SAFETY INFORMATION Do not use Roxus if you take nitrates for chest pain, recreational "poppers," or riociguat, or if you are allergic to vardenafil. Tell your provider about any heart, liver, or kidney problems, and all medicines you take. Seek emergency care for an erection lasting more than 4 hours or sudden vision or hearing loss. Common side effects include headache, flushing, runny or stuffy nose, indigestion, and temporary nasal discomfort. Roxus is a compounded medication prepared for identified individual patient needs based on a valid prescription from a prescribing healthcare practitioner and, as such, is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. Compounded drugs are intended for patients whose prescriber has determined their medical needs are not met by an available FDA-approved drug. These statements have not been evaluated by the FDA. Results may vary. Available by prescription only, when a licensed provider determines it is appropriate. About LTR Pharma: LTR Pharma Limited (ASX: LTP) is an Australian commercial-stage pharmaceutical company that develops fast-acting intranasal medicines using its proprietary nasal spray technology. Its lead products, SPONTAN® (Australia) and Roxus® (U.S.), are nasal sprays for the treatment of erectile dysfunction. SPONTAN is progressing through the U.S. FDA 505(b)(2) pathway toward a planned Phase III study. ltrpharma.com About Mavrox: Mavrox, operated by Shed, is a U.S. men's health telemedicine platform connecting men with licensed providers and personalized treatment. Mavrox.com Reference ¹ Based on pharmacokinetic studies of SPONTAN®, LTR Pharma's intranasal vardenafil formulation, and published prescribing information for oral PDE5 inhibitors. No head-to-head study has compared Roxus with other ED treatments. Viagra is a registered trademark of Pfizer Inc. Media Contact: Fergus Linskey, Levo Health, [email protected] SOURCE LTR Pharma 21% more press release views with Request a Demo

Clinical ResultPhase 1Phase 3Drug Approval

08 Oct 2026

·www.prnewswire.com

LTR Pharma Brings Roxus® Intranasal Vardenafil to U.S. Prescribers: Peak Plasma Levels in a Median of 10 Minutes

On-demand nasal spray now available for patient-specific prescribing through Strive Pharmacy, a Section 503A compounding pharmacy serving patients nationwide MINNEAPOLIS, Oct. 8, 2026 /PRNewswire/ -- LTR Pharma Limited (ASX: LTP), an Australian commercial-stage pharmaceutical company focused on men's health, today announced U.S. availability of Roxus®, a compounded intranasal formulation of vardenafil hydrochloride for erectile dysfunction (ED). Roxus is dispensed exclusively through Strive Pharmacy under Section 503A of the Federal Food, Drug, and Cosmetic Act. It offers urologists, men's health specialists, and primary care clinicians a rapid-onset, on-demand alternative to oral PDE5 inhibitors. Continue Reading View PDF ROXUS® (vardenafil HCl nasal spray) overview for healthcare professionals, including intranasal delivery, patient eligibility, dosing, and prescribing resources. An estimated 30 to 35 percent of men do not respond adequately to oral PDE5 inhibitors,¹ and oral tablets ask every patient to plan intimacy around absorption time and meals. Roxus takes a different approach to both: a different route of delivery rather than a different molecule. Roxus is the U.S. compounded form of SPONTAN®, LTR Pharma's proprietary intranasal vardenafil formulation, which is progressing through the U.S. FDA 505(b)(2) development pathway toward a planned Phase III study. The following clinical data were generated with SPONTAN. Clinical Evidence In a Phase 1 randomized, open-label, two-period crossover study, published in the peer-reviewed European Journal of Pharmaceutical Sciences, 19 healthy men were randomized to intranasal vardenafil (5 mg) and oral vardenafil tablets (10 mg); 18 completed both periods.² Intranasal delivery reached peak plasma concentration in a median of approximately 10 minutes (range 9–15 minutes). The oral tablet took approximately 45 minutes (range 30–150 minutes). Dose-normalized Cmax was higher with the intranasal formulation, and half-life was comparable (4.15 vs. 4.23 hours). Adverse events were similar for the two formulations, with more upper-respiratory irritation following intranasal administration. Final results from LTR Pharma's Phase II pharmacokinetic study, reported in October 2026, were consistent with Phase 1. In 27 healthy men, including 14 aged 65 and older, intranasal vardenafil (5 mg) reached peak plasma concentration in a median of 10 minutes (range 10–15 minutes), versus 60 minutes (range 30–186 minutes) for the 20 mg oral tablet: six-fold faster, at one quarter of the oral dose (p<0.0001). The pharmacokinetic profile was maintained in subjects aged 65 and older. No serious or severe adverse events and no discontinuations were reported. Real-World Experience In a retrospective cohort of 147 Australian men treated with SPONTAN (mean age 65.6 years; 62 percent with a history of prostate cancer), 68 percent reported improved hardness or penetration. Among men who sought a faster-acting option, 93 percent responded; among men with an inadequate response to oral therapy, 57 percent responded; and among men following prostatectomy, 64 percent responded. The study was single-center and patient-reported, and is undergoing peer review.³ "Oral PDE5 inhibitors changed ED care, but they still ask patients to plan intimacy around absorption, food, and timing. Consistent peak levels in about ten minutes, including in men over 65, give clinicians and patients a genuinely different option," said Professor Geoffrey Strange, Chief Medical Officer, LTR Pharma. Ideal Patient Profile Dr. Andrew Sun, Scientific Advisory Board, LTR Pharma said, "In a high-volume men's health practice, the same issues come up again and again: timing, predictability and side effects. ROXUS offers the rapid onset men want." Roxus may be well suited to adult men with ED who are appropriate candidates for PDE5 inhibitor therapy and who: value spontaneity and dislike planning 30 minutes to 2 hours ahead report inconsistent response to oral agents related to meals, particularly high-fat meals experience GI discomfort with oral therapy or have difficulty swallowing tablets are older patients seeking predictable absorption (the PK profile was maintained in patients 65 and older) Patients should have no significant nasal pathology that could impair intranasal absorption. Dosing and Administration LTR Pharma's clinical studies evaluated 5 mg vardenafil delivered intranasally; the compounded strength is specified by the prescriber. Patients administer the dose approximately 10–15 minutes before sexual activity. Maximum dosing frequency is once per 24 hours. Sexual stimulation is required for efficacy. Safety Information Roxus contains vardenafil and carries the established safety considerations of the PDE5 inhibitor class. Contraindications: Do not prescribe to patients using nitrates in any form or guanylate cyclase stimulators such as riociguat, or to patients with known hypersensitivity to vardenafil. Drug interactions: Use caution, and adjust or avoid use, with alpha-blockers and with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, and other HIV protease inhibitors. Cardiac and hepatic caution: Use caution in patients with congenital or acquired QT prolongation, in patients with hepatic impairment, and in patients for whom sexual activity is inadvisable due to cardiovascular status. Patient counseling: Advise patients to seek emergency care for erections lasting more than 4 hours, and to stop use and seek care for sudden vision or hearing loss. Common adverse events: Headache, flushing, nasal congestion or rhinitis, and dyspepsia. Transient nasal irritation may occur with intranasal administration. Important Regulatory Notice: Roxus is a compounded medication prepared for identified individual patient needs based on a valid prescription from a prescribing healthcare practitioner and, as such, is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. Compounded drugs are intended for patients whose prescriber has determined their medical needs are not met by an available FDA-approved drug. These statements have not been evaluated by the FDA. Prescribers should use their independent clinical judgment when determining appropriateness for individual patients. The clinical data referenced above were generated with LTR Pharma's intranasal vardenafil formulation (SPONTAN®/SDS-089). ¹ McMahon CN, Smith CJ, Shabsigh R. Treating erectile dysfunction when PDE5 inhibitors fail. BMJ 2006;332:589–592. ² Chung E, Argent C, Strange G. Pharmacokinetics of an oral versus intranasal delivered formulation of the phosphodiesterase type 5 inhibitor vardenafil in healthy men. Eur J Pharm Sci 2025;213:107226. ³ LTR Pharma ASX announcement, 11 August 2026. Retrospective, single-center cohort; patient-reported outcomes; manuscript under peer review. About LTR Pharma: LTR Pharma Limited (ASX: LTP) is an Australian commercial-stage pharmaceutical company delivering innovative therapies to address significant unmet medical needs through its proprietary intranasal drug-delivery platform. The Company has commercialized its rapid-acting treatment technology in Australia and is expanding access while advancing regulatory pathways in the U.S. and other key markets. Its lead products, SPONTAN® and Roxus®, are fast-acting intranasal sprays for the treatment of erectile dysfunction. SPONTAN is available in Australia under the Therapeutic Goods Administration's Special Access Scheme and is progressing through the U.S. FDA 505(b)(2) pathway toward a planned Phase III study; Roxus is available in the U.S. through the Section 503A personalized-medicine pathway. The Company is also advancing OROFLOW®, an intranasal spray in development for esophageal motility disorders. | Media Contact: Fergus Linskey, Levo Health, [email protected], +1 (585) 703-9535 Investor Relations: Peter McLennan, Chief Operating Officer, LTR Pharma, [email protected] SOURCE LTR Pharma 21% more press release views with Request a Demo

Clinical ResultPhase 3Phase 1Phase 2

05 Oct 2026

·www.prnewswire.com

Zydus, MSN partner to Launch First Generic of Adempas® (Riociguat Tablets) in the U.S.

First-to-market launch brings a lower-cost riociguat to U.S. patients living with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension AHMEDABAD, India and PENNINGTON, N.J., Oct. 5, 2026 /PRNewswire/ -- Zydus Lifesciences Limited (Zydus), in partnership with MSN Laboratories Private Limited (MSN), today announced the launch of Riociguat Tablets, 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg, in the United States. Zydus and MSN are the first companies to launch a generic version of Adempas® (riociguat) in the U.S. market. The product was developed and is manufactured by MSN. Riociguat Tablets are approved by the United States Food and Drug Administration (USFDA) as a generic equivalent of Adempas® Tablets in all five strengths. Riociguat is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class; and for adults with pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity, improve WHO functional class and to delay clinical worsening. Commenting on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, said, "Being first to market with generic riociguat is a milestone for our U.S. business and for patients with pulmonary hypertension. It reflects the strength of our complex-generics pipeline, our ability to execute day-one launches in specialty categories, and the strength of our partnerships that complement our commercial reach in the United States. We are pleased to enable access to the drug across all five strengths, allowing physicians and pharmacies to transition patients with confidence." Dr. MSN Reddy, Founder & CMD, MSN Laboratories, said , "Riociguat is a technically demanding molecule, and bringing the first generic to the U.S. demonstrates the depth of MSN's integrated API and formulation R&D and the scale of our manufacturing. Together with Zydus' established U.S. commercial platform, we are confident of delivering consistent, high-quality supply of this important therapy." PAH and CTEPH are rare, progressive and life-threatening conditions in which patients typically remain on therapy for life. So far, riociguat was available in the United States only as the branded product. Sales of riociguat are not reported by IQVIA. According to Bayer's Annual Report 2025, the global sales of Adempas® were approximately EUR 745 million (approximately USD 850 million) in 2025 (source: ). About Zydus Zydus Lifesciences Ltd., with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 30,000 people worldwide, including 1,500 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through pathbreaking discoveries. Over the last decade, Zydus has introduced several innovative, first-in class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals, and New Chemical Entities. For more details visit About MSN Laboratories MSN Laboratories Group is a research-driven, fully integrated pharmaceutical company established in 2003, with a mission to make high-quality medicines accessible and affordable worldwide. The group operates 25 manufacturing facilities across India and the USA, supported by a unified R&D ecosystem spanning both API and finished dosage development. With over 1,000 patents filed globally, 200+ ANDA submissions and a leading position in US DMF filings, MSN has built a strong global presence. With a portfolio of 550+ APIs and 400+ finished dosage forms across 35+ therapeutic areas, MSN serves over 50 million patients in more than 100 countries. For more details visit . Adempas® is a registered trademark of Bayer. All other trademarks are the property of their respective owners. SOURCE Zydus Lifesciences 21% more press release views with Request a Demo

Drug Approval

100 Deals associated with Riociguat

External Link

KEGG	Wiki	ATC	Drug Bank
D09572	Riociguat	C02KX05	DB08931

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension, Pulmonary	Australia	Bayer AG	14 Apr 2014
Familial Primary Pulmonary Hypertension	European Union	Bayer AG	27 Mar 2014
Familial Primary Pulmonary Hypertension	Iceland	Bayer AG	27 Mar 2014
Familial Primary Pulmonary Hypertension	Liechtenstein	Bayer AG	27 Mar 2014
Familial Primary Pulmonary Hypertension	Norway	Bayer AG	27 Mar 2014
Idiopathic pulmonary arterial hypertension	European Union	Bayer AG	27 Mar 2014
Idiopathic pulmonary arterial hypertension	Iceland	Bayer AG	27 Mar 2014
Idiopathic pulmonary arterial hypertension	Liechtenstein	Bayer AG	27 Mar 2014
Idiopathic pulmonary arterial hypertension	Norway	Bayer AG	27 Mar 2014
Idiopathic pulmonary arterial hypertension	United Kingdom	Bayer Plc	27 Mar 2014
Pulmonary arterial hypertension associated with connective tissue disease	European Union	Bayer AG	27 Mar 2014
Pulmonary arterial hypertension associated with connective tissue disease	Iceland	Bayer AG	27 Mar 2014
Pulmonary arterial hypertension associated with connective tissue disease	Liechtenstein	Bayer AG	27 Mar 2014
Pulmonary arterial hypertension associated with connective tissue disease	Norway	Bayer AG	27 Mar 2014
Chronic thromboembolic pulmonary hypertension	United States	Bayer Healthcare LLC	08 Oct 2013
Chronic thromboembolic pulmonary hypertension	United States	Bayer HealthCare Pharmaceuticals, Inc.	08 Oct 2013
Pulmonary Arterial Hypertension	United States	Bayer HealthCare Pharmaceuticals, Inc.	08 Oct 2013
Pulmonary Arterial Hypertension	United States	Bayer Healthcare LLC	08 Oct 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Heart Diseases	Phase 2	United States	Bayer AG	13 Jun 2018
Pulmonary Vascular Disease	Phase 2	United States	Bayer AG	13 Jun 2018
Thromboembolism	Phase 2	United States	Bayer AG	13 Jun 2018
Digital ulcer	Phase 2	United States	Bayer AG	01 Sep 2016
Scleroderma	Phase 2	United States	Bayer AG	01 Sep 2016
Scleroderma associated digital ulcer	Phase 2	United States	Bayer AG	01 Sep 2016
Scleroderma, Systemic	Phase 2	United States	Bayer AG	01 Sep 2016
Scleroderma, Diffuse	Phase 2	United States	Bayer AG	15 Jan 2015
Scleroderma, Diffuse	Phase 2	Japan	Bayer AG	15 Jan 2015
Scleroderma, Diffuse	Phase 2	Australia	Bayer AG	15 Jan 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2026	Not Applicable	Chronic thromboembolic pulmonary hypertension	18	Riociguat	ogzzquomgl(ekvxpdqcne) = In the riociguat group, median PVR significantly decreased from 7.1 WU (IQR 6.0-10.2) at baseline to 5.4 WU (IQR 3.3-5.9) at first follow-up and to 2.7 WU (IQR 2.4-3.0) at final follow-up (both Bonferroni-adjusted p=0.012). In the selexipag group, median PVR significantly decreased from 9.6 WU (IQR 7.5-12.6) to 6.9 WU (IQR 6.1-10.7) and to 3.4 WU (IQR 2.1-4.3) (Bonferroni-adjusted p=0.035 and p=0.012, respectively). The magnitude of PVR reduction from baseline to final follow-up did not differ significantly between groups (median −4.2 vs −7.7 WU, p=0.387). aekailfhwo (adhkbvzmrr )	Positive	31 Aug 2026
				Selexipag
NCT04954742 (RIVER II, Pubmed \| Respir Res)	Phase 4	Pulmonary Arterial Hypertension	30	Riociguat	dywihfnmnm(ycrbhelgkg) = akbmsydgkq hztvvufbrx (shoadrabmv, 3.8) View more	Positive	28 Jul 2026
NCT04954742 (RIVERII \| RIVER II, CTgov)	Phase 4	Chronic thromboembolic pulmonary hypertension \| Idiopathic pulmonary arterial hypertension	30	Riociguat	qzgndqeaha(ebxlsaqczv) = gyojytyjac oxkxpyywxr (hreafqibgl, kcdbbcssvo - jebxyfwzxe) View more	-	17 Jun 2026
EULAR2026	Phase 2	Pulmonary Arterial Hypertension	35	Riociguat	afwngupjxh(vphlzrcpfy) = haiijvqdok ytwkopizig (nmzjxcuaje, 0.6) View more	Positive	11 Jun 2026
				Placebo	afwngupjxh(vphlzrcpfy) = jurwsbaush ytwkopizig (nmzjxcuaje, 3.29) View more
ATS2026	Not Applicable	Pulmonary Arterial Hypertension	32	Riociguat and Treprostinil	khcayujxox(wpuukqbpnt) = popduefner hyilvatntr (shadtnigab ) View more	Similar	15 May 2026
				Treprostinil	khcayujxox(wpuukqbpnt) = cjmjpnaajf hyilvatntr (shadtnigab ) View more
NCT05339087 (ESRA, CTgov)	Phase 2	Scleroderma, Systemic \| Pulmonary Vascular Disease \| Idiopathic pulmonary arterial hypertension	35	Riociguat Oral Tablet (Riociguat)	hdufujcgrl(bhnxrwexby) = iaxrxncpez mpmfhfwixw (jvnawfswod, 0.60) View more	-	21 Jan 2026
				Placebo (Placebo)	hdufujcgrl(bhnxrwexby) = semamobajj mpmfhfwixw (jvnawfswod, 3.29) View more
NCT06715280 (Pubmed \| BMC Pulm Med)	Phase 4	Chronic thromboembolic pulmonary hypertension	16	Riociguat	mxqwuajiyo(girirjpwtp) = kyvckxdrgw ndrmgusoec (vqquvoikge ) View more	Positive	03 Jan 2026
ESC2025	Not Applicable	Chronic thromboembolic pulmonary hypertension	24	Riociguat	nkpkzecvcd(wojbdqayxw) = lplhlvzawu kbgbwkmwtn (twhmfimtyj, -30.5 to -38.0) View more	Positive	01 Sep 2025
				Selexipag	kepnuuaoir(vdefuziadd) = alezrgnhno ftrizjzzrq (eeenmeeisx, 7.45 - 15.8)
ESC2025	Not Applicable	Chronic thromboembolic pulmonary hypertension	16	Riociguat	qqtdlomqlb(xvtygpthik) = iahcoumlqu sxbuvyjefp (tlvemvwxjh, 4.32 - 45.72) View more	Positive	29 Aug 2025
ATS2024	Not Applicable	Pulmonary Arterial Hypertension	-	Riociguat monotherapy	meqgqiavsn(sdldwevwah) = 4% chxdpnwqme (shdhcowdxb ) View more	-	19 May 2024
				Riociguat combination therapy

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis