RegulationOrphan Drug (United States), Priority Review (China), Special Review Project (China), Overseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (Japan)

Structure/Sequence

Molecular FormulaC27H31N5O7S

InChIKeySXTRWVVIEPWAKM-UHFFFAOYSA-N

CAS Registry157212-55-0

175

Clinical Trials associated with Bosentan

NCT06887062

/ RecruitingPhase 2IIT

Dual Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)

Large vessel vasculitis is a disease that causes damage to blood vessels. This damage to blood vessels can increase the risk of patients with LVV developing cardiovascular disease, including heart attacks and strokes. A chemical produced in the body called endothelin may contribute to this increase in cardiovascular disease risk by causing the vessels to stiffen and blood pressure to increase.
It has previously been shown that by blocking the effects of endothelin, vessel stiffness and blood pressure improve. Bosentan is a tablet that blocks the effects of endothelin. The investigators plan to assess blood vessel function in those with LVV and participants without LVV. Participants with LVV will then be given Bosentan for 6 weeks to evaluate its impact on blood vessel function.

Start Date21 Mar 2025

Sponsor / Collaborator

The University of Edinburgh

NCT06432452

/ Enrolling by invitationPhase 2/3IIT

Efficacy of Endothelin Receptor Antagonism in Treatment of Coronary Artery Spasm: a Randomized Controlled Clinical Trial

The goal of this randomized clinical trial is to assess if adjunctive bosentan therapy, in comparison to placebo, can reduce the rate of epicardial vasospasm at follow-up spasm provocation CFT (fuCFT) in patients with previously proven epicardial vasospasm on acetylcholine reactivity testing (at index CFT) and ongoing angina(-like) complaints.
Participants will
* Use either endothelin receptor antagonist or placebo for 10 weeks
* Undergo follow-up acetylcholine spasm provocation test after 10 weeks
* Answer online questionnaires on angina and quality of life

Start Date11 Nov 2024

Sponsor / Collaborator

Radboud University Medical Center

[+2]

CTR20243649

/ CompletedNot Applicable

波生坦分散片人体生物等效性研究

[Translation] Study on the bioequivalence of bosentan dispersible tablets in healthy volunteers

本试验旨在研究单次空腹和餐后口服江苏天士力帝益药业有限公司研制、生产的波生坦分散片（32 mg（以C27H29N5O6S计））的药代动力学特征；以Actelion Pharmaceuticals Ltd持证、Patheon Inc.生产的波生坦分散片（Tracleer®，32 mg（以C27H29N5O6S计））为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of bosentan dispersible tablets (32 mg (calculated as C27H29N5O6S)) developed and produced by Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using bosentan dispersible tablets (Tracleer®, 32 mg (calculated as C27H29N5O6S)) licensed by Actelion Pharmaceuticals Ltd and produced by Patheon Inc. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.

Start Date18 Sep 2024

Sponsor / Collaborator

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

100 Clinical Results associated with Bosentan

100 Translational Medicine associated with Bosentan

100 Patents (Medical) associated with Bosentan

3,871

Literatures (Medical) associated with Bosentan

01 Apr 2025·ANNALS OF PHARMACOTHERAPY

Pressing Update: Aprocitentan for the Treatment of Hypertension

Review

Author: Whitner, Chardae ; Vascimini, Angelina ; Huston, Jessica ; St. Onge, Erin ; Phillips, Bradley

Objective::

This article reviews the published data including the pharmacology, efficacy, and safety of aprocitentan, a novel endothelin receptor antagonist developed to treat hypertension in conjunction with additional agents.

Data sources::

A literature search was conducted from drug discovery until May 2024 through PubMed, MEDLINE, and National Institutes of Health Clinical Trials Registry utilizing the following search terms: Tryvio, aprocitentan, hypertension, resistant hypertension, endothelin receptor antagonist, and ACT-132577.

Study selection and data extraction::

All relevant English-language studies, or studies that could be appropriately translated into English, containing the pharmacology, pharmacokinetics, safety, and efficacy of aprocitentan, were selected for review.

Data synthesis::

In the setting of resistant hypertension, aprocitentan has shown significant reductions in blood pressure in both medical office and 24-hour ambulatory settings at 4 weeks with a sustained effect at 40 weeks. Studies evaluating cardiovascular risk reduction have not been conducted at this time. Fluid retention and edema were the most frequent adverse events reported in clinical studies with aprocitentan. As a class, endothelin receptor antagonists may cause fetal harm; aprocitentan should be used with caution to avoid embryo-fetal toxicity.

Relevance to patient care and clinical practice in comparison to existing drugs::

Owing to the existent barriers for the treatment of resistant hypertension, aprocitentan presents itself as an effective option when added to traditional antihypertensives. This single-strength, once-daily regimen may serve as an appealing option to both patients and prescribers.

Conclusion::

Aprocitentan is a safe and effective medication for the treatment of hypertension when added to other pharmacological therapies.

01 Apr 2025·Journal of Cachexia Sarcopenia and Muscle

Early Administration of Bosentan in High‐Risk COVID‐19 Outpatients at Risk of Sarcopenia: A Randomized, Double‐Blind, Placebo‐Controlled Trial

Article

Author: Vahdat Shariatpanahi, Zahra ; Shahbazi, Erfan ; Shahbazi, Shaahin ; Zayeri, Farid

ABSTRACT:

Background:

Endothelial damage induces myofibrillar breakdown and muscle degradation in COVID‐19 infection. There is a relationship between increased endothelin‐1 synthesis and sarcopenia. We evaluated the preventive effect of early bosentan therapy as an endothelin receptor blocker in sarcopenia in high‐risk outpatients with COVID‐19 infection.

Methods:

From 15 December 2021 to 15 August 2023, patients within 3 days of the onset of signs and symptoms were randomly assigned to receive bosentan, 62.5 mg, or placebo, twice daily from enrollment for 30 days. The primary outcome was disease progression (death or hospitalization within 15 days after randomization), and the data for this outcome have been previously published. Sarcopenia as a secondary outcome was assessed prospectively at 3, 6, 9 and 12 months after randomization using the criteria of the Asian Working Group for Sarcopenia (AWGS) 2019 (IRCT.ir, IRCT20211203053263N1).

Results:

A total of 313 patients (156 bosentan group, 157 controls) were included in the analyses, which were performed under the intent‐to‐treat principle. Overall, the incidence of sarcopenia was 8.6% (n = 27). Nineteen (73%) had severe sarcopenia. At the 3‐month follow‐up, the incidence of sarcopenia was 8.3% in the total population, with the significant risk difference (RD) of −10.17% in the bosentan group versus the control group. The incidence in the total population and RD in the bosentan group versus the control group at months 6, 9 and 12 were 8.6% (RD: −10.81%, p < 0.001), 8.3% (RD: −10.17%, p = 0.001) and 5.4% (RD: −6.99%, p = 0.003), respectively. During the study, 29 people developed severe COVID‐19 and were hospitalized. At follow‐up, sarcopenia occurred in four inpatients and 23 outpatients (p = 0.23). Mortality occurred in 5.1% (n = 16) of the total population, including 4 (1.3%) of the patients in the bosentan group and 12 (3.8%) of the patients in the placebo group (p = 0.069). None of the patients who died had sarcopenia. Bosentan did not cause any severe adverse events and was well tolerated.

Conclusion:

Early administration of bosentan may prevent sarcopenia in high‐risk outpatients with COVID‐19.

01 Apr 2025·HYPERTENSION

Aprocitentan for Blood Pressure Reduction in Black Patients

Article

Author: Andrawis, Nabil S. ; Danaietash, Parisa ; Scott, David ; Schlaich, Markus P. ; Sassi-Sayadi, Mouna ; Clozel, Martine ; Dreier, Roland F. ; Wang, Ji-Guang ; Ferdinand, Keith C. ; Weber, Michael A. ; Narkiewicz, Krzysztof ; Flack, John M. ; Gabra, Nashwa

BACKGROUND::

Black individuals frequently present with resistant hypertension and disproportionately increased cardiovascular risk. We investigated the blood pressure (BP)-lowering effect of the dual endothelin receptor antagonist aprocitentan in Black individuals enrolled in the PRECISION study (Parallel-Group, Phase 3 Study with Aprocitentan in Subjects with Resistant Hypertension).

METHODS::

Patients with confirmed resistant hypertension were randomized to aprocitentan 12.5 mg, 25 mg, or placebo for 4 weeks (part 1). They subsequently received aprocitentan 25 mg for 32 weeks (part 2) before re-randomization to aprocitentan 25 mg or placebo (part 3).

RESULTS::

Eighty-two patients randomized in the PRECISION study were Black individuals. At week 4, aprocitentan 12.5 and 25 mg reduced office trough systolic BP (−11.3 and −11.9 mm Hg) to a similar degree as placebo (−12.0 mm Hg). Using 24-hour ambulatory BP monitoring, the placebo effect was minimal (−0.7 mm Hg), and aprocitentan reduced systolic BP by 4.0 and 8.6 mm Hg. During part 2, office BP continued to decrease (−16.4 mm Hg at week 36). In part 3, office and ambulatory systolic BP increased on placebo (+9.9 and +8.1 mm Hg, respectively), whereas the BP-lowering effect was maintained with aprocitentan. Aprocitentan markedly reduced albuminuria during the study. The most frequent adverse event was peripheral edema, occurring in 3 patients (10%) receiving aprocitentan 25 mg versus none receiving aprocitentan 12.5 mg or placebo.

CONCLUSIONS::

Aprocitentan reduced BP and albuminuria in Black individuals with resistant hypertension. The BP-lowering efficacy was similar to that of the overall PRECISION population. Aprocitentan may represent an important addition to the often difficult-to-control hypertension in Black individuals.

REGISTRATION::

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03541174.

125

News (Medical) associated with Bosentan

17 Mar 2025

·www.globenewswire.com

US FDA removes REMS requirement for TRYVIO (aprocitentan) – minimizing the burden on the healthcare delivery systems and patients

Ad hoc announcement pursuant to Art. 53 LR FDA confirms that prescribers and pharmacists are no longer expected to interact with the REMS Allschwil, Switzerland – March 17, 2025Idorsia Ltd (SIX: IDIA) today announced that – effective immediately – the US FDA has fully released TRYVIO™ (aprocitentan) from its REMS (Risk Evaluation and Mitigation Strategy) requirement. TRYVIO is Idorsia’s dual endothelin receptor antagonist (ERA) indicated for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs. The US FDA has determined that a REMS is no longer necessary to ensure the benefits of TRYVIO outweigh the risk of embryo-fetal toxicity and that labeling is sufficient for conveying the safety information. The FDA have therefore removed the requirement to minimize the burden on the healthcare delivery system of complying with the REMS. Consequently, Idorsia is also released from the post marketing requirement (PMR) to conduct a worldwide descriptive study that collects prospective and retrospective data in women exposed to TRYVIO during pregnancy and/or lactation as these data are no longer needed. Idorsia no longer has post marketing requirements for TRYVIO. Martine Clozel, Chief Scientific Officer of Idorsia, commented:“As a dual endothelin receptor antagonist (ERA), TRYVIO targets a previously unaddressed but important pathway in systemic hypertension, the endothelin pathway. The FDA decision that a REMS is no longer necessary for TRYVIO reflects the progressive understanding of the risk / benefit of TRYVIO. The decision of the FDA is based on an evaluation of human fetal outcomes after exposure to a drug in the ERA class. This change is very important considering that TRYVIO can be prescribed to a large patient population, who have a high cardiovascular risk and whose hypertension could not be brought under control with the previous classes of medication. This comes on top of the outstanding properties of TRYVIO, the result of over 25 years of optimization in our drug discovery team.” Michael Moye, President and General Manager of Idorsia US, commented:“TRYVIO is the first new antihypertensive working via a new pathway for over 40 years. It is a once-daily tablet, is easy to use for patients and easy to prescribe for physicians. In the absence of clinically relevant drug interactions, it can be safely combined with complex drug regimens and, importantly, can be used by chronic renal failure patients with hypertension without dose modification. On top of existing antihypertensives, aprocitentan has been shown to decrease systolic blood pressure by more than 15 mmHg from baseline at trough, and it is well tolerated over the long term. The release of the REMS is fantastic news as it makes TRYVIO even easier to prescribe. TRYVIO is available to prescribe today, and we are now looking for the best commercial solution to fully launch this important medication that fills a large unmet patient need.” Idorsia will submit revised labeling to the US FDA in accordance with the release of the REMS in the coming weeks. For current information on TRYVIO see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). TRYVIO continues to be commercially available through Walgreens Specialty Pharmacy. For more information visit the following websites: US Healthcare Professionals: www.TRYVIOhcp.com US Patients: www.TRYVIO.com Notes to the editor About aprocitentanAprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan is approved as TRYVIO™ in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. Aprocitentan is approved as JERAYGO™ for the treatment of resistant hypertension in combination with other antihypertensives in the European Union and the UK and marketing authorization applications are under review in Canada, and Switzerland. About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contactInvestor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

Drug Approval

10 Mar 2025

·www.biospace.com

Mineralys’ Hypertension Drug Drops Blood Pressure in Phase II/III, Setting Up Market Clash

Tiny doctors examining heart health flat vector illustration. Cartoon medical specialists doing checkup of blood pressure, pulse rate and cholesterol. Cardiovascular disease and cardiology concept BRO Vector/Getty Images Mineralys’ shares got a more than 50% boost Monday morning as new data showed its hypertension drug reduced blood pressure in a pair of clinical trials. Mineralys Therapeutics’ hypertension drug reduced blood pressure in a Phase III trial , sending the biotech’s shares up by more than 50%. But lorundrostat will face a tough market battle, with incumbent Idorsia settling in with a new medicine and several late-stage options coming down the pike. Lorundrostat is an inhibitor of aldosterone synthase, the enzyme responsible for making the steroid aldosterone. Increased amounts of aldosterone have been often linked to rates of hypertension. The pivotal Phase III Launch-HTN and Phase II Advance-HTN trials tested lorundrostat in 1,000 patients with uncontrolled high blood pressure who were already taking two to five antihypertensive drugs. The Phase III trial met its primary goal, assessing the change in systolic blood pressure from baseline compared to placebo after six weeks. Patients who received 50 mg of lorundrostat on top of their preexisting regimens saw a 9.1 mmHg placebo-adjusted drop in blood pressure. Zooming out, at 12 weeks, patients on the lower dose of lorundrostat had an 11.7 mmHg decrease in blood pressure, while patients in the higher dose group had an 8.4 mmHg drop at 12 weeks when adjusted for placebo. As for safety, 4 patients across the two dosing groups reported adverse events that were deemed related to the treatment. Twelve patients in the 50 mg dose group had events such as increased serum potassium, decreased kidney activity, urinary tract infection and hypertension. In the Phase II study, patients with uncontrolled or treatment-resistant hypertension on background therapy saw their blood pressure drop by 7.9 with 50 mg of lorundrostat, meeting the main goal of the study. The primary endpoint of blood pressure reduction was measured using a 24-hour average at week 12. Adverse events were fewer in this study, with two patients reporting AEs, with one report of hyponatremia, which is when sodium levels in the body drop below normal. Mineralys’ shares rose 52% to $16 per share Monday morning after the results were announced. “We believe the clinical pro for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value,” Mineralys CEO Jon Congleton said in a statement. The company plans to announce more detailed findings later this month at the American College of Cardiology Scientific Sessions. These results continue a positive trend for Mineralys, which in September 2023 announced positive Phase II data from the Target-HTN trial of lorundrostat, also showing improvements in blood pressure. Monday’s data release also comes after a blizzard of activity in the hypertension space. In March 2024, Idorsia won FDA approval for its hypertension drug Tryvio, an endothelin receptor antagonist, claiming to be the first new mechanism in hypertension treatments in decades. Other companies, including Alnylam and George Medicines , have also announced late-stage anti-hypertension data in the last few months.

Clinical ResultDrug ApprovalPhase 2Phase 3

03 Mar 2025

·www.prnewswire.com

Perfuse Therapeutics Announces Positive Visual, Structural and Safety Data from a Ph1/2a Trial of PER-001 in Glaucoma Patients at the American Glaucoma Society Meeting

Twenty-four-week data from the Ph1/2a trial in glaucoma patients reveals PER-001 to be well-tolerated. Proof of concept is established with both strong functional and structural outcomes Glaucoma patients treated with PER-001 on top of IOP reducing therapies experienced a mean improvement in visual field mean deviation of 1 decibel (dB) per year and a mean increase in retinal nerve fiber layer thickness of 3 microns at 24 weeks SAN FRANCISCO, March 3, 2025 /PRNewswire/ -- Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases announced today the presentation of 24-week data from its first-in-human Phase 1/2a trial of PER-001 intravitreal implant in patients with glaucoma. The data was presented by Steven Mansberger, MD, MPH, Chief of Ophthalmology, Director of Glaucoma Services at Legacy Devers Eye Institute, March 1, 2025, at the American Glaucoma Society Meeting in Washington DC. The trial is fully enrolled with glaucoma patients (n=33) receiving a single administration of PER-001 on top of IOP reducing therapies. Data presented included results from the Ph1 (n=6) and Ph2a Dose 1 (n=12) cohorts, both of which completed the trial. The Ph2a Dose 2 (n=15) cohort is ongoing. The 24-week data demonstrated that PER-001 was well-tolerated, with only one drug-related adverse event of vitreous floater (mild and transient), no drug-related serious adverse events and no reports of intraocular inflammation. Patients treated with PER-001 showed a mean increase in optic nerve head blood flow of at least 10% from baseline starting at Week 1, which was sustained out to Week 24 and was associated with a mean improvement in visual field mean deviation of 1 dB/yr and a mean increase in retinal nerve fiber layer thickness of 3 microns, as measured by optical coherence tomography (OCT) at Week 24. In contrast, the sham control group revealed a 0.63 dB/yr decline in visual field mean deviation and a decrease of 1.3 microns in OCT RNFL at Week 24. "These results are distinctive and noteworthy," stated Steven Mansberger, MD, MPH. "There remains an unmet need for neuroprotective therapies for patients with glaucoma and while this is early data, the observed improvements in the optic nerve head blood flow, as well as key functional and structural outcomes are very promising." "We are excited to share first-in-human data from the ongoing PER-001 trials," said Sevgi Gurkan, MD, CEO and Founder. "Endothelin is a well-established, clinically validated pathway with many approved products in systemic diseases. The Ph1/2a trial marks the first ever clinical application of an endothelin antagonist for local treatment of back of the eye diseases, and we are encouraged by the safety profile and efficacy data to date." "Glaucoma is the leading cause of irreversible blindness worldwide, and there are no currently approved therapies. This trial provides the first clinical validation of the key role of endothelin pathway in glaucoma. The results of this trial are highly encouraging and the data supports the potential of PER-001 intravitreal implant as a disease-modifying therapy that could significantly improve the vision and lives of glaucoma patients," said Phil Lai, MD, Chief Medical Officer. About PER-001 Intravitreal Implant, a Long Acting Endothelin Receptor Antagonist PER-001 is a novel (NCE), first-in-class small molecule endothelin receptor antagonist. Endothelin is the most potent vasoconstrictor in the human body and is upregulated in glaucoma. Endothelin is involved in inflammation and cell death through its receptors expressed in retinal vascular and neuroretinal cells. The PER-001 intravitreal implant is a bio-erodible implant, administered into the vitreous cavity of the eye using a single use, 25-gauge applicator and designed to provide a sustained release of PER-001, allowing for a convenient every 6 months dosing frequency. About the Ph1/2a Trial The Phase 1/2a trial is a multi-center two-part trial designed to assess the safety, tolerability and pharmacodynamics of PER-001 in glaucoma patients. The Phase 1 part of the trial was a first-in-human, open-label, single ascending dose (SAD) study that evaluated the safety and tolerability of two doses of PER-001 intravitreal implant in patients with advanced glaucoma. The Phase 2a part of the trial was a patient and reading center masked, randomized, sham-controlled study that evaluated the safety, tolerability, and pharmacodynamics of two doses of PER-001 in patients with progressing, mild to moderate glaucoma. Patients in both phases received a single intravitreal administration of PER-001 while maintaining their pre-study IOP-lowering therapies. Two doses of PER-001 intravitreal implant were tested sequentially in cohorts of 3 patients each during the Ph1 SAD portion and the same two doses were subsequently tested in a larger cohort of patients during the Ph2a portion of the trial. All patients were followed for 24 weeks from their first and single dose. The Ph1 cohorts and Ph2a Dose 1 cohort have completed the trial. Ph2a Dose 2 cohort is ongoing and the topline data will be available in second quarter 2025. About Perfuse Therapeutics, Inc. Perfuse Therapeutics is a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases. Enabled by its proprietary sustained release drug delivery platform, the company is developing a robust pipeline of novel assets against validated targets. Headquartered in South San Francisco, California and with R&D facilities in Durham, North Carolina, Perfuse Therapeutics has established a strong team committed to advancing disease modifying therapies to patients with ocular disease around the world. For more information, please see and on LinkedIn. Investor Relations and Media Contact Please contact us for more information or questions at – [email protected] SOURCE Perfuse Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 1Phase 2

100 Deals associated with Bosentan

External Link

KEGG	Wiki	ATC	Drug Bank
D01227	Bosentan	C02KX01	DB00559

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Ulcer	Japan	Actelion Pharmaceuticals Ltd.	24 Aug 2015
Familial Primary Pulmonary Hypertension	Australia	Janssen-Cilag Pty Ltd.	20 Nov 2002
Idiopathic pulmonary arterial hypertension	Australia	Janssen-Cilag Pty Ltd.	20 Nov 2002
Scleroderma associated digital ulcer	European Union	Janssen-Cilag International NV	14 May 2002
Scleroderma associated digital ulcer	Iceland	Janssen-Cilag International NV	14 May 2002
Scleroderma associated digital ulcer	Liechtenstein	Janssen-Cilag International NV	14 May 2002
Scleroderma associated digital ulcer	Norway	Janssen-Cilag International NV	14 May 2002
Pulmonary Arterial Hypertension	United States	Actelion Pharmaceuticals US, Inc.	20 Nov 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Persistent Fetal Circulation Syndrome	Phase 3	-	Actelion Pharmaceuticals US, Inc.	01 Dec 2011
Connective Tissue Diseases	Phase 3	Canada	Actelion Pharmaceuticals US, Inc.	01 Apr 2009
Diabetes Mellitus, Type 2	Phase 3	Canada	Actelion Pharmaceuticals US, Inc.	01 Jan 2009
Diabetic Nephropathies	Phase 3	Canada	Actelion Pharmaceuticals US, Inc.	01 Jan 2009
Sarcoidosis	Phase 3	United States	Actelion Pharmaceuticals US, Inc.	01 Apr 2008
Anemia, Sickle Cell	Phase 3	-	Actelion Pharmaceuticals US, Inc.	01 Mar 2006
Hypertension, Pulmonary	Phase 3	-	Actelion Pharmaceuticals US, Inc.	01 Mar 2006
Chronic thromboembolic pulmonary hypertension	Phase 3	-	Actelion Pharmaceuticals US, Inc.	01 Oct 2005
Lung Diseases, Interstitial	Phase 3	-	Actelion Pharmaceuticals US, Inc.	01 Jul 2004
Digital ulcer	Phase 3	-	Actelion Pharmaceuticals US, Inc.	01 Oct 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EADV2023	Not Applicable	Vascular Diseases	-	Bosentan 62.5 mg	ybxrmwlsax(dfufnyxbwl): mean treatment effect = 35.6 (95% CI, 13.4 - 57.7), P-Value = <0.05 View more	Positive	11 Oct 2023
				Nifedipine 20 mg
EULAR2019	Not Applicable	Scleroderma, Systemic	35	Bosentan	hbqbkcauab(lnzekjkgfq) = fdhygjboqz aaynzmhwgu (eoobserhdy ) View more	Positive	12 Jun 2019
ERS2018	Not Applicable	Pulmonary Arterial Hypertension	-	Bosentan	gmilbbvrqp(aszvbduvbc) = pwatmcxpdb pkgwvfksaa (hcneoytkxp ) View more	Positive	15 Sep 2018
				Macitentan	gmilbbvrqp(aszvbduvbc) = ajsqbqizgh pkgwvfksaa (hcneoytkxp ) View more
EULAR2018	Not Applicable	Scleroderma, Systemic Endothelin-1 (ET-1)	-	ILO group	zmjpinxjcw(ixfmtocuof) = xjmbxwroaw ypaeaqsfpn (jcdnbwcysj )	Positive	13 Jun 2018
				ILO +BOS group	zmjpinxjcw(ixfmtocuof) = kcgtfaxaou ypaeaqsfpn (jcdnbwcysj )
ESC2018	Not Applicable	Hypertension, Pulmonary	50	Pulmonary artery vasodilators	krkwwbnjbh(ppjkgldinp) = nihdmqhlpo urnyoadxfl (ubztkpkizy ) View more	Negative	27 May 2018
NCT00433329 (COMPASS-3, Pubmed \| Pulm Circ)	Phase 4	Pulmonary Arterial Hypertension Add-on	100	Bosentan monotherapy	xbgwyixovo(elurtubvti) = xsegwbaxcn zpondgapwu (cehretheou )	-	01 Jan 2018
				Add-on sildenafil	xbgwyixovo(elurtubvti) = kyvdjfifbr zpondgapwu (cehretheou )
NCT01338415 (FUTURE 3 Ext, CTgov)	Phase 3	Pulmonary Arterial Hypertension	58	Bosentan (Bosentan 2mg/kg b.i.d.)	qmrqenrvls = qnyfweemva ahofhvydfv (eqfmgfryda, oiycpxvtys - aytbetwvzj) View more	-	11 Dec 2017
				Bosentan (Bosentan 2mg/kg t.i.d.)	qmrqenrvls = dkyvaadqpl ahofhvydfv (eqfmgfryda, ecqtabudso - yxarganlmn) View more
NCT00323297 (Pubmed \| BMC Cardiovasc Disord)	Phase 4	Pulmonary Arterial Hypertension	105	Sildenafil	xfhcabftjp(rtdwcvagqg) = lfxzzmxjqh owqjbikwlu (wcqbsvqwls )	-	06 Sep 2017
				Placebo	xfhcabftjp(rtdwcvagqg) = yqteikkkfm owqjbikwlu (wcqbsvqwls )
ERS2017	Not Applicable	Pulmonary Arterial Hypertension \| Chronic thromboembolic pulmonary hypertension	2	Bosentan 62.5mg/d for 4w, then 125mg/d	qudrarmhyg(cdzvvodasu) = kdkicryzeo gudnsybkjk (lbdokqhtit ) View more	Positive	01 Sep 2017
ESC2017	Not Applicable	Hypertension, Pulmonary	-	Bosentan	xdypyhftkv(vldouxnysb) = pdciqbwjup erbehswtjw (zujmhmiqrq ) View more	-	29 Aug 2017
				bosentan	xdypyhftkv(vldouxnysb) = rnzobyryhl erbehswtjw (zujmhmiqrq ) View more

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis