A Single-center, Open-label, Fixed-sequence Trial to Investigate the Effect of Multiple-dose Aprocitentan on the Single-dose Pharmacokinetics of Combined Oral Contraceptives in Healthy Female Participants

The goal of this clinical trial is to learn if drug aprocitentan has an effect on hormonal contraceptives in healthy female volunteers. The main question it aims to answer is:
Does aprocitentan modify the fate of hormonal contraceptives in the body?
Trial participants will:
* Take a single dose of hormonal contraceptives (fixed combination) alone
* Take aprocitentan every day for 2 weeks
* Take a single dose of the same hormonal contraceptives at the same time as the 10th administration of aprocitentan.

Start Date18 Jan 2025

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

NCT05196399

/ CompletedPhase 1

A Single-center, Open-label, Randomized, Two-way Crossover Phase 1 Study to Compare the Single-dose Pharmacokinetics of Different Tablet Formulations of Aprocitentan in Healthy Subjects

The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.

Start Date02 Feb 2022

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

NCT04252495

/ CompletedPhase 1

An Open-label Phase 1 Study to Investigate the Effect of Moderate Hepatic Impairment Due to Liver Cirrhosis on the Pharmacokinetics of a Single Dose of 25 mg Aprocitentan

This is a prospective, open-label, single-dose, Phase 1 study, to assess the effect of moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan (ACT-132577).

Start Date26 Jun 2020

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

100 Clinical Results associated with Aprocitentan

100 Translational Medicine associated with Aprocitentan

100 Patents (Medical) associated with Aprocitentan

Literatures (Medical) associated with Aprocitentan

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·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.

01 Mar 2025·Cardiology in review

New Therapy Update Aprocitentan: An Endothelin Receptor Antagonist for the Treatment of Drug-Resistant Systemic Hypertension

Review

Author: Frishman, WIlliam H. ; Airo, Michael ; Aronow, Wilbert S.

Resistant hypertension (RH) is the state of uncontrolled blood pressure in the face of ostensibly optimal pharmacological intervention. It accounts for roughly one in six cases of hypertension, and is associated with more severe morbidity and mortality outcomes than is non-RH. The prevalence of RH implies a currently unmanaged pathology, which may involve the potent vasoconstrictor endothelin. Several endothelin receptor antagonists are currently marketed for pulmonary arterial hypertension, but none so far has been marketed for RH. Aprocitentan is currently in development, an endothelin receptor antagonist that effectively produces clinically significant and sustained decreases in systolic and diastolic blood pressure in the setting of RH.

News (Medical) associated with Aprocitentan

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

·endpts.com

Mineralys’ Phase 3 blood pressure pill data support potential FDA approval

Topline pivotal data suggest that Mineralys Therapeutics’ experimental hypertension pill is a good prospect not only for approval but also for widespread adoption as a treatment for patients whose condition has not responded to other drugs. The company’s stock $MLYS rose 52% in early trading. The Phase 3 Launch-HTN trial signed up over 1,000 adults whose high blood pressure was uncontrolled despite taking two to five background antihypertensive medications. Two doses of Mineralys’ lorundrostat were tested: One group received the aldosterone synthase inhibitor at 50 mg once daily, and another group at a 50 mg-daily dose titrated up to 100 mg per day, as needed, at week six. After six weeks, pooled data from patients in both lorundrostat arms showed a blood pressure reduction of 9.1 mmHg more than those with a placebo (p<0.0001), the company said Monday. After a further six weeks, the placebo-adjusted blood pressure drop in the 50 mg-only group had deepened to 11.7 mmHg, which was also significant. However, patients who had their doses titrated up to 100 mg per day had a lesser blood pressure reduction at the 12-week point — just 8.4 mmHg on a placebo-adjusted basis (p<0.0016). Mineralys also said that “equivalent” systolic blood pressure cuts were seen in subjects with uncontrolled hypertension, who were on two antihypertensive medications, and in those with resistant hypertension, who were taking three to five drugs. Treatment emergent serious adverse events (SAEs) were seen in 2.2% of patients in the 50 mg and 0.7% in the 50 mg with optional escalation to 100 mg arms, respectively, Mineralys said, versus 3% with placebo. One subject in the 50 mg arm had an SAE that was related to lorundrostat. The 9.1 mmHg benefit over placebo on the primary endpoint meets Stifel analysts’ “upside” case. In a Feb. 24 note, the analysts wrote that a benefit of between 8 and 10 mmHg would not only be approvable, but should secure broad insurance coverage for lorundrostat as a fourth-line hypertension therapy. Lorundrostat appears to be a better prospect than the last drug approved for resistant hypertension. Idorsia’s endothelin receptor antagonist Tryvio reached the US a year ago on the strength of a 3.8 mmHg reduction. But this was seen with the lower dose in its pivotal trial; the higher dose was not approved because of safety concerns. Tryvio’s label carries a black box warning of embryo-fetal toxicity. Idorsia’s efforts to sign up a partner for Tryvio fell through last month, leaving the company in a difficult financial position. Mineralys also released data from a Phase 2 study called Advance-HTN in patients taking an optimized background treatment of two or three antihypertensive drugs. This study also hit its primary endpoint, yielding a placebo-adjusted reduction in systolic BP of 7.9 mmHg at three months with a 50 mg dose of lorundrostat. Blood pressure was measured slightly differently here, using a 24-hour average, whereas Phase 3 patients’ blood pressure was measured in their doctors’ offices. Office blood pressure measurements tend to be slightly higher than ambulatory measurements because of the so-called white coat syndrome . The company said that efficacy in the dose-escalation cohort and safety and tolerability data “mirrored the pattern” seen in Launch-HTN. Further data from Advance-HTN will be presented on March 29 at the American College of Cardiology’s annual meeting. Editor’s note: This article has been updated with Mineralys’ the latest stock move.

Clinical ResultPhase 3Phase 2

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

100 Deals associated with Aprocitentan

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KEGG	Wiki	ATC	Drug Bank
D11441	-	-	DB15059

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Resistant hypertension	European Union	Idorsia Ltd.	01 Jul 2024
Resistant hypertension	Iceland	Idorsia Ltd.	01 Jul 2024
Resistant hypertension	Liechtenstein	Idorsia Ltd.	01 Jul 2024
Resistant hypertension	Norway	Idorsia Ltd.	01 Jul 2024
Hypertension	United States	Idorsia Pharmaceuticals Ltd.	19 Mar 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	NDA/BLA	Canada	Idorsia Pharmaceuticals Ltd.	01 Jan 2025
Chronic Kidney Diseases	Phase 3	-	Janssen Biotech, Inc.	01 Jan 2020
Chronic Kidney Diseases	Phase 3	-	Idorsia Pharmaceuticals Ltd.	01 Jan 2020
Liver Cirrhosis	Phase 1	Germany	Idorsia Pharmaceuticals Ltd.	26 Jun 2020
Liver Cirrhosis	Phase 1	Poland	Idorsia Pharmaceuticals Ltd.	26 Jun 2020
Liver Injury	Phase 1	Germany	Idorsia Pharmaceuticals Ltd.	26 Jun 2020
Liver Injury	Phase 1	Poland	Idorsia Pharmaceuticals Ltd.	26 Jun 2020
Renal Insufficiency	Phase 1	Czechia	Idorsia Pharmaceuticals Ltd.	03 Jun 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03541174 (PRECISION, Pubmed \| Hypertension)	Phase 3	Hypotension	-	Aprocitentan 12.5 mg	tovaikxrlu(ddqzgudxic) = amrmnhrfga qzejxzuypl (mzmurtxkbw )	Positive	01 Apr 2025
				Aprocitentan 25 mg	tovaikxrlu(ddqzgudxic) = tmghvaquxe qzejxzuypl (mzmurtxkbw )
PRECISION (ESH2024)	Phase 3	Resistant hypertension	-	Aprocitentan 12.5 mg	sfwkxhgotx(qfjrydjxlr) = mdcenessjg nhaquvwgak (vcgjhltopg )	Positive	01 May 2024
				Aprocitentan 25 mg	sfwkxhgotx(qfjrydjxlr) = xwpfzxvqwl nhaquvwgak (vcgjhltopg ) View more
PRECISION (ESH2024)	Phase 3	Resistant hypertension	93	Aprocitentan 12.5 mg	oobadgehlq(anicartowl) = lpcguipbii iixauqebzb (lwwmejweet ) View more	Positive	01 May 2024
				Aprocitentan 25 mg	oobadgehlq(anicartowl) = hujbphqkqg iixauqebzb (lwwmejweet ) View more
NCT03541174 (FDA) Manual	Phase 3	Hypertension	-	Aprocitentan (12.5 mg)	gwiiwwcwsf(eqoejnphpp) = ltdjuzxdls nrmvgkhgmn (kitsmnsguf, −17.5 - −13.3) View more	Superior	19 Mar 2024
				Placebo	gwiiwwcwsf(eqoejnphpp) = xwbtvzhojt nrmvgkhgmn (kitsmnsguf, −13.7 - −9.5) View more
PRECISION (ESH2023)	Phase 3	Resistant hypertension	730	Aprocitentan 12.5 mg	cwsqyckmhl(ppjpwfpnnx) = igvpbouiss fjkphnixbk (zokknookxa )	Positive	01 Jun 2023
				Aprocitentan 25 mg	cwsqyckmhl(ppjpwfpnnx) = ehqsvhlvvk fjkphnixbk (zokknookxa )
NCT03541174 (PRECISION, CTgov)	Phase 3	Resistant hypertension	730	Aprocitentan 12.5 mg (Aprocitentan 12.5 mg in Part 1 (Double-blind))	tvodyvwwee(oyxuyllfug) = infdqdiyhe doxnbthomw (brxnsepgnx, rjjosjmblc - ucbvinbpee) View more	-	21 Mar 2023
				Aprocitentan 25 mg (Aprocitentan 25 mg in Part 1 (Double-blind))	tvodyvwwee(oyxuyllfug) = bxxympqhqs doxnbthomw (brxnsepgnx, zxpdepdccs - vhcydblkck) View more
NCT02603809 (CTgov)	Phase 2	Essential Hypertension	1,659	Placebo (Placebo)	cfvddgjygw(neijgejsnt) = ksyfihchjw ixtijtjfcc (frfgmhrmor, 5.4) View more	-	13 Apr 2020
				Aprocitentan 5 mg (Aprocitentan 5 mg)	cfvddgjygw(neijgejsnt) = qblpxsdyad ixtijtjfcc (frfgmhrmor, 5.5) View more
NCT02603809 (ESC2019)	Phase 2	Hypertension	490	Aprocitentan 5 mg	hfvblwuzbm(hhqivligvk) = vutybdgqqs lcwplpskgq (jburxvegev ) View more	-	31 Aug 2019
				Aprocitentan 10 mg	hfvblwuzbm(hhqivligvk) = webmntdovm lcwplpskgq (jburxvegev ) View more

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