Idorsia’s TRYVIO – First FDA-approved therapy to target the endothelin pathway for systemic hypertension

TRYVIO is the first systemic hypertension treatment to target a new pathway in over 30 years and is the only endothelin receptor antagonist (ERA) to be included in the ACC/AHA clinical practice guidelines, reinforcing the need for novel treatment options for healthcare providers managing patients with difficult-to-control hypertension.

Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented:
“TRYVIO represents a breakthrough for patients with difficult-to-control hypertension. Unlike traditional antihypertensives, TRYVIO is the first and only therapy to target the endothelin pathway – a fundamental driver of disease progression that until now has gone unaddressed. This unique mechanism allows us to tackle a root cause where other treatments fall short. With millions of patients still unable to achieve adequate control, TRYVIO has the potential not only to change the treatment paradigm but also to create significant and lasting value for patients, physicians, and Idorsia investors.”

Despite progress in improving patient outcomes, hypertension remains a major global health issue, and the number one modifiable risk factor of cardiovascular morbidity and premature death. In the US, nearly half of adults – about 120 million people – have hypertension. Roughly 40 million patients are treated with antihypertensive drugs. Of these treated patients, 26 million could potentially be treated under TRYVIO’s US indication for patients “not adequately controlled on other drugs”.

This large and growing addressable population translates into a substantial market opportunity. Aprocitentan is uniquely placed as the first and only therapy targeting the endothelin pathway in the hypertension market.

Patients with difficult-to-control hypertension face significantly higher risks of cardiovascular events, including heart attack, stroke and kidney failure, and have a markedly increased risk of premature mortality compared to those with controlled blood pressure. Difficult-to-control hypertension is defined as above-goal elevated blood pressure in a patient despite the concurrent use of multiple antihypertensive drug classes.

Certain groups of patients face a particularly high risk of hypertension that is difficult-to-control with existing therapies. These include Black patients, individuals with higher body weight, older age and postmenopausal women, and those with conditions such as obstructive sleep apnea, type 2 diabetes, heart failure, or chronic kidney disease. In all these patient populations the endothelin system is upregulated – providing a clear scientific rationale for understanding why hypertension is often resistant to treatment.

AHA Hypertension Scientific Sessions
Idorsia will present two scientific posters at the upcoming American Heart Association's (AHA) Hypertension Scientific Sessions held September 4-7, 2025. One poster presents post-hoc analysis demonstrating that aprocitentan provided rapid onset of blood pressure control and a substantial UACR reduction which were both sustained until Week 36 in patients with grade 2 hypertension (defined as systolic blood pressure 160 to 179 mmHg) at baseline. The other poster shares post-hoc analysis in patients with isolated systolic hypertension-like characteristics at baseline, showing that aprocitentan substantially reduced systolic blood pressure while maintaining diastolic blood pressure above 70 mmHg to achieve clinically optimal values associated with minimal cardiovascular risk.

TRYVIO nominated at 2025 Prix Galien USA Awards
The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, recently announced that TRYVIO has been nominated for the 2025 Prix Galien USA Awards in the category of "Best Pharmaceutical Product". See Idorsia’s announcement.

TRYVIO included in the ACC/AHA Guidelines
The American College of Cardiology and the American Heart Association published updated comprehensive clinical practice guidelines for the management of high blood pressure, focusing on evidence-based practices. The ACC and the AHA regularly publish guidelines and scientific statements, which are developed by volunteer scientists and healthcare professionals. The guidelines are based on the latest research and are rigorously reviewed to ensure that they reflect current best practices in cardiovascular health. See Idorsia’s announcement.

About aprocitentan
Aprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ET_A and ET_B 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.

For more information see the TRYVIO Full Prescribing Information including BOXED Warning (PI and Medication Guide).

Important Safety Information
What is the most important information I should know about TRYVIO?
TRYVIO may cause serious side effects, including:
Serious birth defects.

• TRYVIO may cause serious birth defects if taken during pregnancy.
• Females who can become pregnant should not be pregnant when they start taking TRYVIO or become pregnant during treatment with TRYVIO or for 1 month after stopping treatment with TRYVIO.
• Females who can become pregnant should have a negative pregnancy test before starting treatment with TRYVIO.
• Females who can become pregnant are females who:
  • have entered puberty, even if they have not started their menstrual period, and
  • have a uterus, and
  • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
• Females who cannot become pregnant are females who:
  • have not yet entered puberty, or
  • do not have a uterus, or
  • have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or
  • are infertile for other medical reasons and this infertility is permanent and cannot be reversed.
• Females who can become pregnant should use effective birth control during treatment with TRYVIO, and for 1 month after stopping TRYVIO because the medicine may still be in your body.
  • Talk with your healthcare provider or gynecologist (a healthcare provider who specializes in female reproduction) to find out about options for effective birth control that you may use to prevent pregnancy during treatment with TRYVIO.
  • If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control.
• Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.

• Tell your healthcare provider right away if you miss a menstrual period or you think you might be pregnant.
  
  

Who should not take TRYVIO?
Do not take TRYVIO if you are:

• Pregnant or currently trying to become pregnant.
• allergic to aprocitentan or any of the ingredients in TRYVIO.

Before taking TRYVIO, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have heart failure
• have anemia
• have kidney problems or get dialysis
• are pregnant or plan to become pregnant during treatment with TRYVIO. TRYVIO can cause serious birth defects.
• are breastfeeding or plan to breastfeed. It is not known if TRYVIO passes into your breastmilk. Do not breastfeed if you take TRYVIO. Talk to your healthcare provider about the best way to feed your baby if you take TRYVIO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of TRYVIO? TRYVIO may cause serious side effects, including:

• Serious birth defects.
• Liver problems. TRYVIO may cause liver problems. Your healthcare provider should do blood tests to check your liver before starting treatment and as needed during treatment with TRYVIO. Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with TRYVIO:
  • nausea or vomiting
  • yellowing of your skin or whites of your eyes
  • pain in the upper right stomach
  • dark urine
  • tiredness
  • fever
  • loss of appetite
  • itching
• Fluid retention. Fluid retention and swelling are common during treatment with TRYVIO and can be serious. Tell your healthcare provider right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your healthcare provider may treat you with other medicines (diuretics) if you develop fluid retention or swelling.
• Low red blood cell levels (anemia). Anemia is common during treatment with TRYVIO and can be serious. Your healthcare provider will do blood tests to check your red blood cells before starting and as needed during treatment with TRYVIO.
• Decreased sperm count. TRYVIO may cause decreased sperm counts in males and may affect the ability to father a child. Tell your healthcare provider if being able to have children is important to you.
  
  

Your healthcare provider may stop treatment with TRYVIO if you develop certain side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRYVIO. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Notes to the editor

About Idorsia
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 contact:
Investor & Media Relations
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.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 “intend”, "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, business development activities 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.

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