FDA approved Tryvio (aprocitentan) for Hypertension in Combination with Other AntihypertensivesFDA approved new blood pressure drug Tryvio for hard-to-treat hypertension.

FDA From the archive Source published March 19, 2024 Summary added August 11, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Tryvio as add-on therapy for resistant hypertension, but exclude pregnancy before initiation.

The FDA has approved Tryvio (aprocitentan) for the treatment of hypertension, to be used in combination with other antihypertensive drugs in adult patients who are not adequately controlled on other medications. This approval provides a new option for patients with resistant hypertension, a population at high risk for cardiovascular events. The drug is an endothelin receptor antagonist, a class not previously approved for hypertension, offering a novel mechanism of action.

The approval was supported by the PRECISION trial, a phase 3 study that enrolled adults with systolic blood pressure at least 140 mmHg despite treatment with at least three antihypertensive drugs. In the initial 4-week double-blind period, patients randomized to Tryvio 12.5 mg once daily experienced a statistically significant reduction in sitting systolic blood pressure compared with placebo, measured by unattended automated office blood pressure. The effect was consistent for diastolic blood pressure.

Clinicians should note that Tryvio is not approved as monotherapy; it is intended for use in combination with other antihypertensive agents. The label includes a boxed warning regarding embryo-fetal toxicity, and pregnancy must be excluded before initiating treatment in females of reproductive potential. As with any antihypertensive, blood pressure reduction with Tryvio is expected to reduce cardiovascular risk, but no outcomes trials have been conducted specifically with this drug.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Tryvio (aprocitentan) is an endothelin receptor antagonist. It blocks the binding of endothelin-1 (ET-1) to both ET-A and ET-B receptors, thereby reducing vasoconstriction and blood pressure. The specific contribution of this mechanism to the overall antihypertensive effect has not been fully established.

Indication & Patient Population

Tryvio is indicated for the treatment of hypertension, in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The drug is intended for patients who require additional blood pressure lowering despite existing therapy.

Dosing & Administration

The recommended dosage of Tryvio is 12.5 mg orally once daily, with or without food. Tablets should be swallowed whole. If a dose is missed, the patient should skip the missed dose and take the next dose at the regular time; two doses should not be taken on the same day. In females of reproductive potential, pregnancy must be excluded before initiating treatment.

Key Clinical Trial Data

The efficacy of Tryvio was evaluated in the PRECISION trial (NCT03541174), a phase 3 multicenter study in adults with systolic blood pressure ≥140 mmHg who were prescribed at least three antihypertensive medications. Patients were switched to a standard background regimen of an angiotensin receptor blocker, a calcium channel blocker, and a diuretic, continued throughout the study. After a 4-week placebo run-in, 730 patients were randomized to aprocitentan 12.5 mg, 25 mg, or placebo once daily for 4 weeks (part 1). The primary endpoint was change in sitting systolic blood pressure (SiSBP) from baseline to Week 4, measured by unattended automated office blood pressure (uAOBP). Tryvio 12.5 mg was statistically superior to placebo in reducing SiSBP at Week 4; the effect was consistent for sitting diastolic blood pressure. The trial also included a 32-week single-blind period and a 12-week double-blind withdrawal period, but the primary analysis was based on the initial 4-week data.

Warnings & Contraindications

Tryvio is contraindicated in pregnancy. It may cause fetal harm, and pregnancy must be excluded before initiation in females of reproductive potential. The label includes a boxed warning for embryo-fetal toxicity. Other warnings and precautions were not detailed in the provided label text.

Place in Therapy

Tryvio is an add-on therapy for patients with hypertension who are not adequately controlled on other antihypertensive drugs. It offers a novel mechanism of action (endothelin receptor antagonism) and may be considered in patients with resistant hypertension. However, its place in therapy is limited by the lack of long-term cardiovascular outcomes data and the requirement for use in combination with other agents. Clinicians should weigh the potential benefits against the risks, particularly in women of reproductive potential.

The U.S. Food and Drug Administration (FDA) has approved a new medication called Tryvio (aprocitentan) for the treatment of high blood pressure, also known as hypertension. This drug is specifically for adults whose blood pressure remains high even when they are already taking at least three other blood pressure medications. This condition is called resistant hypertension, and it increases the risk of heart attacks, strokes, and other cardiovascular problems.

Tryvio works in a new way compared to older blood pressure drugs. It blocks the effects of a substance in the body called endothelin, which can narrow blood vessels and raise blood pressure. Because it works differently, it may help people who have not gotten enough benefit from other types of medicines. It is not meant to be used alone; it should be taken together with other blood pressure drugs.

The approval is based on a large study called PRECISION. In that study, people who took Tryvio once a day had a greater drop in their blood pressure after four weeks than those who took a placebo (a pill with no medicine). The effect was seen for both the top number (systolic) and the bottom number (diastolic) of a blood pressure reading.

It is important to know that Tryvio has a boxed warning about the risk of harm to an unborn baby. Because of this, women who can become pregnant must have a negative pregnancy test before starting the drug and must use effective birth control while taking it. Also, no long-term studies have been done yet to see if Tryvio reduces heart attacks or strokes directly. If you have resistant hypertension, talk to your doctor to see if Tryvio might be a good addition to your treatment plan.

What this means for you:

Tryvio is a new add-on treatment for stubborn high blood pressure, but it is not a replacement for your current medicines.

Study Details

Study typeFda approval

PublishedMar 2024

View Original Abstract ↓

1 INDICATIONS AND USAGE TRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering BP reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating reduction of risk of these events with TRYVIO. Control of high BP should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve BP goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is BP reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher BPs, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from BP reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower BP goal. TRYVIO is an endothelin receptor antagonist indicated for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1 )

FDA approved Tryvio (aprocitentan) for Hypertension in Combination with Other AntihypertensivesFDA approved new blood pressure drug Tryvio for hard-to-treat hypertension.

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