Summary report on authorisation – Jeraygo®

Authorisation in Switzerland: 18 September 2025

Film-coated tablet for the treatment of resistant hypertension in adults in combination with at least three antihypertensive medicinal products

Jeraygo contains the active substance aprocitentan and is used to treat adults with resistant hypertension. Resistant hypertension is high blood pressure that cannot be adequately controlled despite treatment with at least three other antihypertensive medicinal products.

In deciding whether to authorise Jeraygo, Swissmedic took into account the assessments of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), as well as the corresponding medicinal product information texts.

Since the assessment of the clinical data was based on the assessment reports of these foreign authorities, the preconditions for a full SwissPAR (Swiss Public Assessment Report - a detailed report for professionals) and a resulting Summary report on authorisation are not met. Swissmedic refers to the authorisation of the foreign reference authorities.
www.ema.europa.eu, www.fda.gov

Information for healthcare professionals:

JERAYGO Filmtabletten

Information for patients (package leaflet):

JERAYGO Filmtabletten

Healthcare professionals can answer any further questions.

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^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}