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aprocitentan

Jeraygo · ATC code C02KN01

Also known as: Aprositentan

Key facts
Active substance
aprocitentan
ATC code
C02KN01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
JERAYGO 12.5 mg film-coated tablets / JERAYGO 25 mg film-coated tablets
Marketing authorisation holder
Idorsia Pharmaceuticals Deutschland GmbH
Information as of
2026-10-29

Key facts

Aprocitentan (Jeraygo) is an endothelin receptor antagonist used for resistant hypertension in adults, in combination with at least three other antihypertensives.

What it is used for

  • Treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.

Dosing

  • 12.5 mg orally once daily; can be increased to 25 mg once daily in patients who tolerate 12.5 mg and need tighter blood pressure control.
  • Taken with or without meals; tablets are swallowed whole.
  • Missed dose: resume the next day; do not take two doses on the same day.
  • Renal impairment: no dose adjustment (including eGFR 15–29 mL/min); not recommended with eGFR < 15 mL/min or on dialysis.
  • Hepatic impairment: no adjustment in Child-Pugh A or B; must not be started in Child-Pugh C.
  • Elderly: no adjustment over 65 years; limited experience over 75 years.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.
  • Pregnancy and breast-feeding.
  • Women of childbearing potential not using reliable contraception.
  • Severe hepatic impairment (Child-Pugh class C).

Important warnings

  • Pregnancy tests are recommended before treatment, monthly during treatment and one month after stopping; reliable contraception is needed during treatment and for one month afterwards.
  • Liver enzymes should be checked before starting and monitored; not recommended if aminotransferases are > 3 × ULN; stop if sustained unexplained elevations occur or with bilirubin > 2 × ULN or symptoms of hepatotoxicity.
  • Oedema and fluid retention can occur; patients should be monitored for oedema or weight gain. The risk is higher with eGFR < 60 mL/min/1.73 m2, pre-existing heart failure or older age.
  • Patients on loop diuretics should not be switched to a less effective diuretic when starting treatment.
  • Haemoglobin may decrease.

Side effects

  • Very common: oedema/fluid retention (9.1% with 12.5 mg and 18.4% with 25 mg).
  • Common: upper respiratory tract infection, haemoglobin decreased, hypersensitivity, headache, dyspnoea.
  • Uncommon: hypotension, flushing, transaminase increased, glomerular filtration rate decreased during initial treatment.

Interactions

  • Aprocitentan exposure is not expected to be affected by inhibitors or inducers of transporters or CYP enzymes.
  • Possible induction of CYP2B6 and CYP1A2: caution with CYP1A2 substrates with a narrow therapeutic index (e.g. tizanidine).
  • Aprocitentan increased the Cmax of rosuvastatin (a BCRP substrate) by 40%, while total exposure was unchanged.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy and breast-feeding; if pregnancy is detected, treatment must be stopped.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • JeraygoIdorsia Pharmaceuticals Deutschland GmbH · EMEA/H/C/006080

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Jeraygo
Liechtenstein
Jeraygo
Norway
Jeraygo

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Jeraygo – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/jeraygo-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.