MedeliX
Start asking

acoramidis

Beyonttra · ATC code C01EB25

Also known as: Akoramidis

Key facts
Active substance
acoramidis
ATC code
C01EB25
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
BEYONTTRA 356 mg film-coated tablets
Marketing authorisation holder
Bayer AG
Information as of
2026-10-28

Key facts

Acoramidis is a transthyretin stabiliser. It is used to treat wild-type or variant transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in adults.

What it is used for

  • Treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) (Beyonttra).

Dosing

  • Beyonttra 356 mg film-coated tablets: recommended dose 712 mg (two 356 mg tablets) orally twice daily, a total daily dose of 1,424 mg.
  • Treatment should be initiated by a physician knowledgeable in the management of ATTR-CM.
  • A missed dose is not made up with a double dose; dosing resumes at the next scheduled time.
  • Elderly (≥ 65 years) and renal impairment: no dose adjustment; data in severe renal impairment (creatinine clearance < 30 mL/min) are limited and there are no data on dialysis, so use with caution.
  • Hepatic impairment: not studied, use not recommended.
  • Tablets are swallowed whole with water, with or without food. There are no efficacy data in NYHA Class IV.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.

Important warnings

  • Not studied in hepatic impairment and therefore not recommended.
  • Severe renal impairment: limited data and no data on dialysis; use with caution.
  • An initial decrease in eGFR with a corresponding rise in serum creatinine occurred in the first month; the change was non-progressive, reversible on interruption and not associated with kidney injury.
  • Contains less than 1 mmol sodium (23 mg) per tablet.

Side effects

  • Most frequently reported: diarrhoea (11.6%) and gout (11.2%), both very common.
  • Most events of diarrhoea and gout were non-serious and resolved.

Interactions

  • Inhibition of OAT-1 and OAT-3 is not expected to cause clinically relevant interactions with their substrates (e.g. NSAIDs, furosemide, methotrexate), based on a study in healthy volunteers.
  • No interaction with BCRP substrates is anticipated at clinically relevant concentrations. See the full text for more.

Pregnancy and breastfeeding

  • No data in pregnant women; animal studies showed developmental toxicity. Not recommended during pregnancy or in women of childbearing potential not using contraception.
  • Acoramidis should not be used during breast-feeding.

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 →

Common questions – ask Medelix

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)

Source: European Medicines Agency (EMA), product information

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

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.

Other substances in the same group

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. Beyonttra – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/beyonttra-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.