Acoramidis: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: November 5, 2025🚩 Report this page

Acoramidis

Other Cardiac Preparations

Sold as Beyonttra

EU EMAGB MHRA

Drug class: Other Cardiac Preparations
Availability: See label
Markets covered: 2
Products on record: 2

Overview

Acoramidis is an active pharmaceutical ingredient in the Other Cardiac Preparations group (C01EB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	November 5, 2025
GB United Kingdom	MHRA	1	May 12, 2025

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised November 5, 2025[1]

BEYONTTRA is indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

How to take

GBUnited Kingdom· MHRA

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].

Brands in United Kingdom (1)

BEYONTTRA

Sources & citations

[1]European Medicines Agency · EMEA/H/C/006333 · revised November 5, 2025
[2]MHRA (UK) · PL000100763 · revised May 12, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised November 5, 2025[1]

2%). Tabulated list of adverse reactions The safety data reflect exposure of 421 participants with ATTR-CM to acoramidis 712 mg (as two tablets of 356 mg) administered orally twice daily in a pivotal Phase 3 randomised, double-blind, placebo-controlled study of 30 months fixed treatment duration in patients diagnosed with ATTR-CM.
Adverse reactions are listed below by MedDRA System Organ Class (SOC) and frequency categories using the standard convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), and Uncommon (≥ 1/1 000 to < 1/100). Adverse reactions listed in the table below are from cumulative clinical data in ATTR-CM participants.
Table 1:
List of adverse reactions System Organ Class Very common Gastrointestinal disorders Diarrhoea Metabolism and nutrition disorders Gout Description of selected adverse reactions The majority of events of diarrhoea and gout were non-serious and resolved.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised November 5, 2025[1]

2). 2) and there are no data for patients on dialysis. Hence acoramidis should be used with caution in this population. 1). This change in eGFR and serum creatinine was non-progressive, reversible in those patients whose treatment was interrupted, and not associated with kidney injury, consistent with a renal haemodynamic effect.
Information about excipients Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free’. 4

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations