Acoramidis
ATTRUBY
What it isOral transthyretin tetramer stabilizer; ATTR cardiomyopathy.
Why this oneIt was designed to mimic a protective TTR variant, producing especially strong tetramer stabilization.
What limits itClinical benefit is delayed; diarrhea and gout can end treatment, while cost commonly blocks access.
FDA-approved for
- ATTR cardiomyopathy (2024)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Cardiomyopathy of transthyretin-mediated amyloidosis (ATTR-CM) | Adults | 712 mg BID | 712 mg BID | 712 mg BID |
Renal No clinically significant PK differences with renal impairment (label PK section); no dosage adjustment provided in dosing section
Hepatic Undefined (effect of hepatic impairment on PK unknown per label)
Instructions
- Swallow tablets whole; do not cut, crush, or chew
- With or without food
Cautions
- Initiation causes increase in serum creatinine (~0.2 mg/dL) and decrease in eGFR (~8 mL/min/1.73 m2) within ~4 weeks; stabilizes and is reversible on discontinuation
Adverse reactions
- Diarrhea (11.6% vs 7.6% placebo), mostly mild
- Upper abdominal pain (5.5% vs 1.4%)
- Reversible increase in serum creatinine / decrease in eGFR
Pregnancy Insufficient human data; no embryofetal abnormalities in rats/rabbits at up to 34x/13x human exposure. Report pregnancies: 1-844-550-2246
Lactation No data on presence in milk or infant effects; weigh benefits of breastfeeding vs need for drug
NO BOXED WARNINGS
Principal riskBenefit takes months to appear
Classes and tags
Clinical profile
Mechanism of action: Acoramidis ballicule
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Memory aids: mascots and interaction avatars
