Wednesday, July 8, 2026

Drug profile · INN

betaine

betaine (CYSTADANE) is a betaine-homocysteine s-methyltransferase substrate. Associated with Recordati Rare Diseases Australia Pty.. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 1
Pipeline programs 1
News articles 0
Drug details — betaine
US status
approved
Class
Route
ORAL
Patents
1
Programs
1
Data quality
0.89

Quick answer

betaine (CYSTADANE) is a betaine-homocysteine s-methyltransferase substrate. Associated with Recordati Rare Diseases Australia Pty.. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN betaine
Brand CYSTADANE
Mechanism Betaine-homocysteine S-methyltransferase substrate
Target Betaine-homocysteine S-methyltransferase
Route ORAL
Formulation FOR SOLUTION

Mechanism of action

Betaine-homocysteine S-methyltransferase substrate

Primary target: Betaine-homocysteine S-methyltransferase

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Betaine Unknown · Ultragenyx UK · Angelman Syndrome

Related & competitor drugs

  1. betaine anhydrous Alimentary tract and metabolism (A16)
  1. US 6242486

    Long chain carboxybetaines in antimicrobial formulations

    Expires Mon May 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is betaine?

betaine (CYSTADANE) is a betaine-homocysteine s-methyltransferase substrate. Associated with Recordati Rare Diseases Australia Pty.. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for betaine?

CYSTADANE is a marketed brand name for betaine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of betaine?

betaine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.