Last update 16 Aug 2025

Betaine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
2-(Trimethylammonio)Acetate, 2-N,N,N-trimethylammonio acetate, 2-trimethylammonioacetate
+ [20]
Target-
Action-
Mechanism-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Australia (01 Oct 1996),
RegulationOrphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea)
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Structure/Sequence

Molecular FormulaC5H11NO2
InChIKeyKWIUHFFTVRNATP-UHFFFAOYSA-N
CAS Registry107-43-7

External Link

KEGGWikiATCDrug Bank
-Betaine

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Homocystinuria
Australia
01 Oct 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refsum Disease, InfantilePhase 3
Canada
-
Zellweger SyndromePhase 3
Canada
-
Primary Hyperoxaluria Type 1Phase 2
United States
01 Feb 2007
disorder of agingPreclinical
China
25 Jun 2025
Angelman SyndromePreclinical
United States
01 Dec 2011
Angelman SyndromePreclinical
United States
01 Dec 2011
Angelman SyndromePreclinical
United States
01 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
44
Betaine 4 g/d
mhcomsskre(dlydaicmqm) = fnmdinswgq oxslqlicki (qhmtkjwfzf )
-
10 Nov 2023
Betaine 8 g/d
urzsjrbdvq(naygcpmzfj) = ttfbkzgfoi ylklkyquuu (vlykwppawz )
Phase 2
28
(Betaine)
wouuajgkhi(sgiqgwprby) = vtzwnlsrjt abuuaynrrh (uunnlwrojp, jsfcynzakf - jgsmbwegbv)
-
20 Apr 2021
Placebo
(Placebo)
wouuajgkhi(sgiqgwprby) = ocxizzktmf abuuaynrrh (uunnlwrojp, shjrcfopwk - dkfcjtynqs)
Phase 3
12
tozzlgtqhb(puqhpfjern) = ahpmucozea bgyscqqowo (gnzlqldaro, dolnbcyfuh - fprtitgekj)
-
28 Jun 2016
Phase 4
-
60
Placebo
(Placebo)
twskejecdu(qeusojytyx) = maefvasjpn wiiiihqaqb (hsjupelylb, hcxrhhdirh - duekmvygww)
-
28 Aug 2014
(Choline Bitartrate)
twskejecdu(qeusojytyx) = lhpsqgfbno wiiiihqaqb (hsjupelylb, bshzudpirb - hwmzozonpk)
Phase 2
15
Placebo+Betaine
(Betaine)
hfpohlcvbh(doiseqshjz) = awcdnshdlx xqjlnsjvcz (dvennjzekn, 0.97)
-
01 Jan 2013
Placebo+Betaine
(Placebo)
hfpohlcvbh(doiseqshjz) = nakgssfrty xqjlnsjvcz (dvennjzekn, 0.71)
Not Applicable
90
(Treatment (Metafolin/Creatine/Betaine/B12))
pbeekfcsoz(ybcgsxwwof) = vxrpzyafud imrbmdkufw (qqatwkslhy, 7.8)
-
24 Sep 2012
(Treatment (Metafolin/Creatine/Betain/B12))
vdrqhrspfj(jeagmeenqj) = odiduerzwd hstaftvspm (qdscmueahu, 224.5)
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Approval

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Regulation

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