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Drug

Betaine

Approved · EMA
Emerging researchLate-stage development
Also known as Abromine, Acidol, Betaína anhidra, Cystadane+17 more

Abromine, Acidol, Betaína anhidra, Cystadane, Glycine betaine, Glycinebetaine, Glykokollbetain, Lycine, Oxyneurine, TMG, Trimethylglycine, Trimethylglycocoll, 2-(Trimethylammonio)Acetate, 2-N,N,N-trimethylammonio acetate, 2-trimethylammonioacetate, Betaine Anhydrous, Betaine Hydrochloride, N,N,N-Trimethylglycine, N,N,N-trimethylammonioacetate, Trimethylaminoacetate, Trimethylammonioacetate.

RxNorm1512ChEMBLCHEMBL1182UNII3SCV180C9W
1
Research papers
2
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II, Double-masked, Placebo-controlled, Randomized, Parallel Treatment Group Trial to Investigate the Safety and Efficacy of Betaine + Standard of Care (SOC) vs. Placebo + SOC Among Participants With Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH) and Elevated Serum Alanine Aminotransferase (ALT) Level

Clinical trial2026-01-08Results expected Q4 2029 · ClinicalTrials.gov

The Effect of Betaine in Refractory Syringomyelia（RS）

Clinical trial2024-03-13Results expected Q1 2027 · ClinicalTrials.gov

Approval: Amversio (EMA)

Regulatory2022-05-05EMA

Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation

Clinical trial2021-04-20Results posted · ClinicalTrials.gov

Metabolic Effects of Betaine: A Randomized Clinical Trial of Betaine Supplementation in Prediabetes.

Research2018-08-01The Journal of clinical endocrinology and metabolism

Betaine METABOLISM OF PATIENTS With Homocystinuria

Clinical trial2018-02-01Completed · ClinicalTrials.gov

A Pilot, Open Label Trial Assessing the Safety and Efficacy of Betaine in Children With Peroxisome Biogenesis Disorders.

Clinical trial2016-06-28Results posted · ClinicalTrials.gov

A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh

Clinical trial2014-08-28Results posted · ClinicalTrials.gov

Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria

Clinical trial2013-12-16Results posted · ClinicalTrials.gov

Pilot Study Evaluating Gastric Re-acidification Using Betaine Hydrochloride in Healthy Volunteers With Pharmacologically Induced Hypochlorhydria

Clinical trial2013-07-02Results posted · ClinicalTrials.gov

Efficacy of a Therapeutic Treatment Trial in Angelman Syndrome

Clinical trial2012-09-24Results posted · ClinicalTrials.gov

Pilot Therapy Using Betaine in Combination With Peginterferon Alpha-2a Plus Ribavirin in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Pegylated Interferon and Ribavirin

Clinical trial2011-01-12Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Betaine
Aliases & brands
AbromineAcidolBetaína anhidraCystadaneGlycine betaineGlycinebetaineGlykokollbetainLycineOxyneurineTMGTrimethylglycineTrimethylglycocoll2-(Trimethylammonio)Acetate2-N,N,N-trimethylammonio acetate2-trimethylammonioacetateBetaine AnhydrousBetaine HydrochlorideN,N,N-TrimethylglycineN,N,N-trimethylammonioacetateTrimethylaminoacetateTrimethylammonioacetate
RxNorm CUI
1512
ChEMBL ID
CHEMBL1182
UNII
3SCV180C9W
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-05-05
Latest approval
2022-05-05
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-05-05Approval
Approval: Amversio (EMA)
Indication: Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS), 5,10 methylene tetrahydrofolate… Show full indication

Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS), 5,10 methylene tetrahydrofolate reductase (MTHFR), cobalamin cofactor metabolism (cbl).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
12
registered trials across all phases
LATEST COMPLETION 2018
2
Active studies
2
Recruiting
5
Late-stage (III+)
9
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 12
Early Phase 11Phase 26Phase 2 / 31Phase 31Phase 41Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh

CompletedPH IVColumbia Universityn=602014

A Pilot, Open Label Trial Assessing the Safety and Efficacy of Betaine in Children With Peroxisome Biogenesis Disorders.

CompletedPH IIIMcGill University Health Centre/Research Institute of the McGill University Health Centren=122015

Chronic Hepatitis C: Treatment of (Peg)Interferon Alpha - Ribavirin Non-Responders With Pegylated Interferon alpha2b, Ribavirin, AdoMet and Betaine

CompletedPH II/IIIUniversity Hospital, Basel, Switzerlandn=302009

Recent completions

Trials that read out recently, adding to the completed evidence base.

Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation

CompletedPH IIJoslin Diabetes Centern=282018

Betaine METABOLISM OF PATIENTS With Homocystinuria

CompletedPH IIAssistance Publique - Hôpitaux de Parisn=122018

A Pilot, Open Label Trial Assessing the Safety and Efficacy of Betaine in Children With Peroxisome Biogenesis Disorders.

CompletedPH IIIMcGill University Health Centre/Research Institute of the McGill University Health Centren=122015

A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh

CompletedPH IVColumbia Universityn=602014

Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria

CompletedPH IIMayo Clinicn=152011

Pilot Study Evaluating Gastric Re-acidification Using Betaine Hydrochloride in Healthy Volunteers With Pharmacologically Induced Hypochlorhydria

CompletedN/AUniversity of California, San Franciscon=62011

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Metabolic Effects of Betaine: A Randomized Clinical Trial of Betaine Supplementation in Prediabetes.

The Journal of clinical endocrinology and metabolism · 2018 · 37 cites
Recent papers

Metabolic Effects of Betaine: A Randomized Clinical Trial of Betaine Supplementation in Prediabetes.

The Journal of clinical endocrinology and metabolism · 2018 · 37 cites
Journals, researchers & institutions
Top journals
  • The Journal of clinical endocrinology and metabolism1
Leading researchers
  • Basu R1
  • Beckman JA1
  • Cloutier E1
  • Dreyfuss JM1
  • Fowler KM1
  • Gerszten RE1
  • Goldfine AB1
  • Grizales AM1
Leading institutions
free-text, unnormalised
  • Beth Israel Deaconess Medical Center1
  • Brigham and Women's Hospital1
  • Harvard Medical School1
  • Joslin Diabetes Center1
  • University of Virginia School of Medicine1
  • Vanderbilt University Medical Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.