Betaine

drug
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Also known as AbromineAcidol pepsinAmversioBetaine anhydrousanhydrousCystadaneFEMA NO. 4223NSC-166511SID11110845SID90341438GlycinebetaineGlycine betaineSID144211476SID144207060SID174007375

Summary

Betaine (CHEMBL95889) is an approved small molecule (ATC A16AA06); indicated across 10 conditions including homocystinuria and depressive disorder.

At a glance

  • Status: Approved (max clinical phase 4)
  • Modality: Small molecule
  • ATC class: A16AA06
  • Indications: 10 conditions
  • Clinical trials: 29
  • Chemistry: 118.15 Da · C5H12NO2+

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL95889
NameBetaine
TypeSmall molecule
Max phase4
FDA approvedno
PubChem CID248
ChEBICHEBI:41139
ATCA16AA06
Molecular formulaC5H12NO2+
Molecular weight118.15
InChIKeyKWIUHFFTVRNATP-UHFFFAOYSA-O

SMILES: C[N+](C)(C)CC(=O)O

IUPAC name: carboxymethyl(trimethyl)azanium

ChEBI definition: A quaternary ammonium ion in which the substituents on nitrogen are methyl (three) and carboxymethyl.

Other ChEBI roles (chemical / environmental): fundamental metabolite.

Also known as: Abromine, Acidol pepsin, Amversio, Betaine, Betaine anhydrous, anhydrous, Cystadane, FEMA NO. 4223, NSC-166511, SID11110845, SID90341438, betaine

Parent form; salt/anhydrous children: CHEMBL1201130

Patent coverage: 2,369 distinct patent families (5,997 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Thyrotropin receptor.

Bioactivity

ChEMBL activities: 2 potent at pChembl ≥ 5 of 2 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

TargetpChemblTypeValueUnitActivity ID
TSHR8.4Potency4nMCHEMBL_ACT_3922759
TSHR8.4Potency4nMCHEMBL_ACT_4618646

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

10 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

IndicationTrial phaseMONDOEFO
homocystinuria4MONDO:0004737MONDO:0004737
depressive disorder4MONDO:0002050MONDO:0002009
obesity disorder2MONDO:0011122EFO:0001073
hepatitis C virus infection2MONDO:0005231EFO:0003047
metabolic dysfunction-associated steatohepatitis2MONDO:0007027EFO:1001249
primary hyperoxaluria2MONDO:0002474MONDO:0002474
syringomyelia2MONDO:0017987MONDO:0017987
male infertility1MONDO:0005372EFO:0004248
chronic hepatitis C virus infection0MONDO:0005354EFO:0004220

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 29.

Phase distribution

PhaseTrials
Not specified16
PHASE26
PHASE2/PHASE32
PHASE41
PHASE31
PHASE1/PHASE21
EARLY_PHASE11
PHASE11

Top trials by phase / activity

NCTPhaseStatusTitle
NCT01749982PHASE4COMPLETEDA Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh
NCT00310336PHASE2/PHASE3COMPLETEDChronic Hepatitis C Non-Responder Study With AdoMet and Betaine
NCT01838941PHASE3COMPLETEDBetaine and Peroxisome Biogenesis Disorders
NCT03702205PHASE2/PHASE3UNKNOWNBetaine Effect in Speed-strength Athletes
NCT04633044PHASE1/PHASE2ACTIVE_NOT_RECRUITINGMaternal Betaine Supplementation During Breastfeeding
NCT06308367PHASE2RECRUITINGThe Therapeutic Effect of Betaine in Syringomyelia
NCT07276204PHASE2NOT_YET_RECRUITINGBetaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH)
NCT00283387PHASE2COMPLETEDEfficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria
NCT00586911PHASE2COMPLETEDBetaine in Patients With Nonalcoholic Steatohepatitis
NCT01950039PHASE2COMPLETEDMetabolic Effects of Betaine Supplementation
NCT02404337PHASE2COMPLETEDBetaine METABOLISM OF PATIENTS With Homocystinuria
NCT02122211PHASE1COMPLETEDCholine Dehydrogenase and Sperm Function: Effects of Betaine
NCT00882193EARLY_PHASE1TERMINATEDPilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers
NCT03073343Not specifiedRECRUITINGA Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
NCT06881511Not specifiedRECRUITINGExploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis
NCT07144527Not specifiedRECRUITINGNicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults
NCT07243678Not specifiedACTIVE_NOT_RECRUITINGPharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers
NCT07607106Not specifiedRECRUITINGEfficacy of a New Composition (BU002) for Debridement of Chronic Cutaneous Ulcers
NCT00102843Not specifiedCOMPLETEDEffect of Betaine and Folic Acid on Vascular Function in Healthy Humans
NCT00348933Not specifiedCOMPLETEDDietary Supplements for the Treatment of Angelman Syndrome
NCT00571714Not specifiedWITHDRAWNPilot Comparison of Standard Antiviral Therapy With and Without 12 Weeks of Betaine in Genotype 1 Naive Patients
NCT01213719Not specifiedCOMPLETEDEffects of Betaine Supplementation on Strength and Muscle Creatine Content
NCT02118142Not specifiedCOMPLETEDModulation of Insulin Sensitivity by Betaine Upregulation of FGF21
NCT02758015Not specifiedCOMPLETEDEffect of Betaine and Food on Gastric pH
NCT04585295Not specifiedCOMPLETEDThe Effects of Pre-Loaded Betaine Supplementation on Thermoregulation and Exercise Metabolism in the Heat
NCT05790070Not specifiedCOMPLETEDPotential Synergistic Effect of Combined Blood Flow Restriction Training and Betaine Supplementation on Skeletal Muscle
NCT06042270Not specifiedCOMPLETEDFirefighter Thermoregulatory Responses in Active Fire with Betaine Supplementation
NCT06344377Not specifiedCOMPLETEDBetaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women
NCT06392360Not specifiedCOMPLETEDBetaine, Exercise Performance, and Gut Permeability

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).