CDEK
← All drugs Report issue

betaine

Small moleculeapprovedOrphan Drug FDA

Approved

Jul 28, 1972

Betaine is a methyl derivative of glycine first isolated from the juice of sugar beets. Betaine is found in many common foods, but concentrated significantly in beets, spinach, wheat foods, and shellfish. In addition, betaine can be synthesized within the human body. Betaine participates in the methionine cycle, which produces vital biomolecules including proteins, hormones, phospholipids, polyamines, and nutrients. Betaine is used as a dietary supplement and has a beneficial effect on the human health. In the USA, FDA approved a betaine-containing drug Cystadane for the treatment of homocystinuria. The drug acts as a methyl group donor in the remethylation of homocysteine to methionine. — NCATS

Clinical trial activity

39 trials · 45 clinical orgs · 7 marketing orgs

Phase 1
6
Phase 2
12
Phase 3
6
Phase 4
3

Earliest trial started Jan 1, 2003 (NCT00586911)

Timeline

1970s

  1. Jul 28, 1972

    Earliest FDA Approval

1990s

  1. May 16, 1994

    Orphan Drug Designation

  2. Oct 25, 1996

    Recordati — Marketing Organization

  3. Oct 25, 1996

    Orphan Europe — NDA Secondary Org

  4. Oct 25, 1996

    Recordati — NDA Secondary Org

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Nov 23, 2021

    Novitium Pharma — Marketing Organization

  2. Nov 23, 2021

    Ani Pharmaceuticals — Marketing Organization

  3. Jan 28, 2022

    Lukare Medical — Marketing Organization

  4. Jan 28, 2022

    Eton Pharmaceuticals, Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJul 28, 1972

Chemistry & pharmacology

Loading structure…

SMILES

C[N+](C)(C)CC(=O)O
Mol. weight
118.16 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 2-n,n,n-trimethylammonio acetate
  • 2-n,n,n-trimethylammonio acetate
  • 2-trimethylammonioacetate
  • 2-trimethylammonioacetate
  • 2-(trimethylammonio)acetate
  • 2-(trimethylammonio)acetate
  • 5107
  • abromine
  • abromine
  • acidol
  • acidol
  • acidol pepsin
  • acidol pepsin
  • betafin
  • betaine
  • betaine
  • betaine
  • betaine
  • betaine
  • betaine
  • betaine
  • betaine
  • betaine
  • betaine
  • betaine anhydrous
  • betaine anhydrous
  • betaine, anhydrous
  • betaine, anhydrous
  • betaine chloride
  • betaine hcl
  • betaine hcl
  • betaine hcl
  • betaine hydrochloride
  • betaine hydrochloride
  • betaine hydrochloride
  • betaine hydrochloride
  • chloral betaine
  • chloral betaine
  • chloral betaine
  • chloral betaine
  • cloral betaine
  • cloral betaine
  • cloral betaine
  • cystadane
  • cystadane
  • cystadane
  • cystadane
  • cystadane
  • glycinebetaine
  • glycinebetaine
  • glycine betaine
  • glycine betaine
  • glycine betaine
  • glycine betaine
  • lycine hcl
  • lycine hcl
  • n,n,n-trimethylammonioacetate
  • n,n,n-trimethylammonioacetate
  • n,n,n-trimethylglycine
  • n,n,n-trimethylglycine
  • oxyneurine
  • tmg
  • tmg
  • trimethylaminoacetate
  • trimethylaminoacetate
  • trimethylammonioacetate
  • trimethylammonioacetate
  • trimethylglycine
  • trimethylglycine
  • trimethylglycocoll
  • trimethylglycocoll

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07276204Phase 2Mar 31, 2026Department of Veteran Affairs
NCT07243678N/ADec 31, 2025Fundació Sant Joan de Déu
NCT07144527N/ASep 15, 2025Concordia University
NCT06392360N/AAug 13, 2024Appalachian State University
NCT06344377N/AApr 21, 2024Poznan University
NCT06308367Phase 2Mar 31, 2024Capital Medical University
NCT06309368Phase 4Mar 14, 2024University of Nevada, Las Vegas
NCT06042270N/AJan 31, 2024Florida State University
NCT05635929N/AOct 11, 2022Mucosa Innovations, S.L.
NCT05463484Phase 2/Phase 3 (Phase 3)Jul 13, 2021Mucosa Innovations, S.L., University of Granada
NCT05790070N/AFeb 1, 2021Baylor University
NCT04633044Phase 1/Phase 2 (Phase 2)Dec 31, 2020Fundació Sant Joan de Déu
NCT04585295N/AJan 21, 2020Florida State University, NOW Foods
NCT03702205Phase 2/Phase 3 (Phase 3)Oct 15, 2018National Science Centre, Poland, Poznan University
NCT03337360N/AApr 23, 2018Goodlife Fertility B.V., Radboud University
NCT05342272Phase 3Sep 22, 2017Spedali Civili di Brescia, University of Brescia
NCT02837367Phase 1/Phase 2 (Phase 2)Sep 1, 2016Romania:The National Authority for Scientific Research, University of Medicine and Pharmacy Victor Babes Timisoara
NCT02758015N/AJun 1, 2016University of California, San Francisco
NCT02404337Phase 2Jul 1, 2015University of Paris
NCT02403804N/AApr 1, 2015University of Colorado, University of Colorado, Denver
Showing 20 of 39 trials
Page 1 / 2

Organizations

Research & Development (45)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of California, San FranciscoAcademic/Hospital4422011
University of NebraskaAcademic/Hospital3232008
Baylor UniversityAcademic/Hospital2112006
Department of Veteran AffairsGovernment2222013
Florida State UniversityAcademic/Hospital2212020
Fundació Sant Joan de DéuAcademic/Hospital2222020
Harvard UniversityAcademic/Hospital2122004
Mayo ClinicAcademic/Hospital2212003
Mucosa Innovations, S.L.For profit2222021
Poznan UniversityAcademic/Hospital2222018
University of North Carolina at Chapel HillAcademic/Hospital2222014
American Diabetes AssociationAcademic/Hospital1012014
Appalachian State UniversityAcademic/Hospital1112024
Brain & Behavior Research FoundationAcademic/Hospital1012004
Capital Medical UniversityAcademic/Hospital1112024
Center for Health, Exercise and Sport Sciences, SerbiaGovernment1112011
Columbia UniversityAcademic/Hospital1112012
Concordia UniversityAcademic/Hospital1112025
GenentechFor profit1012011
Goodlife Fertility B.V.Academic/Hospital1012018
45 organizations
Page 1 / 3

Marketing (8)

OrganizationOrg typeRelationshipDate
Ani PharmaceuticalsFor profitMKTGNov 23, 2021
Eton Pharmaceuticals, Inc.For profitMKTGJan 28, 2022
Lukare MedicalFor profitMKTGJan 28, 2022
Novitium PharmaFor profitMKTGNov 23, 2021
Orphan EuropeFor profitNDA2Oct 25, 1996
Orphan MedicalFor profitNDA—
RecordatiFor profitMKTGOct 25, 1996
RecordatiFor profitNDA2Oct 25, 1996