Drugs / Choline
last change Dec 2025 re-read 2 minutes ago

Choline

Other / unclassified

Developed for
ulcerative colitis · liver disorder · Alzheimer disease · autism · choline deficiency disease · cystic fibrosis · cystic fibrosis-related liver disease · fatty liver disease
+12 more · fetal alcohol syndrome · hepatitis C virus infection · hepatobiliary disorder · hyperhomocysteinemia · iron deficiency anemia · methionine adenosyltransferase deficiency · NAFLD1 · neurobehavioral disorder with prenatal alcohol exposure · partial fetal alcohol syndrome · schizophrenia · triple-negative breast carcinoma · pregnancy disorder
Investigated by
Dietmar Hopp Stiftung · Heidelberg University · Columbia University · Dr. Falk Pharma GmbH · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · University of Minnesota
+26 more · Balchem Corporation · Bambino Gesù Hospital and Research Institute · BodyAesthetic Research Center · Center for Health Sciences, Serbia · Cystic Fibrosis Foundation · Fudan University · Hoffmann-La Roche · Icahn School of Medicine at Mount Sinai · Lipid Therapeutics GmbH · M.D. Anderson Cancer Center · Massachusetts Institute of Technology · National Center for Complementary and Integrative Health (NCCIH) · National Center for Research Resources (NCRR) · Northwestern University · Paul E Schulz · Prof. Wolfgang Stremmel · Professor Wolfgang Stremmel · Protara Therapeutics · Sanofi · Sheba Medical Center · The Israeli Society of Clinical Pediatrics (HIPAK) · UNC Lineberger Comprehensive Cancer Center · University Hospital Tuebingen · University of British Columbia · University of Colorado, Denver · University of Texas

Trials 25 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05880849 Jun 2023 → Jul 2025 Alzheimer disease Paul E Schulz Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT01905605 Sep 2013 → Jan 2017 schizophrenia University of Colorado, Denver Withdrawn No outcome recorded
Phase 1/2 NCT01149538 Jul 2010 → Sep 2014 fetal alcohol syndrome, neurobehavioral disorder with prenatal alcohol exposure, partial fetal alcohol syndrome University of Minnesota Completed No outcome recorded
Phase 26 trials
Phase 2 NCT05076682 Jun 2022 → Dec 2026 expected triple-negative breast carcinoma Fudan University Recruiting No outcome recorded
Phase 2 NCT01011322 Dec 2009 → Jul 2011 diarrheal disease, ulcerative colitis Lipid Therapeutics GmbH Unknown No outcome recorded
Phase 2 NCT00259558 Apr 2003 → Mar 2006 ulcerative colitis Heidelberg University Completed No outcome recorded
Phase 2 NCT00259545 Feb 2003 → Feb 2006 ulcerative colitis Heidelberg University Completed No outcome recorded
Phase 2 NCT00031135 Sep 2001 → Sep 2005 liver disorder Northwestern University Terminated No outcome recorded
Phase 2 NCT00211848 Jun 2000 → Dec 2005 hepatitis C virus infection Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT06910943 Dec 2025 → Jun 2027 expected choline deficiency disease, liver disorder Protara Therapeutics Recruiting No outcome recorded
Phase 2/3 NCT06527391 Aug 2025 → Sep 2027 expected iron deficiency anemia University of Minnesota Recruiting No outcome recorded
Phase 2/3 NCT00259571 ? → Mar 2010 ulcerative colitis Heidelberg University Withdrawn No outcome recorded
Phase 35 trials
Phase 3 NCT02517385 Aug 2015 → Jun 2016 hepatobiliary disorder Sanofi Completed No outcome recorded
Phase 3 NCT02280629 Oct 2014 → Oct 2018 ulcerative colitis Dr. Falk Pharma GmbH Completed No outcome recorded
Phase 3 NCT02142725 Jul 2014 → Nov 2016 ulcerative colitis Dr. Falk Pharma GmbH Terminated No outcome recorded
Phase 3 NCT01934777 Oct 2013 → Oct 2014 NAFLD1, abdominal obesity-metabolic syndrome, fibrotic liver disease, obesity disorder Bambino Gesù Hospital and Research Institute Completed No outcome recorded
Phase 3 NCT01371357 May → Dec 2011 hyperhomocysteinemia Center for Health Sciences, Serbia Completed No outcome recorded
Phase 43 trials
Phase 4 NCT01749982 Dec 2012 → Mar 2013 Columbia University Completed No outcome recorded
Phase 4 NCT01098383 Mar 2010 → Dec 2017 autism Sheba Medical Center Unknown No outcome recorded
Phase 4 NCT00720343 Feb 2009 → Jun 2011 Columbia University Completed No outcome recorded
Phase not applicable5 trials
NCT03312140 Nov 2014 → Apr 2016 cystic fibrosis-related liver disease University Hospital Tuebingen Completed No outcome recorded
NCT00757081 Jun 2008 → Dec 2009 BodyAesthetic Research Center Completed No outcome recorded
NCT00686361 Oct 2007 → Aug 2010 cystic fibrosis University of British Columbia Completed No outcome recorded
NCT00006061 Jan 2000 methionine adenosyltransferase deficiency National Center for Research Resources (NCRR) Completed No outcome recorded
NCT00004697 Nov 1997 → Mar 1999 fatty liver disease University of Texas Completed No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT01731236 Comparator Feb 2011 → Dec 2027 expected The Cleveland Clinic Active not recruiting No outcome recorded
Phase 13 trials
Phase 1 NCT06379971 Comparator Nov 2024 → Apr 2029 expected University of Colorado, Denver Recruiting No outcome recorded
Phase 1 NCT03028857 Comparator Jun 2017 → Dec 2025 University of Colorado, Denver Completed No outcome recorded
Phase 1 NCT00332124 Comparator Jun 2006 → Mar 2017 pregnancy disorder University of Colorado, Denver Completed No outcome recorded
Phase 31 trial
Phase 3 NCT02878863 Background Aug 2016 → Mar 2017 autoimmune hepatitis Xiaoli Fan Withdrawn No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 31 sources stand behind the page.

FieldValueCited text
Known as choline “different dietary agents were used in the past for the treatment of elevated total plasma homocysteine (T-HCy), e. g. betaine, choline (betaine precursor) or folic acid.” NCT01371357
13

NCT06527391

NCT01731236

NCT03028857

NCT00720343

NCT05076682

NCT00686361

NCT05880849

NCT01149538

NCT01934777

NCT01098383

NCT01749982

NCT00332124

NCT06379971

Known as Choline Chloride ClinicalTrials.gov intervention name — accepted as the source's own label NCT00031135
3

NCT06910943

NCT00004697

NCT03312140

Known as Choline Chloride for Injection Choline Chloride for Injection (study drug)” NCT06910943
Known as ESSENTIALE paste “Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks” NCT02517385
Known as LT-02 “The primary objective is to evaluate the efficacy of LT-02, a newly designed modified release phosphatidylcholine formula, in a multicenter setting.” PMID 24796768 May 2014
1

“Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials.” PMID 37806372 Oct 2023

Known as Phosphatidylcholine “The primary objective is to evaluate the efficacy of LT-02, a newly designed modified release phosphatidylcholine formula, in a multicenter setting.” PMID 24796768 May 2014
9

“LT-02, a novel modified-release phosphatidylcholine (PC) formulation” PMID 37806372 Oct 2023

NCT02517385

NCT00259571

NCT02878863

NCT00006061

NCT01905605

NCT00757081

NCT00259558

NCT00259545

Known as Polyenylphosphatidylcholine ClinicalTrials.gov intervention name — accepted as the source's own label NCT00211848
Known as rPC “BACKGROUND: In 2 preceding studies, delayed release phosphatidylcholine (rPC) was found to (a) improve disease activity and (b) withdraw steroids in patients with...” PMID 20048683 May 2010
Action Activate “Choline activates fetal α7-nicotinic acetylcholine receptors” PMID 23318559 Mar 2013
Modality Other / unclassified “dietary phosphatidylcholine supplementation” PMID 23318559 Mar 2013
Route Oral “receives oral phosphatidylcholine supplement” NCT00006061