choline c11

Trade name: choline c-11

Small moleculeapprovedImaging agent

Approved

Dec 15, 2008

Choline C 11 injection was approved to help diagnose recurrent prostate cancer. It is used for a procedure called positron emission tomography (PET) scan to detect tumors that are not detectable by other scanning procedures, such as bone scan, computed tomography (CT), or magnetic resonance imaging (MRI). Choline C 11 is a radioactive diagnostic agent, the analog of choline. Choline is involved in the synthesis of the structural components of cell membranes, as well as modulation of transmembrane signaling. Increased phospholipid synthesis (i.e., increased uptake of choline) has been associated with cell proliferation and the transformation process that occurs in tumor cells. Recently, Choline C 11 PET was studied for diagnosis the patients with hepatocellular carcinoma; although the phase II of clinical trials was not begun. — NCATS

Clinical trial activity

42 trials · 55 clinical orgs · 7 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Nov 1, 1997 (NCT00004697)

Timeline

2000s

Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
Jan 1, 2006
Earliest Phase 1 Sponsor(trial)
Dec 15, 2008
Earliest FDA Approval

2010s

Jan 1, 2011
Earliest Phase 3 Sponsor(trial)
Sep 12, 2012
Mayo Clinic — First NDA Organization
Sep 12, 2012
Mayo Clinic — NDA Organization
Sep 12, 2012
University of Pennsylvania — NDA Secondary Org
Oct 29, 2015
University of Texas at Houston — Marketing Organization
Nov 13, 2015
Decatur Memorial Hospital — Marketing Organization
Nov 13, 2015
Zevacor — Marketing Organization
Jan 10, 2017
Washington University in St. Louis — Marketing Organization
Nov 20, 2017
University of California, San Francisco — Marketing Organization

Mechanism of action

Choline acetylaseBINDING AGENT
CHAT binding agent
- Choline O-acetyltransferase (CHAT) ↗
Unspecified targetOTHER
Diagnostic agent

Approval history

approvedDec 15, 2008

Chemistry & pharmacology

Loading structure…

SMILES

C[N+](C)(C)CCO.[Cl-]

Mol. weight: 139.63 g/mol
Lipinski Ro5: Pass
Rule of 3: Yes
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only
Imaging: 11-carbon

Oral

Parenteral

Yes

Topical

Sources

Also known as

11c-choline
11c-choline
11c-choline
11c-choline chloride
11c-choline chloride
bilineurine
bilineurine
bilineurine
biscolan
c-11 choline
c11-choline
choline
choline
choline
choline
choline
choline
choline
choline
choline (11c)
choline (11c)
choline bitartrate
choline bitartrate
choline bitartrate
choline bitartrate
choline c11
choline c11
choline c11
choline c 11
choline c 11
choline c 11
choline c 11
choline c-11
choline c-11
choline c-11
choline c-11
choline c-11
choline c-11
choline c 11 injection
choline c11 injection
choline chloride
choline chloride
choline chloride
choline chloride
choline chloride
choline chloride
choline chloride
choline dehydrocholate
choline dehydrocholate
choline dihydrogencitrate
f-choline
n,n,n-trimethylethanol-ammonium
n,n,n-trimethylethanol-ammonium
n-trimethylethanolamine
n-trimethylethanolamine
trimethylethanolamine
trimethylethanolamine
vitamin j

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT05087134	Early Phase 1 (Phase 1)	Nov 30, 2021	Chinese Academy of Medical Sciences
NCT04693169	N/A	Jan 15, 2021	Peking University
NCT04560725	N/A	Oct 22, 2020	Chinese Academy of Medical Sciences
NCT03327805	N/A	Jan 31, 2019	Virginia Polytechnic Institute and State University
NCT03404648	Phase 3	Nov 1, 2017	Mayo Clinic
NCT03194659	N/A	Jul 15, 2017	Balchem Corporation, Cornell University, DSM
NCT03028857	Phase 1	Jun 1, 2017	University of Colorado, Denver
NCT03174561	N/A	May 1, 2017	Clinical Emergency Hospital Sf. Spiridon Iasi, SC Fiterman Pharma SRL
NCT03142763	N/A	Jan 1, 2017	University of Connecticut
NCT02837367	Phase 1/Phase 2 (Phase 2)	Sep 1, 2016	Romania:The National Authority for Scientific Research, University of Medicine and Pharmacy Victor Babes Timisoara
NCT02735473	Phase 2	Jun 1, 2016	University of Minnesota
NCT02669641	Phase 4	Jan 1, 2016	SC Fiterman Pharma SRL, University of Medicine and Pharmacy Craiova
NCT02531672	N/A	Aug 1, 2015	Cornell University
NCT02815033	Phase 2	Jul 1, 2015	Leiden University, The European Uro-Oncology Group
NCT02397408	Phase 2	Apr 1, 2015	University of California, San Francisco
NCT02355054	N/A	Jan 29, 2015	Washington University in St. Louis
NCT02371993	Phase 3	Jan 1, 2015	Rohr and Columbo Associates
NCT02852122	N/A	Jan 1, 2015	Chang Gung University
NCT02260817	Phase 3	Oct 1, 2014	Decatur Memorial Hospital, Zevacor
NCT02004418	Phase 1/Phase 2 (Phase 2)	Mar 1, 2014	University of Alberta, University of Calgary

Showing 20 of 42 trials

Page 1 / 3

Organizations

Research & Development (55)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Cornell University	Academic/Hospital	3	3	1	2009
Chinese Academy of Medical Sciences	Academic/Hospital	2	2	2	2020
Columbia University	Academic/Hospital	2	2	1	2009
Cystic Fibrosis Foundation Therapeutics	Academic/Hospital	2	0	1	2007
SC Fiterman Pharma SRL	For profit	2	1	2	2016
University of British Columbia	Academic/Hospital	2	2	1	2007
University of Colorado, Denver	Academic/Hospital	2	2	1	2006
University of Minnesota	Academic/Hospital	2	2	1	2010
Wake Forest University	Academic/Hospital	2	2	1	2008
Abbott	For profit	1	1	1	2008
American Egg Board	Academic/Hospital	1	0	1	2009
Balchem Corporation	For profit	1	0	1	2017
Bambino Gesù Hospital and Research Institute	Academic/Hospital	1	1	1	2013
Ben Gurion University	Academic/Hospital	1	0	1	2010
Cancer Research UK	Academic/Hospital	1	1	1	2010
Center for Health, Exercise and Sport Sciences, Serbia	Government	1	1	1	2011
Chang Gung University	Academic/Hospital	1	1	1	2015
Clinical Emergency Hospital Sf. Spiridon Iasi	Academic/Hospital	1	0	1	2017
Commissariat A L'energie Atomique	Government	1	1	1	2011
Decatur Memorial Hospital	Academic/Hospital	1	0	1	2014

55 organizations