Citicoline

drug
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Also known as Cdp-cholineCiticolinaCytidine 5'-diphosphate cholineCytidine-5'-diphosphocholineIP 302IP-302NicholinNSC-122002SID90340858

Summary

Citicoline (CHEMBL1231700) is a phase-3 clinical-stage small-molecule psychotropic drug (ATC N06BX06); indicated across 11 conditions including stroke disorder and methamphetamine dependence.

At a glance

  • Status: Max clinical phase 3 (not approved)
  • Modality: Small molecule
  • ATC class: N06BX06
  • Indications: 11 conditions
  • Clinical trials: 42
  • Chemistry: 488.32 Da · C14H26N4O11P2

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL1231700
NameCiticoline
TypeSmall molecule
Max phase3
FDA approvedno
PubChem CID11583971
ChEBICHEBI:16436
ATCN06BX06
Molecular formulaC14H26N4O11P2
Molecular weight488.32
InChIKeyRZZPDXZPRHQOCG-OJAKKHQRSA-N

SMILES: C[N+](C)(C)CCOP(=O)(O)OP(=O)([O-])OC[C@@H]1[C@H]([C@H]([C@@H](O1)N2C=CC(=NC2=O)N)O)O

IUPAC name: [(2R,3S,4R,5R)-5-(4-amino-2-oxopyrimidin-1-yl)-3,4-dihydroxyoxolan-2-yl]methyl [hydroxy-[2-(trimethylazaniumyl)ethoxy]phosphoryl] phosphate

ChEBI definition: A member of the class of phosphocholines that is the choline ester of CDP. It is an intermediate obtained in the biosynthetic pathway of structural phospholipids in cell membranes.

Pharmacological roles (ChEBI): psychotropic drug, neuroprotective agent.

Other ChEBI roles (chemical / environmental): human metabolite, Saccharomyces cerevisiae metabolite, mouse metabolite.

Also known as: Cdp-choline, Citicolina, Citicoline, Cytidine 5’-diphosphate choline, Cytidine-5’-diphosphocholine, IP 302, IP-302, Nicholin, NSC-122002, SID90340858, CITICOLINE, citicoline

Parent form; salt/anhydrous children: CHEMBL1256994

Patent coverage: 960 distinct patent families (2,679 SureChEMBL compound mentions), from 3 matched compound structure(s). One matched structure accounts for 2,176 (81%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

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

Indications & clinical

Indications

11 indications (0 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
stroke disorder3MONDO:0005098EFO:0000712
methamphetamine dependence3MONDO:0005419EFO:0004701
attention deficit-hyperactivity disorder3MONDO:0007743EFO:0003888
cerebral infarction3MONDO:0002679MONDO:0002679
brain ischemia3MONDO:0005299MONDO:0005299
brain injury3MONDO:0043510MONDO:0043510
open-angle glaucoma3MONDO:0005338EFO:0004190
cannabis dependence2MONDO:0005689EFO:0007191
alcohol abuse2MONDO:0002046MONDO:0007079
severe acute respiratory syndrome1MONDO:0005091MONDO:0100096

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

Clinical trials

Total trials: 42.

Phase distribution

PhaseTrials
Not specified15
PHASE311
PHASE46
PHASE26
PHASE2/PHASE31
PHASE1/PHASE21
EARLY_PHASE11
PHASE11

Top trials by phase / activity

NCTPhaseStatusTitle
NCT00404729PHASE4COMPLETEDNeural Conduction Along the Visual Pathways After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases
NCT00619723PHASE4COMPLETEDCiticoline for Bipolar 1 Disorder and Cocaine Dependence
NCT02074735PHASE4COMPLETEDCiticoline for Alcohol Dependence
NCT02248233PHASE4COMPLETEDNimodipine for Treating Acute Massive Cerebral Infarction
NCT02582905PHASE4COMPLETEDClinical Medication Development for Bipolar Disorder and Alcohol Use Disorders
NCT02840591PHASE4WITHDRAWNRamelteon and Citicoline for Delirium
NCT03949049PHASE3RECRUITINGCiticoline as Neuroprotector in Neonates Exposed to Hypoxia
NCT03966170PHASE3RECRUITINGCiticoline as Neuroprotector in Preterm
NCT00223236PHASE3COMPLETEDTrial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
NCT00331890PHASE3TERMINATEDICTUS Study: International Citicoline Trial on Acute Stroke
NCT00545662PHASE3TERMINATEDStudy of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)
NCT00950352PHASE3COMPLETEDCiticoline Treatment of Methamphetamine Dependence
NCT01007539PHASE3COMPLETEDEfficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence
NCT01388738PHASE3COMPLETEDNavigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
NCT03181646PHASE3UNKNOWNRole of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
NCT04802785PHASE2/PHASE3UNKNOWNThe Impact of Air Travel on Passenger Cognitive Functions
NCT05154903PHASE3UNKNOWNCiticoline in Ischemic Stroke
NCT06210646PHASE3COMPLETEDCiticoline in Ischemic Stroke, a Randomized Trial
NCT05881135PHASE1/PHASE2ACTIVE_NOT_RECRUITINGSupplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
NCT00158249PHASE2COMPLETEDEffects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals
NCT00509067PHASE2COMPLETEDUse of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia
NCT00727246PHASE2COMPLETEDCDP-Choline and Working Memory After TBI: A Neuroimaging Study
NCT01591759PHASE2WITHDRAWNA Pilot Trial of Citicoline in Individuals With Mild Traumatic Brain Injury (mTBI)
NCT02088983PHASE2UNKNOWNEffects of CDP-Choline on Gating and Cognitive Deficits in First Episode Schizophrenia
NCT02630069PHASE2UNKNOWNCDP-choline Treatment in ATS Users
NCT02823106PHASE1WITHDRAWNSuperselective Citicoline and Verapamil for Ischemic Neuroprotection and Greater Effective Response
NCT01582113EARLY_PHASE1COMPLETEDCognizin Citicoline Dosing in a Healthy Adolescent Male Population
NCT05315206Not specifiedACTIVE_NOT_RECRUITINGMultimodal Morpho-functional Study in Glaucoma Patients-Citicoline Oral Solution
NCT07089238Not specifiedRECRUITINGEvaluate the Effects of Citicoline on Mood in Healthy Adults
NCT00377299Not specifiedCOMPLETEDA Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
NCT01338389Not specifiedCOMPLETEDInfluence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy
NCT01515917Not specifiedWITHDRAWNCiticoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)
NCT02705066Not specifiedCOMPLETEDCiticoline Effects on Cortical Membrane Structure and Function
NCT03369925Not specifiedCOMPLETEDCognitive Effects of Citicoline in Men and Women With Age-Associated Memory Impairment
NCT03444662Not specifiedCOMPLETEDThe Combination Effect of Citicoline and Omega-3
NCT03758118Not specifiedCOMPLETEDCiticoline in Non-Arteritic Ischemic Optic Neuropathy
NCT04003090Not specifiedCOMPLETEDCiticoline Concentration in Human Vitreous
NCT04967157Not specifiedCOMPLETEDCognitive Effects of Citicoline on Attention in Healthy Mean and Women
NCT05200208Not specifiedCOMPLETEDImproving Sleep and Cognition in Alzheimer’s Disease
NCT05527106Not specifiedCOMPLETEDEvaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma

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).