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Citicoline

Phase 3Small molecule

UUniversity of Texas Southwestern Medical Center

Citicoline is used to help improve memory and thinking ability, particularly in patients recovering from stroke or experiencing age-related cognitive decline. It works by supporting brain cell function and protecting brain tissue from damage.[1] Citicoline is currently being investigated across 9 indications[3], with its most advanced program in Phase 3.[1]

Citicoline is one of 144 small molecule programs targeting Neurodegenerative Disease. It is currently in Phase 3.

9

Indications

25

Total Trials

6

Active Trials

143

Competitors

Pipeline

Status by Indication[3][1]

Indication

Neurodegenerative DiseaseActive, not recruiting

Attention Deficit Hyperactivity DisorderUnknown

Major Depressive DisorderActive, not recruiting

Cognitive DeclineRecruiting

EncephalopathyUnknown status

HypoxiaRecruiting

Alcohol Use DisorderRecruiting

Pre-TermRecruiting

Neurodegenerative DiseasePreclinical

Active, not recruiting

Attention Deficit Hyperactivity DisorderPreclinical

Unknown

Major Depressive DisorderPreclinical

Active, not recruiting

Cognitive DeclinePhase 2

Recruiting

EncephalopathyPhase 3

Unknown status

HypoxiaPhase 3

Recruiting

Alcohol Use DisorderPhase 2

Recruiting

Pre-TermPhase 3

Recruiting

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Ketalar

Boehringer Ingelheim

Sunosi

AAxsome Therapeutics, Inc.

Clozaril

LLife Extension Foundation Inc.

Lithobid

SSolvay Pharmaceuticals

Psilocybin

COMPASS Pathways

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Citicoline

UUniversity of Texas Southwestern Medical Center

Aticaprant

Johnson & Johnson

Selective Serotonin Reuptake Inhibitor

Johnson & Johnson

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalNot yet recruiting

Encephalopathy

NCT07763145

Q4 2027

Phase 2Recruiting

Cognitive Decline

NCT07804498

Q4 2028

Phase 3Recruiting

Pre-Term

NCT03966170

Q1 2029

Phase 2Recruiting

Alcohol Use Disorder

NCT05870111

Clinical

Trials by Indication[1]

Brain Injury3 trials

Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)

Withdrawn·DDeborah Yurgelun-Todd·N/A·NCT01515917

Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)

Terminated·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00545662·1,213 enrolled

A Pilot Trial of Citicoline in Individuals With Mild Traumatic Brain Injury (mTBI)

Withdrawn·MMclean Hospital·Phase 2·NCT01591759

Ischemic stroke2 trials

Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.

Completed·—·Phase 3·NCT01388738·30 enrolled

Citicoline in Ischemic Stroke

Unknown status·—·Phase 3·NCT05154903·200 enrolled

Encephalopathy2 trials

Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

Unknown status·—·Phase 3·NCT03181646·50 enrolled

Effect of Citicoline on Neurological Severity Score and Cerebral Doppler Resistive Index in Neonatal Hypoxic Ischemic Encephalopathy: A Randomized Control Trial

Not yet recruiting·KKhyber Girls Medical College·Preclinical·NCT07763145·86 enrolled

Delirium1 trial

Ramelteon and Citicoline for Delirium

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02840591

Pre-Term1 trial

Citicoline as Neuroprotector in Preterm

Recruiting·SSherief Abd-Elsalam·Phase 3·NCT03966170·40 enrolled

16 more indications

Concentration1 trial

Citicoline Concentration in Human Vitreous

Completed·IIstituto di Ricerca Neuroftalmologia S.r.l.·N/A·NCT04003090·26 enrolled

Stroke1 trial

ICTUS Study: International Citicoline Trial on Acute Stroke

Terminated·FFerrer Internacional S.A.·Phase 3·NCT00331890·2,298 enrolled

Injury1 trial

Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)

Active, not recruiting·OOhio State University·Phase 1/2·NCT05881135·80 enrolled

Alcohol Dependence1 trial

Citicoline for Alcohol Dependence

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02074735·62 enrolled

Marijuana1 trial

Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals

Completed·MMclean Hospital·Phase 2·NCT00158249·21 enrolled

Optic Nerve Disease1 trial

Neural Conduction Along the Visual Pathways After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases

Completed·FFondazione G.B. Bietti, IRCCS·Phase 4·NCT00404729·60 enrolled

Adolescent1 trial

Cognizin Citicoline Dosing in a Healthy Adolescent Male Population

Completed·DDeborah Yurgelun-Todd·Phase 1·NCT01582113·84 enrolled

Major Depressive Disorder1 trial

A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence

Completed·UUniversity of Texas Southwestern Medical Center·N/A·NCT00377299·60 enrolled

Anterior Ischemic Optic Neuropathy1 trial

Citicoline Effect on Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Completed·VValen Chia·Phase 4·NCT03046693·38 enrolled

Alcohol Use Disorder1 trial

Citicoline in Youth Alcohol Use Disorder

Recruiting·MMedical University of South Carolina·Phase 2·NCT05870111·56 enrolled

Hypoxia1 trial

Citicoline as Neuroprotector in Neonates Exposed to Hypoxia

Recruiting·SSherief Abd-Elsalam·Phase 3·NCT03949049·40 enrolled

Methamphetamine Dependence1 trial

Citicoline Treatment of Methamphetamine Dependence

Completed·PPerry Renshaw·Phase 3·NCT00950352·104 enrolled

Cognitive Functions1 trial

The Impact of Air Travel on Passenger Cognitive Functions

Unknown status·DDinara Zhumanbayeva·Phase 2/3·NCT04802785·50 enrolled

Cocaine Abuse1 trial

Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence

Completed·UUniversity of Texas Southwestern Medical Center·Phase 3·NCT00223236·44 enrolled

Cocaine Dependence1 trial

Citicoline for Bipolar 1 Disorder and Cocaine Dependence

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00619723·130 enrolled

Cognitive Decline1 trial

Effectiveness of CITicoline (TRAUSAN) in Preventing Cognitive Decline After DELirium in Older Adults With Proximal Hip Fracture - The CITADEL Randomized Controlled Trial

Recruiting·UUniversity of Milano Bicocca·Phase 2·NCT07804498·122 enrolled

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Citicoline. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Citicoline compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Citicoline. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — University of Texas Southwestern Medical Center company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: UUniversity of Texas Southwestern Medical Center

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