Clinical Trials

Numerous clinical trials evaluate the therapeutic utility and physiological effects of citicoline across diverse indications, including acute ischemic stroke, Alzheimer's disease, primary open-angle glaucoma, hypoxic-ischemic encephalopathy, COVID-19, and healthy cognitive performance. Spanning Early Phase 1 through Phase 4 along with observational studies, these investigations range from active enrollment to completed protocols. Research is supported by diverse academic, governmental, and commercial sponsors, including Ohio State University, the National Institute on Aging, and PepsiCo Global R&D.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03949049 RECRUITING
Neonatal Hypoxia
Sherief Abd-Elsalam
 2019-02-01 PHASE3
NCT03966170 RECRUITING
Pre-Term
Sherief Abd-Elsalam
 2019-05-01 PHASE3
NCT07804498 RECRUITING
Perioperative Delirium; Hip Fracture; Post-Operative Cognitive Decline in Older Adults
University of Milano Bicocca
 2026-06-03 PHASE2
NCT07322965 RECRUITING
Glaucoma; Primary Open Angle Glaucoma (POAG); Neuroprotection
Institut Catala de Retina
 2025-04-01
NCT07763145 NOT_YET_RECRUITING
Hypoxic Ischaemic Encephalopathy (HIE)
Khyber Girls Medical College
 2026-09-01
NCT05870111 ACTIVE_NOT_RECRUITING
Alcohol Use Disorder
Medical University of South Carolina
 2024-10-01 PHASE2
NCT05710198 RECRUITING
Glaucoma, Open-Angle
Omikron Italia S.r.l.
 2023-12-11 PHASE3
NCT07089238 RECRUITING
Healthy
Kirin Holdings Company, Limited
 2025-07-31
NCT07567651 COMPLETED
Glaucoma Therapy
Fondazione IRCCS Policlinico San Matteo di Pavia
 2021-08-10
NCT06029894 COMPLETED
Mild Cognitive Impairment; Alzheimer Disease
Emory University
 2023-12-15
NCT05200208 COMPLETED
Alzheimer Disease
Emory University
 2022-07-27
NCT06333236 COMPLETED
Glaucoma
ASST Santi Paolo e Carlo
 2025-04-10
NCT06906848 COMPLETED
Healthy; Cognitive Performance
Kirin Holdings Company, Limited
 2024-11-20
NCT05881135 ACTIVE_NOT_RECRUITING
COVID-19
Ohio State University
 2023-06-06 PHASE1; PHASE2
NCT06431113 COMPLETED
Glaucoma; Neuroprotection
Fondazione IRCCS Policlinico San Matteo di Pavia
 2024-01-27 PHASE3
NCT06522581 UNKNOWN
Hypoxic Ischemic Encephalopathy of Newborn
Armed Forces Hospital, Pakistan
 2024-01-01 PHASE1
NCT06210646 COMPLETED
Ischemic Stroke
Kafrelsheikh University
 2022-12-29 PHASE3
NCT05315206 ACTIVE_NOT_RECRUITING
Primary Open Angle Glaucoma
Fondazione G.B. Bietti, IRCCS
 2022-01-25
NCT06890962 COMPLETED
Cognitive Performance; Gaming Performance; Blood Pressure; Heart Rate; Mood
Nathaniel Jenkins
 2023-06-09
NCT05881135 Recruiting
COVID-19
Ohio State University
 2023-06-06 Phase 1|Phase 2
NCT02582905 COMPLETED
Alcohol Use Disorder; Bipolar Disorder; Schizoaffective Disorder Bipolar Type
Sherwood Brown, MD, PhD
 2016-05 PHASE4
NCT04967157 COMPLETED
Healthy
Kirin Holdings Company, Limited
 2021-09-08
NCT05000190 COMPLETED
Attention
PepsiCo Global R&D
 2021-09-13
NCT05200208 Recruiting
Alzheimer Disease
Emory University|National Institute on Aging (NIA)|Goizueta Alzheimer''s Disease Research Center (ADRC)
 2022-07-27 Not Applicable
NCT05527106 COMPLETED
Glaucoma
Institut Catala de Retina
 2015-03-12
NCT05154903 UNKNOWN
Acute Ischemic Stroke
Ain Shams University
 2021-07-22 PHASE3
NCT05315206 Recruiting
Primary Open Angle Glaucoma
Fondazione G.B. Bietti IRCCS
 2022-01-25 Not Applicable
NCT04046809 COMPLETED
Glaucoma
Omikron Italia S.r.l.
 2019-02-13
NCT05000190 Completed
Attention
PepsiCo Global R&D
 2021-09-13 Not Applicable
NCT04802785 UNKNOWN
Air Travel
Dinara Zhumanbayeva
 2021-06 PHASE2; PHASE3
NCT05154903 Unknown status
Acute Ischemic Stroke
Ain Shams University|Kafrelsheikh University
 2021-07-22 Phase 3
NCT04422743 TERMINATED
Glaucoma
Fondazione IRCCS Policlinico San Matteo di Pavia
 2018-01-25
NCT03444662 COMPLETED
Healthy
Kyowa Hakko Bio Co., Ltd.
 2018-06-12
NCT04020705 COMPLETED
Glaucoma
Istituto di Ricerca Neuroftalmologia S.r.l.
 2015-09-22
NCT04003090 COMPLETED
Neurodegenerative Diseases
Istituto di Ricerca Neuroftalmologia S.r.l.
 2018-03-21
NCT03369925 COMPLETED
Healthy
Kyowa Hakko Bio Co., Ltd.
 2018-01-02
NCT01502813 COMPLETED
Cognitive Benefits
Deborah Yurgelun-Todd
 2012-02-01
NCT04009980 COMPLETED
Diabetic Retinopathy
Fondazione G.B. Bietti, IRCCS
 2015-09-23
NCT02705066 COMPLETED
Healthy
Kyowa Hakko Bio Co., Ltd.
 2016-03
NCT04003090 Completed
Neurodegenerative Diseases
Istituto di Ricerca Neuroftalmologia S.r.l.|Fondazione G.B. Bietti IRCCS
 2018-03-21 Not Applicable
NCT03181646 UNKNOWN
Hypoxic-Ischemic Encephalopathy
Armed Forces Hospital, Pakistan
 2017-06-15 PHASE3
NCT02840591 WITHDRAWN
Delirium
University of Texas Southwestern Medical Center
 2016-07 PHASE4
NCT03758118 COMPLETED
Non-arteritic Ischemic Optic Neuropathy
Fondazione G.B. Bietti, IRCCS
 2017-02-20
NCT01338389 COMPLETED
Uveal Melanoma
Centre Hospitalier Universitaire de Nice
 2012-06-25
NCT01582113 COMPLETED
Neurocognitive Improvement
Deborah Yurgelun-Todd
 2012-06 EARLY_PHASE1
NCT03046693 COMPLETED
Non-arteritic Anterior Ischemic Optic Neuropathy
Valen Chia
 2017-01-16 PHASE4
NCT02074735 COMPLETED
Alcohol Dependence
University of Texas Southwestern Medical Center
 2014-04 PHASE4
NCT02823106 WITHDRAWN
Ischemic Stroke
Justin Fraser
 2016-08 PHASE1
NCT01515917 WITHDRAWN
Traumatic Brain Injury; Substance Abuse; Substance Dependence
Deborah Yurgelun-Todd
 2013-11
NCT02248233 COMPLETED
Cerebral Infarction
Fengtian Hospital
 2014-10 PHASE4
NCT01591759 WITHDRAWN
Traumatic Brain Injury
Mclean Hospital
 2012-04 PHASE2
NCT00158249 COMPLETED
Marijuana Abuse
Mclean Hospital
 2009-09 PHASE2
NCT00950352 COMPLETED
Methamphetamine Dependence
Perry Renshaw
 2010-01 PHASE3
NCT00223236 COMPLETED
Mania; Hypomania; Cocaine Abuse; Cocaine Dependence
University of Texas Southwestern Medical Center
 2010-07 PHASE3
NCT00619723 COMPLETED
Bipolar Disorder; Cocaine Dependence
University of Texas Southwestern Medical Center
 2008-04 PHASE4
NCT00331890 TERMINATED
Acute Stroke; Cerebral Infarction
Ferrer Internacional S.A.
 2006-10 PHASE3
NCT01388738 COMPLETED
Stroke
Clinical Institute of the Brain, Russia
 2011-01 PHASE3
NCT00545662 TERMINATED
Traumatic Brain Injury
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2007-07 PHASE3
NCT00377299 COMPLETED
Amphetamine Abuse; Amphetamine Dependence; Bipolar Disorder; Major Depressive Disorder
University of Texas Southwestern Medical Center
 2006-10
NCT00404729 COMPLETED
Glaucoma; Optic Neuropathy, Ischemic; Visual Pathway Disorder; Optic Nerve; Neural Conduction
Fondazione G.B. Bietti, IRCCS
 2005-02-28 PHASE4

(data from https://clinicaltrials.gov, updated on 2019-05-29)

Check the Citicoline product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a naturally occurring endogenous intermediate, citicoline serves as the rate-limiting precursor in the synthesis of phosphatidylcholine, supplying essential choline and cytidine to promote cellular membrane phospholipid regeneration and enhance central neurotransmitter production. By restoring structural membrane integrity and mitigating neuronal breakdown, this compound supports functional neuroprotection and cognitive stability, underpinning its therapeutic investigation in clinical trial conditions such as acute ischemic stroke, Alzheimer's disease, and glaucoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.