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Corenalin (CITICOLINE)
Corenalin (generic name: CITICOLINE) is a citicoline drug. It is currently in Phase 3 development.
Corenalin works by increasing the production of phosphatidylcholine, a key component of brain cell membranes, which helps to protect and repair damaged brain cells.
Corenalin, also known as citicoline, is a small molecule drug in the citicoline class. It is a synthetic compound that has been developed for various neurological disorders, although its exact target is unknown. Corenalin is not FDA-approved for any indications, and its commercial status is unclear. As a citicoline, it is believed to have neuroprotective and neuroregenerative properties, although further research is needed to confirm its efficacy and safety. The development and ownership of Corenalin are also unclear.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | CITICOLINE |
|---|---|
| Drug class | citicoline |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | Phase 3 |
Mechanism of action
Think of your brain cells like houses with walls made of bricks. When these walls get damaged, the house can't function properly. Corenalin helps to repair these walls by increasing the production of a special kind of brick called phosphatidylcholine, which is essential for maintaining healthy brain cells.
Approved indications
Common side effects
- Blood triglycerides increased
- Apraxia
- Perseveration
- Drug interaction
- Neuroleptic malignant syndrome
- Hyperglycaemia
- Blood cholesterol increased
Key clinical trials
- Improving Sleep and AD Biomarkers (NA)
- Combination of Conditioned Medium and Umbilical Cord-Mesenchymal Stem Cells Therapy for Acute Stroke Infarct (PHASE1,PHASE2)
- Evaluation of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma (NA)
- A Brain-Computer Interface-Based Attention Training Program Compared With Methylphenidate and Citicoline
- Evaluation of the Impact of a Nutritional Formulation on Cognitive Performance Following Stress Exposure. (NA)
- Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin (NA)
- Improving Sleep and Cognition in Alzheimer's Disease (NA)
- Citicoline in Youth Alcohol Use Disorder (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Corenalin CI brief — competitive landscape report
- Corenalin updates RSS · CI watch RSS
Frequently asked questions about Corenalin
What is Corenalin?
How does Corenalin work?
What is the generic name of Corenalin?
What drug class is Corenalin in?
What development phase is Corenalin in?
What are the side effects of Corenalin?
Related
- Drug class: All citicoline drugs
- Therapeutic area: All drugs in Nephrology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing