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citocoline
citocoline is a Small molecule drug developed by Rush University Medical Center. It is currently in Phase 2 development. Also known as: CDP-choline.
Citicoline has been studied as a potential treatment for ischemic stroke and Fragile X Tremor/Ataxia Syndrome in clinical trials. The exact dosage used in these trials includes 2000, 1000, and an unspecified amount of citicoline.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | citocoline |
|---|---|
| Also known as | CDP-choline |
| Sponsor | Rush University Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Citicoline in Ischemic Stroke, a Randomized Trial (PHASE3)
- Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome (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:
- citocoline CI brief — competitive landscape report
- citocoline updates RSS · CI watch RSS
- Rush University Medical Center portfolio CI
Frequently asked questions about citocoline
What is citocoline?
Who makes citocoline?
Is citocoline also known as anything else?
What development phase is citocoline in?
Related
- Manufacturer: Rush University Medical Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: CDP-choline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing