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L-Alpha-Glycerophosphocholine (CHOLINE ALFOSCERATE)
L-Alpha-Glycerophosphocholine (generic name: CHOLINE ALFOSCERATE) is a choline alfoscerate drug. It is currently in Phase 3 development.
Choline Alfoscerate works by increasing the levels of choline in the brain, which is then converted into acetylcholine, a neurotransmitter involved in memory and learning.
L-Alpha-Glycerophosphocholine, also known as Choline Alfoscerate, is a small molecule drug in the choline alfoscerate class. Its exact mechanism of action is not well understood, but it is believed to have neuroprotective and neuroregenerative effects. Choline Alfoscerate is not FDA-approved for any indications, and its commercial status is unclear. As a result, there is limited information available on its safety profile and efficacy. Further research is needed to fully understand the potential benefits and risks of this compound.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | CHOLINE ALFOSCERATE |
|---|---|
| Drug class | choline alfoscerate |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Mechanism of action
Think of it like a key that unlocks a door in your brain. Acetylcholine is like the key that helps you remember things and learn new information. Choline Alfoscerate helps make more of this key, which can help improve memory and cognitive function.
Approved indications
Common side effects
Key clinical trials
- The Acute Effects of Onnit Alpha Brain on Cognition and Mood States (NA)
- Acute Effects of Alpha-glycerylphosphorylcholine (A-GPC) on Lower Body Muscular Performance. (NA)
- Investigation of Docosahexaenoic Acid (DHA) Metabolic Pathway in Human by Using 13C Labeled Molecules (NA)
- The Effect of α-GPC on Cognitive Function and Sports Performance (NA)
- Clinical Study to Evaluate Drug-drug Interaction and Safety After Co-administration of D352 and D794 in Healthy Adult Volunteers (PHASE1)
- Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease (PHASE4)
- Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults (PHASE1)
- Safety, and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) (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:
- L-Alpha-Glycerophosphocholine CI brief — competitive landscape report
- L-Alpha-Glycerophosphocholine updates RSS · CI watch RSS
Frequently asked questions about L-Alpha-Glycerophosphocholine
What is L-Alpha-Glycerophosphocholine?
How does L-Alpha-Glycerophosphocholine work?
What is the generic name of L-Alpha-Glycerophosphocholine?
What drug class is L-Alpha-Glycerophosphocholine in?
What development phase is L-Alpha-Glycerophosphocholine in?
Related
- Drug class: All choline alfoscerate drugs
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing