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overencapsulated caffeine
overencapsulated caffeine is a stimulant Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 3 development for Attention deficit hyperactivity disorder (ADHD), Narcolepsy.
Overencapsulated caffeine acts as a stimulant by increasing the levels of dopamine and norepinephrine in the brain.
Overencapsulated caffeine acts as a stimulant by increasing the levels of dopamine and norepinephrine in the brain. Used for Attention deficit hyperactivity disorder (ADHD), Narcolepsy.
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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 | overencapsulated caffeine |
|---|---|
| Sponsor | Astellas Pharma Inc |
| Drug class | stimulant |
| Target | adenosine receptor |
| Modality | Small molecule |
| Therapeutic area | Central Nervous System |
| Phase | Phase 3 |
Mechanism of action
Caffeine works by blocking adenosine receptors in the brain, leading to increased activity of neurotransmitters such as dopamine and norepinephrine. This results in increased alertness, energy, and improved mental performance.
Approved indications
- Attention deficit hyperactivity disorder (ADHD)
- Narcolepsy
Common side effects
- Insomnia
- Anxiety
- Headache
- Nervousness
- Stomach upset
Key clinical trials
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:
- overencapsulated caffeine CI brief — competitive landscape report
- overencapsulated caffeine updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about overencapsulated caffeine
What is overencapsulated caffeine?
How does overencapsulated caffeine work?
What is overencapsulated caffeine used for?
Who makes overencapsulated caffeine?
What drug class is overencapsulated caffeine in?
What development phase is overencapsulated caffeine in?
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What does overencapsulated caffeine target?
Related
- Drug class: All stimulant drugs
- Target: All drugs targeting adenosine receptor
- Manufacturer: Astellas Pharma Inc — full pipeline
- Therapeutic area: All drugs in Central Nervous System
- Indication: Drugs for Attention deficit hyperactivity disorder (ADHD)
- Indication: Drugs for Narcolepsy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing