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(-)-Cafedrine (CAFEDRINE)
(-)-Cafedrine (generic name: CAFEDRINE) is a cafedrine drug. It is currently in Phase 2 development.
(-)-Cafedrine is believed to work by interacting with the body's central nervous system to produce a stimulant effect.
(-)-Cafedrine, also known as CAFEDRINE, is a small molecule drug in the cafedrine class. Unfortunately, there is limited information available on this compound, including its target, approved indications, and pharmacokinetic properties. As a result, its clinical use and safety profile are unclear. Further research is needed to fully understand the potential benefits and risks of (-)-Cafedrine. Its commercial status and patent status are also unknown.
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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). -
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 | 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 | CAFEDRINE |
|---|---|
| Drug class | cafedrine |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 2 |
Mechanism of action
Imagine your brain is like a computer, and (-)-Cafedrine is like a software update that makes you feel more alert and awake. It does this by increasing the activity of certain chemicals in the brain that help you feel more focused and energized. This can be helpful for people who need a mental boost, but it's also important to use it carefully and follow the recommended dosage.
Approved indications
Common side effects
Key clinical trials
- Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting
- Non-invasive Early Goal Directed Therapy in Colorectal Surgery: a Feasibility Study (NA)
- Effect of Cafedrine/Theodrenaline and Urapidil on Cerebral Oxygenation (NA)
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:
- (-)-Cafedrine CI brief — competitive landscape report
- (-)-Cafedrine updates RSS · CI watch RSS
Frequently asked questions about (-)-Cafedrine
What is (-)-Cafedrine?
How does (-)-Cafedrine work?
What is the generic name of (-)-Cafedrine?
What drug class is (-)-Cafedrine in?
What development phase is (-)-Cafedrine in?
Related
- Drug class: All cafedrine drugs
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing