Caffeine clinical trials
Caffeine is named as an intervention in 12 current clinical trials in our USA, Poland, Egypt, UK, Germany, Belgium, France, Spain, Canada, Brazil and Australia registers. 5 are recruiting patients now. The most common phase is Phase 1. The sponsor with the most trials is Poznan University of Physical Education (2). The most-studied condition is Caffeine.
Where Caffeine is approved
All regulators →Of the three regulators tracked here, the first to approve Caffeine was the US, on 21 Sep 1999. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for prevention of bronchopulmonary dysplasia (11 Apr 2014, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Caffeine
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Caffeine works
All drug targets →- Adenosine receptor antagonist AntagonistTarget: Adenosine receptor✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- Low back painPhase 3
- Neck painPhase 3
- Parkinson diseasePhase 3
- Bronchopulmonary dysplasiaPhase 3
- Common coldPhase 3
- Intermittent vascular claudicationPhase 3
- Obesity disorderPhase 3
- Peripheral arterial diseasePhase 3
- Cocaine dependencePhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL113, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 407, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Caffeine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Gencebok, Peyona (previously Nymusa)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Caffeine
- ATC code
- N06BC01
- ChEMBL
- CHEMBL113
- DrugBank
- DB00201
- PubChem CID
- 2519
- CAS number
- 58-08-2
- FDA UNII
- 3G6A5W338E
- Wikidata
- Q60235
- Wikipedia
- Caffeine
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Caffeine
12 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Caffeine across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Caffeine on the HPRA medicines list.
- Peyona 20 mg/mL solution for infusion and oral solutionChiesi Farmaceutici S.p.A. · EU/1/09/528/001
Supply shortages
No entry for Caffeine in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Caffeine
24 conditionsAll 24 conditions
| Condition (as registered) | Trials |
|---|---|
| Caffeine | 2 |
| Physical Performance | 2 |
| Placebo Effect | 2 |
| Cognitive Performance | 2 |
| Active Ulcerative Colitis | 1 |
| Healthy | 1 |
| Drug Drug Interaction (DDI) | 1 |
| Alzheimer Disease | 1 |
| Fat Metabolism | 1 |
| Cycling | 1 |
| Exercise | 1 |
| Preterm Birth | 1 |
| Neonatal Outcomes | 1 |
| Common Cold/Flu | 1 |
| Nasal Congestion | 1 |
| Nasal Obstruction | 1 |
| Steatohepatitis, Nonalcoholic | 1 |
| Osteo Arthritis | 1 |
| Spinal Hypotension | 1 |
| Vasopressor | 1 |
| Migraine | 1 |
| Migraine Disease | 1 |
| Migraine Headache | 1 |
| Migraine Headache, With or Without Aura | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Caffeine trials
How many clinical trials are testing Caffeine?
12 current trials in our USA, Poland, Egypt, UK, Germany, Belgium, France, Spain, Canada, Brazil and Australia registers name Caffeine as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Caffeine trials recruiting patients?
Yes. 5 of the 12 trials are recruiting: 2 with sites in USA, 1 with sites in Poland, 1 with sites in Egypt, 1 with sites in UK, 1 with sites in Germany, 1 with sites in Belgium, 1 with sites in France and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Caffeine clinical trials?
Poznan University of Physical Education (2), Hoffmann-La Roche (1), Eli Lilly and Company (1) and Allyx Therapeutics (1), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Caffeine licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Caffeine, for example Peyona 20 mg/mL solution for infusion and oral solution (Chiesi Farmaceutici S.p.A.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Caffeine shortage?
Not in the lists we track: Caffeine has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Caffeine works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Caffeine works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Caffeine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.