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Drug

Caffeine citrate

Approved · EMA
Emerging researchLate-stage development

Also known as Cafcit, Caffeine, CITRATED CAFFEINE.

RxNorm20033
1
Research papers
23
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Effects of Different Caffeine Ingestion Forms on Fat Oxidation During Cycle Ergometer Exercise

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates After Treatment With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis

Clinical trial2026-06-24Results expected Q3 2027 · ClinicalTrials.gov

Caffeine for Hypoxic Ischemic Encephalopathy (CHIME Trial)

Clinical trial2026-06-24Results expected Q4 2029 · ClinicalTrials.gov

Effect of Preoperative Oral Caffeine on Prophylactic Noradrenaline Requirement During Cesarean Delivery: A Double-blind Placebo-controlled Trial

Clinical trial2026-06-17Results expected Q3 2026 · ClinicalTrials.gov

Optimizing Caffeine Therapy for Hypoxia in Preterm Neonates: A Randomized Trial Assessing Efficacy, Acute Kidney and Brain Injury, Safety, and Pharmacokinetics

Clinical trial2026-06-04Results expected Q1 2030 · ClinicalTrials.gov

Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy

Clinical trial2026-06-04Results expected Q2 2027 · ClinicalTrials.gov

Caffeine for Oxygen Dependent Meconium Aspiration Syndrome

Clinical trial2026-06-01Results expected Q3 2027 · ClinicalTrials.gov

Effect of Caffeine on Cold-stimulated Brown Adipose Tissue Activity

Clinical trial2026-05-31Primary completion · ClinicalTrials.gov

Approval: Gencebok (EMA)

Regulatory2020-08-19EMA

Randomization to randomization probability: Estimating treatment effects under actual conditions of use.

Research2017-04-13Psychological methods

Drug Safety Update: Caffeine citrate: 2 products of different strengths now available

Regulatory2014-12-11MHRA

Approval: Peyona (previously Nymusa) (EMA)

Regulatory2009-07-02EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Caffeine citrate
Aliases & brands
CafcitCaffeineCITRATED CAFFEINE
RxNorm CUI
20033
Regulatory jurisdictions
emamhra

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-07-02
Latest approval
2020-08-19
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 2 events
2020-08-19Approval
Approval: Gencebok (EMA)

Indication: Treatment of primary apnoea of premature newborns.

Evidence ↗
2009-07-02Approval
Approval: Peyona (previously Nymusa) (EMA)

Indication: Treatment of primary apnoea of premature newborns.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Caffeine citrate: 2 products of different strengths now available
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

176 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
176
registered trials across all phases
LATEST COMPLETION 2026
23
Active studies
18
Recruiting
81
Late-stage (III+)
124
Completed
29
Discontinued
PHASE DISTRIBUTIONn = 176
Early Phase 18Phase 167Phase 1 / 24Phase 216Phase 2 / 33Phase 316Phase 422Phase N / A40

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate

RecruitingPH IVSemmelweis Universityn=2262028

Measure Striatal Adenosine-dopamine Receptors Interactions: from Molecule to Behaviors

RecruitingPH IVHsiao-Ying Weyn=122026

Assessment of Oral Caffeine Intake in Reducing the Severity of Acute Migraine Attack Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals: A Randomized Controlled Trial

RecruitingPH IVAin Shams Universityn=1202025

Oral Caffeine Decreases the Frequency of Opioid Demand in AIS Patients After Spinal Fusion

CompletedPH IVChildren's Mercy Hospital Kansas Cityn=612024

A Randomized, Placebo-controlled Trial of Early Caffeine in Preterm Neonates

Unknown statusPH IVJennifer Shepherdn=242022

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open-label, Drug-drug Interaction Study to Investigate the Effects of Amlitelimab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Participants With Moderate-to-severe Atopic Dermatitis

CompletedPH ISanofin=232026

Comparative Efficacy of Early Caffeine Administration Versus Supportive Therapy in Preventing Acute Kidney Injury in Preterm Neonates

CompletedN/AMuhammad Aamir Latifn=2362026

An Open-label, Non-randomised, Fixed-sequence, Two Period, Phase I Trial to Evaluate the Effect of Different Doses of BI 456906 (Survodutide) on the Single Dose Pharmacokinetics of Bupropion, Caffeine and Midazolam on Otherwise Healthy Volunteers With Overweight or Obesity

CompletedPH IBoehringer Ingelheimn=342026

Effectiveness of Preoperative Oral Caffeine in Preventing Spinal-Induced Hypotension During Cesarean Delivery: A Double Blind Randomized Controlled Trial

CompletedN/ACairo Universityn=902025

An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Effect of Multiple Doses of AZD2389 on the Pharmacokinetics of Midazolam, Caffeine, and Bupropion

CompletedPH IAstraZenecan=162025

A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-323 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

CompletedPH IEnanta Pharmaceuticals, Incn=242025

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes2
Random Allocation1Research Design1
Journals, researchers & institutions
Top journals
  • Psychological methods1
Leading researchers
  • Allison DB1
  • Brown AW1
  • Dutton GR1
  • Fontaine KR1
  • George BJ1
  • Idigo AJ1
  • Jeansonne MM1
  • Li P1
Leading institutions
free-text, unnormalised
  • Harvard University.1
  • University of Alabama at Birmingham.1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.