Drugs / Caffeine
last change 11 days ago re-read 8 days ago

Caffeine

Small molecule

Developed for
apnea of prematurity · obesity disorder · migraine disorder · cancer · headache disorder · CGF1 · cocaine dependence · neuropathy, painful
+48 more · Parkinson disease · respiratory distress syndrome in premature infants · Alzheimer disease · autonomic nervous system disorder · bronchopulmonary dysplasia · gallbladder disorder · infantile apnea · ischemic disease · obstructive sleep apnea syndrome · sleep disorder · acute kidney injury · alcohol-induced mental disorder · atrial fibrillation · brain hypoxia - ischemia · brain injury · breast carcinoma · cellulitis · common cold · delirium · hypersomnia · intracerebral hemorrhage · ischemic stroke · lung disorder · meconium aspiration syndrome · migraine with aura · migraine without aura · morbid obesity · narcolepsy · orthostatic hypotension · paralytic ileus · pulmonary immaturity · pulpitis · respiratory failure · sexual disorder · syncope, familial vasovagal · urinary tract obstruction · adolescent idiopathic scoliosis · amblyopia · arthropathy · bronchiolitis · episodic memory defect leukoencephalopathy · hypotensive disorder · ileus · intermittent vascular claudication · nasal cavity disorder · schizophrenia · spinal cord injury · viral respiratory tract infection
Investigated by
Boehringer Ingelheim · GlaxoSmithKline · Radboud University Medical Center · AstraZeneca · Bristol-Myers Squibb · Eli Lilly and Company
+249 more · Janssen Research & Development, LLC · Pfizer · Canadian Institutes of Health Research (CIHR) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Johns Hopkins University · National Institute on Drug Abuse (NIDA) · Pennington Biomedical Research Center · University of Alabama at Birmingham · Uppsala University · Ache Laboratorios Farmaceuticos S.A. · Ain Shams University · Enanta Pharmaceuticals, Inc · Liverpool John Moores University · Sanofi · The University of Texas Health Science Center, Houston · University Hospital, Basel, Switzerland · University of Chicago · University of Copenhagen · University of Michigan · University of Wisconsin, Madison · AbbVie · American SIDS Institute · Bayer · Boston University · Cairo University · Emalex Biosciences Inc. · H. Lundbeck A/S · Herning Hospital · Hoffmann-La Roche · Hospital Universitari Vall d'Hebron Research Institute · Jules Desmeules · Merck Sharp & Dohme LLC · National Center for Complementary and Integrative Health (NCCIH) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of General Medical Sciences (NIGMS) · National Institute on Aging (NIA) · Novartis Pharmaceuticals · Nuventra, Inc. · Psychiatric Hospital of the University of Basel · Ron Postuma · Swiss National Science Foundation · University Teaching Hospital, Lusaka, Zambia · University of Oklahoma · University of Texas at Austin · ViiV Healthcare · Virginia Commonwealth University · Washington State University · ZonMw: The Netherlands Organisation for Health Research and Development · Abivax S.A. · Abliva AB · Aga Khan University · Allyx Therapeutics · Alnylam Pharmaceuticals · Amgen · Aptuit · Assistance Publique - Hôpitaux de Paris · Assistance Publique Hopitaux De Marseille · Astellas Pharma Europe B.V. · Astellas Pharma Global Development, Inc. · Astellas Pharma Inc · Basilea Pharmaceutica International Ltd · Beth Israel Medical Center · Bill and Melinda Gates Foundation · Blade Therapeutics · Brainfarma · Brown University · CTI BioPharma · Canopy Growth Corporation · Celgene Corporation · Centers for Disease Control and Prevention · Centre for Infectious Disease Research in Zambia · Charite University, Berlin, Germany · Children's Hospital of Chongqing Medical University · Children's Hospital of Philadelphia · all 255 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Peyona (previously Nymusa) — 2009-07-02 europa.eu ↗
Label expansion US (FDA) CAFCIT — 2000-04-12 fda.gov ↗
Approved US (FDA) CAFERGOT — 1948-11-26 fda.gov ↗

Trials 249 · started per year

today
US approved 1948
EU approved 2009
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 011 trials · 1 missed
Phase 0 NCT07466732 Dec 2025 → Mar 2026 overdue — Liverpool John Moores University Enrolling by invitation No outcome recorded
Phase 0 NCT06693960 Sep 2024 → Dec 2026 expected — Washington State University Recruiting No outcome recorded
Phase 0 NCT06359197 Apr → Aug 2024 — Hamilton Health Sciences Corporation Unknown No outcome recorded
Phase 0 NCT05478863 Jan 2023 → Oct 2024 — Johns Hopkins University Completed No outcome recorded
Phase 0 NCT04730193 Feb 2021 → Aug 2022 — University of Oklahoma Completed No outcome recorded
Phase 0 NCT03937687 May 2019 → Nov 2020 — University of South Carolina Completed No outcome recorded
Phase 0 NCT03577730 Jul 2018 → Nov 2019 neuropathy, painful University of Michigan Completed Missed primary
Phase 0 NCT01747590 Jul 2011 → Dec 2013 drug-induced mental disorder Mclean Hospital Unknown No outcome recorded
Phase 0 NCT01435837 Oct 2010 → May 2013 voice disorders Southern Illinois University Carbondale Completed No outcome recorded
Phase 0 NCT02135965 Apr 2009 → Aug 2011 — Pennington Biomedical Research Center Completed No outcome recorded
Phase 1109 trials
Phase 1 NCT07710768 Jul 2026 → Apr 2027 expected obesity disorder Novo Nordisk A/S Not yet recruiting No outcome recorded
Phase 1 NCT07665723 Jun 2026 → Jul 2027 expected ulcerative colitis Hoffmann-La Roche Recruiting No outcome recorded
Phase 1 NCT07570121 Jun 2026 → Jun 2027 expected apnea of prematurity, bronchopulmonary dysplasia, respiratory distress syndrome in premature infants Indiana University Recruiting No outcome recorded
Phase 1 NCT07426042 Apr → May 2026 overdue — Min Kyu Park Not yet recruiting No outcome recorded
Phase 1 NCT06930872 Jun → Oct 2025 — Harmony Biosciences Management, Inc. Completed No outcome recorded
Phase 1 NCT06973005 May → Jul 2025 liver disorder AstraZeneca Completed No outcome recorded
Phase 1 NCT06917508 Mar → Jun 2025 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT06821698 Feb → May 2025 — Kaken Pharmaceutical Completed No outcome recorded
Phase 1 NCT06686628 Nov 2024 → Nov 2025 atopic eczema Sanofi Completed No outcome recorded
Phase 1 NCT06632990 Nov 2024 → Apr 2025 overdue — Allyx Therapeutics Active not recruiting No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT07469852 Jan → Mar 2026 overdue — Liverpool John Moores University Active not recruiting No outcome recorded
Phase 1/2 NCT06538584 Sep 2024 → Jul 2026 overdue — University of Chicago Recruiting No outcome recorded
Phase 1/2 NCT04044001 Nov 2019 → Mar 2022 pulmonary tuberculosis Michael Hoelscher Completed No outcome recorded
Phase 1/2 NCT02832336 Oct 2016 → May 2017 narcolepsy King Saud University Completed No outcome recorded
Phase 1/2 NCT01086722 Feb 2010 → Feb 2013 morbid obesity Hospital del Mar Medical Research Institute (IMIM) Completed No outcome recorded
Phase 1/2 NCT00733993 Apr 2008 → Jul 2011 cocaine dependence Virginia Commonwealth University Completed No outcome recorded
Phase 1/2 NCT00515294 Oct 2006 → Oct 2009 alcohol-related disorders, neurodevelopmental disorder, sleep disorder Boston University Completed No outcome recorded
Phase 1/2 NCT00299416 Feb 2003 → Jan 2009 ischemic stroke The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 219 trials · 1 met primary · 1 missed
Phase 2 NCT06972108 Sep 2026 → Aug 2027 expected meconium aspiration syndrome University of Alberta Not yet recruiting No outcome recorded
Phase 2 NCT07216365 Jun 2026 → Sep 2027 expected infantile apnea University of Rochester Not yet recruiting No outcome recorded
Phase 2 NCT07262060 May 2026 → Mar 2030 expected acute kidney injury University of Wisconsin, Madison Recruiting No outcome recorded
Phase 2 NCT07456670 Apr 2026 → Mar 2028 expected — Queen's University Not yet recruiting No outcome recorded
Phase 2 NCT06345716 Apr 2024 → Mar 2025 overdue urinary tract obstruction University of Monastir Recruiting No outcome recorded
Phase 2 NCT05574400 Feb 2023 → Apr 2026 cognitive impairment with or without cerebellar ataxia, delirium University of Michigan Completed No outcome recorded
Phase 2 NCT05232734 Nov 2022 → Dec 2025 — Singapore General Hospital Suspended No outcome recorded Stop: Enrollment
Phase 2 NCT04562116 Dec 2021 → Jun 2023 atopic eczema Galderma R&D Completed No outcome recorded
Phase 2 NCT05079880 Aug → Oct 2021 gallbladder disorder Tunis University Unknown No outcome recorded
Phase 2 NCT04972123 Jul 2021 → Aug 2023 syncope, familial vasovagal University of Wisconsin, Madison Completed Missed primary
Phase 2/37 trials · 1 missed
Phase 2/3 NCT06026163 Oct 2023 → Oct 2027 expected pulmonary immaturity Ministry of Health, Saudi Arabia Recruiting No outcome recorded
Phase 2/3 NCT03556917 Jun 2018 → Mar 2019 cellulitis Universidade Norte do Paraná Completed No outcome recorded
Phase 2/3 NCT01755702 Jul 2009 → Mar 2010 headache disorder GlaxoSmithKline Terminated Missed primary Stop: Enrollment
Phase 2/3 NCT00459420 Apr 2007 → Jul 2011 Parkinson disease, hypersomnia Ron Postuma Completed No outcome recorded
Phase 2/3 NCT00302263 Jan → Apr 2005 obesity disorder University of Copenhagen Completed No outcome recorded
Phase 2/3 NCT00495092 Jan 2005 → Dec 2009 cocaine dependence Hospital Universitari Vall d'Hebron Research Institute Completed No outcome recorded
Phase 2/3 NCT00302276 Jan → Jul 2004 obesity disorder University of Copenhagen Completed No outcome recorded
Phase 325 trials · 5 met primary · 6 missed
Phase 3 NCT06855108 Apr 2026 → Dec 2029 expected brain hypoxia - ischemia NICHD Global Network for Women's and Children's Health Recruiting No outcome recorded
Phase 3 NCT05485805 Sep 2022 → Jan 2024 — Bayer Completed Met primary
Phase 3 NCT04570085 Mar 2021 → Dec 2027 expected Alzheimer disease University Hospital, Lille Recruiting No outcome recorded
Phase 3 NCT02985671 Jan → Sep 2021 — Ache Laboratorios Farmaceuticos S.A. Unknown No outcome recorded
Phase 3 NCT02582996 Apr 2020 → Apr 2021 migraine disorder Ache Laboratorios Farmaceuticos S.A. Suspended No outcome recorded Stop: Business
Phase 3 NCT03508167 Jan → Oct 2020 — Ache Laboratorios Farmaceuticos S.A. Withdrawn No outcome recorded
Phase 3 NCT04001712 Apr → May 2019 — Ain Shams University Completed No outcome recorded
Phase 3 NCT03340727 Feb 2019 → Jan 2023 apnea of prematurity NICHD Neonatal Research Network Terminated Missed primary
Phase 3 NCT02863575 Oct 2017 → Apr 2018 — Pfizer Completed Missed primary
Phase 3 NCT03003000 Dec 2016 → Sep 2017 — Boehringer Ingelheim Completed Missed primary
Phase 422 trials · 1 met primary · 2 missed
Phase 4 NCT06518603 Jun 2026 → May 2027 expected apnea of prematurity, respiratory distress syndrome in premature infants University of Alabama at Birmingham Recruiting No outcome recorded
Phase 4 NCT07466628 Nov 2024 → Jul 2025 — Liverpool John Moores University Completed No outcome recorded
Phase 4 NCT06763172 May 2023 → Dec 2026 expected — Hsiao-Ying Wey Recruiting No outcome recorded
Phase 4 NCT07022496 Apr 2023 → Jul 2025 overdue migraine disorder Ain Shams University Recruiting No outcome recorded
Phase 4 NCT05454332 Apr 2022 → Dec 2025 overdue lung disorder Hospital de Clinicas de Porto Alegre Recruiting No outcome recorded
Phase 4 NCT04868565 May 2021 → Oct 2023 apnea of prematurity Children's Hospital of Chongqing Medical University Completed No outcome recorded
Phase 4 NCT03951649 Feb 2020 → Dec 2022 headache disorder, pregnancy disorder University of Alabama at Birmingham Completed Missed primary
Phase 4 NCT03360903 Jan → Dec 2018 — University of Chicago Completed No outcome recorded
Phase 4 NCT03086473 Feb 2017 → Jan 2022 apnea of prematurity, bronchopulmonary dysplasia Jennifer Shepherd Unknown No outcome recorded
Phase 4 NCT02760615 Nov 2016 → Aug 2020 Crohn disease, ulcerative colitis Takeda Withdrawn No outcome recorded Stop: Enrollment
Phase not applicable48 trials · 3 missed
— NCT07748429 Jan 2027 → Mar 2028 expected CGF1 Poznan University of Physical Education Not yet recruiting No outcome recorded
— NCT07536568 Apr → Jul 2026 overdue — Cairo University Recruiting No outcome recorded
— NCT07402902 Mar → Jul 2026 overdue disorder of fatty acid and ketone body metabolism Universidad Rey Juan Carlos Enrolling by invitation No outcome recorded
— NCT06461429 Nov 2025 → Dec 2050 expected — University of Melbourne Not yet recruiting No outcome recorded
— NCT07305935 Oct 2025 → Mar 2026 — Muhammad Aamir Latif Completed No outcome recorded
— NCT07652424 Jan → May 2025 circadian rhythm sleep disorder The Higher Institute of Sport and Physical Education of Sfax Completed No outcome recorded
— NCT06704711 Nov → Dec 2024 overdue — University of Gaziantep Not yet recruiting No outcome recorded
— NCT06145490 Oct 2024 → May 2025 panic disorder Uppsala University Completed No outcome recorded
— NCT06210984 Jan 2024 → Dec 2025 — St. Mary's University, Twickenham Unknown No outcome recorded
— NCT05761756 Nov 2023 → Jan 2027 — Duke University Suspended No outcome recorded Stop: Business
Comparator or background therapy75 trials
Phase 0 NCT06097767 Comparator Oct 2023 → Apr 2024 — Al-Azhar University Unknown No outcome recorded
Phase 0 NCT07204379 Comparator Jan → Jul 2023 — Armed Forces Institute of Dentistry, Pakistan Completed No outcome recorded
Phase 1 NCT06448780 Comparator Jul 2024 → Jul 2026 overdue brain hypoxia - ischemia University of North Carolina, Chapel Hill Active not recruiting No outcome recorded
Phase 1 NCT05295784 Comparator May 2024 acute kidney injury, brain hypoxia - ischemia University of Arkansas Withdrawn No outcome recorded
Phase 1 NCT04942340 Comparator May 2023 → Apr 2026 — University of Chicago Withdrawn No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2022-04-13 Zydus Lifesciences Limited Zydus to supply Sagents Caffeine Citrate Oral Solution from Jarod, post USFDAs PAS Approval zyduslife.com ↗

Evidence & citations 58 cited values

Every value below carries the sentence it was read from. 325 sources stand behind the page.

FieldValueCited text
Known as Caffeine “We administered the Basel phenotyping cocktail (caffeine, efavirenz, flurbiprofen, omeprazole, metoprolol, midazolam) to patients with liver cirrhosis (n = 16 Child A, n = 15...” PMID 37328712 ↗ Jun 2023
311

“Ten healthy Caucasian subjects were orally dosed with the CIME combination (caffeine-CYP1A2, repaglinide-CYP2C8, tolbutamide-CYP2C9, omeprazole-CYP2C19,...” PMID 25465228 ↗ Dec 2014

“two pieces of caffeinated chewing gum at an absolute dose of 200 mg (Military Energy Gum®, Ford Gum and Machine Go, Akron, NY, USA) (CAF trial) or two pieces of similar looking...” NCT06693505 ↗

“A CYP probe cocktail composed of approved, commercially available drugs (caffeine, flurbiprofen, omeprazole, and midazolam) will be administered concomitantly as a single-dose...” NCT07426042 ↗

“The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior...” NCT00245375 ↗

“The BTZ-043 groups also received oral dolutegravir (a third of participants) or a probe drug cocktail (caffeine [probe for CYP1A2], tolbutamide [CYP2C9], dextromethorphan...” PMID 39793592 ↗ Jan 2025

“The objective of the present study was to investigate the acute and sub-chronic effect of a supplement containing green tea extract, capsaisin, caffeine, tyrosine and calcium...” NCT00302276 ↗

“A single dose of selective substrates (probe drugs) was administered orally on days 15 and 30: caffeine (CYP1A2), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan...” PMID 37768317 ↗ Sep 2023

“CYP substrates (Caffeine, Warfarin Sodium, Midazolam, Omeprazole, and Metoprolol Tartrate) will administered orally at Week 0 (Day 1) and Week 10 as per the commercially...” NCT04562116 ↗

“Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin)...” NCT02578277 ↗

“Dorilax® (Fixed Association of Paracetamol 350 mg, Carisoprodol 150 mg and Caffeine 50 mg) Plus Thermal Band Compared to Placebo Plus Thermal Band in the Treatment of Acute Low...” NCT03508167 ↗

Show 301 more sources

Known as anhydrous caffeine ClinicalTrials.gov intervention name — accepted as the source's own label NCT01462370 ↗
Known as CAF “caffeine (CAF)” NCT06704711 ↗
Known as Cafcit ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as cafeine “Group 3: Paracetamol-cafeine group who will receive an association of 500 mg of Paracetamol and 65 mg of cafeine : one pill 3 times a day for 7 days .” NCT05229965 ↗
1

“CAFEINE : (solution orale) 2 ampoules de 2 ml = 100 mg de CAFEINE” NCT01443039 ↗

Known as cafeislaine c “we will use cafeislaine c (caffeine) +galvanic current” NCT03556917 ↗
Known as Caffeine alkaloid “Drug: Caffeine alkaloid” NCT01190735 ↗
Known as Caffeine Anhydrous ClinicalTrials.gov intervention name — accepted as the source's own label NCT03694886 ↗
Known as caffeine base “active drug (caffeine base)” NCT03321734 ↗
Known as Caffeine citrate “It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml...” NCT06097767 ↗
11

“Caffeine citrate is a combination of caffeine and citric acid, commonly used as a central nervous system stimulant. It is primarily used to treat apnea of prematurity in neonates.” NCT06905496 ↗

“Neonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose.” NCT07305935 ↗

“Drug: Caffeine Citrate” NCT03340727 ↗

“Drug: Caffeine Citrate” NCT07216365 ↗

NCT03086473 ↗

NCT02098785 ↗

NCT04044976 ↗

NCT04868565 ↗

NCT06401083 ↗

NCT00809055 ↗

Show 1 more source

Known as Caffeine component of anoquan ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of cafergot ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of darvon compound ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of dhc plus ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of esgic ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of excedrin ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of femcet ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of fioricet ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of fiorinal ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of invagesic ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of invagesic forte ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of lanorinal ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of medigesic plus ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of migergot ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗
Known as Caffeine component of norgesic ChEMBL registry synonym — accepted as the source's own label CHEMBL113 ↗