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caffeine

Small moleculeapproved

Approved

Nov 26, 1948

Caffeine is a methylxanthine alkaloid found in the seeds, nuts, or leaves of a number of plants native to South America and East Asia that is structurally related to adenosine and acts primarily as an adenosine receptor antagonist with psychotropic and anti-inflammatory activities. Upon ingestion, caffeine binds to adenosine receptors in the central nervous system (CNS), which inhibits adenosine binding. This inhibits the adenosine-mediated downregulation of CNS activity; thus, stimulating the activity of the medullary, vagal, vasomotor, and respiratory centers in the brain. The anti-inflammatory effects of caffeine are due the nonselective competitive inhibition of phosphodiesterases. Caffeine is used by mouth or rectally in combination with painkillers (such as aspirin and acetaminophen) and a chemical called ergotamine for treating migraineheadaches. It is also used with painkillers for simple headaches and preventing and treating headaches after epidural anesthesia. Caffeine creams are applied to the skin to reduce redness and itching in dermatitis. Healthcare providers sometimes give caffeine intravenously (by IV) for headache after epidural anesthesia, breathing problems in newborns, and to increase urine flow. In foods, caffeine is used as an ingredient in soft drinks, energy drinks, and other beverages. — NCATS

Clinical trial activity

409 trials · 386 clinical orgs · 73 marketing orgs

Phase 1
110
Phase 2
68
Phase 3
51
Phase 4
36

Earliest trial started Jul 1, 1995 (NCT00162383)

Timeline

1940s

  1. Nov 26, 1948

    Earliest FDA Approval

  2. Nov 26, 1948

    Novartis — NDA Secondary Org

1950s

  1. Nov 12, 1957

    Xanodyne Pharmaceuticals — NDA Secondary Org

  2. Jul 7, 1958

    Sun Pharmaceuticals — NDA Secondary Org

1960s

  1. Mar 4, 1964

    Bausch Health Companies — NDA Secondary Org

  2. Mar 4, 1964

    Medicis — NDA Secondary Org

1970s

  1. Dec 22, 1970

    Sandoz — Marketing Organization

  2. Sep 23, 1975

    Alta Pharma — Marketing Organization

  3. May 4, 1976

    Allergan — NDA Secondary Org

  4. Aug 21, 1978

    Watson Pharmaceuticals — Marketing Organization

  5. Jun 5, 1979

    Hikma — Marketing Organization

  6. Jul 25, 1979

    Actavis — Marketing Organization

1980s

  1. Apr 30, 1980

    Puracap Pharmaceutical — Marketing Organization

  2. Jul 30, 1980

    Fosun — Marketing Organization

  3. Nov 5, 1980

    Organon — Marketing Organization

  4. Dec 28, 1981

    Lannett Company, Inc. — Marketing Organization

  5. Oct 4, 1983

    Cosette — Marketing Organization

  6. Nov 9, 1984

    Actavis — NDA Secondary Org

  7. Jan 24, 1985

    Specgx Llc — Marketing Organization

  8. Mar 27, 1985

    Graham Dm — Marketing Organization

  9. Mar 27, 1985

    Mallinckrodt — Marketing Organization

  10. Mar 27, 1985

    Avon Products — Marketing Organization

  11. Mar 29, 1985

    Teva — Marketing Organization

  12. Mar 4, 1986

    Pharmaceutical Research Associates, Inc. (PRA) — Marketing Organization

  13. Mar 17, 1986

    Dr. Reddy's Laboratories — Marketing Organization

  14. Mar 17, 1986

    Mayne Pharma — Marketing Organization

  15. May 14, 1986

    Leitner Pharms — Marketing Organization

  16. Oct 1, 1986

    Shire — Marketing Organization

  17. Jan 21, 1987

    Mikart — Marketing Organization

1990s

  1. Oct 26, 1990

    SmithKline Beecham — NDA Secondary Org

  2. Nov 27, 1996

    Novartis — Marketing Organization

  3. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

  4. Jan 14, 1998

    GlaxoSmithKline — NDA Secondary Org

  5. May 29, 1998

    Galt Pharmaceuticals — Marketing Organization

  6. Aug 31, 1998

    Jerome Stevens Pharmaceuticals — Marketing Organization

  7. Sep 21, 1999

    West-Ward Pharmaceutical — NDA Secondary Org

  8. Sep 21, 1999

    Hikma — NDA Secondary Org

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Jul 23, 2001

    Able Laboratories — Marketing Organization

  3. Aug 22, 2001

    Bausch Health Companies — Marketing Organization

  4. Nov 26, 2001

    Perrigo — Marketing Organization

  5. Nov 30, 2001

    LGM Pharma — Marketing Organization

  6. Apr 22, 2002

    Vintage — Marketing Organization

  7. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  8. Sep 21, 2006

    Exela Pharma Sciences, LLC. — Marketing Organization

  9. Sep 22, 2006

    West-Ward Pharmaceutical — Marketing Organization

  10. Apr 3, 2007

    Boca Pharmacal — Marketing Organization

  11. Apr 3, 2007

    Wraser Pharmaceuticals — Marketing Organization

  12. May 15, 2007

    Lutipold — Marketing Organization

  13. May 15, 2007

    Sankyo — Marketing Organization

  14. May 15, 2007

    Daiichi Sankyo — Marketing Organization

  15. Jun 13, 2007

    Nostrum Laboratories — Marketing Organization

  16. Jul 20, 2007

    Fresenius — Marketing Organization

  17. Dec 1, 2008

    Novast Labs — Marketing Organization

  18. Dec 23, 2008

    Mirror Pharms — Marketing Organization

  19. Sep 30, 2009

    Sun Pharmaceuticals — Marketing Organization

  20. Nov 16, 2009

    Nexgen Pharma, Inc — Marketing Organization

2010s

  1. Aug 29, 2012

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  2. Sep 22, 2015

    Aurobindo Pharma — Marketing Organization

  3. Sep 22, 2015

    Eugia Pharma — Marketing Organization

  4. Sep 22, 2016

    Pharmaceutics International, Inc. — Marketing Organization

  5. Sep 22, 2016

    Strides Pharma Science — Marketing Organization

  6. Sep 22, 2016

    Esteve Labs — Marketing Organization

  7. Sep 30, 2016

    Larken Labs Inc — Marketing Organization

  8. Oct 28, 2016

    Nuvo Research Inc. — Marketing Organization

  9. Jan 10, 2017

    County Line — Marketing Organization

  10. Jan 10, 2017

    Alvogen — Marketing Organization

  11. Aug 4, 2017

    Xspire Pharma — Marketing Organization

  12. Dec 14, 2017

    Micro Labs Ltd India — Marketing Organization

  13. Sep 26, 2018

    Abhai LLC — Marketing Organization

2020s

  1. Apr 8, 2020

    Granules India — Marketing Organization

  2. Jul 1, 2020

    Taro Pharmaceuticals — Marketing Organization

  3. Jul 17, 2020

    Nesher Pharms — Marketing Organization

  4. Jul 17, 2020

    Zydus Discovery DMCC — Marketing Organization

  5. Aug 13, 2021

    Senores Pharms — Marketing Organization

  6. Aug 13, 2021

    RISE PHARMA — Marketing Organization

  7. Nov 17, 2021

    RiconPharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedNov 26, 1948

Chemistry & pharmacology

Loading structure…

SMILES

Cn1c(=O)c2c(ncn2C)n(C)c1=O
Mol. weight
194.19 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Over the Counter

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • 1,3,7-trimethyl-2,6-dioxopurine
  • 1,3,7-trimethyl-2,6-dioxopurine
  • 1,3,7-trimethyl-2,6-dioxopurine
  • 1,3,7-trimethylpurine-2,6-dione
  • 1,3,7-trimethylpurine-2,6-dione
  • 1,3,7-trimethylxanthine
  • 1,3,7-trimethylxanthine
  • 1-methyltheobromine
  • 1-methyltheobromine
  • 3,7-dihydro-1,3,7-trimethyl-1h-purin-2,6-dion
  • 3,7-dihydro-1,3,7-trimethyl-1h-purin-2,6-dion
  • 7-methyltheophylline
  • 7-methyltheophylline
  • 7-methyltheophylline
  • acetaminophen mixture with caffeine and dipyrone
  • anhydrous caffeine
  • anhydrous caffeine
  • anhydrous caffeine
  • anhydrous caffeine
  • anhydrous caffeine
  • anhydrous caffeine
  • cafalgine
  • cafcit
  • cafcit
  • cafcit
  • cafeina
  • cafeína
  • cafeína
  • caféine
  • caféine
  • caffeine
  • caffeine
  • caffeine
  • caffeine
  • caffeine
  • caffeine
  • caffeine
  • caffeine
  • caffeine
  • caffeine citrate
  • caffeine citrate
  • caffeine citrate
  • caffeine citrate
  • caffeine citrate
  • caffeine citrate
  • caffeine citrate
  • caffeine, citrated
  • caffeine, citrated
  • caffeine, citrated
  • caffeinol
  • caffeinol
  • caffeinum
  • caffeinum
  • citrated caffeine
  • coffein
  • coffein
  • coffeine
  • coffeine
  • coffeinum
  • coffeinum
  • durvitan
  • guaranine
  • guaranine
  • guaranine
  • koffein
  • koffein
  • mateína
  • mateína
  • methyltheobromine
  • methyltheobromine
  • methyltheobromine
  • nodoz
  • nodoz
  • nodoz caplets and chewable tablets
  • nodoz caplets and chewable tablets
  • nymusa
  • orphenadrine caffeine
  • peyona
  • peyona
  • peyona
  • pro-plus
  • teína
  • teína
  • thein
  • thein
  • thein
  • theine
  • theine
  • theine
  • yeast-vite
  • zanthine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07262060Phase 2Mar 31, 2026National Institutes of Health (NIH), University of Wisconsin
NCT06978777N/AJan 15, 2026University of Basel
NCT07238465Phase 3Dec 31, 2025Linda Crnic Institute for Down Syndrome, National Institute on Aging (NIA), University of Colorado, Denver
NCT06972108Phase 2Dec 1, 2025University of Alberta
NCT07216365Phase 2Nov 1, 2025University of Rochester
NCT07212803Phase 4Nov 1, 2025University of the Pacific
NCT06972849N/AOct 31, 2025University of Melbourne
NCT07193264N/AOct 31, 2025—
NCT07305935N/AOct 1, 2025RESnTEC, Institute of Research
NCT07268573N/AAug 1, 2025Sinop University
NCT07076654N/AJul 12, 2025Cairo University
NCT06638372N/AJul 1, 2025National Taiwan Sport University
NCT06855108Phase 3Jun 30, 2025Aga Khan University, Bill and Melinda Gates Foundation, Columbia University, Institute of Nutrition of Central America and Panama, International Center for Diarrheal Disease Research, Jawaharlal Nehru Medical College, Lata Medical Research Foundation, Nagpur, India, National Institute of Child Health and Human Development (NICHD), RTI International, Thomas Jefferson University, University of Alabama, Birmingham, University of Colorado, Denver, University of Kinshasa, University of North Carolina at Chapel Hill, University of Virginia, University Teaching Hospital, Lusaka, Zambia
NCT07047105N/AJun 13, 2025Mibelle AG, Northumbria University
NCT07210099N/AMay 30, 2025Anglia Ruskin University
NCT06973005Phase 1May 8, 2025AstraZeneca, Parexel
NCT06935214N/AMay 1, 2025St Mary's University, Twickenham
NCT06939608N/AApr 28, 2025University of Greifswald
NCT06917508Phase 1Mar 13, 2025Enanta Pharmaceuticals
NCT07056231N/AMar 5, 2025Sinop University
Showing 20 of 409 trials
Page 1 / 21

Organizations

Research & Development (386)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Boehringer IngelheimFor profit141331998
National Institutes of Health (NIH)Government9042008
GlaxoSmithKlineFor profit8832006
National Taiwan Sport UniversityAcademic/Hospital8822022
Radboud UniversityAcademic/Hospital8832003
AstraZenecaFor profit7622007
Johnson and JohnsonFor profit6522004
Northumbria UniversityAcademic/Hospital6422005
United States ArmyGovernment6322017
Universidad de Alcala, MadridAcademic/Hospital6612023
University of BaselAcademic/Hospital6422012
Canadian Institutes of Health Research (CIHR)Academic/Hospital5031999
Harvard UniversityAcademic/Hospital5332005
University of BernAcademic/Hospital5422010
University of ChicagoAcademic/Hospital5542004
University of CopenhagenAcademic/Hospital5532000
Ache Laboratorios Farmaceuticos S.A.For profit4412017
AstellasFor profit4331999
Bristol-Myers SquibbFor profit4422008
Johns Hopkins UniversityAcademic/Hospital4322011
386 organizations
Page 1 / 20

Marketing (93)

OrganizationOrg typeRelationshipDate
Abhai LLCFor profitMKTGSep 26, 2018
Able LaboratoriesFor profitMKTGJul 23, 2001
ActavisFor profitNDA2Nov 9, 1984
ActavisFor profitMKTGJul 25, 1979
AllerganFor profitNDA2May 4, 1976
Alta PharmaFor profitMKTGSep 23, 1975
AlvogenFor profitMKTGJan 10, 2017
Aurobindo PharmaFor profitMKTGSep 22, 2015
Aurobindo PharmaFor profitSYNSep 26, 2018
Avon ProductsFor profitMKTGMar 27, 1985
Bausch Health CompaniesFor profitNDA2Mar 4, 1964
Bausch Health CompaniesFor profitMKTGAug 22, 2001
Boca PharmacalFor profitMKTGApr 3, 2007
CosetteFor profitMKTGOct 4, 1983
CosetteFor profitSYNOct 4, 1983
County LineFor profitMKTGJan 10, 2017
Daiichi SankyoFor profitMKTGMay 15, 2007
Dr. Reddy's LaboratoriesFor profitMKTGMar 17, 1986
Esteve LabsFor profitMKTGSep 22, 2016
Eugia PharmaFor profitMKTGSep 22, 2015
Exela Pharma Sciences, LLC.For profitSYNSep 21, 2006
Exela Pharma Sciences, LLC.For profitMKTGSep 21, 2006
Exela Pharma Sciences, LLC.For profitSYNSep 21, 2006
Forest LaboratoriesFor profitMKTG—
FosunFor profitMKTGJul 30, 1980
FreseniusFor profitMKTGJul 20, 2007
Galt PharmaceuticalsFor profitMKTGMay 29, 1998
GlaxoSmithKlineFor profitNDA2Jan 14, 1998
Graham DmFor profitMKTGMar 27, 1985
Granules IndiaFor profitMKTGApr 8, 2020
Granules IndiaFor profitSYNFeb 23, 2021
HalseyFor profitMKTG—
HikmaFor profitSYNSep 21, 1999
HikmaFor profitMKTGJun 5, 1979
HikmaFor profitSYNJun 12, 1995
HikmaFor profitNDA2Sep 21, 1999
IvaxFor profitMKTG—
Jerome Stevens PharmaceuticalsFor profitMKTGAug 31, 1998
LGM PharmaFor profitMKTGNov 30, 2001
Laboratoires GilbertFor profitMKTG—
Lannett Company, Inc.For profitSYNSep 13, 2012
Lannett Company, Inc.For profitMKTGDec 28, 1981
Larken Labs IncFor profitMKTGSep 30, 2016
Leitner PharmsFor profitMKTGMay 14, 1986
LutipoldFor profitMKTGMay 15, 2007
MallinckrodtFor profitMKTGMar 27, 1985
Mayne PharmaFor profitMKTGMar 17, 1986
MedicisFor profitNDA2Mar 4, 1964
Micro Labs Ltd IndiaFor profitMKTGDec 14, 2017
MikartFor profitMKTGJan 21, 1987
Mirror PharmsFor profitMKTGDec 23, 2008
Nesher PharmsFor profitMKTGJul 17, 2020
Nexgen Pharma, IncFor profitMKTGNov 16, 2009
Nexgen Pharma, IncFor profitSYNNov 30, 2001
Nostrum LaboratoriesFor profitMKTGJun 13, 2007
NovartisFor profitNDA2Nov 26, 1948
NovartisFor profitMKTGNov 27, 1996
Novast LabsFor profitMKTGDec 1, 2008
Nuvo Research Inc.For profitMKTGOct 28, 2016
OrganonFor profitMKTGNov 5, 1980
PerrigoFor profitMKTGNov 26, 2001
Pharmaceutical Research Associates, Inc. (PRA)For profitMKTGMar 4, 1986
Pharmaceutics International, Inc.For profitMKTGSep 22, 2016
Puracap PharmaceuticalFor profitMKTGApr 30, 1980
Quantum PharmaceuticalFor profitMKTG—
RISE PHARMAFor profitMKTGAug 13, 2021
RiconPharmaFor profitMKTGNov 17, 2021
Sagent Pharmaceuticals, Inc.For profitMKTGAug 29, 2012
SandozFor profitNDA—
SandozFor profitMKTGDec 22, 1970
SankyoFor profitMKTGMay 15, 2007
Senores PharmsFor profitMKTGAug 13, 2021
ShireFor profitMKTGOct 1, 1986
SmithKline BeechamFor profitNDA2Oct 26, 1990
Specgx LlcFor profitMKTGJan 24, 1985
Strides Pharma ScienceFor profitMKTGSep 22, 2016
Sun PharmaceuticalsFor profitSYNSep 30, 2009
Sun PharmaceuticalsFor profitMKTGSep 30, 2009
Sun PharmaceuticalsFor profitNDA2Jul 7, 1958
Taro PharmaceuticalsFor profitSYNJul 1, 2020
Taro PharmaceuticalsFor profitMKTGJul 1, 2020
TevaFor profitSYNApr 14, 1978
TevaFor profitMKTGMar 29, 1985
US CHEMFor profitMKTG—
VintageFor profitMKTGApr 22, 2002
VintageFor profitSYNMar 5, 1999
Watson PharmaceuticalsFor profitMKTGAug 21, 1978
West-Ward PharmaceuticalFor profitNDA2Sep 21, 1999
West-Ward PharmaceuticalFor profitMKTGSep 22, 2006
Wraser PharmaceuticalsFor profitMKTGApr 3, 2007
Xanodyne PharmaceuticalsFor profitNDA2Nov 12, 1957
Xspire PharmaFor profitMKTGAug 4, 2017
Zydus Discovery DMCCFor profitMKTGJul 17, 2020