Vivarin

(Caffeine)

ApprovedSmall molecule

Caffeine is a stimulant that helps you feel more alert and awake by blocking chemicals in your brain that make you tired. It's commonly used to combat fatigue and improve concentration and focus.[2] Vivarin is currently approved and in use across 65 indications[4].[1]

Vivarin is one of 1316 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

144

Total Trials

Active Trials

1,315

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseApproved

MetastasisApproved

Cardiac ArrhythmiaActive, not recruiting

Migraine Without AuraApproved

Low Back PainApproved

Bronchopulmonary DysplasiaActive, not recruiting

Neck PainActive, not recruiting

Post Operative Nausea and VomitingActive, not recruiting

Migraine DisorderActive, not recruiting

Common ColdApproved

Coronary Artery DiseaseApproved

Approved

MetastasisApproved

Approved

Cardiac ArrhythmiaPreclinical

Active, not recruiting

Migraine Without AuraApproved

Approved

Low Back PainApproved

Approved

Bronchopulmonary DysplasiaPhase 3

Active, not recruiting

Neck PainPhase 3

Active, not recruiting

Post Operative Nausea and VomitingPreclinical

Active, not recruiting

Migraine DisorderApproved

Active, not recruiting

Common ColdApproved

Approved

Showing 10 of 62 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Vivarin

HHikma Pharmaceuticals LLC

Halaven

38 3

Tecentriq

Roche

Preclinical

36 4

Adriamycin

GGynecologic Oncology Group

Preclinical

87 5

Gemzar

GGynecologic Oncology Group

Preclinical

22 6

DATROWAY

Daiichi Sankyo

Preclinical

4 7

Lexiscan

Astellas

Preclinical

1 8

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—9

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

1 10

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

N/ARecruiting

Toxicity

NCT05761756

Q4 2026

N/AActive, not recruiting

Study completion

NCT00961792

Phase 3Recruiting

Cognition

NCT04570085

N/ARecruiting

Caffeine

NCT06978777

Post-ApprovalRecruiting

Caffeine

NCT06763172

Phase 2Active, not recruiting

Caffeine

NCT06327152

Clinical

Trials by Indication[1]

Caffeine25 trials

A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT05067439·26 enrolled

The Effect of Caffeine in Elderly Citizens

Completed·—·Phase 4·NCT00117520·30 enrolled

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine

Completed· Astellas logo

Astellas·Phase 1·NCT02128321·24 enrolled

Show 22 more trials

Consequences of Caffeine Intake in Sleep Restricted Teenagers

Unknown status·PPsychiatric Hospital of the University of Basel·N/A·NCT05790161·54 enrolled

Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

Completed·UUniversity of Wisconsin, Madison·N/A·NCT00205166·50 enrolled

Caffeine and Cocaine

Completed·VVirginia Commonwealth University·Phase 1/2·NCT00733993·23 enrolled

The Pharmacodynamics of Cannabinoid-Caffeine Combinations

Completed·JJohns Hopkins University·Phase 1·NCT05478863·20 enrolled

Effect of Caffeine on Cold-stimulated Brown Adipose Tissue Activity

Recruiting·UUniversity Hospital, Basel, Switzerland·N/A·NCT06978777·12 enrolled

Effects of Caffeine on Reinforcement Learning in Healthy Adults Using PET/MRI

Recruiting·HHsiao-Ying Wey·Phase 4·NCT06763172·12 enrolled

Effects of Caffeine Ingestion on Morning Cognitive and 4-km Time Trial Performance in Males

Active, not recruiting·LLiverpool John Moores University·Phase 1/2·NCT07469852·15 enrolled

Caffeine Strategies and Fat Oxidation

Not yet recruiting·UUniversidad Rey Juan Carlos·N/A·NCT07402902·10 enrolled

Caffeine and Cerebrovascular Reactivity

Completed·UUniversity of Oklahoma·Phase 1·NCT04730193·10 enrolled

Effects of Caffeine Ingestion on Morning Cognitive and Muscle Repeated Sprint Performance in Males

Enrolling by invitation·LLiverpool John Moores University·Phase 1·NCT07466732·15 enrolled

Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02256813·20 enrolled

The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement

Completed·UUniversity of South Carolina·Phase 1·NCT03937687·49 enrolled

Caffeine Use in the Management of Preterm Infants

Active, not recruiting·UUniversity of California, Irvine·Phase 2·NCT06327152·80 enrolled

Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

Completed·SSharp HealthCare·Phase 4·NCT01783561·21 enrolled

Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise

Unknown status·UUniversidade Estadual Paulista Júlio de Mesquita Filho·N/A·NCT02917889·35 enrolled

The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy Subjects

Unknown status·—·Phase 4·NCT01693809·25 enrolled

Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support

Not yet recruiting·QQueen's University·Phase 2·NCT07456670·62 enrolled

Influence of Caffeine Consumption on the Human Circadian System

Completed·PPsychiatric Hospital of the University of Basel·N/A·NCT05409339·20 enrolled

The Effects of Caffeine on Pain-Based Pacing During a Cycling Time-Trial

Completed·UUniversity of Oklahoma·Phase 1·NCT02115763·15 enrolled

Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT

Completed·UUniversity of Alabama at Birmingham·N/A·NCT02461693·205 enrolled

Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin

Completed·TTobira Therapeutics, Inc.·Phase 1·NCT02685462·36 enrolled

The Effect of Caffeine in Elderly Citizen Following Eight Hour Abstinence From Caffeine Containing Drinks & Foods

Completed·—·Phase 4·NCT01048515·30 enrolled

Interaction15 trials

Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

Completed·Ppharmaand GmbH·Phase 1·NCT02740712·17 enrolled

Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT05594615·24 enrolled

Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer Subjects

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT01517399·28 enrolled

Show 12 more trials

Drug-drug Interaction Study of KL1333 in Healthy Subjects

Completed·AAbliva AB·Phase 1·NCT04643249·14 enrolled

Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults

Completed· GSK logo

GSK·Phase 1·NCT04425902·20 enrolled

A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05445232·32 enrolled

A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05852769·18 enrolled

Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study

Withdrawn· Takeda logo

Takeda·Phase 4·NCT02760615

Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464

Completed·AAbivax S.A.·Phase 1·NCT05121714·59 enrolled

Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT03187496·24 enrolled

Drug-Drug Interaction (DDI) Study for TD-9855

Completed·TTheravance Biopharma·Phase 1·NCT03432793·41 enrolled

A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT06917508·24 enrolled

Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation

Completed· GSK logo

GSK·Phase 1·NCT00964106·87 enrolled

Dabigatran in an Interaction Probe Drug Cocktail

Completed·TTurku University Hospital·Phase 1·NCT02361619·16 enrolled

A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT03970798·50 enrolled

Headache4 trials

Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

Completed·—·Phase 4·NCT03910088·30 enrolled

Assessment of Oral Caffeine Intake in Changing the Severity of Acute Migraine Attack Using VAS Score Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals

Recruiting·—·Phase 4·NCT07022496·120 enrolled

Caffeine Versus Placebo for Spinal Headaches

Withdrawn·UUnited States Naval Medical Center, Portsmouth·N/A·NCT00809627

Show 1 more trial

Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02183688·1,889 enrolled

Tics3 trials

A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02211079·16 enrolled

Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01766050·45 enrolled

Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics

Completed·IInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbH·Phase 1·NCT01845194·117 enrolled

Midazolam3 trials

A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06973005·16 enrolled

The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02254148·24 enrolled

Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00824057·24 enrolled

70 more indications

Single Dose3 trials

A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05932277·22 enrolled

Estimation of the Effect of Multiple Dose Ritlecitinib (PF-06651600) on the Pharmacokinetics of a Single Dose of Caffeine in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT04655040·12 enrolled

A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo

Completed· Bayer logo

Bayer·Phase 3·NCT05485805·541 enrolled

Oral2 trials

A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy Subjects

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03058419·16 enrolled

A Study of Effect of Multiple Doses of LOXO-305 on the Pharmacokinetics of Single Oral Doses of CYP1A2, CYP2C9, CYP2C19 Substrates in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06215430·16 enrolled

Cognition2 trials

The Acute Effects of Caffeine on Exercise and Cognition

Completed·WWestern University, Canada·Phase 4·NCT03400423·64 enrolled

Effect of CAFfeine on Cognition in Alzheimer's Disease

Recruiting·UUniversity Hospital, Lille·Phase 3·NCT04570085·248 enrolled

Heart Rate Variability2 trials

The Effects of Caffeine on Heart Rate and Heart Rate Variability

Unknown status·—·N/A·NCT05521386·16 enrolled

The Influences of Caffeine on Heart Rate Variability of Preterm Infants

Completed·RRambam Health Care Campus··NCT01769118·25 enrolled

Advanced Solid Tumors2 trials

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03864042·56 enrolled

A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT02520752·37 enrolled

Premature Infants2 trials

Effect of Feedings on Caffeine in Premature Infants

Completed·—··NCT02293824·50 enrolled

Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

Unknown status·UUniversity of Oxford··NCT06416956·30 enrolled

Treatment2 trials

Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients

Completed·MMarkus Joerger·Phase 4·NCT01402089·54 enrolled

Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women

Completed·UUniversity of Texas at Austin·Phase 1·NCT05685407·20 enrolled

Ulcerative Colitis2 trials

A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03358706·28 enrolled

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

Recruiting· Roche logo

Roche·Phase 1·NCT07665723·25 enrolled

Function2 trials

Effect of Oral Caffeine and L-Citrulline Supplementation on Arterial Function in Healthy Males

Completed·FFlorida State University·N/A·NCT02214290·16 enrolled

Effects of Low Doses of Caffeine on Mood, Physiology and Mental Function

Completed·NNorthumbria University·N/A·NCT00487227·20 enrolled

Obstructive Sleep Apnea2 trials

Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Completed·VVirginia Commonwealth University·N/A·NCT00310323·69 enrolled

The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT00273754·74 enrolled

Ischemia2 trials

Does Caffeine Reduce Dipyridamole-Induced Protection Against Ischemia-Reperfusion Injury?

Completed·RRadboud University Medical Center·Phase 4·NCT00430170·20 enrolled

Adenosine Receptors Influence Ischemia-Reperfusion Injury

Suspended·RRadboud University Medical Center·N/A·NCT00184847·8 enrolled

Atopic Dermatitis2 trials

Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)

Completed· Regeneron logo

Regeneron·Phase 1·NCT02647086·14 enrolled

Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4

Completed· LEO Pharma logo

LEO Pharma·Phase 1·NCT03556592·40 enrolled

Efficacy2 trials

Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women.

Completed· Bayer logo

Bayer·Phase 4·NCT00781586·22 enrolled

Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients

Completed·HHospital Universitari Vall d'Hebron Research Institute·Phase 2/3·NCT00495092·85 enrolled

Rheumatoid Arthritis2 trials

Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4

Completed·UUnknown Sponsor·Phase 1·NCT04246762·17 enrolled

A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01636557·12 enrolled

Anesthesia2 trials

A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

Completed·UUniversity of Chicago·Phase 4·NCT03360903·8 enrolled

A Study to Determine if Caffeine Accelerates Emergence From Anesthesia

Completed·UUniversity of Chicago·Phase 4·NCT02567968·8 enrolled

Cancer Pain1 trial

Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain

Completed·KKorea Research Foundation·Phase 2·NCT00879775·41 enrolled

Schizophrenia1 trial

The Impact of Caffeine on Cognition in Schizophrenia

Completed·NNova Scotia Health Authority·N/A·NCT02832401·24 enrolled

Pain Control1 trial

Caffeine Study for Pain Control Following Total Joint Replacement

Unknown status·RRothman Institute Orthopaedics·N/A·NCT04280263·70 enrolled

Amyotrophic Lateral Sclerosis1 trial

A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis

Completed· Roche logo

Roche·Phase 1·NCT02655614·54 enrolled

Cirrhosis1 trial

A Study to Compare How Different Substances (Caffeine, Warfarin, Omeprazole, Metoprolol, and Midazolam) Are Handled by the Body of Healthy People and People With Liver Cirrhosis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·N/A·NCT05741385·4 enrolled

Nausea and vomiting1 trial

Caffeine in the Prevention of Post-operative Nausea and Vomiting

Completed·—·N/A·NCT00130026·135 enrolled

TED1 trial

Study To Investigate If Repeat Doses Of GSK598809 Are Safe And Well Tolerated And To Evaluate Blood Levels Of GSK598809

Completed· GSK logo

GSK·Phase 1·NCT00437632·104 enrolled

AML1 trial

An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates

Active, not recruiting· Sanofi logo

Sanofi·Phase 1·NCT06686628·23 enrolled

Subcutaneous Fat1 trial

"Pecos" B-adrenergic and PPAR-G Stimulation Upregulates Lipid Metabolism in Human Subcutaneous Fat

Completed·PPennington Biomedical Research Center·Phase 2·NCT00377975·96 enrolled

Drug1 trial

Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02182336·23 enrolled

Concentration1 trial

To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02629354·36 enrolled

Cocaine Dependence1 trial

Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence

Unknown status·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT00495183·108 enrolled

Toxicity1 trial

Oxygen Toxicity: Mechanisms in Humans

Recruiting·—·N/A·NCT05761756·62 enrolled

Psoriasis1 trial

Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02397382·16 enrolled

Prostate Cancer1 trial

A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer

Completed· Astellas logo

Astellas·Phase 1·NCT02225093·12 enrolled

Impaired Renal Function1 trial

A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01275170·49 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01929031·562 enrolled

Obesity1 trial

Effect on Energy Metabolism at Cellular Level of Diet Plus Treatment With Ephedrine and Caffeine in Obesity

Completed·IIstituto Auxologico Italiano·Phase 3·NCT02048215·13 enrolled

Preconditioning1 trial

The Effect of Caffeine on Ischemic Preconditioning

Completed·RRadboud University Medical Center·N/A·NCT00184912·24 enrolled

Migraine1 trial

The Effects of Caffeine Withdrawal on Migraine

Terminated·NNordlandssykehuset HF·Phase 2/3·NCT03022838·10 enrolled

Memory1 trial

The Acute Effects of Exercise and Caffeine on Working Memory During Acute Caffeine Deprivation

Completed·WWestern University, Canada·Phase 2/3·NCT05170464·7 enrolled

Exercise1 trial

Evaluation of the Effect of Fasting and Exercise on Uptake of Tc-99m Sestamibi in Breast Tissue

Completed·MMayo Clinic·Phase 1·NCT01944215·154 enrolled

Drug Metabolism1 trial

KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism

Completed·HHelsinki University Central Hospital·N/A·NCT06566794·12 enrolled

Dietary Supplements1 trial

Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

Completed·UUniversity of Illinois at Chicago·Phase 1·NCT03948243·19 enrolled

Paralysis1 trial

Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?

Terminated·TThomas Steffen·N/A·NCT02510911·60 enrolled

Spinal Fusion1 trial

Oral Caffeine Use for Pain Management in AIS Patients After Spinal Fusion

Completed·—·Phase 4·NCT04950660·61 enrolled

Hypotension1 trial

Oral Caffeine and Spinal-Induced Hypotension

Completed·—·N/A·NCT07076654·90 enrolled

Inflammation1 trial

A Possible Therapeutic Role for Adenosine During Inflammation

Completed·RRadboud University Medical Center·Phase 1·NCT00513110·33 enrolled

Spinal Cord Injury1 trial

Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury

Completed·SSpaulding Rehabilitation Hospital·Phase 1/2·NCT02323698·36 enrolled

Acute Kidney Injury1 trial

Comparison of Early Caffeine Administration Vs Supportive Therapy in Preventing Acute Kidney Injury

Recruiting·MMuhammad Aamir Latif·N/A·NCT07305935·236 enrolled

Overweight1 trial

A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06564441·34 enrolled

Bronchopulmonary Dysplasia1 trial

Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

Unknown status·TTanta University·Phase 3·NCT05682807·90 enrolled

Imaging1 trial

Imaging the Effects of Zolpidem and Alprazolam in Healthy Volunteers at 3T

Unknown status·MMclean Hospital·Phase 1·NCT01747590·12 enrolled

Carbon Dioxide1 trial

Influence of Caffeine on Psychomotor Vigilance and Carbon Dioxide Tolerance During Graded Hypercapnia

Completed·—·N/A·NCT06636825·29 enrolled

Statin1 trial

Is Augmentation of PORH by Rosuvastatin Adenosine-receptor Mediated?

Completed·RRadboud University Medical Center·Phase 4·NCT00851175·8 enrolled

Patients With Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT01596647·39 enrolled

Severe Pain1 trial

Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed

Completed· Bayer logo

Bayer·Phase 2·NCT04132336·193 enrolled

Amblyopia1 trial

Caffeine in Amblyopia Study

Withdrawn·JJohns Hopkins University·Phase 1/2·NCT02594358

Myocardial Infarction1 trial

Coronary Care Caffeine: Influence of Coffee on Heart Rate Post Myocardial Infarction

Completed·—··NCT00137098·100 enrolled

Chronic Hepatitis1 trial

Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01525628·72 enrolled

Psoriatic Arthritis1 trial

This Study Tests the Effect of Risankizumab on the Metabolism in the Liver of Five Additional Drugs to Study Possible Drug Interactions in Patients With Psoriasis With or Without Psoriatic Arthritis

Completed· AbbVie logo

AbbVie·Phase 1·NCT02772601·21 enrolled

Cardiac Arrhythmia1 trial

A Study of Caffeine on Cardiac Arrhythmias

Completed·OOttawa Heart Institute Research Corporation·N/A·NCT02095405·160 enrolled

Heart Disease1 trial

The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects and in Patients With Ischemic Heart Disease

Completed·SSheba Medical Center·Phase 3·NCT00564824·80 enrolled

ESS1 trial

Cognitive Hyper-performance - Effects of Stimulating Substances in Chess-players

Completed·UUnknown Sponsor·Phase 1·NCT01834547·40 enrolled

Newborns1 trial

Early Versus Late Caffeine for ELBW Newborns

Terminated·WWayne State University·N/A·NCT02524249·110 enrolled

Type 2 Diabetes1 trial

Metformin's Effect on Drug Metabolism in Patients With Type 2 Diabetes

Terminated·UUniversity of Southern Denmark·Phase 1·NCT04504045·10 enrolled

Hypoxia1 trial

Intermittent Hypoxia and Caffeine in Infants Born Preterm

Completed·—·Phase 2·NCT03321734·170 enrolled

Dyspnea1 trial

Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor

Terminated·UUppsala University·Phase 2·NCT02311088·26 enrolled

Parkinson's Disease1 trial

Caffeine as a Therapy for Parkinson's Disease

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 3·NCT01738178·119 enrolled

Methotrexate1 trial

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03131973·26 enrolled

Neck pain1 trial

Ibuprofen/Caffeine Lower Back or Neck Pain Study

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT03003000·635 enrolled

Shivering1 trial

Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT01950520·47 enrolled

Systemic1 trial

A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates

Active, not recruiting·AAllyx Therapeutics·Phase 1·NCT06632990·36 enrolled

Metabolism1 trial

Effects of Caffeine in Hydration and Energy Metabolism

Completed·—·N/A·NCT01477294·30 enrolled

Unspecified9 trials

Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02243553·34 enrolled

AZD2066 Cocktail Study

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00930306·15 enrolled

Enhancement of Postocclusive Reactive Hyperaemia by Dipyridamole

Completed·RRadboud University Medical Center·N/A·NCT00268554·12 enrolled

Show 6 more trials

Chicago Social Drinking Project

Active, not recruiting·UUniversity of Chicago·N/A·NCT00961792·800 enrolled

EIMD Mechanisms Causing Force Loss

Terminated·UUniversity of Oklahoma·Phase 1·NCT02125643·3 enrolled

Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human

Completed·IInje University·Phase 1·NCT01570569·26 enrolled

Metabolic Capacity of Israeli Populations

Unknown status·HHadassah Medical Organization·N/A·NCT00162383·1,200 enrolled

Determine the Effect of Multiple Doses of AZD7325, CYP Study

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00790114·24 enrolled

Caffein Consumption and Response Inhibition

Completed·UUppsala University·N/A·NCT01815203·21 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 21, 1999

CAFCIT

NDA NDA020793

Sources

References

[1]
ClinicalTrials.gov — 144 trial records for Caffeine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vivarin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Caffeine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Caffeine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020793). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Hikma Pharmaceuticals LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adenosine Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: HHikma Pharmaceuticals LLC