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Cafcit

(Caffeine Citrate)

Phase 3Small molecule

KKaken Pharmaceutical

Caffeine citrate is used to treat apnea of prematurity, a condition where premature babies stop breathing for short periods. It stimulates the respiratory system to help these infants breathe more regularly.[1] Cafcit is currently being investigated across 15 indications[3], with its most advanced program in Phase 3.[1]

Cafcit is one of 227 small molecule programs targeting Premature Birth. It is currently in Phase 3.

15

Indications

30

Total Trials

8

Active Trials

226

Competitors

Pipeline

Status by Indication[3][1]

Indication

Premature BirthActive, not recruiting

Respiratory Distress Syndrome in Premature InfantsActive, not recruiting

BronchiolitisActive, not recruiting

Bronchopulmonary DysplasiaActive, not recruiting

IleusActive, not recruiting

ApneaUnknown

Retinopathy of PrematurityActive, not recruiting

DeliriumActive, not recruiting

EncephalopathyActive, not recruiting

Necrotizing EnterocolitisActive, not recruiting

Premature BirthPhase 3

Active, not recruiting

Respiratory Distress Syndrome in Premature InfantsPreclinical

Active, not recruiting

BronchiolitisPreclinical

Active, not recruiting

Bronchopulmonary DysplasiaPreclinical

Active, not recruiting

IleusPhase 2

Active, not recruiting

ApneaPreclinical

Unknown

Retinopathy of PrematurityPhase 2

Active, not recruiting

DeliriumPhase 2

Active, not recruiting

EncephalopathyPhase 3

Active, not recruiting

Necrotizing EnterocolitisPhase 1

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

221 competitors in Liver Disease

#DrugCompanyPhaseTrials

Cafcit

KKaken Pharmaceutical

Mounjaro

Neurontin

VViatris Specialty LLC

Inderal

WWyeth-Lederle Vaccines

Viagra

VViatris Specialty LLC

Sandostatin

Neupogen

EEastern Cooperative Oncology Group

Retatrutide

Virazole

CConrado Roberto Hoffmann Filho

Plasma

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

Timeline

Expected Milestones

Q3 2027

Phase 2Not yet recruiting

Caffeine

NCT07216365

Q1 2028

Phase 2/3Recruiting

Adjuvant Therapy

NCT06026163

Q4 2028

Post-ApprovalRecruiting

Extubation

NCT06401083

Phase 2Not yet recruiting

Meconium Aspiration Syndrome

NCT06972108

Q3 2030

Phase 3Recruiting

Hypoxic-Ischemic Encephalopathy (HIE)

NCT06855108

Phase 2Not yet recruiting

Caffeine

NCT07262060

Clinical

Trials by Indication[1]

Caffeine10 trials

Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

Terminated·NNICHD Neonatal Research Network·Phase 3·NCT03340727·827 enrolled

Caffeine as Respiratory Stimulant in Preterm Infants

Unknown status·—·Phase 1·NCT04144712·80 enrolled

To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers

Completed·KKaken Pharmaceutical·Phase 1·NCT06821698·38 enrolled

Show 7 more trials

Caffeine Citrate Use and Electronic Activity of the Diaphragm (EDI) Changes

Completed·SSeoul St. Mary's Hospital··NCT05393817·14 enrolled

Caffeine Optimization for Oxygen Saturation Index in ELBW Infants

Not yet recruiting·UUniversity of Rochester·Phase 2·NCT07216365·40 enrolled

Direct Effect of Caffeine on Diaphragmatic Muscles

Unknown status·HHacettepe University··NCT04483492·56 enrolled

Improving Preterm Kidney Outcomes With Caffeine

Not yet recruiting·UUniversity of Wisconsin, Madison·Phase 2·NCT07262060·102 enrolled

Inhibition of VAP-1 by Caffeine in Healthy Human Volunteers Study

Withdrawn·UUniversity of Birmingham·Phase 1·NCT02098785

Effect of Early Use of Caffeine Citrate in Preterm Neonates

Completed·—·Phase 3·NCT04001712·54 enrolled

Early Caffeine in Preterm Neonates

Unknown status·JJennifer Shepherd·Phase 4·NCT03086473·24 enrolled

Apnea of Prematurity3 trials

Caffeine for Apnea of Prematurity (CAP)

Completed·MMcMaster University·Phase 3·NCT00182312·2,000 enrolled

Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study

Completed·MMcMaster University·Phase 3·NCT01020357·201 enrolled

High Versus Low Dose of Caffeine for Apnea of Prematurity

Completed·MMansoura University Children Hospital·Phase 3·NCT02103777·120 enrolled

Neurodevelopment1 trial

MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine

Completed·WWashington University School of Medicine·Phase 4·NCT00809055·74 enrolled

Encephalopathy1 trial

PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia

Withdrawn·UUniversity of Arkansas·Phase 1·NCT05295784

Meconium Aspiration Syndrome1 trial

CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)

Not yet recruiting·UUniversity of Alberta·Phase 2·NCT06972108·20 enrolled

14 more indications

Delirium1 trial

The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study

Recruiting·UUniversity of Michigan·Phase 2·NCT05574400·250 enrolled

Bronchiolitis1 trial

Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants

Completed·HHamad Medical Corporation·N/A·NCT01435486·90 enrolled

Mechanical Ventilation1 trial

Caffeine to Reduce Mechanical Ventilation in Preterm Infants

Terminated·UUniversity of Miami·N/A·NCT01751724·87 enrolled

Neonatal1 trial

Caffeine Citrate to Improve Neonatal Outcomes.

Not yet recruiting·UUniversity of Melbourne·N/A·NCT06972849·3,900 enrolled

Infants1 trial

Management of Apnea in Late Preterm and Term Infants

Withdrawn·—·Phase 2·NCT02408328

Adjuvant Therapy1 trial

Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

Recruiting·MMinistry of Health, Saudi Arabia·Phase 2/3·NCT06026163·134 enrolled

General Anesthesia1 trial

Caffeine and Neurologic Recovery Following Surgery and General Anesthesia

Completed·UUniversity of Michigan·Phase 1·NCT03577730·71 enrolled

Treatment1 trial

Caffeine Treatment in in the Delivery Room

Completed·UUniversity of Florence·N/A·NCT04044976·42 enrolled

Prevention1 trial

Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)

Completed·SState University of New York - Downstate Medical Center·Phase 2·NCT02344225·14 enrolled

Necrotizing Enterocolitis1 trial

the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy

Unknown status·—·Phase 1·NCT06097767·50 enrolled

Extubation1 trial

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

Recruiting·SSemmelweis University·Phase 4·NCT06401083·226 enrolled

Colorectal Surgery1 trial

Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

Completed·HHadassah Medical Organization·Phase 2·NCT03097900·70 enrolled

Hypoxic-ischemic Encephalopathy (HIE)1 trial

Caffeine for Hypoxic Ischemic Encephalopathy (CHIME Trial)

Recruiting·NNICHD Global Network for Women's and Children's Health·Phase 3·NCT06855108·830 enrolled

Unspecified1 trial

Target Weaning Oxygen to Determine Cafffeine Duration for AOP

Completed·—·Phase 4·NCT04868565·310 enrolled

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Caffeine Citrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Caffeine Citrate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Caffeine Citrate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Kaken Pharmaceutical company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adenosine Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: KKaken Pharmaceutical

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