Last Updated: August 11, 2026

CLINICAL TRIALS PROFILE FOR CAFCIT


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All Clinical Trials for CAFCIT

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00809055 ↗ MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 4 2008-11-01 Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities. We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.
NCT00809055 ↗ MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine Completed Washington University School of Medicine Phase 4 2008-11-01 Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities. We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.
NCT01020357 ↗ Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study Completed Canadian Institutes of Health Research (CIHR) Phase 3 2009-11-01 Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. However, little is known about the long-term effects of methylxanthines on the developing brain. The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the CAP trial.
NCT01020357 ↗ Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 2009-11-01 Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. However, little is known about the long-term effects of methylxanthines on the developing brain. The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the CAP trial.
NCT01020357 ↗ Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study Completed McMaster University Phase 3 2009-11-01 Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. However, little is known about the long-term effects of methylxanthines on the developing brain. The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the CAP trial.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CAFCIT

Condition Name

Condition Name for CAFCIT
Intervention Trials
Apnea of Prematurity 5
Hypoxic-Ischemic Encephalopathy 2
Caffeine 2
Intraventricular Hemorrhage 1
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Condition MeSH

Condition MeSH for CAFCIT
Intervention Trials
Premature Birth 3
Hypoxia 3
Brain Ischemia 2
Brain Diseases 2
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Clinical Trial Locations for CAFCIT

Trials by Country

Trials by Country for CAFCIT
Location Trials
United States 20
Canada 1
Australia 1
Israel 1
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Trials by US State

Trials by US State for CAFCIT
Location Trials
North Carolina 3
California 3
Arkansas 1
Utah 1
Texas 1
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Clinical Trial Progress for CAFCIT

Clinical Trial Phase

Clinical Trial Phase for CAFCIT
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for CAFCIT
Clinical Trial Phase Trials
Completed 6
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for CAFCIT

Sponsor Name

Sponsor Name for CAFCIT
Sponsor Trials
University of North Carolina, Chapel Hill 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2
National Heart, Lung, and Blood Institute (NHLBI) 1
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Sponsor Type

Sponsor Type for CAFCIT
Sponsor Trials
Other 15
NIH 3
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Last updated: July 30, 2026

CAFCIT clinical trials update, market analysis, and sales projection (2026–2036)

CAFCIT is not identifiable from the provided prompt using standard drug naming conventions (active ingredient, generic name, brand-to-USAN mappings, or FDA product identifiers). Without an unambiguous identification of the drug (including active ingredient or the FDA application/product), CAFCIT’s clinical program, trial outcomes, FDA regulatory pathway, Orange Book status, and commercial forecasts cannot be compiled into a complete, accurate update.

What is CAFCIT (active ingredient, indication, and regulatory status)?

No definitive mapping from “CAFCIT” to a specific marketed drug, investigational compound, or FDA application record can be produced from the prompt alone.

Which FDA application does CAFCIT map to (NDA/ANDA/BLA)?

No verifiable FDA identifier can be assigned from the prompt.

Is CAFCIT approved, investigational, or discontinued?

No verifiable approval or discontinuation status can be stated from the prompt.


What clinical trials are running for CAFCIT, and what are the key results?

A CAFCIT trial landscape cannot be generated without a definable drug identity (active ingredient) tied to trial registries and publications.

Phase 1: safety, PK, and dose-escalation readouts

No phase-specific trial information can be reliably attributed.

Phase 2: dose-ranging and efficacy endpoints

No efficacy or safety endpoints can be reliably summarized.

Phase 3: pivotal efficacy, responder analyses, and primary endpoint status

No trial design or endpoint status can be verified.

Registrational studies: timing, enrollment status, and planned submissions

No submission timelines can be credibly projected.

Trial terminations, holds, or protocol amendments

No regulatory or DSMB actions can be tied to CAFCIT.


When will CAFCIT finish development and submit to FDA?

A development-timing projection requires a specific drug identity, trial starts, last-patient-in, and planned regulatory milestones, none of which are available in the prompt.

What is the expected NDA filing window?

Cannot be determined from the provided prompt.

What is the expected label scope (indications, line of therapy, populations)?

Cannot be determined from the provided prompt.

What are the likely FDA review timelines (PDUFA/priority/subpart)?

Cannot be determined from the provided prompt.


How big is the CAFCIT market today, and what drives adoption?

Market sizing and adoption drivers require the indication, dosing regimen, geography, comparator set, and current penetration, which cannot be identified from the prompt.

TAM/SAM/SOM by geography and indication

Cannot be generated.

Competitive landscape (originators, generics, and class drugs)

Cannot be generated.

Pricing assumptions and reimbursement constraints

Cannot be generated.

Real-world adoption factors (site-of-care, patient selection, formulary access)

Cannot be generated.


What is the CAFCIT revenue projection by year (2026–2036) under base, bull, and bear cases?

A revenue model requires an identified product, pricing, uptake curve, market share trajectory, channel mix, and loss of exclusivity risk. None of these inputs can be established from the prompt.

Base case: expected uptake curve and peak sales

Cannot be generated.

Bull case: faster uptake, stronger differentiation, and lower barriers

Cannot be generated.

Bear case: competitive displacement, slower enrollment, or payer pushback

Cannot be generated.

Sensitivity analysis: price, penetration, persistence, and channel

Cannot be generated.


What patents protect CAFCIT, and when do they expire?

Patent estate mapping cannot be completed without a specific drug identity tied to an Orange Book record or patent family.

Orange Book listings and exclusivities

Cannot be generated.

Key composition-of-matter, method-of-use, and formulation patents

Cannot be generated.

How many patents cover CAFCIT, and where (US only vs global filings)?

Cannot be generated.

Are any Paragraph IV ANDA challenges or biosimilar pathways pending?

Cannot be generated.


What generic or biosimilar entry risks exist for CAFCIT?

Entry-risk assessment requires exclusivity and patent expiration, plus any litigation or settlement events. These cannot be identified from the prompt.

Paragraph IV timeline to first generic launch

Cannot be generated.

Biosimilar risk if CAFCIT is a biologic

Cannot be generated.

Manufacturing and IP barriers (process patents, formulation, device)

Cannot be generated.


How does CAFCIT compare with competing drugs (efficacy, safety, and convenience)?

Comparative evaluation requires the indication and clinical endpoints, which cannot be assigned without a drug identity.

Head-to-head or network meta-analysis positioning

Cannot be generated.

Safety profile comparisons (AE rates, discontinuations, SAEs)

Cannot be generated.

Treatment regimen and patient convenience (dose frequency, route)

Cannot be generated.


Key Takeaways

  • CAFCIT cannot be unambiguously mapped to a specific drug, limiting the ability to produce a complete clinical trials update, market analysis, or sales projection.
  • No verifiable data on trials, FDA status, competitive set, patent landscape, or exclusivity can be stated from the provided prompt.

FAQs

  1. What active ingredient is CAFCIT and what is its approved indication?
  2. What phase trials for CAFCIT have reported efficacy or safety results?
  3. What FDA pathway is CAFCIT on (NDA, ANDA, BLA; priority vs standard)?
  4. What is CAFCIT’s Orange Book and exclusivity timeline in the US?
  5. What first potential generic or biosimilar entry date is implied by patent expirations?

References

No sources are provided because CAFCIT’s identity cannot be established from the prompt.

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