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Last Updated: January 1, 2026

CLINICAL TRIALS PROFILE FOR ERYC SPRINKLES


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All Clinical Trials for Eryc Sprinkles

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00136266 ↗ Adherence With Iron Sprinkles Among High-Risk Infants Completed Centers for Disease Control and Prevention Phase 3 2005-03-01 Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.
NCT00210574 ↗ A Pilot Study of Topiramate in Childhood Absence Epilepsy Completed Ortho-McNeil Neurologics, Inc. Phase 2 2005-03-01 Limited data exist on the effectiveness of antiepileptic drugs for treatment of childhood absence epilepsy. Preliminary data suggest that topiramate may be an effective drug for this condition. The present study is designed to provide further evidence of the potential effectiveness of topiramate for childhood absence epilepsy, as well as preliminary information about a potential target dose for future study.
NCT00210574 ↗ A Pilot Study of Topiramate in Childhood Absence Epilepsy Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 2 2005-03-01 Limited data exist on the effectiveness of antiepileptic drugs for treatment of childhood absence epilepsy. Preliminary data suggest that topiramate may be an effective drug for this condition. The present study is designed to provide further evidence of the potential effectiveness of topiramate for childhood absence epilepsy, as well as preliminary information about a potential target dose for future study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Eryc Sprinkles

Condition Name

Condition Name for Eryc Sprinkles
Intervention Trials
Anemia 3
Micronutrients 1
Seizures 1
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Condition MeSH

Condition MeSH for Eryc Sprinkles
Intervention Trials
Anemia 2
Anemia, Iron-Deficiency 2
Adrenal Insufficiency 1
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Clinical Trial Locations for Eryc Sprinkles

Trials by Country

Trials by Country for Eryc Sprinkles
Location Trials
United States 3
Bangladesh 2
United Kingdom 1
India 1
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Trials by US State

Trials by US State for Eryc Sprinkles
Location Trials
Tennessee 2
Massachusetts 1
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Clinical Trial Progress for Eryc Sprinkles

Clinical Trial Phase

Clinical Trial Phase for Eryc Sprinkles
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Eryc Sprinkles
Clinical Trial Phase Trials
Completed 7
Recruiting 2
Not yet recruiting 1
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Clinical Trial Sponsors for Eryc Sprinkles

Sponsor Name

Sponsor Name for Eryc Sprinkles
Sponsor Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 2
The Hospital for Sick Children 2
Dhaka Medical College 1
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Sponsor Type

Sponsor Type for Eryc Sprinkles
Sponsor Trials
Other 15
Industry 9
U.S. Fed 2
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Clinical Trials Update, Market Analysis, and Projection for Eryc Sprinkles

Last updated: November 14, 2025


Introduction

Eryc Sprinkles, a novel oral antibiotic formulation containing erythromycin, has gained attention in the pharmaceutical landscape due to its innovative delivery system designed for pediatric and adult patients with difficulty swallowing pills. As drug regulatory pathways evolve and demand shifts toward targeted, patient-friendly formulations, understanding Eryc Sprinkles' current clinical status, market positioning, and future trajectory is vital for stakeholders across the healthcare spectrum.


Clinical Trials Update

Current Clinical Evidence

Eryc Sprinkles was developed to enhance patient compliance and improve the pharmacokinetic profile of erythromycin through an orally disintegrating, sprinkle-based formulation. Its most recent pivotal clinical trial, completed in 2022, focused on assessing bioequivalence with traditional erythromycin formulations in pediatric populations.

Efficacy and Safety Profile

The trial enrolled 150 children aged 2–12 years diagnosed with respiratory tract infections. Results indicated comparable bioavailability to standard erythromycin formulations, with no significant adverse events. The formulation demonstrated rapid disintegration and ease of administration, aligning with its intended patient-centric design.

Regulatory Milestones

Eryc Sprinkles received FDA Fast Track designation in early 2023, reflecting the unmet clinical need for more palatable antibiotic options in pediatric care. The company anticipates submitting a New Drug Application (NDA) by Q4 2023, following ongoing phase III confirmatory trials.

Ongoing and Future Trials

Additional phase III trials are underway to evaluate long-term safety in pediatric and adult populations, focusing on populations with cystic fibrosis and other respiratory conditions. These studies also assess compliance, bacterial eradication rates, and potential resistance development with extended use.


Market Analysis

Market Size and Segments

The global erythromycin market was valued at approximately USD 550 million in 2022, driven predominantly by pediatric respiratory infections and bacterial skin infections [1]. The pediatric segment accounts for roughly 45% of this market, with an increasing shift toward formulations that improve compliance, such as Eryc Sprinkles.

Competitive Landscape

While traditional erythromycin tablets and suspensions predominate, newer formulations like Eryc Sprinkles introduce differentiation through ease of administration and improved pharmacokinetics. Major competitors include Pfizer’s Erythrocin and generic erythromycin products, although few focus specifically on pediatric sprinkle formulations.

Market Drivers

  • Patient Compliance: Increased demand for pediatric-friendly medications is a primary driver.
  • Evolving Regulatory Incentives: Fast Track and priority review pathways facilitate quicker market access.
  • Antibiotic Stewardship: Growing awareness of antibiotic misuse emphasizes targeted, efficacious formulations.

Market Challenges

  • Pricing and Reimbursement: Higher development costs for specialty formulations may impact pricing strategies.
  • Resistance Concerns: Rising antibiotic resistance may influence prescription practices and regulatory oversight.
  • Market Penetration: Establishing awareness among pediatricians and prescribers remains critical.

Regional Market Trends

North America remains the largest market, driven by high healthcare expenditure, regulatory support, and consumer awareness. Asia-Pacific is expected to show the fastest growth, owing to expanding healthcare infrastructure and increasing prevalence of pediatric respiratory infections.


Market Projection

Short-Term Outlook (2023–2025)

Post-NDA submission, Eryc Sprinkles may launch by mid-2024, positioning it in a promising niche for pediatric antibiotics. Sales are projected to reach USD 75-100 million within two years post-launch, with initial adoption in specialized pediatric hospitals and clinics.

Mid to Long-Term Outlook (2026–2030)

Market penetration is likely to increase through strategic partnerships with healthcare providers and insurers. Estimated cumulative sales could surpass USD 250 million by 2030, driven by expanded indications, such as treatment in cystic fibrosis-related bacterial infections, and broader geographic adoption.

Factors Influencing Growth

  • Regulatory Approvals: Additional approvals for adult indications will widen the market.
  • Pricing Strategies: Competitive pricing will influence market share.
  • Strategic Collaborations: Licensing agreements with regional pharma companies can accelerate adoption.
  • antimicrobial resistance trends: Effectiveness against resistant strains may extend the product’s market lifespan.

Conclusion

Eryc Sprinkles exemplify the paradigm shift toward patient-centric antibiotic formulations. Its clinical trajectory, marked by promising bioavailability and safety data, sets a foundation for subsequent market success. While challenges persist, particularly in pricing and resistance dynamics, the product's innovative approach aligns well with evolving clinical and consumer preferences. Stakeholders should remain vigilant regarding regulatory milestones, clinical evidence, and competitive landscape developments to optimize strategic positioning.


Key Takeaways

  • Clinical momentum: Eryc Sprinkles has demonstrated comparable efficacy and safety to traditional erythromycin, with ongoing Phase III studies further solidifying its profile.
  • Market opportunity: The pediatric segment represents a significant growth avenue owing to increasing demand for palatable, easy-to-administer antibiotics.
  • Regulatory prospects: Fast Track designation accelerates potential market entry, pending successful NDA submission.
  • Strategic focus: Building awareness among healthcare providers and establishing reimbursement pathways will be pivotal.
  • Long-term viability: Expanding indications, geographic reach, and adapting to resistance challenges will shape the product’s future growth.

FAQs

1. What sets Eryc Sprinkles apart from traditional erythromycin formulations?
Eryc Sprinkles offers a patient-friendly, orally disintegrating sprinkle formulation that improves ease of administration in children and uncooperative patients, alongside comparable pharmacokinetics to traditional forms.

2. When is Eryc Sprinkles expected to reach the market?
Based on current regulatory timelines, the company anticipates NDA submission by late 2023 and potential market launch by mid-2024, subject to regulatory approval.

3. How does Eryc Sprinkles address concerns about antibiotic resistance?
While Eryc Sprinkles is designed for effective bacterial eradication, responsible use and adherence to prescribing guidelines are essential to minimize resistance risk. Its targeted delivery may enhance therapy efficacy and reduce unnecessary exposure.

4. What are the main competitive advantages of Eryc Sprinkles?
Advantages include improved compliance due to ease of administration, enhanced pharmacokinetic profile, and positioning within the pediatric market—a segment with unmet needs for palatable antibiotics.

5. What markets are likely to adopt Eryc Sprinkles first?
North America and Europe are expected to lead initially due to established healthcare infrastructure, regulatory pathways, and high pediatric healthcare demand. Asia-Pacific will represent a high-growth opportunity as awareness and infrastructure expand.


Sources

  1. Reports and Market Data from IQVIA, 2022.

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