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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR GASTROCROM


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All Clinical Trials for GASTROCROM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01841307 ↗ Cromolyn Detection of Silent Aspiration Terminated Aradign Corportation Phase 1 2015-07-01 The overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration.
NCT01841307 ↗ Cromolyn Detection of Silent Aspiration Terminated National Heart, Lung, and Blood Institute (NHLBI) Phase 1 2015-07-01 The overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration.
NCT01841307 ↗ Cromolyn Detection of Silent Aspiration Terminated University of California, San Francisco Phase 1 2015-07-01 The overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration.
NCT02371941 ↗ Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis Completed University of Tennessee Phase 4 2014-12-01 This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when made into a viscous preparation for the treatment of eosinophilic esophagitis.
NCT03167216 ↗ Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction Recruiting National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Early Phase 1 2017-08-01 The objective of this study is to evaluate inhibition of mast cells and the histamine 1 receptor (H1R) for treatment of chronic prostatitis (CP) and chronic pelvic pain syndrome (CPPS).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for GASTROCROM

Condition Name

Condition Name for GASTROCROM
Intervention Trials
Idiopathic Pulmonary Fibrosis 1
Lung Transplantation 1
Respiratory Aspiration 1
Chronic Prostatitis With Chronic Pelvic Pain Syndrome 1
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Condition MeSH

Condition MeSH for GASTROCROM
Intervention Trials
Eosinophilic Esophagitis 1
Respiratory Aspiration 1
Pulmonary Fibrosis 1
Idiopathic Pulmonary Fibrosis 1
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Clinical Trial Locations for GASTROCROM

Trials by Country

Trials by Country for GASTROCROM
Location Trials
United States 3
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Trials by US State

Trials by US State for GASTROCROM
Location Trials
Illinois 1
Tennessee 1
California 1
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Clinical Trial Progress for GASTROCROM

Clinical Trial Phase

Clinical Trial Phase for GASTROCROM
Clinical Trial Phase Trials
Phase 4 1
Phase 1 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for GASTROCROM
Clinical Trial Phase Trials
Recruiting 1
Terminated 1
Completed 1
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Clinical Trial Sponsors for GASTROCROM

Sponsor Name

Sponsor Name for GASTROCROM
Sponsor Trials
University of Tennessee 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 1
Northwestern University 1
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Sponsor Type

Sponsor Type for GASTROCROM
Sponsor Trials
Other 4
NIH 2
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Clinical Trials Update, Market Analysis, and Projection for GASTROCROM (Cromoglicate Sodium)

Last updated: February 1, 2026


Summary

GASTROCROM, known generically as Cromoglicate Sodium, is a well-established anti-allergic agent primarily used in the management of asthma, allergic conjunctivitis, and other allergic conditions. Developed originally in the 1960s, it remains integral for both prophylaxis and symptom control. This analysis covers recent clinical trial developments, current market positioning, competitive landscape, and future growth projections until 2030, providing actionable insights for stakeholders.


What is GASTROCROM (Cromoglicate Sodium)?

Feature Details
Drug Class Mast cell stabilizer
Formulation Inhalation aerosols, eye drops, oral tablets
Approved Uses Asthma prophylaxis, allergic conjunctivitis, rhinoconjunctivitis, food allergy mitigation
Approval Body FDA (United States), EMA (Europe), other global agencies

Recent Clinical Trials for GASTROCROM

What Are the Latest Clinical Trials and Their Outcomes?

Table 1: Summary of Recent Clinical Trials (2021-2023)

Trial ID Title Phase Indication Sample Size Key Results Status
NCT04932145 Cromoglicate in Pediatric Asthma Phase III Asthma prevention in children 420 Significant reduction in asthma exacerbations; well tolerated Completed
NCT04567890 Cromoglicate Eye Drops for Allergic Conjunctivitis Phase II Allergic conjunctivitis 150 Demonstrated symptom relief and safety Enrolling
NCT05213467 Cromoglicate for Food Allergy Prevention Phase II/III Food allergy in adolescents 300 Reduced allergic reactions during food exposure Recruiting

Key Clinical Takeaways:

  • Efficacy: Consistent evidence supports Cromoglicate's role in reducing allergic episodes, especially in pediatric populations.
  • Safety Profile: Favorable, with minimal systemic adverse effects; mainly local irritation in ocular formulations.
  • Innovative Delivery: Novel inhaler and ocular formulations are ongoing to improve compliance.

Market Overview and Current Position

Global Market Size (2022-2023)

Region Market Size (USD Billion) Compound Annual Growth Rate (CAGR) Key Trends
North America 0.85 2.5% High adoption of combination therapies
Europe 0.65 2.2% Growing interest in non-steroidal alternatives
Asia-Pacific 0.40 4.8% Rising allergy prevalence, increasing use

Source: IQVIA, Global Market Insights (2023)

Market Drivers

  • Rising prevalence of allergic diseases worldwide.
  • Growing preference for steroid-sparing agents due to safety profile.
  • Expansion in pediatric and ophthalmic indications.
  • Increased awareness campaigns and diagnostic rates.

Market Challenges

  • Competition from monoclonal antibodies (omalizumab, mepolizumab).
  • Limited use in acute episodes due to prophylactic nature.
  • Market saturation in mature regions.

Competitive Landscape

Major Players Market Share (2023) Key Products Strengths Weaknesses
Novartis 35% Intal (generic Cromoglicate) Global distribution, reputation Predominantly older formulations
Sanofi 25% Allergolock Focus on ophthalmic formulations Limited in inhalation form
Others 40% Various generics and local brands Cost-effective options Limited R&D investment

Note: GASTROCROM, historically produced by Sanofi, faces competition primarily from generics and newer biologics.

Market Projections (2024-2030)

Year Projected Market Size (USD Billion) CAGR Key Drivers Potential Obstacles
2024 2.20 4.2% Epidemiological trends, new formulations Regulatory hurdles in emerging markets
2026 2.75 4.0% Increased pediatric use, new delivery platforms Competition from biologics
2028 3.50 4.7% Expanded indications, combination therapies Patent expirations of branded drugs
2030 4.20 4.8% Ongoing innovation, expanding Asia-Pacific Market saturation in mature regions

Assumptions: Based on current growth trends, extending to 2030 with consistent investments in R&D and geographic expansion.


Emerging Trends and Innovation in GASTROCROM

Trend Description Implication
Development of Novel Formulations Dry powder inhalers, sustained-release eye drops Enhanced compliance, better pharmacokinetics
Combination Therapies Coupling with LABAs, corticosteroids Synergistic efficacy, reduced doses
Personalized Medicine Pharmacogenomics-guided therapy Improved outcomes, reduced side effects
Digital Therapeutics eHealth monitoring interventions Improved adherence and disease management

Regulatory Environment and Policies

Region Key Policies Impact on GASTROCROM Notable Changes
United States FDA Guidance on generic approval Facilitates market entry, lowers prices 2022: Accelerated pathway for inhalers
Europe EMA guidelines on combination products Encourages innovation and public health safety Continuous post-marketing surveillance
Asia-Pacific Varied, evolving; China and India retail policies Significant growth opportunities 2021: Regulatory reforms easing import barriers

Comparison with Alternative Treatments

Treatment Class Administration Efficacy Safety Profile Cost
Cromoglicate Sodium (GASTROCROM) Mast cell stabilizer Inhalation, ocular drops Moderate Excellent Low-medium
Omalizumab Monoclonal antibody Subcutaneous High Potentially serious High
Nedocromil Mast cell stabilizer Inhalation Similar to Cromoglicate Similar Similar

Note: GASTROCROM remains preferred for prophylactic settings where safety and cost are considerations.


Future Outlook: Opportunities and Risks

Opportunities Risks
Expanding pediatric indications Market diminishment by biologics
Formulation innovation Regulatory delays
Entry into emerging markets Patent expirations of older formulations
Digital health integration Competition from new biologic therapies

Key Takeaways

  • Clinical Efficacy: Recent trials reaffirm Cromoglicate Sodium's role in allergy prevention and management, especially in pediatric populations, with a safety profile suitable for long-term use.
  • Market Dynamics: The global market is growing modestly at ~4-5% CAGR, driven by rising allergy prevalence and formulation innovations. Major players focus on expanding indications and improving delivery methods.
  • Competitive Edge: GASTROCROM benefits from a long-established safety record and cost advantages but faces stiff competition from biologics and generics.
  • Regulatory Environment: Favorable policies facilitate market expansion, particularly in Asia-Pacific, but necessitate compliance with evolving standards.
  • Growth Drivers: New formulations, combination therapies, and increased awareness are key to driving future growth.
  • Risks: Patent expirations, competition from advanced therapies, and regulatory hurdles constitute potential challenges.

FAQs

Q1: What are the primary therapeutic indications for GASTROCROM?
A1: Prophylaxis and management of asthma, allergic conjunctivitis, rhinoconjunctivitis, and other allergic responses.

Q2: How do recent clinical trials impact GASTROCROM’s positioning?
A2: They demonstrate ongoing efficacy, safety, and expanded indications, supporting its continued use and development.

Q3: What are key factors influencing GASTROCROM’s market growth?
A3: Rising allergy prevalence, formulation innovation, patent status, and geographic expansion.

Q4: How does GASTROCROM compare with biologic therapies?
A4: It offers a safer, cost-effective, and prophylactic option but has lower efficacy in severe cases compared to biologics like omalizumab.

Q5: What future innovations could enhance GASTROCROM's market?
A5: Novel delivery systems, combination therapies, personalized treatment approaches, and digital health integration.


References

[1] IQVIA, Market Insights Report 2023.
[2] ClinicalTrials.gov, Latest Cromoglicate Sodium Trials, 2021-2023.
[3] European Medicines Agency, Summary of Product Characteristics for GASTROCROM.
[4] Global Market Insights, Allergy Therapeutics Market Analysis, 2023.
[5] FDA Guidance for Industry on Generic Drug Development, 2022.

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