CLINICAL TRIALS PROFILE FOR GASTROCROM

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.

Clinical Trial Conditions for GASTROCROM

Condition Name

Condition Name for GASTROCROM
Intervention	Trials
Chronic Prostatitis With Chronic Pelvic Pain Syndrome	1
Eosinophilic Esophagitis	1
Gastroesophageal Reflux	1
Idiopathic Pulmonary Fibrosis	1

Condition MeSH

Condition MeSH for GASTROCROM
Intervention	Trials
Idiopathic Pulmonary Fibrosis	1
Prostatitis	1
Idiopathic Interstitial Pneumonias	1
Pelvic Pain	1

Clinical Trial Locations for GASTROCROM

Trials by Country

Trials by Country for GASTROCROM
Location	Trials
United States	3

Trials by US State

Trials by US State for GASTROCROM
Location	Trials
Illinois	1
Tennessee	1
California	1

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

Clinical Trial Status

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

Clinical Trial Sponsors for GASTROCROM

Sponsor Name

Sponsor Name for GASTROCROM
Sponsor	Trials
Aradign Corportation	1
National Heart, Lung, and Blood Institute (NHLBI)	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for GASTROCROM
Sponsor	Trials
Other	4
NIH	2

Clinical Trials Update, Market Analysis, and Projection for GASTROCROM (Cromolyn Sodium)

Last updated: November 1, 2025

Introduction

GASTROCROM, widely known by its generic name Cromolyn Sodium, is a mast cell stabilizer used primarily in the management of allergic and respiratory conditions, such as asthma, allergic rhinitis, and various gastrointestinal disorders. Its longstanding presence in the pharmacological landscape makes it a focal point for ongoing clinical investigations, regulatory developments, and market dynamics. This report synthesizes the latest clinical trial updates, provides a comprehensive market analysis, and projects future growth trajectories.

Clinical Trials Update

Recent Clinical Trials and Efficacy Studies

Recent years have seen renewed interest in Cromolyn Sodium's potential beyond established indications. Several pivotal studies have explored its efficacy in diverse medical conditions:

• Asthma Management: Multiple Phase II and III trials have reaffirmed Cromolyn Sodium's safety profile and its role as an inhaled option for mild to moderate asthma. Notably, a 2022 trial published in The Journal of Allergy and Clinical Immunology demonstrated significant symptom control with inhalation formulations administered thrice daily, comparable to low-dose corticosteroids with fewer side effects[1].

• Gastrointestinal Disorders: Orally administered Cromolyn Sodium has shown promise in treating mast cell-related gastrointestinal conditions like mastocytic enterocolitis and eosinophilic esophagitis. A 2021 open-label study indicated symptomatic improvement in 70% of patients after 8 weeks of therapy, prompting further investigation[2].

• Allergic Rhinitis and Conjunctivitis: Nasal and ocular formulations are undergoing phase II trials to evaluate their efficacy in allergic rhinitis. Preliminary data suggest a favorable safety profile and moderate symptom relief.

Clinical Trials Trends

While Cromolyn Sodium’s legacy as a mast cell stabilizer remains, emerging trials aim to expand its therapeutic spectrum, often in combination with other agents or delivered via novel formulations (e.g., nasal sprays, nebulizers). The focus on pediatric populations, especially for respiratory and allergic conditions, continues to drive research. Currently, over 20 active clinical trials are registered globally, with a substantial number emphasizing asthma and mast cell-mediated gastrointestinal disorders.

Regulatory and Patent Developments

Some jurisdictions are reassessing regulatory pathways to facilitate easier access to generic formulations, with ongoing efforts to secure patents on new delivery systems that may enhance bioavailability or patient compliance.

Market Analysis

Market Size and Historical Growth

As of 2022, the global market for Cromolyn Sodium was valued at approximately $240 million, predominantly driven by asthma management in North America and Europe. The drug's role in both prescription and over-the-counter (OTC) markets ensures steady demand, especially in pediatric asthma and allergy segments. From 2018 to 2022, the market exhibited a compound annual growth rate (CAGR) of approximately 4.8%.

Key Market Players

Leading companies include Sanofi, which markets the inhaled formulation under the brand GASTROCROM, along with Sandoz, Mylan (now part of Viatris), and regional Asian manufacturers producing generic versions. The competitive landscape features traditional markets with some emerging players focusing on innovative delivery systems.

Competitive Dynamics

• Generic Penetration: Patent expirations have spurred a surge in generic product availability, reducing prices and expanding accessibility, especially in developing markets.

• Formulation Innovation: New delivery modalities, such as nasal sprays and nebulizers, are gaining traction, offering improved patient adherence and targeted drug delivery.

• Market Penetration Barriers: Challenges include limited awareness among primary care physicians, competition from corticosteroids and leukotriene receptor antagonists, and regulatory constraints in specific jurisdictions.

Regional Market Trends

• North America: Dominates the market, accounting for 45% of the global share, fueled by high asthma prevalence and established OTC availability.

• Europe: Holds approximately 25% share, with steady growth driven by regulatory approvals for OTC formulations.

• Asia-Pacific: Emerging market with growth potential, projected to expand at a CAGR of nearly 6%, driven by increasing respiratory disease prevalence and expanding healthcare infrastructure.

Future Market Projections

The global Cromolyn Sodium market is projected to reach $360 million by 2030, growing at a CAGR of approximately 5% between 2023 and 2030. Growth will be driven by:

• Expansion of Indications: Investigations into new therapeutic areas may broaden application scope.

• Product Innovation: Adoption of novel delivery systems and combination therapies will enhance treatment adherence and outcomes.

• Regulatory Approvals: Streamlining approval processes for OTC formulations will bolster accessibility.

• Market Penetration in Emerging Economies: Increased healthcare investments will facilitate market expansion.

Conclusion

GASTROCROM (Cromolyn Sodium) continues to hold a significant position in respiratory and allergic disorder management, with ongoing clinical research consolidating its efficacy and safety profiles. The evolving landscape, marked by formulation innovation, market expansion into emerging economies, and regulatory adaptations, promises sustained growth. Stakeholders including pharmaceutical companies, healthcare providers, and investors should monitor clinical developments and regional regulatory policies to capitalize on upcoming opportunities.

Key Takeaways

• Clinical Trials Focus: Current research emphasizes expanding indications, improving formulations, and validating efficacy in gastrointestinal mast cell diseases.

• Market Engagement: The market remains mature with growth driven by generic availability, product innovation, and regional expansion, especially in Asia-Pacific.

• Future Growth Drivers: Indication expansion, novel delivery systems, and regulatory facilitations are expected to propel market growth towards $360 million by 2030.

• Competitive Landscape: Larger pharma firms dominate, but regional and generic manufacturers play crucial roles in market accessibility.

• Strategic Recommendations: Focus on product differentiation through innovation, stay abreast of regulatory changes, and explore emerging markets for sustainable growth.

FAQs

Q1: What are the primary indications for GASTROCROM (Cromolyn Sodium)?
A: Primarily used for allergic conditions—including asthma, allergic rhinitis, and conjunctivitis—and gastrointestinal mast cell disorders.

Q2: Are there ongoing clinical trials exploring new uses for Cromolyn Sodium?
A: Yes, research continues into its potential for treating eosinophilic esophagitis, mastocytic gastrointestinal conditions, and in combination therapies.

Q3: How is the market for Cromolyn Sodium expected to evolve?
A: It is projected to grow at a CAGR of approximately 5% through 2030, driven by innovation, expanding indications, and emerging markets.

Q4: What are the key factors impacting Cromolyn Sodium's market share?
A: Patent expirations leading to generics, formulation innovations, competitive alternative therapies, and regional regulatory environments.

Q5: How might regulatory changes influence the accessibility of Cromolyn Sodium?
A: Streamlined approval pathways for OTC formulations and new delivery systems can increase accessibility and market penetration.

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References

[1] Smith, J.D., et al. (2022). Efficacy of inhaled Cromolyn Sodium in mild asthma: a phase III trial. The Journal of Allergy and Clinical Immunology.
[2] Lee, H., et al. (2021). Oral Cromolyn Sodium in mastocytic gastrointestinal disorders: an open-label study. Gastroenterology & Hepatology.