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
Pulmonary Fibrosis	1
Idiopathic Pulmonary Fibrosis	1
Prostatitis	1
Idiopathic Interstitial Pneumonias	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
Northwestern University	1
Aradign Corportation	1
National Heart, Lung, and Blood Institute (NHLBI)	1

Sponsor Type

Sponsor Type for GASTROCROM
Sponsor	Trials
Other	4
NIH	2

Last updated: May 4, 2026

GASTROCROM (cromolyn sodium): Clinical Trials Update, Market Analysis, and Projection

What is GASTROCROM and what is its regulatory status?

GASTROCROM is cromolyn sodium, an oral mast cell stabilizer approved for mastocytosis-related GI symptoms. The product label supports use in indicated gastrointestinal (GI) manifestations associated with mast cell disorders (see prescribing information for the approved indications and dosing).

Because cromolyn sodium is an established, off-patent small molecule, the competitive landscape is driven by generic penetration, formulation availability, and continuity of supply, not new-wave exclusivity.

---

What is the clinical trials update for cromolyn sodium (GASTROCROM)?

No new, clearly identifiable, late-stage (Phase 3) pivotal dataset for cromolyn sodium was found in the most commonly indexed public trial repositories at the level needed to support a complete, decision-grade “trial update” for the specific branded product GASTROCROM.

Implication for business planning: Cromolyn sodium’s development cycle is best characterized as maintenance of existing evidence rather than a pipeline-building Phase 3 program. Clinical activity, when present, tends to concentrate in:

• Retrospective or observational assessments of mast cell stabilization and GI symptom patterns
• Smaller mechanistic or limited clinical studies rather than regulator-defining trials

---

How does the market size and demand profile look for GASTROCROM?

Market structure

• Drug class: Oral mast cell stabilizer (cromolyn sodium)
• Therapy area: Rare or orphan-linked mast cell disorders with GI involvement
• Primary demand drivers: Diagnosed patient populations with GI symptoms tied to mast cell activation, ongoing symptom management needs, and clinician familiarity
• Supply and pricing drivers: Generic availability, payer formulary placement, and acquisition cost

Commercial reality for branded GASTROCROM

• The brand sits in a market environment where generic cromolyn sodium typically constrains brand pricing power.
• Demand tends to be steady and cohort-based rather than growth-led by a new clinical indication or new mechanism entrant.

Decision-grade market positioning (what matters)

• For investment and commercialization: monitor generic entry depth, coverage breadth, pharmacy channel availability, and rebate dynamics.
• For R&D: the clinical bar for competing products is high because the therapeutic niche is narrow and the standard of care is already drug-accessible.

---

What is the competitive landscape and how does it affect projections?

Core competitors

• Generic cromolyn sodium products (same active ingredient)
• Other mast cell targeted approaches may exist in practice, but cromolyn’s positioning is constrained by its mechanism fit and historical guideline/prescriber usage.

Competitive impact on GASTROCROM

• Brand revenues generally trend with:
  • Generic market share erosion over time
  • Formulary narrowing at payers when lower-cost generics are accessible
  • Stability of diagnosed patient volumes

If the goal is growth

• Growth levers are limited for a legacy molecule:
  • payer contracting to preserve coverage
  • distribution and supply reliability
  • disease awareness and diagnosis-rate effects (slow-moving)

---

What is the demand outlook and revenue projection range?

A complete, model-based projection (with explicit forecasts and numeric assumptions) requires inputs like historical branded revenue, units, payer coverage, and market size estimates by geography that are not provided here. Under this constraint, the only decision-valid projection framing is qualitative.

Projection (directional)

• Base case: Flattish to modest decline in branded share driven by ongoing generic substitution and coverage pressure.
• Bear case: Accelerated erosion if additional generic entrants gain preferential coverage or if supply constraints disrupt pharmacy availability.
• Bull case: Stabilization if formulary status remains intact in key payer segments and diagnosis-driven demand offsets substitution.

What to watch for quarterly

• Generic pricing and rebate intensity
• Share shifts in the cromolyn sodium category
• Persistent brand access in top plan formularies

---

What is the patent and exclusivity context that controls future upside?

Cromolyn sodium is a legacy active ingredient, so forward-looking upside is constrained by:

• Patent expiration and generic competition
• Any remaining exclusivity typically tied to specific formulations, indications, or regulatory events (if applicable)
• Brand support depends on market access rather than exclusivity

A defensible patent map requires access to specific patent family documents and expiration dates for the branded product’s protection envelope, which is not included in the provided material here.

---

Key Takeaways

• Clinical trials: No decision-grade late-stage (Phase 3) branded-product pivotal updates can be stated from commonly indexed public trial evidence within the constraints of this prompt.
• Market: Demand remains steady-cohort driven in mast-cell linked GI symptom populations, with branded performance constrained by generic cromolyn sodium penetration.
• Projection: Directionally flat to modest decline for GASTROCROM absent major label expansions or a payer/access shift.
• Business focus: Track category generic pricing, formulary coverage, and distribution reliability; these variables dominate near-term financial outcomes.

---

FAQs

1) Is GASTROCROM still the primary oral option for mast-cell GI symptoms?

It is used for mastocytosis-related GI symptom management, but generic cromolyn sodium typically competes directly on active ingredient and pricing.

2) Are there any new approvals expected for cromolyn sodium?

No new approval trajectory can be confirmed here because a complete trial and regulatory watchlist update is not supported by the provided data.

3) What drives branded versus generic performance in cromolyn sodium?

Payer coverage, rebates, contract placement, and channel availability drive share more than clinical differentiation.

4) What is the most important commercial KPI to monitor?

For a legacy niche brand: net revenue per unit and share in the cromolyn sodium category across major plans, plus coverage continuity.

5) How should an R&D team interpret the clinical landscape?

The absence of late-stage pivotal signals implies a high bar for new claims; differentiation would likely need novel formulations, delivery, or new indication evidence rather than repeating the same mechanism proof path.

---

References

[1] GASTROCROM (cromolyn sodium) Prescribing Information.
[2] U.S. National Library of Medicine. ClinicalTrials.gov (search results for cromolyn sodium / cromolyn oral).