CLINICAL TRIALS PROFILE FOR NEDOCROMIL SODIUM

All Clinical Trials for NEDOCROMIL SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000575 ↗	Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)	Completed	CAMP Steering Committee	Phase 3	1991-09-01	The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗	Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1991-09-01	The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗	Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)	Completed	Johns Hopkins Bloomberg School of Public Health	Phase 3	1991-09-01	The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000622 ↗	Prevention of Early Asthma in Kids (PEAK)	Completed	Childhood Asthma Research and Education Network	N/A	2001-01-01	To evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.
NCT00000622 ↗	Prevention of Early Asthma in Kids (PEAK)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	2001-01-01	To evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.

Clinical Trial Conditions for NEDOCROMIL SODIUM

Condition Name

Condition Name for NEDOCROMIL SODIUM
Intervention	Trials
Asthma	6
Lung Diseases	5
Exercise-induced Arterial Hypoxemia	1

Condition MeSH

Condition MeSH for NEDOCROMIL SODIUM
Intervention	Trials
Asthma	6
Lung Diseases	5
Hypoxia	1

Clinical Trial Locations for NEDOCROMIL SODIUM

Trials by Country

Trials by Country for NEDOCROMIL SODIUM
Location	Trials
United States	12
United Kingdom	1

Trials by US State

Trials by US State for NEDOCROMIL SODIUM
Location	Trials
Wisconsin	2
Missouri	2
Colorado	2
California	2
Indiana	1

Clinical Trial Progress for NEDOCROMIL SODIUM

Clinical Trial Phase

Clinical Trial Phase for NEDOCROMIL SODIUM
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for NEDOCROMIL SODIUM
Clinical Trial Phase	Trials
Completed	5
Recruiting	1
Withdrawn	1

Clinical Trial Sponsors for NEDOCROMIL SODIUM

Sponsor Name

Sponsor Name for NEDOCROMIL SODIUM
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	6
Childhood Asthma Research and Education Network	3
CAMP Steering Committee	1

Sponsor Type

Sponsor Type for NEDOCROMIL SODIUM
Sponsor	Trials
Other	8
NIH	6

Nedocromil Sodium Clinical Trials Update, Market Analysis and Price-Impact Projection (2026)

Last updated: July 28, 2026

No verifiable, current, decision-grade dataset is available here to support a complete clinical-trials update, competitive market sizing, and forward price or revenue projection for nedocromil sodium.

Clinical trials update: What is the latest status of nedocromil sodium trials?
Featured answer: No current trial registry or sponsor-status information is provided here that can be used to credibly update the nedocromil sodium clinical-development timeline.

What trial phases matter for nedocromil sodium

• Phase 1 tolerability and pharmacokinetic (if reintroduced by reformulation or new delivery route)
• Phase 2 proof-of-mechanism in target indications (asthma or allergic/airway inflammation phenotypes)
• Phase 3 endpoints tied to guideline-relevant outcomes (symptom control, rescue medication use, exacerbation rates)

Trial modalities to watch

• Reformulation work (particle engineering, HFA conversion, or device changes)
• Head-to-head or non-inferiority studies against contemporary inhaled controllers
• Pediatric-focused studies if labeling expansion is pursued

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Market analysis: How big is the nedocromil sodium market and who drives demand?
Featured answer: No audited market size, channel mix, or sales dataset is provided here that can support a quantified market analysis for nedocromil sodium.

Demand drivers typically relevant to nedocromil sodium

• Role in asthma management pathways and step-therapy alternatives
• Availability vs branded and generic alternatives (competitor controller inhalers)
• Geographic regulatory status and reimbursement coverage

Competitive landscape risks

• Therapeutic-class substitution (inhaled corticosteroids, leukotriene modifiers, and newer add-on options)
• Formulary exclusion and clinician preference shifts toward other controller regimens
• Supply continuity and generic manufacturer coverage

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Exclusivity and patent estate: What patents protect nedocromil sodium and how does that affect market pricing?
Featured answer: No patent-portfolio dataset is provided here to compile expiration dates, listed Orange Book codes, or litigation posture that would inform pricing or generic-entry timing.

What must be true to forecast exclusivity-driven pricing

• Confirmed US reference-listed drug status (if applicable)
• Granted composition, formulation, method-of-use, and device patents
• Patent term adjustments and pediatric exclusivity (if any)
• ANDA/BLA certifications and any Paragraph IV litigation records

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FDA and regulatory status: What is the Orange Book status of nedocromil sodium and what pathways apply?
Featured answer: No FDA approval-pathway or Orange Book listing record is provided here to support a current regulatory status statement.

Regulatory items that typically shape entry timing

• Whether the product is RLD or only a legacy NDA
• Generic availability in key dosage forms
• Labeling scope for asthma indications and age ranges
• Any safety communications affecting use

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Generic entry and biosimilar risk: What generic entry risks exist for nedocromil sodium?
Featured answer: No Paragraph IV, ANDA, or other FDA litigation/certification data is provided here to quantify generic-entry risk.

What the market needs to know for generic timing

• Current number of approved ANDAs
• Switching barriers (prescriber preference, device differences, local formulary contracts)
• Current price dispersion vs other controller inhalers

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Revenue and price projection: When will nedocromil sodium revenues stabilize or decline?
Featured answer: No current revenue baseline, net price history, or inventory/supply data is provided here to build a credible projection.

Projection framework that cannot be completed with provided inputs

• Net sales trend baseline (annualized last 3 to 5 years)
• Price erosion curve for generics (accounting for competitive intensity)
• Volume shifts tied to guideline and payer behavior
• Manufacturing supply and tender effects

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Key Takeaways

• A decision-grade clinical-trials update, market sizing, and price or revenue projection for nedocromil sodium cannot be produced from the information available in this prompt.
• Any quantified outlook would require verified clinical registry status, audited sales/market data, and an exclusivity/patent and FDA entry timeline. None is present here.

FAQs

1. Is nedocromil sodium still being tested in new clinical trials?
2. What are the main competitors to nedocromil sodium in asthma controller therapy?
3. Which countries still market nedocromil sodium and under what regulatory status?
4. What generic manufacturers sell nedocromil sodium and how is pricing moving?
5. Are there any current patent or litigation events that could affect generic entry for nedocromil sodium?

References (APA)

No sources were provided or cited in the available content.