Last reviewed · How we verify
CROMOLYN SODIUM
Cromolyn Sodium is a mast cell stabilizer used primarily in the management of mastocytosis. It prevents the release of mediators like histamine from mast cells, reducing symptoms such as diarrhea, flushing, and headaches. Approved by the FDA, it is marketed as GASTROCROM and is administered orally. While it does not affect urinary histamine levels or peripheral eosinophilia, it provides clinically significant improvements in gastrointestinal and cutaneous symptoms. The drug is currently marketed and has a niche but important role in treating mastocytosis.
At a glance
| Generic name | CROMOLYN SODIUM |
|---|---|
| Also known as | sodium cromoglicate, cromoglicate sodium |
| Drug class | Mast cell stabilizer |
| Target | Mast cells |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1982 |
Approved indications
- Mastocytosis — any
Pipeline indications
- Amyotrophic Lateral Sclerosis (ALS) — Phase 2
- Triple-negative Breast Cancer — Phase 2
- Psoriasis — Phase 2
- Burn Scar Itch — Phase 3
- Eosinophilic Esophagitis — Phase 4
Common side effects
- Transient ocular stinging or burning upon instillation
- Conjunctival injection
- Watery eyes
- Itchy eyes
- Dryness around the eye
- Puffy eyes
- Eye irritation
- Styes
Serious adverse events
- Dyspnea
- Edema
- Rash
Drug interactions
- Isoproterenol
Key clinical trials
- Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia (PHASE1, PHASE2)
- Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer (PHASE2)
- PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS (PHASE2)
- Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray in Patients With Allergic Rhinitis
- Reverse Triple Negative Immune Resistant Breast Cancer (PHASE2)
- Novel Strategies for Reducing Burn Scar Itch (PHASE3)
- Cromoglicate in Psoriasis (PHASE2)
- Cromoglicate in Mastocytosis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CROMOLYN SODIUM CI brief — competitive landscape report
- CROMOLYN SODIUM updates RSS · CI watch RSS