Last reviewed · How we verify
CROMOLYN
Cromolyn is a marketed drug primarily indicated for the management of mastocytosis, with a key composition patent expiring in 2028. Its primary strength lies in its established market presence and specific indication for mastocytosis, a niche but significant therapeutic area. The primary risk is the potential increase in competition post-patent expiry in 2028.
At a glance
| Generic name | CROMOLYN |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1982 |
Approved indications
- Management of mastocytosis
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
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 |