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Cromoglycate
Cromoglycate is a Small molecule drug developed by Vishwajit Nimgaonkar, MD PhD. It is currently in Phase 3 development for Allergic Keratoconjunctivitis, Allergic conjunctivitis, Allergic rhinitis. Also known as: NasalCrom, DNCG Iso, Lomudal.
Cromoglycate is a small molecule drug, classified as a mast cell stabilizer, which prevents the release of inflammatory chemicals such as histamine from mast cells. It has been studied in various clinical trials for conditions including pediatric asthma, rhinitis, and allergic reactions, as well as Alzheimer's disease and acute stroke.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Cromoglycate |
|---|---|
| Also known as | NasalCrom, DNCG Iso, Lomudal |
| Sponsor | Vishwajit Nimgaonkar, MD PhD |
| Target | Protein S100-P, G-protein coupled receptor 35, Taste receptor type 2 member 20 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 3 |
Approved indications
- Allergic Keratoconjunctivitis
- Allergic conjunctivitis
- Allergic rhinitis
- Asthma
- Asthma management
- Bronchospasm Prevention
- Giant papillary conjunctivitis
- Systemic mast cell disease
- Vernal Keratitis
- Vernal conjunctivitis
- Vernal keratoconjunctivitis
Common side effects
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 |
|---|---|
| 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:
- Cromoglycate CI brief — competitive landscape report
- Cromoglycate updates RSS · CI watch RSS
- Vishwajit Nimgaonkar, MD PhD portfolio CI
Frequently asked questions about Cromoglycate
What is Cromoglycate?
What is Cromoglycate used for?
Who makes Cromoglycate?
Is Cromoglycate also known as anything else?
What development phase is Cromoglycate in?
What does Cromoglycate target?
Related
- Target: All drugs targeting Protein S100-P, G-protein coupled receptor 35, Taste receptor type 2 member 20
- Manufacturer: Vishwajit Nimgaonkar, MD PhD — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Allergic Keratoconjunctivitis
- Indication: Drugs for Allergic conjunctivitis
- Indication: Drugs for Allergic rhinitis
- Also known as: NasalCrom, DNCG Iso, Lomudal
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing