Cromolyn
Cromolyn, Gastrocrom (cromolyn) is a small molecule pharmaceutical. Cromolyn was first approved as Intal on 1982-01-01. It is used to treat allergic rhinitis perennial, asthma, bronchial spasm, conjunctivitis, and food hypersensitivity amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Cromolyn, Gastrocrom (discontinued: Crolom, Cromolyn, Cromoptic, Gastrocrom, Intal, Nasalcrom, Opticrom)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cromolyn sodium | ANDA | 2024-11-07 |
| cromolyn sodium inhalation solution | ANDA | 2024-06-26 |
| cromolyn sodium oral solution (concentrate) | ANDA | 2024-06-26 |
| gastrocrom | New Drug Application | 2024-06-26 |
| nasalcrom | ANDA | 2023-12-05 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EB: Antiallergic intestinal antiinflammatory drugs, excl. corticosteroids
— A07EB01: Cromoglicic acid
D: Dermatologicals
— D11: Other dermatological preparations in atc
— D11A: Other dermatological preparations in atc
— D11AH: Agents for dermatitis, excluding corticosteroids
— D11AH03: Cromoglicic acid
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AC: Antiallergic nasal preparations for topical use, excl. corticosteroids
— R01AC01: Cromoglicic acid
— R01AC51: Cromoglicic acid, combinations
— R03: Drugs for obstructive airway diseases
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BC: Antiallergic inhalants for obstructive airway diseases, excl. corticosteroids
— R03BC01: Cromoglicic acid
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01G: Decongestants and antiallergics
— S01GX: Other antiallergics in atc
— S01GX01: Cromoglicic acid
— S01GX51: Cromoglicic acid, combinations
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | 1 | — | 1 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | — | — | 1 | — | 1 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mastocytosis | D008415 | — | D47.09 | — | 4 | 2 | — | — | 6 |
| Systemic mastocytosis | D034721 | — | C96.21 | — | 1 | 2 | — | — | 3 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | 1 | — | 1 | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | 1 | — | — | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 1 | — | — | 2 |
| Bronchoconstriction | D016084 | — | — | — | — | 1 | — | — | 1 |
| Covid-19 | D000086382 | — | — | — | — | 1 | — | — | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | 1 | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Pruritus | D011537 | HP_0000989 | L29 | — | 1 | — | — | — | 1 |
| Cutaneous mastocytosis | D034701 | — | D47.01 | — | 1 | — | — | — | 1 |
| Mastocytoma | D034801 | — | D47.09 | — | 1 | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | — | 1 | — | — | — | 1 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 1 | — | — | — | 1 |
| Sclerosis | D012598 | — | — | — | 1 | — | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 1 | — | — | — | 1 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 2 | — | — | — | — | 2 |
| Prostatitis | D011472 | EFO_0003830 | N41 | 1 | — | — | — | — | 1 |
| Pelvic pain | D017699 | — | — | 1 | — | — | — | — | 1 |
| Lung transplantation | D016040 | — | — | 1 | — | — | — | — | 1 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 1 | — | — | — | — | 1 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 1 | — | — | — | — | 1 |
| Pulmonary fibrosis | D011658 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis | D065631 | — | J30.9 | — | — | — | — | 2 | 2 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | — | — | — | 2 | 2 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cromolyn |
| INN | cromoglicic acid |
| Description | Cromoglycic acid is a dicarboxylic acid that is the bis-chromone derivative of glycerol. It is effective as a mast cell stabilizer. It has a role as a calcium channel blocker and an anti-asthmatic drug. It is a dicarboxylic acid and a member of chromones. It is a conjugate acid of a cromoglycate(1-). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)c1cc(=O)c2c(OCC(O)COc3cccc4oc(C(=O)O)cc(=O)c34)cccc2o1 |
Identifiers
| PDB | — |
| CAS-ID | 16110-51-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL428880 |
| ChEBI ID | 59773 |
| PubChem CID | 2882 |
| DrugBank | DB01003 |
| UNII ID | Y0TK0FS77W (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Cromolyn
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 6,935 documents
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Safety
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No Black-box warning
Adverse Events
Top Adverse Reactions
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1,882 adverse events reported
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