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
Gastrocrom (generic drugs available since 1999-06-16, discontinued: Crolom, Cromoptic, Intal, Nasalcrom, Opticrom)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cromolyn sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GASTROCROM | Mylan | N-020479 RX | 1996-02-29 | 1 products, RLD, RS |
Show 6 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cromolyn sodium inhalation | ANDA | 2023-04-13 |
| gastrocrom | New Drug Application | 2018-10-10 |
| nasalcrom | ANDA | 2020-08-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
| asthma | EFO_0000270 | D001249 | J45 |
| bronchial spasm | — | D001986 | — |
| conjunctivitis | — | D003231 | H10 |
| food hypersensitivity | EFO_1001890 | D005512 | — |
| inflammatory bowel diseases | EFO_0003767 | D015212 | — |
| mastocytosis | — | D008415 | D47.09 |
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
424 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 11 | 20 | 8 | 2 | 2 | 39 | |
| Septic shock | D012772 | A48.3 | 1 | 7 | 12 | 5 | 4 | 26 | |
| Adrenal insufficiency | D000309 | 4 | 3 | 3 | 8 | 3 | 20 | ||
| Sepsis | D018805 | A41.9 | — | 4 | 6 | 3 | 7 | 19 | |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 6 | — | 5 | 3 | 15 |
| Congenital adrenal hyperplasia | D000312 | E25.0 | 4 | 8 | 2 | 2 | 1 | 15 | |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | 3 | 9 | 13 |
| Healthy volunteers/patients | — | 5 | 1 | 1 | 2 | — | 9 | ||
| Addison disease | D000224 | E27.1 | 1 | 5 | 1 | 1 | 3 | 9 | |
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | 2 | 3 | 1 | — | 7 |
Show 39 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | C95 | 1 | 12 | 10 | — | 2 | 24 | |
| Prostatic neoplasms | D011471 | C61 | 2 | 11 | 5 | — | 1 | 17 | |
| Lymphoma | D008223 | C85.9 | — | 6 | 6 | — | — | 12 | |
| Myeloid leukemia acute | D015470 | C92.0 | 6 | 3 | 2 | — | — | 10 | |
| Myelodysplastic syndromes | D009190 | D46 | 3 | — | 3 | — | — | 6 | |
| Heart arrest | D006323 | EFO_0009492 | I46 | 2 | 2 | 2 | — | 2 | 6 |
| Covid-19 | D000086382 | U07.1 | — | — | 2 | — | 3 | 5 | |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 3 | — | 1 | 4 |
| Bronchopulmonary dysplasia | D001997 | P27.8 | — | 2 | 2 | — | — | 4 | |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | 1 | 1 | 1 | — | 1 | 3 |
Show 35 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 1 | — | — | 2 | 5 |
| Hemorrhoids | D006484 | EFO_0009552 | K64 | — | 3 | — | — | 1 | 4 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | 2 | — | — | 1 | 3 |
| Neoplasms | D009369 | C80 | — | 3 | — | — | — | 3 | |
| Burkitt lymphoma | D002051 | C83.7 | 1 | 3 | — | — | — | 3 | |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 3 | — | — | — | 3 |
| Biphenotypic leukemia acute | D015456 | C95.0 | — | 2 | — | — | — | 2 | |
| Head and neck neoplasms | D006258 | — | 1 | — | — | 1 | 2 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | 1 | 2 |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 1 | 2 | — | — | — | 2 |
Show 44 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 4 | — | — | — | 2 | 6 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | — | — | — | — | 2 |
| Hematologic neoplasms | D019337 | 1 | — | — | — | 1 | 2 | ||
| Blood pressure | D001794 | EFO_0004325 | 2 | — | — | — | — | 2 | |
| T-cell lymphoma | D016399 | 2 | — | — | — | — | 2 | ||
| Insulin resistance | D007333 | EFO_0002614 | 1 | — | — | — | 1 | 2 | |
| Cocaine-related disorders | D019970 | F14 | 1 | — | — | — | 1 | 2 | |
| Infections | D007239 | EFO_0000544 | 1 | — | — | — | 1 | 2 | |
| Recurrence | D012008 | 2 | — | — | — | — | 2 | ||
| T-cell lymphoma peripheral | D016411 | C84.9 | 1 | — | — | — | — | 1 |
Show 23 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 3 | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 2 | 2 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | — | 2 | 2 | |
| Plantar fasciitis | D036981 | EFO_1001909 | M72.2 | — | — | — | — | 1 | 1 |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | — | — | 1 | 1 |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | — | — | — | 1 | 1 |
| Thyroidectomy | D013965 | — | — | — | — | 1 | 1 | ||
| Pituitary diseases | D010900 | E23.7 | — | — | — | — | 1 | 1 | |
| Circadian rhythm sleep disorders | D020178 | G47.2 | — | — | — | — | 1 | 1 | |
| Hypopituitarism | D007018 | EFO_0001380 | E23.0 | — | — | — | — | 1 | 1 |
Show 48 more
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 | 42612 |
| ChEMBL ID | CHEMBL428880 |
| ChEBI ID | 59773 |
| PubChem CID | 2882 |
| DrugBank | DB01003 |
| UNII ID | Y0TK0FS77W (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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21,357 adverse events reported
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