cromoglicic acid Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antiallergics, cromoglicic acid derivatives 741 16110-51-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sodium cromoglicate
  • cromolyn sodium
  • sodium cromolyn
  • sodium cromoglycate
  • cromoglicic acid
  • cromoglycic acid
  • cromolyn
  • cromoglycate
  • cromoglicate
  • intal
  • cromolyn disodium salt
  • cromolyn disodium
  • disodium cromoglycate
A chromone complex that acts by inhibiting the release of chemical mediators from sensitized mast cells. It is used in the prophylactic treatment of both allergic and exercise-induced asthma, but does not affect an established asthmatic attack.
  • Molecular weight: 468.37
  • Formula: C23H16O11
  • CLOGP: 1.48
  • LIPINSKI: 1
  • HAC: 11
  • HDO: 3
  • TPSA: 165.89
  • ALOGS: -4.12
  • ROTB: 8

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.80 g O
40 mg N
40 mg Inhal.aerosol
80 mg Inhal.powder
80 mg Inhal.solution

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 210 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 28.40 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
May 28, 1982 FDA KING PHARMS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07EB01 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Antiallergic agents, excl. corticosteroids
ATC D11AH03 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Agents for dermatitis, excluding corticosteroids
ATC R01AC01 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Antiallergic agents, excl. corticosteroids
ATC R03BC01 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Antiallergic agents, excl. corticosteroids
ATC S01GX01 SENSORY ORGANS
OPHTHALMOLOGICALS
DECONGESTANTS AND ANTIALLERGICS
Other antiallergics
ATC R01AC51 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Antiallergic agents, excl. corticosteroids
ATC R03AK04 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC S01GX51 SENSORY ORGANS
OPHTHALMOLOGICALS
DECONGESTANTS AND ANTIALLERGICS
Other antiallergics
FDA PE N0000175628 Decreased Histamine Release
FDA EPC N0000175630 Mast Cell Stabilizer
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:49167 anti-asthmatic drug

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Allergic rhinitis indication 61582004
Asthma indication 195967001 DOID:2841
Giant papillary conjunctivitis indication 231857004 DOID:2457
Vernal keratoconjunctivitis indication 317349009
Vernal conjunctivitis indication 318316003 DOID:2474
Systemic mast cell disease indication 397016004 DOID:349
Asthma management indication 406162001
Allergic conjunctivitis indication 473460002 DOID:11204
Allergic Keratoconjunctivitis indication
Bronchospasm Prevention indication
Vernal Keratitis indication
Inflammatory bowel disease off-label use 24526004 DOID:0050589
Gastrointestinal food allergy off-label use 414314005
Nasal polyp contraindication 52756005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 1.32 acidic
pKa2 1.92 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Protein S100-P Unclassified SCIENTIFIC LITERATURE
G-protein coupled receptor 35 GPCR Ki 5.63 CHEMBL
G-protein coupled receptor 35 GPCR EC50 5.32 CHEMBL
G protein-coupled receptor GPR35 GPCR EC50 6.01 CHEMBL

External reference:

IDSource
D004205 MESH_DESCRIPTOR_UI
4018903 VUID
N0000147197 NUI
C0012694 UMLSCUI
D00526 KEGG_DRUG
372672009 SNOMEDCT_US
21701005 SNOMEDCT_US
4019696 VANDF
42612 RXNORM
d00200 MMSL
004808 NDDF
CHEMBL74 ChEMBL_ID
CHEMBL428880 ChEMBL_ID
DB01003 DRUGBANK_ID
Q2WXR1I0PK UNII
15826-37-6 SECONDARY_CAS_RN
CHEBI:59773 CHEBI
2427 INN_ID
7608 IUPHAR_LIGAND_ID
2882 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Gastrocrom HUMAN PRESCRIPTION DRUG LABEL 1 0037-0678 LIQUID 20 mg ORAL NDA 12 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0172-6406 SOLUTION 20 mg INTRABRONCHIAL ANDA 13 sections
Cromolyn Sodium HUMAN OTC DRUG LABEL 1 0904-5532 SPRAY, METERED 5.20 mg NASAL ANDA 9 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 16571-600 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 13 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 17478-291 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 11 sections
Cromolyn Sodium HUMAN OTC DRUG LABEL 1 37205-223 SPRAY, METERED 5.20 mg NASAL ANDA 10 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 42571-132 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 12 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-1202 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 10 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-3042 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 11 sections
cromolyn sodium HUMAN PRESCRIPTION DRUG LABEL 1 51525-0470 SOLUTION 20 mg ORAL NDA authorized generic 12 sections
NasalCrom HUMAN OTC DRUG LABEL 1 52183-199 SPRAY, METERED 5.20 mg NASAL ANDA 9 sections
Cromolyn Sodium HUMAN OTC DRUG LABEL 1 57782-397 SPRAY, METERED 5.20 mg NASAL ANDA 9 sections
Cromolyn Sodium HUMAN OTC DRUG LABEL 1 59779-075 SPRAY, METERED 5.20 mg NASAL ANDA 10 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 61314-237 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 10 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 63187-473 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 10 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 69784-200 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 13 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 69784-205 SOLUTION 20 mg INTRABRONCHIAL ANDA 13 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 70556-101 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 13 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 70556-102 SOLUTION 20 mg INTRABRONCHIAL ANDA 13 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 71205-085 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 11 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 71205-230 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 10 sections