> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/cromolyn-sodium-7000bfa3-7ee5-4612-9d8a-10a27581d655
> Record changed: 2026-10-13
# Cromolyn sodium
Highest phase reached
Approved
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
Drug type
Small molecule
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
First approval year
1982
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
## Development status
**First approval year**
1982
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
**Listing at source**
Listed
**Highest phase reached**
Approved
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
## Names and chemistry
**Drug type**
Small molecule
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
**Drug name**
Cromolyn sodium
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
**Molecular weight**
512.33
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
**Structure (SMILES)**
O=C(\[O-\])c1cc(=O)c2c(OCC(O)COc3cccc4oc(C(=O)\[O-\])cc(=O)c34)cccc2o1.\[Na+\].\[Na+\]
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
### Brand names (78)
- aerocrom
- Aerocrom
- allercrom
- Allercrom
- aspire
- Aspire
- brol eze
- Brol-eze
- catacrom
- Catacrom
- clariteyes
- Clariteyes
- crolom
- Crolom
- cromogen
- Cromogen
- cromogen e breathe
- Cromogen e-breathe
- cromolux
- Cromolux
- cromolyn sodium
- Cromolyn sodium
- cromoptic
- Cromoptic
- cromosol
And 53 more, listed on the interactive page.
### Other names (55)
- 4h 1 benzopyran 2 carboxylic acid 5 5 2 hydroxy 1 3 propanediyl bis oxy bis 4 oxo disodium salt
- 4H-1-BENZOPYRAN-2-CARBOXYLIC ACID, 5,5'-((2-HYDROXY-1,3-PROPANEDIYL)BIS(OXY))BIS(4-OXO-, DISODIUM SALT)
- astilyn
- Astilyn
- cromoglicate sodium
- Cromoglicate sodium
- Cromoglicate sodium \[WHO-DD\]
- cromoglicate sodium who dd
- cromoglycic acid
- Cromoglycic acid
- cromolyn disodium salt
- Cromolyn disodium salt
- CROMOLYN DISODIUM SALT \[MI\]
- cromolyn disodium salt mi
- cromolyn sodium
- Cromolyn sodium
- CROMOLYN SODIUM \[ORANGE BOOK\]
- CROMOLYN SODIUM \[USAN\]
- CROMOLYN SODIUM \[USP MONOGRAPH\]
- CROMOLYN SODIUM \[USP-RS\]
- CROMOLYN SODIUM \[VANDF\]
- cromolyn sodium orange book
- cromolyn sodium usan
- cromolyn sodium usp monograph
- cromolyn sodium usp rs
And 30 more, listed on the interactive page.
## Identifiers
**CAS registry numbers**
- 15826-37-6
**ChEMBL ID**
CHEMBL74
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
**InChIKey**
VLARUOGDXDTHEH-UHFFFAOYSA-L
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL74)
**RxNorm IDs (RxCUI)**
- 3538
**FDA ingredient codes (UNII)**
- Q2WXR1I0PK
### PubChem compound IDs (2)
- 27503
- 59057527
## Regulatory information
### United States
**Applicant**
VIATRIS SPECIALTY
**Approval date**
29 Feb 1996
**Application number**
NDA020479
### Other regulatory facts
**Patents**
0
**Designations**
5
**First in class**
No
**Fast track**
No
**Breakthrough designation**
No
**Orphan designation**
No
**Priority review**
No
**Orphan exclusivity**
No
**Accelerated approval**
No
**Availability**
Over the counter
## Pharmacology
### Drug classification
**Pharmacology name**
cromoglicic acid
**Type**
Synthetic organic
#### Administration routes
- Oral
- topical
### Mechanisms of action (2)
- **Action type**
Agonist
**Target**
TAS2R20
**Gene symbol**
TAS2R20
- **Action type**
Agonist
**Target**
TAS2R7
**Gene symbol**
TAS2R7
### Investigated indications (10)
- **Condition**
Prostatitis
**Highest recorded phase**
0.5
**Condition identifier**
EFO:0003830
**Subject identifier**
D011472
- **Condition**
Urticaria
**Highest recorded phase**
4
**Condition identifier**
EFO:0005531
**Subject identifier**
D014581
- **Condition**
Triple Negative Breast Neoplasms
**Highest recorded phase**
2
**Condition identifier**
EFO:0005537
**Subject identifier**
D064726
- **Condition**
Conjunctivitis, Allergic
**Highest recorded phase**
4
**Condition identifier**
EFO:0007141
**Subject identifier**
D003233
- **Condition**
Mastocytosis
**Highest recorded phase**
4
**Condition identifier**
EFO:0009001
**Subject identifier**
D008415
- **Condition**
Rosacea
**Highest recorded phase**
1
**Condition identifier**
EFO:1000760
**Subject identifier**
D012393
- **Condition**
Vomiting
**Highest recorded phase**
4
**Condition identifier**
HP:0002013
**Subject identifier**
D014839
- **Condition**
Abdominal Pain
**Highest recorded phase**
4
**Condition identifier**
HP:0002027
**Subject identifier**
D015746
- **Condition**
Headache
**Highest recorded phase**
4
**Condition identifier**
HP:0002315
**Subject identifier**
D006261
- **Condition**
Asthma
**Highest recorded phase**
4
**Condition identifier**
MONDO:0004979
**Subject identifier**
D001249
### Open Targets indications (25)
- **Condition identifier**
EFO\_0000274
- **Condition identifier**
EFO\_0000768
**Highest recorded phase**
2
- **Condition identifier**
EFO\_0003830
- **Condition identifier**
EFO\_0005531
- **Condition identifier**
EFO\_0007141
- **Condition identifier**
EFO\_0009001
- **Condition identifier**
HP\_0002013
- **Condition identifier**
HP\_0002013
**Highest recorded phase**
4
- **Condition identifier**
HP\_0002027
- **Condition identifier**
HP\_0002027
**Highest recorded phase**
4
- **Condition identifier**
HP\_0002315
- **Condition identifier**
HP\_0002315
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0004976
**Highest recorded phase**
2
- **Condition identifier**
MONDO\_0004979
- **Condition identifier**
MONDO\_0004979
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0004980
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0005275
**Highest recorded phase**
1
- **Condition identifier**
MONDO\_0005492
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0005494
**Highest recorded phase**
2
- **Condition identifier**
MONDO\_0005642
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0006604
**Highest recorded phase**
1
- **Condition identifier**
MONDO\_0007950
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0019023
**Highest recorded phase**
2
- **Condition identifier**
MONDO\_0019091
**Highest recorded phase**
1
- **Condition identifier**
MONDO\_0022103
**Highest recorded phase**
1
### Reported adverse events (28)
- **Event**
anaphylactic reaction
**Reports**
9
**Reporting signal score**
8.52831
- **Event**
behaviour disorder
**Reports**
5
**Reporting signal score**
16.1192
- **Event**
blood glucose increased
**Reports**
9
**Reporting signal score**
8.3101
- **Event**
blood pressure increased
**Reports**
11
**Reporting signal score**
8.94438
- **Event**
bone pain
**Reports**
9
**Reporting signal score**
11.1966
- **Event**
conjunctivitis allergic
**Reports**
2
**Reporting signal score**
6.57489
- **Event**
diffuse cutaneous mastocytosis
**Reports**
1
**Reporting signal score**
6.32435
- **Event**
drug hypersensitivity
**Reports**
17
**Reporting signal score**
7.68604
- **Event**
eye irritation
**Reports**
5
**Reporting signal score**
7.09105
- **Event**
flushing
**Reports**
9
**Reporting signal score**
8.14159
- **Event**
gastric cancer stage 0
**Reports**
2
**Reporting signal score**
14.7505
- **Event**
headache
**Reports**
1
**Reporting signal score**
7.1035
- **Event**
hypersensitivity
**Reports**
21
**Reporting signal score**
21.9017
- **Event**
injection site pruritus
**Reports**
9
**Reporting signal score**
8.96297
- **Event**
leukocytoclastic vasculitis
**Reports**
6
**Reporting signal score**
20.6659
- **Event**
mast cell activation syndrome
**Reports**
6
**Reporting signal score**
31.8922
- **Event**
mastocytosis
**Reports**
9
**Reporting signal score**
54.9809
- **Event**
nausea
**Reports**
2
**Reporting signal score**
8.54434
- **Event**
osteoporosis
**Reports**
9
**Reporting signal score**
17.7215
- **Event**
perfume sensitivity
**Reports**
11
**Reporting signal score**
68.5059
- **Event**
scratch
**Reports**
9
**Reporting signal score**
30.7259
- **Event**
skin reaction
**Reports**
9
**Reporting signal score**
22.2989
- **Event**
systemic mastocytosis
**Reports**
3
**Reporting signal score**
15.1443
- **Event**
treatment failure
**Reports**
204
**Reporting signal score**
851.817
- **Event**
tubulointerstitial nephritis
**Reports**
7
**Reporting signal score**
12.7071
And 3 more, listed on the interactive page.
### Trial references (4)
- NCT00777348
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00777348)
- NCT01933464
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01933464)
- NCT03167216
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03167216)
- NCT05076682
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05076682)
## Dosing
**Dose**
1 or 2 drops
**Route**
Ocular
**How often**
4 to 6 times a day
### Conditions of use
- Use at regular intervals
## Chemical properties
**Hydrogen bond acceptors**
9
**Hydrogen bond donors**
3
**Polar surface area**
173.71
**Calculated partition coefficient (ALogP)**
2.11
**Prodrug**
No
**Chirality**
Achiral
**Inorganic**
No
**Rule-of-five violations**
0
**Rotatable bonds**
8
**Heavy atoms**
36
**Molecular formula**
C23H14Na2O11
**Monoisotopic mass**
512.03314982
**Natural product**
Yes
## National Drug Codes
- 0037-0678
- 0172-6406
- 16571-600
- 42571-132
- 61314-237
- 71205-230
- 81665-104
- 50090-1202
- 68788-8490
## Evidence counts
**Recorded assays**
1,354
**Active assays**
21
### Active assay types
- Confirmatory
## Pharmacologic actions
- Mast Cell Stabilizers
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000082142.html)
- Anti-Asthmatic Agents
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018927.html)
## Related records
### Trials (27)
- [A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects](https://trialight.com/data/trial/a-randomized-single-intravenous-dose-parallel-phase-i-3042c37b-fbb7-40ad-a2c3-ceb4170f67ef.md)
- A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease
- A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies
- An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
- Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis
- Cromoglicate in Mastocytosis
- Cromoglicate in Psoriasis
- Cromolyn Detection of Silent Aspiration
- Cromolyn Sodium for Treatment of COVID-19 Pneumonia
- Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)
- Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
- Guanfacine and Cromolyn Sodium for POTS: The DBPOTS Trial
- Influence of Cromones on Eucapnic Hyperventilation (EVH)-Test in Young (Elite) Athletes Who Tested Positive for EIB.
- Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer
- Mast Cell Treatment in Post-tick Bite Illness (PTBI)
- Mast Cells in Acid-induced Intestinal Permeability
- Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction
- Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
- Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
- Orphan Indications for CD19 Redirected Autologous T Cells
### Approved for (4)
- [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md)
- Atopic conjunctivitis
- Mastocytosis
- Urticaria
### In development for (3)
- Prostatitis Early phase 1
- Rosacea Phase 1
- [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) Phase 2
### Other linked conditions (1)
- [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md)
---
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