Cromoglicic acid

Overview

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.

Indication

For the management of patients with bronchial asthma. Also used in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

Associated Conditions

Asthma
Conjunctivitis, Vernal
Exercise-Induced Bronchospasm
Food Allergy
Keratoconjunctivitis
Perennial Allergic Rhinitis (PAR)
Seasonal Allergic Conjunctivitis
Seasonal Allergic Rhinitis
Urticaria Pigmentosa
Vernal Keratoconjunctivitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Cromolyn Sodium for Treatment of COVID-19 Pneumonia	2021/10/14	NCT05077917	Phase 3	Terminated	Texas Tech University Health Sciences Center, El Paso
Reverse Triple Negative Immune Resistant Breast Cancer	2021/10/13	NCT05076682	Phase 2	Recruiting	Fudan University
Influence of Cromones on Eucapnic Hyperventilation (EVH)-Test in Young (Elite) Athletes Who Tested Positive for EIB.	2020/05/29	NCT04408664	Phase 3	Terminated	Universitaire Ziekenhuizen KU Leuven
Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia	2019/01/04	NCT03794076	Phase 1	Recruiting	Vishwajit Nimgaonkar, MD PhD
Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)	2017/06/28	NCT03202147	Phase 2	Withdrawn	AZTherapies, Inc.
Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction	2017/05/25	NCT03167216	Early Phase 1	Completed	Northwestern University
Mast Cells in Acid-induced Intestinal Permeability	2016/01/26	NCT02664051	Phase 4	Terminated	Universitaire Ziekenhuizen KU Leuven
Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)	2015/10/02	NCT02566252	Phase 1	Completed	Pulmotect, Inc.
Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease	2015/09/11	NCT02547818	Phase 3	Completed	AZTherapies, Inc.
Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers	2015/06/26	NCT02482324	Phase 1	Completed	AZTherapies, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cromolyn Sodium	Micro Labs Limited	42571-350	INTRABRONCHIAL	20 mg in 2 mL	5/4/2022
Cromolyn Sodium Inhalation Solution	VIRTUS PHARMACEUTICALS LLC	69543-456	INTRABRONCHIAL	20 mg in 2 mL	1/17/2024
Cromolyn Sodium	Proficient Rx LP	71205-230	OPHTHALMIC	40 mg in 1 mL	3/1/2019
Cromolyn Sodium	RPK Pharmaceuticals, Inc.	53002-0140	OPHTHALMIC	40 mg in 1 mL	12/14/2018
Cromolyn Sodium Oral Solution (Concentrate)	Ritedose Pharmaceuticals, LLC	76204-025	ORAL	100 mg in 5 mL	12/20/2023
Gastrocrom	Meda Pharmaceuticals	0037-0678	ORAL	20 mg in 1 mL	6/26/2024
Gastrocrom	Viatris Specialty LLC	0037-0678	ORAL	20 mg in 1 mL	6/26/2024
Cromolyn Sodium	A-S Medication Solutions	50090-1202	OPHTHALMIC	40 mg in 1 mL	12/14/2018
Cromolyn Sodium	Ailex Pharmaceuticals, LLC	70556-102	INTRABRONCHIAL	20 mg in 2 mL	8/14/2023
cromolyn sodium	Mylan Pharmaceuticals Inc.	51525-0470	ORAL	100 mg in 5 mL	6/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ALLERGOCROM EYE DROPS 20 mg/ml	URSAPHARM ARZNEIMITTEL GMBH	SIN09796P	SOLUTION	20 mg/ml	6/4/1998
Allergo-COMOD eye drops	URSAPHARM Arzneimittel GmbH	SIN13423P	SOLUTION, STERILE	20mg/ml	3/5/2008
VIVIDRIN EYE DROPS 20 mg/ml	DR GERHARD MANN CHEM-PHARM FABRIK GMBH	SIN04854P	SOLUTION	20 mg/ml	6/28/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CROMO-FRESH sodium cromoglycate 2% w/v eye drops solution botttle	220683	AFT Pharmaceuticals Pty Ltd	Medicine	A	3/4/2014
OPTIGLYCATE sodium cromoglycate 20mg/mL eye drop solution bottle	301941	Neo Health (OTC) Pty Ltd	Medicine	A	4/17/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RYNACROM SOLUTION 2%	rhone-poulenc rorer canada inc.	00605255	Metered-Dose Aerosol - Nasal	2 %	12/31/1984
RHINARIS-CS ANTI-ALLERGIC NASAL MIST	pendopharm division of pharmascience inc	01950541	Spray, Metered Dose - Nasal	2 % / W/V	12/31/1993
PMS-SODIUM CROMOGLYCATE	Pharmascience Inc	02046113	Solution - Inhalation	1 %	12/31/1993
NOVO-CROMOLYN NEBULIZER SOLUTION 1%	novopharm limited	02049082	Solution - Inhalation	1 %	12/31/1993
SOLU-CROM	sabex inc	02239657	Liquid - Ophthalmic	2 %	7/1/1999
INTAL NEBULIZER 1%	aventis pharma inc	00534609	Solution - Inhalation	1 %	12/31/1981
ANTI-ALLERGY EYE DROPS	pendopharm division of pharmascience inc	02279967	Solution - Ophthalmic	2 %	N/A
NU-CROMOLYN PLASTIC AMPULES	nu-pharm inc	02231671	Solution - Inhalation	10 MG / ML	12/3/1997
NU-CROMOLYN	nu-pharm inc	02231351	Liquid , Spray - Nasal	2 %	N/A
INTAL INHALER	sanofi-aventis canada inc	00555649	Metered-Dose Aerosol - Inhalation	1 MG / DOSE	12/31/1982

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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