Delving into the Latest Updates on Cromolyn Sodium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Cromolyn sodium (USP), DSCG, Disodium Cromoglycate

+ [29]

Target-

Action

modulators, stabilizers

Mechanism

Glial cells modulators, Mast cells stabilizers

Therapeutic Areas

Immune System DiseasesEye DiseasesRespiratory Diseases+ [1]

Active Indication

Vernal KeratoconjunctivitisFood HypersensitivityConjunctivitis, Allergic+ [1]

Inactive Indication

Alzheimer DiseaseAmyotrophic Lateral SclerosisMastocytosis+ [1]

Originator Organization

Sanofi

Active Organization

Hubei Dongsheng Pharmaceutical Co. Ltd.

Aventis Pharmaceuticals, Inc.

King Pharmaceuticals LLC

+ [2]

Inactive Organization

AZTherapies, Inc.

Leo Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

Ireland (01 Nov 1980),

Asthma

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC23H16Na2O11

InChIKeyAIXRIMKZFKFIAF-UHFFFAOYSA-N

CAS Registry15826-37-6

This is a Phase II, open-label, three-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, or efavirenz) with immune checkpoint inhibitor in mTNBC (triple negative breast cancer) patients who progressed during previous immune checkpoint inhibitors.

Start Date30 Jun 2022

Sponsor / Collaborator

Fudan University

NCT05077917

/ TerminatedPhase 3IIT

Cromolyn Sodium for Treatment of COVID-19 Pneumonia

The study hypothesis is that cromolyn, when combined with standard COVID-19 treatment, will improve patient symptoms and reduce the number of days to improved quality of life.
Investigators will study the effects of adding cromolyn to the standard treatment of hospitalized patients with COVID-19 pneumonia and who require supplemental oxygen. Cromolyn will be administered as a nebulized treatment four times a day for four days followed by intranasal administration for two weeks. Investigators may also screen for biomarkers that could indicate inflammatory responses and treatment-induced improvement.
Participants will receive either study drug or placebo which will be administered by nebulization for 4 days followed by 14 days of intranasal administration. Participants will be followed while in the hospital and then as outpatients up to day 21 following randomization.

Start Date15 Nov 2021

Sponsor / Collaborator

Texas Tech University Health Sciences Center

ChiCTR2100050716

/ RecruitingPhase 4IIT

Efficacy of Sodium Cromoglicate in combination with nasal glucocorticoids in the treatment of drug-induced rhinitis: a multicenter randomized controlled trial

Start Date04 Sep 2021

Sponsor / Collaborator

Yantai Yuhuangding Hospital

100 Clinical Results associated with Cromolyn Sodium

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100 Translational Medicine associated with Cromolyn Sodium

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100 Patents (Medical) associated with Cromolyn Sodium

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4,743

Literatures (Medical) associated with Cromolyn Sodium

04 Mar 2025·Nanomedicine

Formation and evaluation of doxorubicin and cromoglycate metal–organic framework for anti-cancer activity

Article

Author: Hamadneh, Imad ; Shalan, Naeem ; Alshaer, Walhan ; Abu Saleem, Ebaa ; Lafi, Zainab

AIMSWe develop and evaluate copper-based metal-organic frameworks (Cu-MOFs) incorporating cromolyn as a linker to enhance structural stability, drug delivery efficiency, and therapeutic potential, particularly for breast cancer treatment.MATERIALS & METHODSTwo Cu-MOF formulations were synthesized: Cu-MOFs-BDC-DOX (using terephthalic acid) and Cu-MOFs-CROMO-DOX (using cromolyn as a linker). Characterization was performed using SEM/TEM for morphology, and FTIR, XRD, and TGA to confirm structural integrity. Drug encapsulation efficiency and release profiles were assessed, followed by in vitro cytotoxicity, cell migration, and colony formation assays using MDA-MB-231 breast cancer cells.RESULTSBoth formulations demonstrated a high encapsulation efficiency (83-91%) and sustained drug release over 48 h at pH 7.4. Cu-MOFs-CROMO-DOX exhibited superior cytotoxicity with an IC50 of 0.88 ± 0.07 µM compared to 7.1 ± 0.11 µM for Cu-MOFs-BDC-DOX. Both formulations inhibit cancer cell migration and colony formation in a dose-dependent manner.CONCLUSIONSThe Cu-MOFs-CROMO-DOX formulation demonstrated enhanced therapeutic potential, outperforming its counterpart in targeting breast cancer cells. This study highlights the promise of MOF-based nanocarriers in overcoming the limitations of conventional chemotherapy, offering a pathway to more effective and targeted cancer treatments with reduced side effects.

01 Feb 2025·Journal of the Science of Food and Agriculture

Spent coffee grounds as an alternative fertilizer: impact on bioaccessibility of antioxidants and commercial quality of lettuce

Article

Author: Hasperué, Héctor Joaquín ; Pastoriza, Silvia ; Cervera‐Mata, Ana ; Patrignani, Mariela ; Rufián Henares, José Ángel

AbstractBackgroundDuring the processing of spent coffee grounds (SCGs) several residues are obtained, which are mostly disposed of in landfills. There is an urgent need for a comprehensive waste management strategy for these residues. This study evaluates the potential of SCGs as a biofertilizer by assessing their effects on lettuce leaves and the release of antioxidants following in vitro digestion and fermentation.ResultsLettuce plants were grown with different amounts of SCGs (0–150 g kg−1) in the substrate. High SCG concentrations in the soil generated lighter colored tissues, a decrease in the green color, less root development, and lower dry weight of leaves (P < 0.05). The SCG levels also affected the release of antioxidants by the final product. This effect was more pronounced in the digested fraction: applying the Ferric Reducing Antioxidant Power (FRAP) method, the addition of SCGs from 10 g kg−1 to 125 g kg−1 increased the amount of antioxidant from 43.88 ± 4.81 to 105.96 ± 29.09 μmol Trolox g−1 of dry weight (P < 0.05). The Indigo Carmine Reducing Capacity (ICRED) method also showed a similar trend, but in this case the highest value was obtained with 150 g kg−1 of SCGs (16.41 ± 3.93 mmol catechin g−1 of dry weight) (P < 0.05). Moreover, in the fermented fraction a significant increase in the antioxidant released was found with low levels of SCG(P<0.05), while lettuces fertilized with intermediate amounts of SCGs (25 and 50 g kg−1) presented the highest amount of insoluble antioxidant (P < 0.05).ConclusionA compromise should be found in order to achieve a product with a high antioxidant capacity and an acceptable visual quality. © 2024 Society of Chemical Industry.

01 Jan 2025·Journal of Allergy and Clinical Immunology

Omalizumab for mast cell disorders

Author: Akin, Cem

A review.The goals of treatment in MCD include avoidance of known triggers; treatment of the underlying pathol. when known; and pharmacotherapy targeting mast cell mediators such as with H1 and H2 histamine receptor blockers, leukotriene pathway modifiers, and mast cell stabilizers (which traditionally include cromolyn and ketotifen but may also be expanded to include calcineurin inhibitors and currently investigational agents such as Bruton tyrosine kinase [BTK] inhibitors).Well-designed prospective trials are needed to gain more information on the effect of omalizumab on mastocytosis and idiopathic anaphylaxis and determine the best approach to preventive therapy of anaphylaxis in these patient populations.Those subsets of patients with severe anaphylaxis or MCAS (with or without known mastocytosis) and an IgE-dependent trigger identified at diagnosis or during follow-up who experience breakthrough severe MCA events despite their best efforts at trigger avoidance and preventive antimediator therapy appear particularly well suited to benefit from omalizumab therapy.

4

News (Medical) associated with Cromolyn Sodium

15 Aug 2023

·www.fiercepharma.com

Stada in 'exploratory talks' about possible sale, CEO says, but nothing is certain

Early this month, Bloomberg reported that Stada Arzneimittel’s private equity owners were weighing options for the drugmaker, including a possible sale. Speculation that Stada Arzneimittel may be looking for a buyout has largely been confirmed after the company’s CEO said as much in a recent German-language news story. Responding to recent acquisition rumors, Stada CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.” From the company’s view, Goldschmidt said, “our owners are in an orientation phase in which initial exploratory talks are taking place.” A Stada press representative emailed a translated version of the remarks early Tuesday along with the company's second-quarter results. Goldschmidt added that he doesn’t expect a decision before 2024. Additionally, the company's investors “have no pressure to sell,” the CEO pointed out. "What speaks in favor of a sale process is that it is common for financial investors to exit after five to six years,” Goldschmidt opined. Early this month, Bloomberg reported that Stada’s private equity owners were weighing options for the drugmaker, including a possible sale. At the time, sources close to the talks told Bloomberg the sale could value Stada at 10 billion euros or more. Bain and Cinven agreed to buy Stada for 5.3 billion euros in 2017. The deal gave the private equity firms control of what was one of the last independent generic-drug businesses in Europe. Goldschmidt's comments came as Stada reported first-half sales growth of 16% to 2.1 billion euros. The company is tracking to a record annual profit of 1 billion euros this year, the company said. Stada has been busy in recent months, both filling out its medicine chest and bolstering drug production abroad. In mid-July, Stada dropped an undisclosed sum on a range of Sanofi consumer health brands with “well-established” footholds in places such as Belgium, Germany, Hungary, Spain and the U.K., plus Nordic countries. The deal covered several brands, including the pain relief med Antistax, the allergy eye drops Lomudal and Opticrom, Omnivit vitamins and painkillers AAS and Dolalgial plus Bila-Git for gallbladder complaints. The purchase marked the “next step” in Stada’s quest to grow in the European consumer health market, the company’s Western Europe and Germany head Stephan Eder said in a statement at the time. In late November, Stada became the first international medicines company to build a plant in Romania in more than 30 years. At the time, Stada broke ground on a pill manufacturing facility in the Aries Industrial Park in Turda, which was set to create 375 jobs and to go online by the end of 2024.

AcquisitionBiosimilar

12 Jul 2023

·www.fiercepharma.com

Stada raids Sanofi's medicine chest once more, picking up clutch of consumer health brands in Europe

Despite repeat over-the-counter sales to Stada Arzneimittel, Sanofi continues to operate its own large consumer healthcare venture. Two years after it enriched itself with 16 Sanofi drugs, Germany’s Stada Arzneimittel is purchasing another clutch of consumer health brands across multiple European countries. Stada is dropping an undisclosed sum on a range of Sanofi consumer health products with “well-established” footholds in places such as Belgium, Germany, Hungary, Spain and the U.K., plus Nordic countries. The deal covers several brands, including the pain relief med Antistax, the allergy eye drops Lomudal and Opticrom, Omnivit vitamins and painkillers AAS and Dolalgial plus Bila-Git for gallbladder complaints, Stada said Wednesday. Stada will finance the transaction with a mix of cash from its balance sheet and existing debt facilities. It aims to close the deal in the fourth quarter of 2023. The purchase marks the “next step” in Stada’s quest to grow in the European consumer health market, the company’s Western Europe and Germany head Stephan Eder said in a statement “Stada’s extensive sales, marketing and distribution network throughout Europe, along with our long-established partnerships with pharmacists, will enable the group to grow these brands by also developing additional offerings,” he added. Consumer healthcare comprises one of three pillars in Stada’s business alongside specialty medicines and generics. The company operates predominantly in Western European countries. Two summers ago, Stada struck a similar deal with Sanofi for more than a dozen consumer health brands spanning 13 European countries. That portfolio purchase covered cold and flu meds, skincare and food supplement brands. Prior to that, Stada in early 2020 tapped GSK for 15 over-the-counter drugs in a deal worth at least 300 million euros ($325 million). For GSK, the asset sale was part of a broader ambition to spin out its consumer healthcare business into the standalone company Haleon, which formally flew the nest in July 2022. That move formed part of a broader spinoff trend across the industry, with similar maneuvers having been charted by Johnson & Johnson with its OTC spinoff Kenvue, Pfizer and Mylan with Viatris and Novartis’ ongoing effort to hive off Sandoz. Despite repeat over-the-counter sales to Stada, Sanofi continues to operate its own large consumer healthcare venture. The division was a key revenue driver for the French pharma in 2023’s first quarter, growing sales 11.2% to 1.5 billion euros (about $1.7 billion).

Acquisition

12 Jul 2023

·firstwordpharma.com

Sanofi offloads more consumer health brands to STADA in Europe

STADA Arzneimittel announced Wednesday that it is acquiring another range of consumer healthcare brands from Sanofi across European countries, including in Belgium, Germany, Hungary, Spain and the UK, as well as Nordic countries. The transaction, whose financial terms were not disclosed, is scheduled to close in the fourth quarter.In 2021, STADA acquired 16 of Sanofi's consumer healthcare products across 13 countries in Europe and shortly afterwards entered into a deal to distribute and market Sanofi's portfolio of consumer healthcare brands in 20 European countries. It has since agreed to distribute Sanofi's consumer healthcare portfolio in 10 countries in Central Asia as well."We are pleased to continue our collaboration with Sanofi," stated CEO Peter Goldschmidt, adding that the latest acquisition "further strengthens STADA as a top-four player in Europe's consumer healthcare market and supports our growth acceleration." Goldschmidt said "the brands being acquired, and their geographic presence, are well aligned and synergistic with the organic activities in [our] core countries."The new transaction covers Antistax for pain relief and tiredness in the legs; the allergy eye drops Lomudal and Opticrom; Omnivit vitamins; pain drugs AAS and Dolalgial; as well as Bila-Git for gallbladder complaints.In 2019, STADA acquired Takeda's portfolio of 20 prescription and over-the-counter drugs for $660 million, later tapping GSK for 15 consumer healthcare brands.

AcquisitionBiosimilar

100 Deals associated with Cromolyn Sodium

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External Link

KEGG	Wiki	ATC	Drug Bank
D00526	Cromolyn Sodium	D11AH03 R01AC01 R03BC01 A07EB01 S01GX01	DBSALT000985

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Vernal Keratoconjunctivitis	Australia	AFT Pharmaceuticals (AU) Pty Ltd.	04 Mar 2014
Food Hypersensitivity	United Kingdom	Aventis Pharmaceuticals, Inc.	01 May 2005
Conjunctivitis, Allergic	China	Hubei Dongsheng Pharmaceutical Co. Ltd.	01 Jan 1990
Asthma	Ireland	King Pharmaceuticals LLC	01 Nov 1980

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 2	United States	AZTherapies, Inc.	15 Sep 2015
Alzheimer Disease	Phase 2	Poland	AZTherapies, Inc.	15 Sep 2015
Alzheimer Disease	Phase 2	Czechia	AZTherapies, Inc.	15 Sep 2015
Alzheimer Disease	Phase 2	Hungary	AZTherapies, Inc.	15 Sep 2015
Alzheimer Disease	Phase 2	Australia	AZTherapies, Inc.	15 Sep 2015
Alzheimer Disease	Phase 2	Bulgaria	AZTherapies, Inc.	15 Sep 2015
Alzheimer Disease	Phase 2	Canada	AZTherapies, Inc.	15 Sep 2015
Psoriasis	Phase 2	Germany	Leo Pharma, Inc.	01 Nov 2012
Mastocytosis	Preclinical	Germany	Leo Pharma, Inc.	01 Oct 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01933464 (CTgov)	Phase 1/2	Rosacea	10	Cromolyn Sodium (Cromolyn)	cqkmzkjozk(vvjldcsdov) = telkxkjoxy zivdmlaram (wzlrkphlux, jnfmazexia - fiwpobjfzf) View more	-	30 Jul 2019
				Normal saline (Vehicle)	cqkmzkjozk(vvjldcsdov) = nnbyocpvqp zivdmlaram (wzlrkphlux, khikazrojk - doorrkygce) View more
UEGW2018	Not Applicable	Mast Cell Activation Disorders	-	Ketotifen	iwllkhkhgb(oqrndcxzwv) = smtrjwiosi hnxaxlpedw (qrqiakupea )	-	01 Oct 2018
				Fexofenadine	iwllkhkhgb(oqrndcxzwv) = mawhbhonia hnxaxlpedw (qrqiakupea )
ASN2010	Not Applicable	Reperfusion Injury serum creatinine	36	Sodium Cromoglicate 160 mg/kg	vsxdjkbxqj(vkfwfsruzz) = wftkjivvwg czhpebzmpc (vpnbivawkl ) View more	Positive	16 Nov 2010
				Sodium Cromoglicate (Control)	vsxdjkbxqj(vkfwfsruzz) = aimafguegm czhpebzmpc (vpnbivawkl ) View more
ARVO2008	Not Applicable	Uveal Melanoma S100A1	7	Cromolyn	(pigdnchatu) = cvxkgmzhyp iylpnivkxh (qxyowuhbmk )	-	01 May 2008
				Artificial tears	(pigdnchatu) = dggdxmjndh iylpnivkxh (qxyowuhbmk )
AAAAI2002	Not Applicable	-	-	Delivery agent + Cromolyn	(ugdpakieyu) = bqsnwblbsi msivwennbi (jvruofvuml ) View more	-	01 Mar 2002