Erdosteine Attains Orphan-Drug Status from the FDA

Erdosteine Attains Orphan-Drug Status from the FDA

As the latest molecule in the mucoactive drug class Erdosteine has recently received Orphan-Drug Designation from the FDA. Erdosteine was developed by Edmond Pharma and this productive drug is already marketed in 40 countries around the world for the treatment of both chronic obstructive pulmonary disease (COPD) and chronic bronchitis. There are currently no medications approved in the United States for the treatment of Bronchiectasis, therefore the ultimate approval of Erdosteine would be beneficial for this urgent unmet need. Bronchiectasis is a frustrating and serious condition that can develop at any age and may be a result of prior illness such as pneumonia, disease like tuberculosis or from a genetic defect. Symptoms of Bronchiectasis occur when the airways in the lungs become overstretched due to a blockage of excess mucous. This mucosal buildup leads to an abnormal growth of bacteria and subsequent infection. Proper treatment is essential for patients to live a successful and normal life, and the hopeful approval of Erdosteine for this purpose will be welcomed by patients, practitioners and pharmacies.


Erdosteine is unique in that it is a diversified molecule that is ideal for treating chronic bronchitis and COPD throughout both stable times and during acute exacerbations. Over 3,000 clinical trial participants have been treated with Erdosteine in a ten year span of time and in more than 60 individual trials. The efficacy, safety and tolerability of Erdosteine has been proven in all studies, leading to the ultimate use of this drug as an adjunct treatment for patients around the world suffering from chronic bronchitis and COPD.


Clinical study results have specifically demonstrated an effectual response in patients administered 300 milligrams of Erdosteine twice daily for the treatment of Bronchiectasis. The use of Erdosteine effectively reduced the frequency and severity of coughing in patients, as well as aiding in the elimination of sputum, in comparison to a placebo. Adverse effects from Erdosteine are limited, with mild gastrointestinal distress being the most severe complaint from a few patients. Erdosteine is currently available in four dosages: 150 milligram/300 milligram capsules; 225 milligram/300 milligram sachets; 175 milligram dry syrup and 300 milligrams dispersible tablets.

As the only recommended mucolytic from the American College of Chest Physicians for expectoration in patients with chronic bronchitis, Erdosteine is clearly an up and coming product to watch. LGM Pharma provides the API Erdosteine, CAS # 84611-23-4 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.


Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.



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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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