Denufosol

Overview

Denufosol was an inhaled drug used for the treatment of cystic fibrosis (CF), showing various improvements in lung function during a phase III clinical trial. A new drug application (NDA) was filed with the FDA in 2011, however, the second phase III clinical trial showed a lack of improvement in lung function for cystic fibrosis patients taking denufosol. The drug was also evaluated in the treatment of retinal detachment and other diseases of the retina. Denufosol has not gained FDA approval, and clinical trials with this drug have ceased since 2011.

Indication

For use as an inhaled treatment for cystic fibrosis.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Safety and Tolerability Study of Denufosol in 2-4 Year Olds	2010/08/13	NCT01181622	Phase 2	Completed	Merck Sharp & Dohme LLC
Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)	2009/02/19	NCT00846781	Phase 3	Terminated	Merck Sharp & Dohme LLC
Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease	2008/02/28	NCT00625612	Phase 3	Completed	Merck Sharp & Dohme LLC
Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease	2007/01/22	NCT00425165	Phase 2	Terminated	Merck Sharp & Dohme LLC
Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease	2006/07/27	NCT00357279	Phase 3	Completed	Merck Sharp & Dohme LLC
A Pharmacokinetic Evaluation Study in Healthy Volunteers	2005/09/21	NCT00210054	Phase 1	Completed	Merck Sharp & Dohme LLC
A Study in Subjects With Retinal Detachment	2005/09/21	NCT00210067	Phase 1	Completed	Merck Sharp & Dohme LLC
A Pharmacokinetic Evaluation Study in Healthy Volunteers	2005/09/21	NCT00210093	Phase 1	Completed	Merck Sharp & Dohme LLC
A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema	2005/08/26	NCT00135655	Phase 2	Withdrawn	Merck Sharp & Dohme LLC
A Study in Pediatric Patients With Cystic Fibrosis Lung Disease	2005/08/15	NCT00130182	Phase 2	Completed	Merck Sharp & Dohme LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
No HSA approvals found for this drug.

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

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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