Roflumilast
- Generic Name
- Roflumilast
- Brand Names
- Daliresp, Zoryve, Daxas
- Drug Type
- Small Molecule
- Chemical Formula
- C17H14Cl2F2N2O3
- CAS Number
- 162401-32-3
- Unique Ingredient Identifier
- 0P6C6ZOP5U
- Background
Roflumilast is a highly selective phosphodiesterase-4 (PDE4) inhibitor. PDE4 is a major cyclic-3',5′-adenosinemonophosphate (cyclic AMP, cAMP)-metabolizing enzyme expressed on nearly all immune and pro-inflammatory cells, in addition to structural cells like those of the smooth muscle or epithelium. The resultant increase in intracellular cAMP induced by ro...
- Indication
Oral roflumilast is indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Topical roflumilast is indicated to treat plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
- Associated Conditions
- Exacerbation of COPD, Psoriasis Vulgaris (Plaque Psoriasis)
- Associated Therapies
- -
The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)
- Conditions
- First Posted Date
- 2004-01-15
- Last Posted Date
- 2016-12-02
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 822
- Registration Number
- NCT00076076
- Locations
- 🇺🇦
ALTANA Pharma, Cities in the Ukraine, Ukraine
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
- Conditions
- First Posted Date
- 2004-01-15
- Last Posted Date
- 2016-12-02
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1100
- Registration Number
- NCT00076089
- Locations
- 🇿🇦
ALTANA Pharma, Cities in South Africa, South Africa
Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
- Conditions
- First Posted Date
- 2003-11-19
- Last Posted Date
- 2016-10-25
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 819
- Registration Number
- NCT00073177
- Locations
- 🇵🇪
ALTANA Pharma, Cities in Peru, Peru
Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)
- Conditions
- First Posted Date
- 2003-06-10
- Last Posted Date
- 2016-11-23
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1000
- Registration Number
- NCT00062582
- Locations
- 🇺🇸
ATLANA Pharma, Cities in Colorado, Colorado, United States
🇵🇪ALTANA Pharma, Cities in Peru, Peru
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.