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 roflumilast's inhibition of PDE4 is thought to mediate its disease-modifying effects, although its precise mechanism of action has yet to be elucidated.
The oral formulation of roflumilast is indicated to manage the chronic obstructive pulmonary disease. It was first approved by the EMA in July 2010, and by the FDA in January 2018. Roflumilast topical cream is indicated to treat plaque psoriasis. It was first approved by FDA in July 2022 and by Health Canada in April 2023.
- 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
- -
Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients
- Conditions
- Mild Cognitive ImpairmentMild DementiaAmnestic Mild Cognitive Disorder
- Interventions
- Drug: RoflumilastDrug: Placebo oral tablet
- First Posted Date
- 2020-12-08
- Last Posted Date
- 2022-04-21
- Lead Sponsor
- Maastricht University Medical Center
- Target Recruit Count
- 81
- Registration Number
- NCT04658654
- Locations
- 🇳🇱
University of Maastricht, Faculty of Psychology and Neuropsychology, Maastricht, Netherlands
A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2020-11-19
- Last Posted Date
- 2024-04-18
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Target Recruit Count
- 3980
- Registration Number
- NCT04636814
- Locations
- 🇧🇬
Chiesi Clinical Trial - Site 100527, Lovech, Bulgaria
🇧🇬Chiesi Clinical Trial - Site 100533, Kozloduy, Bulgaria
🇺🇸Chiesi Clinical Trial - Site 840724, Muncie, Indiana, United States
Efficacy of Roflumilast in the Treatment of Psoriasis
- First Posted Date
- 2020-09-16
- Last Posted Date
- 2023-06-28
- Lead Sponsor
- Bispebjerg Hospital
- Target Recruit Count
- 46
- Registration Number
- NCT04549870
- Locations
- 🇩🇰
Bispebjerg Hospital, Copenhagen, Denmark
Roflumilast TMS-EEG Plasticity
- Conditions
- Synaptic Plasticity
- Interventions
- First Posted Date
- 2020-04-30
- Last Posted Date
- 2021-12-28
- Lead Sponsor
- University of Calgary
- Registration Number
- NCT04369547
- Locations
- 🇨🇦
University of Calgary, Calgary, Alberta, Canada
Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
- First Posted Date
- 2020-02-27
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- Arcutis Biotherapeutics, Inc.
- Target Recruit Count
- 333
- Registration Number
- NCT04286607
- Locations
- 🇺🇸
Arcutis Biotherapeutics Clinical Site 508, Los Angeles, California, United States
🇺🇸Arcutis Biotherapeutics Clinical Site 135, Pittsburgh, Pennsylvania, United States
🇺🇸Arcutis Biotherapeutics Clinical Site 238, Houston, Texas, United States
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis
- Conditions
- BronchiectasisExacerbation CopdLung Function Decreased
- Interventions
- Drug: PlaceboDrug: Roflumilast
- First Posted Date
- 2019-10-10
- Last Posted Date
- 2019-10-10
- Lead Sponsor
- Prince of Songkla University
- Target Recruit Count
- 40
- Registration Number
- NCT04122547
- Locations
- 🇹🇭
Songklanagarind hospital, Songkhla, Thailand
Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma
- First Posted Date
- 2019-09-30
- Last Posted Date
- 2023-10-24
- Lead Sponsor
- University of California, Davis
- Target Recruit Count
- 5
- Registration Number
- NCT04108377
- Locations
- 🇺🇸
UC Davis, Sacramento, California, United States
Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis
- First Posted Date
- 2019-09-16
- Last Posted Date
- 2019-10-03
- Lead Sponsor
- Assiut University
- Target Recruit Count
- 35
- Registration Number
- NCT04090294
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
- Conditions
- Chronic Obstructive Pulmonary Disease SevereChronic Bronchitis
- Interventions
- First Posted Date
- 2019-08-28
- Last Posted Date
- 2024-06-10
- Lead Sponsor
- Johns Hopkins University
- Target Recruit Count
- 1250
- Registration Number
- NCT04069312
- Locations
- 🇺🇸
Houston Methodist Hospital, Houston, Texas, United States
🇺🇸Mount Sinai, New York, New York, United States
🇺🇸Lenox Hill Hospital/Northwell Health, New York, New York, United States
Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis
- First Posted Date
- 2019-06-17
- Last Posted Date
- 2020-01-13
- Lead Sponsor
- University of Sao Paulo General Hospital
- Target Recruit Count
- 30
- Registration Number
- NCT03988816
- Locations
- 🇧🇷
Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
Drug Development Updates
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