Roflumilast

Generic Name: Roflumilast

Brand Names: Daliresp, Zoryve, Daxas

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₄Cl_₂F_₂N_₂O_₃

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: -

Clinical Trials

Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia

Phase 1

Completed

Conditions: Schizophrenia

Interventions: Drug: Roflumilast
Drug: Placebo
Drug: Second generation antipsychotic

First Posted Date: 2014-03-06

Last Posted Date: 2016-10-03

Lead Sponsor: Takeda

Target Recruit Count: 20

Registration Number: NCT02079844

Post Marketing Surveillance of Roflumilast in Korea

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Roflumilast

First Posted Date: 2014-02-21

Last Posted Date: 2017-06-22

Lead Sponsor: AstraZeneca

Target Recruit Count: 1837

Registration Number: NCT02068456

Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults

Phase 1

Completed

Conditions: Alzheimer's Disease
Memory Impairment

Interventions: Drug: Roflumilast
Drug: Roflumilast placebo
Drug: Donepezil
Drug: Donepezil placebo
Drug: Scopolamine

First Posted Date: 2014-01-31

Last Posted Date: 2017-02-01

Lead Sponsor: AstraZeneca

Target Recruit Count: 27

Registration Number: NCT02051335

Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization

Phase 3

Completed

Conditions: COPD

Interventions: Drug: Roflumilast
Drug: Placebo

First Posted Date: 2013-11-01

Last Posted Date: 2020-03-12

Lead Sponsor: Temple University

Target Recruit Count: 68

Registration Number: NCT01973998

Locations: 🇺🇸
Temple University Hospital, Philadelphia, Pennsylvania, United States

Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)

Early Phase 1

Completed

Conditions: Advanced B-cell Lymphoid Malignancies

Interventions: Drug: Prednisone
Drug: Roflumilast

First Posted Date: 2013-06-28

Last Posted Date: 2017-02-27

Lead Sponsor: Anand B. Karnad

Target Recruit Count: 10

Registration Number: NCT01888952

Locations: 🇺🇸
Ctrc @ Uthscsa, San Antonio, Texas, United States

Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals

Phase 1

Completed

Conditions: Obesity

Interventions: Drug: Roflumilast

First Posted Date: 2013-05-24

Last Posted Date: 2018-09-04

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 24

Registration Number: NCT01862029

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)

Phase 4

Conditions: Sarcoidosis

Interventions: Drug: Placebo
Drug: Roflumilast

First Posted Date: 2013-04-12

Last Posted Date: 2015-12-08

Lead Sponsor: University of Cincinnati

Target Recruit Count: 50

Registration Number: NCT01830959

Locations: 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States

Roflumilast Plus Montelukast in Adults With Severe Asthma

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: Roflumilast
Drug: Roflumilast placebo
Drug: Montelukast

First Posted Date: 2013-01-10

Last Posted Date: 2017-02-01

Lead Sponsor: AstraZeneca

Target Recruit Count: 64

Registration Number: NCT01765192

Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Roflumilast

First Posted Date: 2012-12-10

Last Posted Date: 2017-08-29

Lead Sponsor: University of Pittsburgh

Target Recruit Count: 26

Registration Number: NCT01745848

Locations: 🇺🇸
Emphysema COPD Research Center, Pittsburgh, Pennsylvania, United States

Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients

Phase 2

Completed

Conditions: COPD

Interventions: Drug: CHF6001 DPI
Drug: Placebo
Drug: Roflumilast

First Posted Date: 2012-11-21

Last Posted Date: 2017-03-29

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Target Recruit Count: 55

Registration Number: NCT01730404

Locations: 🇮🇪
Celerion, Belfast, Ireland
🇬🇧
Medicines Evaluation Unit Ltd, Manchester, United Kingdom
🇬🇧
Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom

and more 2 locations

Drug Development Updates

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