roflumilast
roflumilast: sourced relationships with 1 company · 3 clinical trials tracked · 1 FDA decision.
roflumilast evidence translation
What we can confirm
1 FDA record · 3 tracked trials
What it means
What to watch
Prepared research question
How could roflumilast → AZN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| ASTRAZENECA PLC (AZN) Reported 2011-02-28 · Current development: unknownSource Bronchial Asthma | Phase 3 |
Clinical Trial Registry Records (3)
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Primary endpoint: Mean Change in Nail Psoriasis Severity Index (NAPSI)
A Long-term Study of APTA-2217 in Adult Patients With Bronchial Asthma
Primary endpoint: Long-term safety after 28 weeks treatment of Roflumilast at (total 52 weeks, 24 weeks of study APTA-2217-05 followed by 28 weeks) .
A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)
Primary endpoint: change in lung function parameters.
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with roflumilast?
roflumilast has dated SEC/FDA relationship records for ASTRAZENECA PLC.
How many clinical trials involve roflumilast?
BioSniper tracks 3 clinical trials involving roflumilast.
What is roflumilast's latest FDA decision?
The most recent tracked FDA decision for roflumilast is Approval for 1 INDICATIONS AND USAGE DALIRESP ® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. DALIRESP is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. ( 1 , 14 ) Limitations of Use : • DALIRESP is not a bronchodilator and is not indica, dated February 28, 2011.