Roflumilast
As of the edition of 20 October 2026, Roflumilast is a small molecule: marketed, first approved in 2010 (EU); acts on PDE4A, PDE4B and PDE4C and 1 more; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Daliresp
- First approved
- 5 July 2010 (EU)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Arcutis Biotherapeutics; 3 holders in all
- Withdrawn from market
- 11 January 2018 (in some regions)
- Registered trials
- 92, 5 stopped early
- Disease areas
- Lungs and airways; Skin and connective tissue; Immune system; Inherited and neonatal; Nervous system; Mental health
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Arcutis Biotherapeutics holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Roflumilast.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 4 | 0 | 0 |
| Phase 1 | 15 | 9 | 2 | 3 |
| Phase 2 | 33 | 16 | 11 | 2 |
| Phase 3 | 30 | 28 | 1 | 0 |
| Phase 4 | 9 | 3 | 4 | 0 |
| All trials | 92 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant, Acquired holder and Lead sponsor of trials | 2003 to now |
| Arcutis Biotherapeutics | Later holder and Lead sponsor of trials | 2017 to now |