Wednesday, July 8, 2026

Drug profile · INN

roflumilast

roflumilast (DAXAS) is a phosphodiesterase 4 inhibitor. Associated with Arcutis Biotherapeutics. Route of administration: topical. Current US regulatory status: approved.

FDA: approved EMA: approved Respiratory system (R03) R03DX07
US status approved
Patents linked 20
Pipeline programs 21
News articles 0
Drug details — roflumilast
US status
approved
Class
Respiratory system (R03)
Route
TOPICAL
Patents
20
Programs
21
Data quality
0.89

Quick answer

roflumilast (DAXAS) is a phosphodiesterase 4 inhibitor. Associated with Arcutis Biotherapeutics. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN roflumilast
Brand DAXAS
Mechanism Phosphodiesterase 4 inhibitor
Target Phosphodiesterase 4
Therapeutic class Respiratory system (R03)
Route TOPICAL
Formulation FOAM
ATC code R03DX07

Mechanism of action

Phosphodiesterase 4 inhibitor

Primary target: Phosphodiesterase 4

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. CLI-06001AA1-05 Phase 3 · Chiesi Farmaceutici S.p.A · Chronic Obstructive Pulmonary Disease (COPD)
  2. Roflumilast Phase 3 · AstraZeneca · Asthma
  3. Roflumilast Phase 3 · AstraZeneca · COPD
  4. Roflumilast 0.3% cream Phase 3 · Arcutis Biotherapeutics · Chronic Plaque Psoriasis
  5. Roflumilast Cream Phase 3 · Arcutis Biotherapeutics · Atopic Dermatitis Eczema
  6. Roflumilast Cream 0.05% Phase 3 · Arcutis Biotherapeutics · Atopic Dermatitis Eczema
  7. Roflumilast Cream 0.15% Phase 3 · Arcutis Biotherapeutics · Atopic Dermatitis Eczema
  8. Roflumilast Foam Phase 3 · Arcutis Biotherapeutics · Seborrheic Dermatitis

Related & competitor drugs

  1. apremilast Antineoplastic and immunomodulating agents (L04)
  2. desloratadine Respiratory system (R01)
  3. deutivacaftor / tezacaftor / vanzacaftor Respiratory system (R07)
  4. ivacaftor Respiratory system (R07)
  5. lumacaftor Respiratory system (R07)
  6. mannitol Respiratory system (R05)
  1. US 12390453

    Method for reducing side effects from administration of phosphodiesterase-4 inhibitors

    Expires Mon Aug 14 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12336983

    Inhibition of crystal growth of roflumilast

    Expires Mon Jun 19 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12329751

    Topical roflumilast formulation having antifungal properties

    Expires Mon Jun 12 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12310956

    Topical roflumilast formulation having improved delivery and plasma half-life

    Expires Mon May 22 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 12257242

    Inhibition of crystal growth of roflumilast

    Expires Mon Mar 20 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 12220409

    Roflumilast formulations with an improved pharmacokinetic profile

    Expires Mon Feb 06 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 12144802

    Pharmaceutical compositions of roflumilast and solvents capable of dissolving high amounts of the drug

    Expires Mon Nov 14 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 12053481

    Compositions and methods for deep dermal drug delivery

    Expires Mon Aug 01 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 12042487

    Method for reducing side effects from administration of phosphodiesterase-4 inhibitors

    Expires Mon Jul 18 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 12042558

    Method and formulation for improving roflumilast skin penetration lag time

    Expires Mon Jul 18 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 12016848

    Roflumilast formulations with an improved pharmacokinetic profile

    Expires Mon Jun 20 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 12011437

    Roflumilast formulations with an improved pharmacokinetic profile

    Expires Mon Jun 13 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 12005052

    Topical roflumilast formulation having improved delivery and plasma half-life

    Expires Mon Jun 06 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 12005051

    Topical roflumilast formulation having improved delivery and plasma half life

    Expires Mon Jun 06 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 11992480

    Method for reducing side effects from administration of phosphodiesterase-4 inhibitors

    Expires Mon May 23 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 11819496

    Topical roflumilast formulation having improved delivery and plasma half-life

    Expires Mon Nov 16 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 11793796

    Inhibition of crystal growth of roflumilast

    Expires Mon Oct 19 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 11707454

    Topical roflumilast formulation having antifungal properties

    Expires Mon Jul 20 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 11628177

    Compositions and methods for deep dermal drug delivery

    Expires Mon Apr 13 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 11534493

    Pharmaceutical compositions of roflumilast in aqueous blends of water-miscible, pharmaceutically acceptable solvents

    Expires Mon Dec 22 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is roflumilast?

roflumilast (DAXAS) is a phosphodiesterase 4 inhibitor. Associated with Arcutis Biotherapeutics. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for roflumilast?

DAXAS is a marketed brand name for roflumilast. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of roflumilast?

roflumilast has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.