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Drug

Roflumilast

Approved · FDA / EMA
Emerging researchLate-stage development

Also known as Daliresp, Zoryve, Roflumilastum.

RxNorm1091836ChEMBLCHEMBL193240UNII0P6C6ZOP5U
2
Research papers
12
Active clinical trials
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Indication expansion: ROFLUMILAST (NDA215985)

Regulatory2026-06-29FDA

Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)

Clinical trial2026-06-22Results expected Q4 2026 · ClinicalTrials.gov

Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis

Clinical trial2026-06-08Results expected Q4 2026 · ClinicalTrials.gov

Exercise-induced Adrenergic Receptor Signaling as an Immune Adjuvant for Allogeneic Cell Therapies

Clinical trial2026-06-05Results expected Q2 2031 · ClinicalTrials.gov

Utilization of a Cutaneous Therapy In Situ Microdevice

Clinical trial2026-06-03Results expected Q2 2030 · ClinicalTrials.gov

Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Atopic Dermatitis: a Pilot Study

Clinical trial2026-05-20Primary completion · ClinicalTrials.gov

Indication expansion: ROFLUMILAST (NDA215985)

Regulatory2025-10-04FDA

Indication expansion: ROFLUMILAST (NDA215985)

Regulatory2024-07-09FDA

Indication expansion: ROFLUMILAST (NDA215985)

Regulatory2023-10-05FDA

Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.

Research2009-08-01Lancet (London, England)

Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials.

Research2009-08-01Lancet (London, England)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Roflumilast
Aliases & brands
DalirespZoryveRoflumilastum
RxNorm CUI
1091836
ChEMBL ID
CHEMBL193240
UNII
0P6C6ZOP5U
Regulatory jurisdictions
emamhrafda

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2010-07-05
Latest approval
2026-06-29
Authorities
FDA · EMA · MHRA
Total events
7
fdaU.S. Food and Drug Administration· 5 events
2026-06-29Indication expansion
Indication expansion: ROFLUMILAST (NDA215985)
Evidence ↗
2025-10-04Indication expansion
Indication expansion: ROFLUMILAST (NDA215985)
Evidence ↗
2024-07-09Indication expansion
Indication expansion: ROFLUMILAST (NDA215985)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2010-07-05Approval
Approval: Daxas (EMA)
Indication: Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic… Show full indication

Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Roflumilast (Daxas▼): risk of suicidal behaviour
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

90 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
90
registered trials across all phases
LATEST COMPLETION 2026
12
Active studies
10
Recruiting
45
Late-stage (III+)
60
Completed
18
Discontinued
PHASE DISTRIBUTIONn = 90
Early Phase 13Phase 110Phase 1 / 24Phase 228Phase 2 / 33Phase 328Phase 413Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utilization of a Cutaneous Therapy In Situ Microdevice

Not yet recruitingPH IVUniversity of California, San Franciscon=102030

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) - a Randomized Controlled Trial

Unknown statusPH IVJacob Pontoppidan Thyssenn=402026

Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata: A Randomized Controlled Trial.

CompletedPH IVCairo Universityn=502025

Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.

CompletedPH IVTanta Universityn=522024

Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin

Unknown statusPH IVRao Dermatologyn=32024

Recent completions

Trials that read out recently, adding to the completed evidence base.

Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial

CompletedPH IIIKey trialJohns Hopkins Universityn=1,0322026

Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata: A Randomized Controlled Trial.

CompletedPH IVCairo Universityn=502025

Anti-inflammatory Effects of Roflumilast Treatment for 12 Weeks in Stable-state Non-cystic Fibrosis Bronchiectasis

CompletedPH IIThe University of Hong Kongn=422024

Efficacy and Safety of Roflumilast in Patients with Non-Alcoholic Steatohepatitis

CompletedPH IITanta Universityn=552024

Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.

CompletedPH IVTanta Universityn=522024

Phase Ib Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy for High-risk Diffuse Large B-cell Lymphoma

CompletedPH IThe University of Texas Health Science Center at San Antonion=142024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes1
Phosphodiesterase 4 Inhibitors1
Journals, researchers & institutions
Top journals
  • Lancet (London, England)2
Leading researchers
  • Calverley PM2
  • Fabbri LM2
  • Martinez FJ2
  • Rabe KF2
  • Brose M1
  • Bundschuh DS1
  • Goehring UM1
  • Izquierdo-Alonso JL1
Leading institutions
free-text, unnormalised
  • School of Clinical Sciences1
  • University of Modena and Reggio Emilia1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.