THERAPY DOSSIER · th-82472a0f2935

Roflumilast

Drug · Selective phosphodiesterase 4 (PDE4) inhibitor

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Evidence & regulatory context

Mechanism: Selective phosphodiesterase 4 (PDE4) inhibitor
Target: CHEMBL2093863
Injury models: Other
Reported indication: Not recorded
First approval: 2010
Development stage: Not recorded
ChEMBL record: CHEMBL193240 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Roflumilast; Daliresp; Daxas; Zoryve
Note: Not recorded

Clinical trials 8

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT03073798 ↗PHASE4completed

Effectiveness of Roflumilast in Improving Mucociliary Clearance in COPD and Chronic Bronchitis

COPD · Chronic Bronchitis · Emphysema

Enrolment: 12 · Results not recorded

NCT00246935 ↗PHASE3completed

A Long-term Study of APTA-2217 (Roflumilast) in Patients With COPD

Chronic Obstructive Pulmonary Disease (COPD)

Enrolment: 150 · Results not recorded

NCT01313494 ↗PHASE3completed

Effect of Roflumilast 500 ug Once Daily vs Placebo on Pulmonary Function in COPD (ACROSS)

COPD

Enrolment: 626 · Results not recorded

NCT04211389 ↗PHASE3completed

Safety and Efficacy of ARQ-151 (Roflumilast) Cream 0.3% in Chronic Plaque Psoriasis

Chronic Plaque Psoriasis

Enrolment: 442 · Results not recorded

NCT04211363 ↗PHASE3completed

Safety and Efficacy of ARQ-151 (Roflumilast) Cream 0.3% in Chronic Plaque Psoriasis

Chronic Plaque Psoriasis

Enrolment: 439 · Results not recorded

NCT07105254 ↗PHASE2recruiting

Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo

Non-segmental Vitiligo

Enrolment: 20 · Results not recorded

NCT06998056 ↗PHASE2completed

Safety Study of Roflumilast Cream 0.05% in Infants With Atopic Dermatitis

Atopic Dermatitis

Enrolment: 101 · Results not recorded

NCT01433666 ↗PHASE2completed

Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study

Dementia

Enrolment: 22 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 32574434 ↗2020Reported benefit

Roflumilast, a phosphodiesterase-4 inhibitor, improves hyperoxia-induced lung injury via anti-inflammation.

RatOtherSprague-DawleyMaleOral2.5 mg/kg or 5 mg/kgOnce before hyperoxia exposure

Model: Hyperoxia-induced acute lung injury, pressurised to 250 kPa with pure oxygen

Roflumilast at both doses significantly reduced lung oedema, improved lung pathology and reduced inflammatory cytokine expression in the lung, with effects appearing dose related.

Extraction: extract · Supplied extraction confidence: 0.75. Machine-extracted fields require source verification.

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