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DRUG:

roflumilast

i
Other names: APTA-2217, B9302-107, BY-217, BYK 20869, IN-ALR 01
Company:
Generic mfg.
Drug class:
PDE4 inhibitor
Related drugs:
10d
New P2 trial
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roflumilast
13d
Allo-X: Exercise as an Immune Adjuvant for Allogeneic Cell Therapies (clinicaltrials.gov)
P1, N=200, Recruiting, University of Arizona | N=100 --> 200 | Trial completion date: Dec 2028 --> May 2031 | Trial primary completion date: Dec 2028 --> May 2031
Enrollment change • Trial completion date • Trial primary completion date
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roflumilast
15d
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (clinicaltrials.gov)
P4, N=10, Not yet recruiting, University of California, San Francisco | Initiation date: Jan 2026 --> Aug 2026
Trial initiation date
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5-fluorouracil • Jakafi (ruxolitinib) • hydroxychloroquine • cyclosporine • roflumilast • tofacitinib • Cosentyx (secukinumab) • Dupixent (dupilumab) • Ilumya (tildrakizumab-asmn) • chloroquine phosphate
15d
Roflumilast prevented tissue damage caused by lipopolysaccharide-induced sepsis via anti-inflammatory action. (PubMed, PLoS One)
While 1.5 mg/kg Roflumilast showed no protective effects, 3 mg/kg markedly reduced inflammatory and injury markers, improved tissue architecture, and decreased KIM-1 expression. These findings suggest that a higher dose of Roflumilast effectively mitigates LPS-induced systemic inflammation and organ injury, supporting its potential as a therapeutic option for sepsis.
Journal
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IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • KIM1 (Kidney injury molecule 1) • IL1B (Interleukin 1, beta)
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roflumilast
21d
Unveiling Remyelinating Properties of Roflumilast in CPZ-Induced Neuronal Demyelination in Mice. (PubMed, Drug Dev Res)
Remyelination was confirmed through Luxol fast blue staining, accompanied by reduced apoptotic marker, caspase-3, in oligodendrocytes. Collectively, these findings suggest that ROFL exerts neuroprotective effects and highlight the therapeutic potential of PDE-4 inhibition as a strategy for MS treatment.
Preclinical • Journal
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TNFA (Tumor Necrosis Factor-Alpha) • CD163 (CD163 Molecule) • CASP3 (Caspase 3)
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roflumilast
1m
New P2 trial
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roflumilast
2ms
Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients (clinicaltrials.gov)
P3, N=60, Recruiting, Tanta University | Trial completion date: Aug 2026 --> Aug 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
Trial completion date • Trial primary completion date
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fluoxetine • roflumilast
3ms
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE) (clinicaltrials.gov)
P4, N=1032, Completed, Johns Hopkins University | Active, not recruiting --> Completed
Trial completion
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roflumilast
5ms
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (clinicaltrials.gov)
P4, N=10, Not yet recruiting, University of California, San Francisco
New P4 trial
|
5-fluorouracil • Jakafi (ruxolitinib) • hydroxychloroquine • cyclosporine • roflumilast • tofacitinib • Cosentyx (secukinumab) • Dupixent (dupilumab) • Ilumya (tildrakizumab-asmn) • chloroquine phosphate
5ms
Ulcerative pyoderma gangrenosum in a 78-year-old woman treated with brodalumab: A case report. (PubMed, SAGE Open Med Case Rep)
The patient was refractory to corticosteroids, dapsone, and roflumilast, and developed recurrent Gram-negative infections. Brodalumab may offer a safe and effective treatment option in refractory pyoderma gangrenosum, particularly in patients with contraindications to conventional therapies. This case supports further evaluation of IL-17 pathway inhibition in neutrophilic dermatoses.
Journal
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IL17A (Interleukin 17A) • IL17RA (Interleukin 17 Receptor A)
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roflumilast
5ms
Trial termination
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roflumilast