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Roflumilast Cream 0.3%
Roflumilast Cream 0.3% is a Phosphodiesterase-4 inhibitor Small molecule drug developed by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD). Also known as: Zoryve, ARQ-151.
Roflumilast is a phosphodiesterase-4 inhibitor, which reduces inflammation by inhibiting the production of pro-inflammatory cytokines.
Roflumilast is a phosphodiesterase-4 inhibitor, which reduces inflammation by inhibiting the production of pro-inflammatory cytokines. Used for Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | Roflumilast Cream 0.3% |
|---|---|
| Also known as | Zoryve, ARQ-151 |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
| Drug class | Phosphodiesterase-4 inhibitor |
| Target | Phosphodiesterase-4 |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
By inhibiting phosphodiesterase-4, roflumilast decreases the levels of cyclic adenosine monophosphate (cAMP) in inflammatory cells, leading to a reduction in the production of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-alpha) and interleukin-1 beta (IL-1β). This results in decreased inflammation and improved symptoms in patients with chronic obstructive pulmonary disease (COPD).
Approved indications
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Diarrhea
- Nausea
- Headache
- Dizziness
- Fatigue
Key clinical trials
- Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study (PHASE3)
- Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (PHASE3)
- Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis (PHASE3)
- Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin (PHASE4)
- Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215) (PHASE2)
- Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216) (PHASE2)
- Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (PHASE3)
- Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Roflumilast Cream 0.3% CI brief — competitive landscape report
- Roflumilast Cream 0.3% updates RSS · CI watch RSS
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Roflumilast Cream 0.3%
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Related
- Drug class: All Phosphodiesterase-4 inhibitor drugs
- Target: All drugs targeting Phosphodiesterase-4
- Manufacturer: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
- Also known as: Zoryve, ARQ-151
- Compare: Roflumilast Cream 0.3% vs similar drugs
- Pricing: Roflumilast Cream 0.3% cost, discount & access