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Topical roflumilast
Topical roflumilast is a phosphodiesterase 4 inhibitor Small molecule drug developed by Arcutis Biotherapeutics, Inc.. It is currently in Phase 3 development for Moderate to severe plaque psoriasis. Also known as: ARQ-151 Cream 0.3%.
Topical roflumilast is a phosphodiesterase 4 inhibitor that reduces inflammation in the skin.
Roflumilast is a small molecule phosphodiesterase 4 inhibitor used in topical form to treat various skin conditions, including atopic dermatitis, flexural psoriasis, and seborrheic dermatatitis. It is available as a 0.05% cream and has been studied in clinical trials for its safety and efficacy in comparison to vehicle cream and methotrexate.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Topical roflumilast |
|---|---|
| Also known as | ARQ-151 Cream 0.3% |
| Sponsor | Arcutis Biotherapeutics, Inc. |
| Drug class | phosphodiesterase 4 inhibitor |
| Target | phosphodiesterase 4 |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting phosphodiesterase 4, roflumilast decreases the production of pro-inflammatory cytokines, leading to reduced inflammation in the skin. This mechanism is particularly useful for treating inflammatory skin conditions such as psoriasis.
Approved indications
- Moderate to severe plaque psoriasis
Common side effects
- Application site reactions
- Headache
- Nausea
Key clinical trials
- The Safety and Efficacy of Roflumilast Foam in HS (PHASE2)
- A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa (PHASE2)
- Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED) (PHASE3)
- An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV) (PHASE2)
- Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR) (PHASE3)
- 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)
- Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II) (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:
- Topical roflumilast CI brief — competitive landscape report
- Topical roflumilast updates RSS · CI watch RSS
- Arcutis Biotherapeutics, Inc. portfolio CI
Frequently asked questions about Topical roflumilast
What is Topical roflumilast?
How does Topical roflumilast work?
What is Topical roflumilast used for?
Who makes Topical roflumilast?
Is Topical roflumilast also known as anything else?
What drug class is Topical roflumilast in?
What development phase is Topical roflumilast in?
What are the side effects of Topical roflumilast?
What does Topical roflumilast target?
Related
- Drug class: All phosphodiesterase 4 inhibitor drugs
- Target: All drugs targeting phosphodiesterase 4
- Manufacturer: Arcutis Biotherapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Moderate to severe plaque psoriasis
- Also known as: ARQ-151 Cream 0.3%
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing