Arcutis Biotherapeutics, Inc. engages in the development and commercialization of treatments for dermatological diseases. Its pipeline consists of topical treatments for plaque psoriasis, atopic dermatitis, hand eczema, vitiligo, scalp psoriasis, alopecia areata, and seborrheic dermatitis. The company was founded by Bhaskar Chaudhuri and David W. Osborne in June 2016 and is headquartered in Westlake Village, CA.
Clinical Trials
30
5 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
2016
Active, not recruiting
5
16.7%
Completed
23
76.7%
Recruiting
1
3.3%
Terminated
1
3.3%
- Arcutis Biotherapeutics forecasts ZORYVE net product sales of $455-470 million for 2026, representing continued strong growth of the PDE4 inhibitor franchise across multiple inflammatory skin conditions. - The company plans to expand its dermatology sales force by approximately 20% in 2026 to accelerate conversion from topical corticosteroids and deepen ZORYVE adoption among prescribers. - Phase 2 proof-of-concept trials are underway for ZORYVE in vitiligo and hidradenitis suppurativa, with program advancement decisions expected in Q4 2026 and Q1 2027 respectively. - ARQ-234, a selective CD200 receptor agonist biologic for atopic dermatitis, will begin Phase 1 enrollment in Q1 2026 as part of Arcutis' pipeline expansion strategy.
- The FDA is scheduled to make approval decisions on five significant therapies in Q4 2025, including treatments for rare pediatric conditions and infectious diseases. - Navepegritide represents a potential breakthrough for achondroplasia treatment, designed as a once-weekly prodrug that provides continuous CNP exposure to inhibit the overactive FGFR3 pathway. - Two novel oral antibiotics, gepotidacin and zoliflodacin, are under review for gonorrhea treatment in patients 12 years and older, addressing the growing need for new therapeutic options. - Roflumilast cream 0.05% could expand atopic dermatitis treatment options for young children aged 2-5 years, based on phase 3 data from 652 pediatric patients.
- DelveInsight's 2025 Psoriasis Pipeline Report reveals over 80 companies developing 80+ pipeline therapies, highlighting significant R&D investment in this therapeutic area. - Promising treatments in development include topical roflumilast (Arcutis Biotherapeutics) in Phase III trials and GSK2982772 (GlaxoSmithKline), a novel RIPK1 inhibitor in Phase I development. - Alumis Inc. has initiated a long-term extension study for ESK-001 in moderate to severe plaque psoriasis patients, evaluating safety, efficacy, and durability of response over 24 weeks.
• The FDA is reviewing Dupixent for chronic spontaneous urticaria, with a PDUFA date of April 18, 2025, potentially offering a novel targeted therapy after a decade of limited options. • Abeona Therapeutics' pz-cel for recessive dystrophic epidermolysis bullosa has a resubmitted BLA with a PDUFA date of April 29, 2025, following a Complete Response Letter earlier in 2024. • Arcutis Biotherapeutics' roflumilast foam for scalp and body psoriasis has a PDUFA date of May 22, 2025, offering a steroid-free alternative for hard-to-treat areas.
• Dupilumab (Dupixent) gains FDA approval as the first treatment specifically for children aged 1-11 with eosinophilic esophagitis, addressing a critical unmet need for this age group. • Epinephrine nasal spray (Neffy) is approved as the first nasal spray for anaphylaxis treatment in adults and children over 66 lbs, offering a needle-free alternative for emergency use. • Roflumilast cream 0.15% (Zoryve) receives FDA approval for mild to moderate atopic dermatitis in patients aged 6 and older, providing a new nonsteroidal option.
- Arcutis Biotherapeutics has submitted an sNDA to the FDA for roflumilast cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years. - The sNDA is supported by data from the INTEGUMENT-PED trial, which showed roflumilast cream significantly improved disease clearance and reduced itch. - Roflumilast 0.05% cream was well-tolerated in studies, with adverse events consistent with previous trials, offering a potential steroid-free option. - If approved, roflumilast cream 0.05% could provide a new, effective topical treatment for young children with atopic dermatitis, addressing a significant unmet need.
• Roflumilast cream 0.15% demonstrated significantly higher efficacy than the vehicle in achieving a validated IGA-AD score of 0/1 in patients with atopic dermatitis. • The study found that over 95% of patients treated with roflumilast cream reported no signs of application site irritation, highlighting its tolerability. • Roflumilast significantly improved EASI 75 scores compared to the vehicle, indicating a substantial reduction in eczema severity among treated patients. • This once-daily, nonsteroidal cream addresses key unmet needs in atopic dermatitis treatment, potentially improving patient adherence and outcomes.
• Arcutis Biotherapeutics' ZORYVE franchise achieved $44.8 million in net product revenues in Q3 2024, marking a 452% increase compared to Q3 2023, driven by strong demand for both cream and foam formulations. • The FDA accepted the sNDA for ZORYVE foam for scalp and body psoriasis, with a PDUFA action date of May 22, 2025, potentially expanding the drug's approved indications. • Health Canada approved ZORYVE foam for seborrheic dermatitis, with commercial launch planned by the end of 2024, extending the drug's availability to international markets. • Arcutis is advancing its pipeline with the completion of enrollment in the ARQ-255 alopecia areata phase 1 trial and progress towards an IND for ARQ-234 in atopic dermatitis.
• Roflumilast foam 0.3% significantly improved Dermatology Life Quality Index (DLQI) scores in seborrheic dermatitis patients as early as Week 2, compared to the vehicle. • The STRATUM phase 3 trial data showed that roflumilast foam maintained these improvements through 8 weeks of treatment, indicating a sustained benefit. • Patients using roflumilast foam were significantly more likely to achieve a clinically meaningful improvement in DLQI scores compared to those using the vehicle. • Roflumilast foam 0.3% significantly increased the odds of patients achieving a DLQI score of 0 or 1, indicating minimal impact on quality of life.
• Health Canada has approved Arcutis Biotherapeutics' ZORYVE (roflumilast) topical foam 0.3% for treating seborrheic dermatitis in patients aged nine years and older. • The approval was based on the Phase III STRATUM study, where 80% of patients achieved treatment success by week eight using ZORYVE foam. • ZORYVE foam offers a novel mechanism of action and provides significant itch relief within 48 hours, marking a new advancement in seborrheic dermatitis treatment. • This marks the second international approval for ZORYVE, offering a steroid-free option for over two million Canadians affected by this chronic skin condition.
