ARQ-234 / Arcutis - LARVOL DELTA

Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234 (clinicaltrials.gov) - P1 | N=125 | Not yet recruiting | Sponsor: Arcutis Biotherapeutics, Inc.

First-in-human • New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234 (clinicaltrials.gov) - P1 | N=125 | Recruiting | Sponsor: Arcutis Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Arcutis Biotherapeutics…announced that the first participant has been enrolled in a Phase 1a/1b, double-blind, randomized, placebo-controlled study, ARQ-234-131, evaluating the safety and tolerability of ARQ-234 (GlobeNewswire) - "Phase 1a/1b, first-in-human study to evaluate safety and tolerability for investigational ARQ-234 in healthy volunteers and adults with moderate to severe atopic dermatitis...will enroll approximately 125 participants aged 18 to 65 years..."

First-in-human • Trial status • Atopic Dermatitis

Begin enrolling patients in the Phase 1 study of ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 receptor, being developed as a potential biologic treatment for atopic dermatitis, in the first quarter of 2026. (The Manila Times)

New P1 trial • Atopic Dermatitis

Clinical and Regulatory Developments (GlobeNewswire) - "The Company has begun enrolling patients in Phase 2 proof-of-concept studies with ZORYVE foam 0.3% for the treatment of patients with vitiligo, as well as patients with hidradenitis suppurativa, the first trials in the Company's effort to investigate further indication expansion opportunities for ZORYVE; The Company is preparing to initiate a Phase 1 study of ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 receptor being developed as a potential biologic treatment in atopic dermatitis."

Enrollment status • New P1 trial • Atopic Dermatitis • Hidradenitis Suppurativa • Vitiligo

Arcutis Biotherapeutics to Host Virtual Investor Day and Report Third Quarter 2025 Financial Results on October 28, 2025 (Arcutis Press Release) - "In addition to discussing third quarter 2025 financial results, the Investor Day will feature: An in-depth look into the Company’s strategy for long-term, sustained growth for ZORYVE (roflumilast); A detailed review of clinical development activities and advancements for new ZORYVE indications and ARQ-234; An overview of the Company’s capital allocation strategy and financial outlook."

Clinical • Atopic Dermatitis • Immunology

Arcutis Announces Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "ARQ-234 - a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis. The Company submitted its IND for ARQ-234 in July 2025."

IND • Atopic Dermatitis

Arcutis Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "ZORYVE cream: The Company aims to obtain Medicaid coverage in additional states, as well as some Medicare coverage, during 2025....The Company submitted an sNDA for ZORYVE cream 0.05% to the FDA for the treatment of atopic dermatitis in children ages 2 to 5 with an anticipated target action date in Q4 of 2025, if accepted as submitted....ZORYVE foam...which was accepted by the FDA in September with a PDUFA action date set for May 22, 2025....ARQ-255...the Company announced that it completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata, with data expected in H1 2025....ARQ-234...being developed as a potential biologic treatment in atopic dermatitis....The Company has continued preclinical development efforts and is working towards submitting an Investigational New Drug application in 2025."

Enrollment closed • IND • P1 data • PDUFA • Reimbursement • Alopecia • Atopic Dermatitis • Psoriasis

ARQ-234: a high affinity CD200-Fc fusion protein for the treatment of atopic dermatitis (ISDS 2023) - "Finally, we describe ARQ-234, a high affinity CD200-Fc protein with antibody-like serum half-life in NHP, due to the introduction of mutations in the Fc domain which increase relative binding to the neonatal Fc receptor at low (endosomal) pH. ARQ-234 is currently in pre-clinical development as a therapeutic for atopic dermatitis."

Atopic Dermatitis • Contact Dermatitis • Dermatitis • Dermatology • Gastrointestinal Disorder • Immunology • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • CD200 • CD200R1 • CD4 • IL6