Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company, focuses on developing and commercializing treatments for dermatological diseases with high unmet medical needs.
The company's portfolio consists of highly differentiated topical and systemic treatments with significant potential to treat immune-mediated dermatological diseases and conditions. The company has built a platform for dermatologic product development and commercialization. The company’s strategy is to focus...
Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company, focuses on developing and commercializing treatments for dermatological diseases with high unmet medical needs.
The company's portfolio consists of highly differentiated topical and systemic treatments with significant potential to treat immune-mediated dermatological diseases and conditions. The company has built a platform for dermatologic product development and commercialization. The company’s strategy is to focus on validated biological targets, and to use its drug development platform and deep dermatology expertise to develop and commercialize differentiated products that have the potential to address the major shortcomings of existing therapies in its targeted indications.
The company launched its lead product, ZORYVE (roflumilast) cream 0.3% (ZORYVE cream 0.3%) in August 2022 after obtaining its initial U.S. Food and Drug Administration (FDA) approval for the treatment of plaque psoriasis, including psoriasis in the intertriginous areas (e.g., groin or axillae), in individuals 12 years of age or older. ZORYVE cream 0.3% is a once-daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor. ZORYVE cream 0.3% is approved for once-daily treatment of mild, moderate, and severe plaque psoriasis with no limitations on location or duration of use. In October 2023, the company received FDA approval for an expanded indication in plaque psoriasis down to 6 years of age. The company is working with the FDA to potentially further expand this indication in plaque psoriasis down to 2 years of age following the generation of additional clinical data. In April 2023, the company had its first commercial launch outside of the United States following Health Canada approval of ZORYVE cream 0.3% for the treatment of plaque psoriasis in individuals 12 years of age or older.
In December 2023, the company received FDA approval for ZORYVE (roflumilast) topical foam 0.3% (ZORYVE foam) for the treatment of seborrheic dermatitis in individuals aged 9 years and older, with no limitation on severity, location, or duration of use. ZORYVE foam is a once-daily steroid-free foam, and as a PDE4 inhibitor, is the first drug approved for the treatment of seborrheic dermatitis with a new mechanism of action in over two decades. ZORYVE foam became commercially available in the United States in late January 2024, and was approved by Health Canada in October 2024 and became commercially available in Canada in December 2024.
In addition to the approval of ZORYVE cream 0.3% for plaque psoriasis and ZORYVE foam for seborrheic dermatitis, the company also received FDA approval for and commercially launched ZORYVE (roflumilast) cream 0.15% (ZORYVE cream 0.15%), (collectively, ZORYVE), in July 2024 for the treatment of mild to moderate atopic dermatitis in adults and pediatric patients 6 years of age and older, with no limitation on location, body surface area treated, concomitant use, or duration of use specified in the approved labeling. ZORYVE cream 0.15% is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch and has been specifically developed to be a treatment option for long-term disease control. The company has also completed a Phase 3 trial of ZORYVE cream 0.05% in pediatric patients 2 to 5 years of age with mild to moderate atopic dermatitis (INTEGUMENT-PED). Based on the positive results from the INTEGUMENT-PED study, and given the company’s recent approval of ZORYVE cream 0.15% for the treatment of mild to moderate atopic dermatitis in individuals 6 years of age or older, the company submitted a supplemental new drug application (sNDA) for topical ZORYVE cream 0.05% for children 2 to 5 years of age in December 2024. The company conducted INTEGUMENT-OLE, an open-label extension study of the long-term safety of ZORYVE cream 0.15% in subjects 6 years of age and older and ZORYVE cream 0.05% in subjects between the ages of 2 and 5 years, for which the company reported positive results in September 2023 and August 2024, respectively.
Beyond seborrheic dermatitis, the company is also developing ZORYVE foam for scalp and body psoriasis and has successfully completed its Phase 2b and pivotal Phase 3 clinical trials. The company announced positive topline data in September 2022, with ZORYVE foam showing rapid disease clearance and significant reduction in itch. In the pivotal Phase 3 ARRECTOR study, at Week 8, 66% of individuals treated with ZORYVE foam achieved the co-primary efficacy endpoint of Scalp IGA Success, defined as a Scalp IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement, and 46% of patients achieved the co-primary efficacy endpoint of Body IGA Success, defined as a Body IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement. In addition, individuals treated with ZORYVE foam reported reductions in itch from baseline within 24 hours of first application. Based on the ARRECTOR results and a Phase 2b study, the company submitted an sNDA to the FDA for a label expansion to include scalp and body psoriasis in adults and adolescents ages 12 and over, which was recently accepted by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date in May 2025.
In July 2024, the company entered into a co-promotion agreement with Kowa Pharmaceuticals, Inc. (Kowa) to leverage Kowa's primary care sales force to exclusively market and promote ZORYVE in the United States to primary care practitioners and pediatricians for all FDA-approved indications until at least July 2029. Promotion of ZORYVE in primary care and pediatrics under the Kowa agreement began in late September 2024.
In addition to ZORYVE, the company is developing ARQ-255, a deep-penetrating topical formulation of ivarmacitinib, a potent and highly selective topical Janus kinase type 1 (JAK1) inhibitor, designed to preferentially deliver the drug deep into the hair follicle, the site of inflammation in alopecia areata, in order to potentially develop the first topical treatment for this disease. The company completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata and expects data in the first half of 2025.
In September 2022, the company acquired Ducentis BioTherapeutics LTD (Ducentis) and its lead asset, DS-234 (now ARQ-234), a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R). In the preclinical stage, the company plans to develop ARQ-234 in atopic dermatitis.
Strategy
The company’s strategy is to leverage innovations in inflammation and immunology to identify molecules against validated biological targets in dermatology, and to develop and commercialize best-in-class products based on those molecules that address significant unmet needs in immuno-dermatology. Key elements of the company’s strategy include: commercializing ZORYVE cream 0.3% for the treatment of patients with plaque psoriasis and ZORYVE cream 0.15% for the treatment of patients with atopic dermatitis; commercializing ZORYVE foam for the treatment of patients with seborrheic dermatitis and further expanding the company’s addressable market with the potential approval of the foam in scalp and body psoriasis; exploiting the company’s integrated development and commercial organization to maximize the value of the company’s products and product candidates; executing the company’s responsible pricing strategy and product access to enable rapid and high-quality insurance coverage and product access; further expanding the company’s product portfolio through the development of ARQ-255 and ARQ-252; developing ARQ-234 as a complementary treatment to ZORYVE; leveraging the company’s product development platform to continue innovating and developing novel new treatments for dermatological diseases; and evaluating strategic opportunities to in-license or acquire best-in-class dermatology assets consistent with the company’s core strategy.
ZORYVE Cream (ARQ-151)
The company’s lead product, ZORYVE cream, offers symptomatic improvement in psoriasis and atopic dermatitis patients similar to the combination of a high potency steroid and calcipotriene, a favorable tolerability profile, the ability to be used chronically, and little to none of the application site reactions associated with many existing topical treatments. ZORYVE cream is designed for simple once-a-day application for chronic use, does not burn or sting on application, and can be used on any part of the body, including sensitive or difficult-to-treat areas, such as the face and intertriginous regions. It quickly and easily rubs into the skin without leaving a greasy residue, does not stain clothing or bedding, or have an unpleasant smell. Roflumilast is a highly potent and selective PDE4 inhibitor that was approved by the FDA as an oral systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) in 2011. Roflumilast has demonstrated a potency advantage of approximately 25x to in excess of 300x compared to the active ingredients in the two other FDA-approved PDE4 inhibitors, Eucrisa, and Otezla.
The company commercially launched ZORYVE cream 0.3% in August 2022 after obtaining FDA approval for the treatment of plaque psoriasis, including psoriasis in the intertriginous areas (e.g., groin or axillae), in individuals 12 years of age or older. ZORYVE cream 0.3% is approved for once-daily treatment of mild, moderate, and severe plaque psoriasis with no limitations on location or duration of use. In October 2023, the company announced FDA approval of its sNDA to expand the indication of ZORYVE cream for the treatment of plaque psoriasis, including psoriasis in intertriginous areas (e.g., groin or axillae), to children ages 6 to 11 years of age. Following this approval, ZORYVE cream is indicated for use in patients 6 years of age and older.
The company also commercially launched topical ZORYVE cream 0.15% in July 2024 after obtaining approval for the treatment of mild to moderate atopic dermatitis in individuals 6 years and older. The company has developed a lower-dose concentration, ZORYVE cream 0.05%, and has completed its Phase 2 and Phase 3 studies in this population. Based on positive data, the company submitted an sNDA in December 2024.
In July 2018, the company executed a licensing agreement with AstraZeneca AB (AstraZeneca) for exclusive worldwide rights to roflumilast as a topical product in humans solely for dermatological indications. The company has built its own intellectual property portfolio around topical uses of roflumilast, with issued and pending formulation, pharmacokinetic, and method-of-use patents in the United States and other jurisdictions from several distinct patent families, which should provide the company with exclusivity for its product at least into 2037.
ZORYVE Cream Clinical Development
Plaque Psoriasis
The company commercially launched ZORYVE cream in August 2022 after obtaining FDA approval for the treatment of plaque psoriasis, including psoriasis in the intertriginous areas (e.g., groin or axillae), in individuals 12 years of age or older. In October 2023, the company received FDA approval for an expanded indication down to 6 years of age. ZORYVE cream is approved for once-daily treatment of mild, moderate, and severe plaque psoriasis with no limitations on duration of use. The company’s NDA submission was supported by the positive data from the pivotal Phase 3 clinical studies, DERMIS-1 and DERMIS-2, and its long-term Phase 2b open-label study. In all trials, ZORYVE cream was generally well-tolerated with a favorable safety and tolerability profile.
Atopic Dermatitis
The company commercially launched ZORYVE cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children down to age six in August 2024. The company’s NDA submission was based on three Phase 3 studies, as well as a Phase 2 dose-ranging study, and two Phase 1 pharmacokinetic studies. The company has also developed ZORYVE cream 0.05% for the treatment of atopic dermatitis between the ages of 2 and 5 years of age. Based on positive data from its two Phase 3 studies in this age group, the company submitted an sNDA in December 2024.
Key Completed Trials
INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase 3 studies
The company’s atopic dermatitis Phase 3 program includes three 4-week pivotal studies and a 52-week open-label extension study. The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis (INTEGUMENT) 1 and 2 were multi-center, double-blind, vehicle-controlled Phase 3 studies, with more than 650 subjects in each study, ages 6 and above with mild to moderate atopic dermatitis. Subjects were randomized to receive once daily topical applications for 4 weeks of ZORYVE cream 0.15%, or vehicle. The primary endpoint was the proportion of all randomized subjects who attained IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from Baseline at Week 4.
INTEGUMENT-PED Trial
In September 2023, the company announced positive topline data from the INTEGUMENT-PED trial. This pivotal trial investigated ZORYVE cream 0.05% as a potential treatment for children 2 to 5 years of age with mild to moderate atopic dermatitis. The trial was a Phase 3, randomized, parallel group, double-blind, vehicle-controlled trial in which subjects ages 2 to 5 with mild to moderate atopic dermatitis involving 3% or greater body surface area received 4 weeks of ZORYVE cream 0.05% once daily or vehicle once daily. A total of 652 children were enrolled in INTEGUMENT-PED.
INTEGUMENT OLE (long-range study)
In addition, the company’s ‘INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis Open Label Extension’ (INTEGUMENT-OLE) study is a Phase 3, multicenter, open-label extension study that has enrolled 1,220 subjects who have completed INTEGUMENT-1, -2, or -PED. The study examines the long-term safety of ZORYVE cream 0.15% in subjects 6 years of age and older with atopic dermatitis and ZORYVE cream 0.05% in subjects 2 to 5 years of age with atopic dermatitis.
In September 2023, the company announced positive interim results from this ongoing study regarding subjects 6 years of age and older with atopic dermatitis. A total of 657 subjects had been enrolled in INTEGUMENT-OLE at such time. After 4 weeks of treatment, subjects who achieved a vIGA-AD score of ‘clear’ transitioned to twice-weekly maintenance dosing, after which any subjects who reached a vIGA-AD score of ‘mild’ would resume once-daily dosing. Subjects could also resume once-daily dosing if signs or symptoms were not adequately controlled with maintenance dosing despite maintaining a vIGA-AD score of ‘almost clear.’ More than two-thirds of participants who transitioned to maintenance dosing remained on the twice-weekly maintenance dosing schedule for more than half of their time in the trial.
In August 2024, the company announced positive results for subjects 2 to 5 years old. In the study, ZORYVE cream 0.05% was well-tolerated, with no new safety signals observed during treatment of up to 56 weeks in duration. Efficacy results were not only maintained but also improved over time, with 71.9% of participants who rolled over from the roflumilast cream 0.05% treatment arm in INTEGUMENT-PED achieving EASI 75 after 56 weeks.
ZORYVE Foam (ARQ-154)
The company is also developing a foam formulation of topical ZORYVE for the treatment of scalp and body psoriasis and seborrheic dermatitis. ZORYVE foam contains the same highly potent and selective PDE4 inhibitor in ZORYVE cream, and is nearly identical to ZORYVE cream, with all ingredients in the foam being the same as those in the cream, other than reduced oil content and the addition of a propellant in the can to create the foam. ZORYVE foam is a light foam that has been designed to deliver the drug to the scalp while not leaving a greasy residue or disturbing hairstyle. Additionally, the product does not melt on the fingers prior to application. ZORYVE foam is designed for simple once-a-day application and neither burns nor stings on application.
In December 2023, the company received FDA approval for ZORYVE foam for the treatment of seborrheic dermatitis in individuals aged 9 years and older, with no limitation on severity, location, or duration of use. ZORYVE foam has been shown to provide rapid disease clearance and significant reduction in itch in clinical studies. In a pivotal Phase 3 study, 80% of individuals treated with ZORYVE foam achieved the primary efficacy endpoint of IGA Success, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement at Week 8, and just over 50% of individuals achieved an IGA score of clear at Week 8. In addition, individuals treated with ZORYVE foam reported reductions in itch from baseline within 48 hours of first application. ZORYVE foam is a once-daily steroid-free foam and the first drug approved for the treatment of seborrheic dermatitis with a new mechanism of action in over two decades. ZORYVE foam became commercially available in late January 2024.
The company has successfully completed its pivotal Phase 3 study of ZORYVE foam in scalp and body psoriasis (ARRECTOR), demonstrating promising efficacy and tolerability results. The company announced positive topline data in September 2022, and has submitted its sNDA with a PDUFA in May 2025.
ARQ-234
In September 2022, the company acquired Ducentis and its lead asset, DS-234 (now ARQ-234), a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R). CD200R is an immune-regulatory receptor that is thought to be an important immunological checkpoint with a pivotal role in the maintenance of immune tolerance. Checkpoint agonism is an emerging immunomodulatory approach that works to amplify pathways that inhibit over-active immune cells and suppress unwanted immune responses. ARQ-234 binds to CD200R and has the potential to restore immune homeostasis by inducing inhibitory signaling on immune cells that regulate inflammation.
CD200R has been validated as a target in atopic dermatitis, with preclinical data for ARQ-234 and clinical data for a similar molecule under development by another company each providing evidence of a robust and durable therapeutic response, even after discontinuation of treatment. Ducentis completed preclinical comparisons of ARQ-234 against the clinically-validated CD200R antibody. The data compare favorably across key metrics, including potency, efficacy, and pharmacokinetics, and indicate potential differentiation from the clinically-validated CD200R antibody with an improved ability to modulate the CD200R pathway, a longer half-life, and a higher steady-state volume of distribution. The company plans to develop ARQ-234 in atopic dermatitis, where it could be a potentially highly complementary treatment option to ZORYVE cream in that indication.
ARQ-255
The company is developing ARQ-255, an innovative topical formulation of ivarmacitinib, a potent and highly selective small molecule inhibitor of JAK1, for the treatment of alopecia areata. Alopecia areata is an autoimmune disorder that causes the immune system to incorrectly attack the body’s own cells, specifically the hair follicles, leading to loss of hair—usually in patches—on the scalp, face, or sometimes other areas of the body. While oral JAK inhibitors have shown symptomatic improvement in the treatment of alopecia areata and baricitinib is FDA approved for this indication, multiple topically applied JAK inhibitors have failed to demonstrate symptomatic improvement in alopecia areata. The company has developed a unique drug delivery technology that it refers to as Deep Dermal Drug Delivery (‘4D’ technology). Additionally, in a nonclinical study, ivarmactinib proved to be highly selective to JAK1 over JAK2.
ARQ-255 Clinical Development
Alopecia Areata
ARQ-255-126 Study (Phase 1b Study)
The company completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata and expects data in the first half of 2025. The Phase 1b study is a vehicle-controlled, double-blind, multi-center study designed to evaluate the safety, tolerability, and pharmacokinetics of treatment with ARQ-255 topical suspension 3% or vehicle in healthy adult subjects and individuals with patchy alopecia areata.
ARQ-252
ARQ-252 is an alternative topical cream formulation of ivarmacitinib that the company is developing for chronic hand eczema and vitiligo.
In May 2021, the company announced that the Phase 1/2b study of ARQ-252 in chronic hand eczema did not meet its primary endpoint, with further analyses of the study pointing to inadequate local drug delivery to the skin. Importantly, there were no safety or tolerability issues seen in that study. Given these analyses, the company also elected to terminate the Phase 2a clinical trial evaluating ARQ-252 as a potential treatment in vitiligo, as it began reformulation efforts to develop an enhanced formulation of ARQ-252 that delivers more active drug to targets in the skin. The ARQ-255 formulation, a topical suspension using its 4D technology, is separate and distinct from the ARQ-252 cream formulation, and thus there are no implications to ARQ-255 from ARQ-252.
Competition
For psoriasis, the company’s primary competitors include injected biologic therapies, such as Humira, marketed by AbbVie Inc. and Eisai Co., Ltd., and Enbrel, marketed by Amgen Inc.; Pfizer Inc., and Takeda Pharmaceutical Company Limited; non-injectable systemic therapies used to treat plaque psoriasis, such as Otezla, marketed by Amgen Inc., and Sotyktu, marketed by Bristol Myers Squibb; topical therapies, such as tapinarof, marketed by Organon; branded and generic versions of clobetasol, such as Clobex, marketed by Galderma Laboratories, LP.
For atopic dermatitis, the company’s primary competitors include topical therapies such as Eucrisa, marketed by Pfizer Inc.; Opzelura, marketed by Incyte Corporation, which was approved in September 2021, and generic and branded versions of low to mid-potency steroids such as hydrocortisone or triamcinolone. In the moderate-to-severe setting, the injected biologic therapy Dupixent, marketed by Regeneron Pharmaceuticals, Inc., is approved, as well as the recently approved injectable biologic therapy Adbry, marketed by LEO Pharma.
For alopecia areata, the company’s primary competitors include topical therapies such as branded and generic versions of high potency steroids, including Clobex, marketed by Galderma Laboratories, LP; intralesional corticosteroid injections such as branded and generic versions of triamcinolone, including Kenalog, marketed by Bristol-Myers Squibb; and systemic immunosuppressants, including generic versions of systemic steroids such as prednisone, branded and generic versions of cyclosporine, including Sandimmune, marketed by Sandoz, and branded systemic JAK inhibitors, especially Olumiant (baricitinib), marketed by Eli Lilly and Company, an oral JAK inhibitor and the first FDA-approved treatment for alopecia areata.
For hand eczema, the company’s primary competitors include topical therapies such as branded and generic versions of clobetasol, such as Clobex, and generic versions of betamethasone dipropionate.
For vitiligo, the company’s primary competitors include topical therapies such as generic and branded versions of calcineurin inhibitors, including Elidel, marketed by Bausch Health; branded and generic versions of high potency steroids, including Clobex, marketed by Galderma Laboratories, LP; the topical JAK inhibitor Opzelura, marketed by Incyte Corporation; and other treatments including various lasers and ultraviolet light-based therapies.
Commercial Operations
The company intends to commercialize ZORYVE and its other product candidates itself in the United States and Canada within the dermatology specialty. In the United States, the company has completed the build-out of its commercial organization, including marketing, market access, sales and marketing operations, and professional relations. The company has also built its own focused specialty sales force to target dermatologists in the United States.
Intellectual Property
As of February 25, 2025, the company owns or has an exclusive license to 32 issued U.S. patents and 58 issued foreign patents, which include granted European patent rights that have been validated in various European Patent Organization (EPO) member states, and 31 pending U.S. patent applications, 200 pending foreign patent applications, including 4 applications filed under the Patent Cooperation Treaty. Of these patents and patent applications:
Roflumilast cream & roflumilast foam: As of February 25, 2025, the company owns 20 issued U.S. patents, three issued Australian patents, three issued Canadian patents, two issued Chinese patents, two issued Eurasian patents, two issued European patents (validated in various EPO member states), one issued Hong Kong patent, two issued Indian patents, two issued Israeli patents, seven issued Japanese patents, three issued Mexican patents, two issued New Zealand patents, and two issued South Korean patents. The company also owns 19 pending U.S. patent applications, and 76 pending foreign applications (four in Australia, seven in Brazil, five in Canada, ten in China, one in Eurasia, eight in Europe, seven in Hong Kong, two in India, five in Israel, five in Japan, four in Mexico, seven in New Zealand, five in South Korea, three in Singapore, and three under the Patent Cooperation Treaty), relating to a roflumilast cream and/or roflumilast foam. Twelve of the company’s U.S. patents are listed in the FDA’s Orange Book for its roflumilast 0.15% and 0.3% cream products, and thirteen of the company’s U.S. patents are listed in the Orange Book patents for its roflumilast 0.3% foam product. The issued U.S. patent that the company has licensed from AstraZeneca claiming a composition of matter encompassing roflumilast, the active pharmaceutical ingredient in roflumilast cream and roflumilast foam, expired on January 27, 2020. Data exclusivity for oral roflumilast expired on January 23, 2021. The company’s issued patents relating to a roflumilast cream and/or a roflumilast foam contain claims directed to, among other things, pharmaceutical compositions comprising roflumilast and hexylene glycol, pharmaceutical compositions comprising roflumilast and diethylene glycol monoethyl ether, pharmaceutical compositions comprising roflumilast and cetostearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate, methods of making such compositions, and methods of treatment using such compositions, methods of treating fungal infections by administering compositions comprising roflumilast, and methods for improving treatment adherence by improving delivery and extending the plasma half-life of a roflumilast composition. These issued U.S. patents relating to roflumilast cream and roflumilast foam will expire not earlier than June 2037. The company also has a method of treatment patent for roflumilast foam in the treatment of seborrheic dermatitis which expires in 2041. The company’s pending patents relating to roflumilast cream and roflumilast foam contain claims directed to, among other things, pharmaceutical compositions comprising roflumilast and diethylene glycol monoethyl ether, pharmaceutical compositions comprising roflumilast, cetostearyl alcohol, dicetyl phosphate, and/or ceteth-10 phosphate, methods of treatment using such compositions, methods of manufacturing such compositions, and other aspects of its roflumilast formulations, including unique pharmacokinetic aspects of topical roflumilast compositions.
ARQ-252 & ARQ-255: As of February 25, 2025, the company has an exclusive license from Hengrui to six issued U.S. patents, five issued Japanese patents, and five issued EU patents (validated in various EPO member states) relating to ivarmacitinib. These patents and patent applications contain claims directed towards the composition of matter of the ivarmacitinib compound and bisulfate and crystalline forms thereof, pharmaceutical compositions and treatment methods. The issued patents and pending applications, if issued, relating to ivarmacitinib will not begin to expire until December 2032. The company owns four issued U.S. patents, two issued Japanese patents, and has filed four pending U.S. patent applications and 44 pending foreign patent applications (three in each of Australia, Brazil, Canada, China, Europe, India, Israel, Japan, Mexico, Singapore, South Korea, and New Zealand, two in each of Hong Kong, Indonesia, Thailand, and Vietnam) relating to, among other things, ivarmacitinib compositions and methods of treatment using ivarmacitinib compositions.
ARQ-234 and other CD200 mutant proteins: As of February 25, 2025, the company owns one issued U.S. patent, one issued Australian patent, one issued Chinese patent, one issued Eurasian patent, one issued Israeli patent, one issued Indian patent, one issued Japanese patent, one issued Mexican patent, two issued South Korean patents, one issued Singapore patent, one issued South African patent, and three pending U.S. applications, and 37 pending foreign applications (four in each of Canada and Europe, three in each of China, Japan, and New Zealand, two in each of Australia, Brazil, India, Israel, and South Korea, and one in each of Eurasia, Great Britain, Hong Kong, Indonesia, Mexico, Philippines, Singapore, South Africa, Thailand, and the Patent Cooperation Treaty), relating to ARQ-234 and other CD200 mutant proteins.
License, Collaboration and Co-Promotion Agreements
Kowa Co-Promotion Agreement
In July 2024, the company entered into a co-promotion agreement with Kowa Pharmaceuticals, Inc. to leverage Kowa's primary care sales force to exclusively market and promote ZORYVE in the United States to primary care practitioners and pediatricians for all FDA-approved indications until at least July 2029. Under the terms of the agreement, Kowa receives a commission from net sales attributed to Kowa. Promotion of ZORYVE in primary care and pediatrics under the Kowa agreement began in late September 2024.
Sato License Agreement
On February 27, 2024, the company entered into a License Agreement with Sato Pharmaceutical Co., Ltd. (Sato). Pursuant to the terms of the License Agreement, the company grants to Sato an exclusive, sublicensable (under certain circumstances) license under certain patent rights and know-how controlled by the company for Sato to develop, conduct medical affairs activities for, manufacture, commercialize, and otherwise exploit roflumilast formulations (the Licensed Products) for all therapeutic uses for certain dermatological indications in humans (the Field) in Japan (the Territory).
Huadong License and Collaboration Agreement
In August 2023, the company entered into a license and collaboration agreement (Huadong Agreement) with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Huadong), a wholly owned subsidiary of Huadong Medicine Co., Ltd., whereby, pursuant to the terms of the agreement, the company granted to Huadong an exclusive, sublicensable (under certain circumstances) license under certain patent rights and know-how controlled by the company for Huadong to develop, conduct medical affairs activities for, manufacture, commercialize, and otherwise exploit both ZORYVE cream and ZORYVE foam (the Huadong Licensed Products) for all therapeutic uses for certain dermatological indications (the Field) in Greater China (mainland China, Hong Kong, Macau, and Taiwan) and Southeast Asia (Indonesia, Singapore, The Philippines, Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia, and Vietnam) (the Huadong Territories).
AstraZeneca
In July 2018, the company entered into an exclusive license agreement, or the AstraZeneca License Agreement, with AstraZeneca, pursuant to which the company obtained a worldwide exclusive license, with the right to sublicense through multiple tiers, under certain AstraZeneca-controlled patent rights, know-how, and regulatory documentation, to research, develop, manufacture, commercialize, and otherwise exploit products containing roflumilast in topical forms, as well as delivery systems sold with or for the administration of roflumilast, or collectively, the AZ-Licensed Products, for all diagnostic, prophylactic, and therapeutic uses for human dermatological indications, or the Dermatology Field. Under this agreement, the company has sole responsibility for development, regulatory, and commercialization activities for the AZ-Licensed Products in the Dermatology Field, at its expense, and the company shall use commercially reasonable efforts to develop, obtain, and maintain regulatory approvals for, and commercialize the AZ-Licensed Products in the Dermatology Field in each of the United States, Italy, Spain, Germany, the United Kingdom, France, China, and Japan.
Jiangsu Hengrui Medicine Co., Ltd.
In January 2018, the company entered into an exclusive option and license agreement, or the Hengrui License Agreement, with Jiangsu Hengrui Medicine Co., Ltd, or Hengrui, whereby Hengrui granted the company an exclusive option to obtain certain exclusive rights to research, develop, and commercialize products containing the compound designated by Hengrui as ivarmacitinib, a potent and selective JAK1 inhibitor, in topical formulations for the treatment of skin diseases, disorders, and conditions, or the Field, in the United States, Japan, and the EU (including for clarity the United Kingdom), or the Territory.
In December 2019, the company exercised its exclusive option, and also contemporaneously amended the agreement to expand the territory to additionally include Canada, and therefore now has a license from Hengrui under certain patent rights and know-how controlled by Hengrui to research, develop, and commercialize products containing ivarmacitinib in the Field in the Territory. Such license is sublicensable through multiple tiers, exclusive as to the patent rights licensed from Hengrui and nonexclusive with respect to the know-how licensed from Hengrui, and does not extend to patent rights for improvements to ivarmacitinib which Hengrui may come to control in the future unless otherwise mutually agreed by the parties.
In June 2022, the company entered into a side letter agreement with Hengrui and one of its subsidiaries to extend certain rights and obligations under the Hengrui License Agreement to the subsidiary under specified circumstances, including a change of control of such subsidiary.
History
The company was founded in 2016. It was incorporated under the laws of the state of Delaware in 2016. The company was formerly known as Arcutis, Inc. and changed its name to Arcutis Biotherapeutics, Inc. in 2019.
