JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors), JAK3 inhibitors(Tyrosine-protein kinase JAK3 inhibitors)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases+ [1]

Active Indication

Chronic eczemaChronic hand eczemaDermatitis, Atopic+ [8]

Inactive Indication

Allergic skin reactionAlopecia AreataLupus Erythematosus, Discoid+ [3]

Originator Organization

Japan Tobacco (Hong Kong) Ltd.

Active Organization

Leo Pharma, Inc.

Japan Tobacco, Inc.

LEO Pharma A/S

+ [4]

Inactive Organization-

License Organization

Japan Tobacco, Inc.

Torii Pharmaceutical Co., Ltd.

LEO Pharma A/S

+ [1]

Drug Highest PhaseApproved

First Approval Date

Japan (23 Jan 2020),

Dermatitis, Atopic

Regulation-

Structure/Sequence

Molecular FormulaC16H18N6O

InChIKeyLOWWYYZBZNSPDT-ZBEGNZNMSA-N

CAS Registry1263774-59-9

Clinical Trials associated with Delgocitinib

NCT07671157

/ Not yet recruitingPhase 2IIT

Phase 2 Open Label Trial of Delgocitinib 20 mg/g Cream in Subjects With Frontal Fibrosing Alopecia (FFA)

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational study drug to learn whether the delgocitinib 20 mg/g cream works in treating a specific disease. "Investigational" means that the delgocitinib 20 mg/g cream is being studied.

Start Date10 Sep 2026

Sponsor / Collaborator

Lahey at Arlington

NCT07781449

/ Not yet recruitingPhase 2IIT

An Investigator-Initiated, Descriptive, Proof-of-Concept, Open-Label Pilot Study Focusing on Topical JAK Inhibition as a Novel Treatment of Cutaneous T-Cell Lymphoma

This study tests whether a cream named delgocitinib (Anzupgo), applied twice daily to the skin, is safe and well tolerated in people with early-stage cutaneous T-cell lymphoma (a rare type of skin cancer called mycosis fungoides). The cream works by blocking proteins called JAK enzymes, which are involved in inflammation and cancer cell growth in the skin.
Delgocitinib cream is already approved for treating chronic hand eczema, but it has not yet been studied in people with cutaneous T-cell lymphoma. In this study, up to 15 participants with stable, early-stage disease will apply the cream to their affected skin for 16 weeks. Researchers will closely monitor for side effects and also look at whether the cream improves skin symptoms, such as itching and the appearance of the skin. Participants will be followed for 4 additional weeks after treatment ends.
This is an early, exploratory study (a "proof-of-concept" trial) designed mainly to check safety, not to prove that the treatment works. The findings will help researchers decide whether to test this cream in larger studies in the future.

Start Date01 Sep 2026

Sponsor / Collaborator

Århus Universitetshospital

[+3]

CTIS2025-523472-23-01

/ Not yet recruitingPhase 2IIT

An Investigator-Initiated, Descriptive, Proof-of-Concept, Open-Label Pilot Study Focusing on Topical JAK Inhibition as a Novel Treatment of Cutaneous T-Cell Lymphoma

Start Date01 Jul 2026

Sponsor / Collaborator-

100 Clinical Results associated with Delgocitinib

100 Translational Medicine associated with Delgocitinib

100 Patents (Medical) associated with Delgocitinib

159

Literatures (Medical) associated with Delgocitinib

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Budget impact analysis of delgocitinib for moderate to severe Chronic Hand Eczema in the United States

Article

Author: Bappoo, Yasmin ; Balu, Sanjeev ; Llewellyn, Ben ; Maslin, Douglas ; Singh-Landa, Jianni ; Bin Sawad, Aseel ; Barnes, Megan

BACKGROUND:

Chronic Hand Eczema (CHE) is an inflammatory skin disease defined as eczema affecting the hands and/or wrists lasting >3 months and/or re-occurring ≥2 times per year. Delgocitinib cream 20 mg/g, a topical janus kinase inhibitor (JAKi), is approved in multiple countries for the treatment of moderate to severe CHE in adults who have had an inadequate response to topical corticosteroids (TCS) or for whom TCS are inadvisable. This budget impact analysis aimed to estimate the economic impact of the introduction of delgocitinib cream as a treatment for moderate to severe CHE in the United States (US).

METHODOLOGY:

The model was developed with a 3-year time horizon from the perspective of a hypothetical US commercial healthcare plan involving one million members. Comparator treatments included other topical and oral JAKis and biologics. Proportions of patients using each treatment were accounted for in calculating healthcare costs. The eligible population with moderate to severe CHE refractory to steroids was estimated considering prevalent and incident populations. Different healthcare costs, including drug, monitoring, and adverse event (AE) costs, were accounted for. AEs were included based on clinical trial data. Costs were adjusted to 2024.

RESULTS:

Of one million members overall, the study population included 10,494, 11,095, and 11,696 patients with CHE in Years 1, 2 and 3, respectively. The introduction of delgocitinib cream was associated with overall cost savings of $2,973,478 in Year 1, $21,424,214 in Year 2, and $63,355,366 in Year 3, constituting total accumulated savings of $87,753,057. Savings were derived almost entirely from drug costs (97.2%), with reduced AE (1.54%) and monitoring costs (1.27%) also contributing.

CONCLUSION:

Adoption of delgocitinib cream for moderate to severe CHE in adults for whom TCS were inadequate or inadvisable is predicted to generate significant cost savings to US commercial healthcare plans over 3 years.

01 Sep 2026·ANNALES DE DERMATOLOGIE ET DE VENEREOLOGIE

Topical JAK inhibitors in the lichen planus spectrum: a systematic review

Article

Author: Shanshal, M ; Uthayakumar, A

BACKGROUND:

The lichen planus spectrum includes cutaneous, scalp, pigmentary, and nail phenotypes. Topical Janus kinase inhibitors offer targeted treatment with limited systemic exposure.

OBJECTIVE:

To map and critically appraise clinical, safety, and molecular evidence for topical Janus kinase inhibitors across lichen planus phenotypes.

METHODS:

We performed a PRISMA-guided systematic review (PROSPERO CRD420251155683) searching MEDLINE, Embase, Scopus, trial registries, and other sources to 1 November 2025. Human studies of topical JAK inhibitors for cutaneous lichen planus (LP), lichen planopilaris, frontal fibrosing alopecia (FFA), lichen planus pigmentosus (LPPig), or nail lichen planus were included. Risk of bias was assessed, certainty of evidence was graded, and findings were synthesized narratively.

RESULTS:

Thirteen studies (n = 118 patients) and one registry trial were included. In FFA, a phase 2 double-blind, vehicle-controlled trial of delgocitinib 2% cream in 30 patients met its molecular primary endpoint and showed greater clinical improvements than vehicle over 12 weeks. Two cohorts reported improvement with topical tofacitinib 2% and topical ruxolitinib 1.5% in scarring alopecia. In cutaneous LP (n = 12), an open-label study showed improvement in lesion severity and symptoms with topical ruxolitinib. Evidence for LPPig and nail LP was limited to case reports. Topical JAK inhibitors were well tolerated with infrequent local irritation and no serious adverse events.

CONCLUSIONS:

Topical Janus kinase inhibitors appear promising, well tolerated, and potentially steroid-sparing, particularly in lichen planopilaris and FFA. However, the evidence remains limited, and well-designed vehicle-controlled trials are needed before routine use can be justified.

01 Aug 2026·Lancet Child & Adolescent Health

Delgocitinib cream for adolescents with moderate to severe chronic hand eczema (DELTA TEEN): a multicentre, double-blind, phase 3 randomised controlled trial

Article

Author: Reguiai, Ziad ; Antonsen, Stine Dalsbø ; Marcoux, Danielle ; Halpern, James ; Baselga, Eulalia ; Brzewski, Paweł ; Schepper, Sofie De ; Thøgersen, Patrick ; Søhoel, Anders ; Rubel, Diana ; Molin, Sonja ; Navarro-Triviño, Francisco J ; Su, John C ; Hiort, Line Conradsen

BACKGROUND:

Chronic hand eczema is a multifactorial, inflammatory skin disease associated with itch, pain, and a substantial physical and psychosocial burden. Delgocitinib cream (2%, 20 mg/g), a topical, non-steroidal, pan-Janus kinase inhibitor, is approved for the treatment of moderate to severe chronic hand eczema in adults. We aimed to assess the efficacy and safety of delgocitinib cream in adolescents with moderate to severe chronic hand eczema.

METHODS:

DELTA TEEN was a double-blind, vehicle-controlled, multicentre, phase 3 randomised controlled trial conducted at 29 trial sites in Australia, Belgium, Canada, France, Poland, Spain, and the UK. Adolescents (aged 12-17 years) with moderate to severe chronic hand eczema were randomly assigned 3:1 via an interactive response technology system to twice-daily application of delgocitinib cream or cream vehicle for 16 weeks. The primary endpoint was the Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) treatment success at week 16, defined as an IGA-CHE score of 0 or 1 (clear or almost clear) with a 2 step or greater improvement from baseline. Efficacy of delgocitinib cream versus cream vehicle was assessed in all randomly assigned patients exposed to trial treatment, and safety was assessed in all patients exposed to trial treatment. This trial is registered with clinicaltrials.gov, NCT05355818, and is complete.

FINDINGS:

DELTA TEEN was conducted between July 14, 2022, and Dec 17, 2024. Patients (N=98, of whom 58 [59%] were female and 40 [41%] were male, and 89 (91%) patients were White) were randomly assigned to delgocitinib cream (n=74) or cream vehicle (n=24). Superiority of delgocitinib cream to cream vehicle was shown for the primary endpoint (IGA-CHE treatment success at week 16). 47 (64%) of 74 of patients treated with delgocitinib versus seven (29%) of 24 patients treated with the cream vehicle had IGA-CHE treatment success at week 16 (difference 37·9%; 95% credibility interval 13·5-58·2). Adverse events were reported by 37 (50%) patients treated with delgocitinib and eight (33%) patients treated with the cream vehicle. All adverse events with delgocitinib cream were mild or moderate in severity. No serious adverse events were reported in either group.

INTERPRETATION:

Delgocitinib cream showed superior efficacy compared with cream vehicle and was well tolerated over 16 weeks. The results support delgocitinib cream as a treatment option for adolescents with moderate to severe chronic hand eczema.

FUNDING:

LEO Pharma.

News (Medical) associated with Delgocitinib

18 Aug 2026

·www.biospace.com

LEO Pharma delivers 10% revenue growth at CER and strengthens late-stage pipeline

BALLERUP, Denmark--(BUSINESS WIRE)--In H1 2026, LEO Pharma delivered strong revenue growth, driven by the dermatology portfolio, with an improved gross margin alongside significantly increased investments in commercial and innovation activities. In August, LEO Pharma agreed to acquire the global rights for dersimelagon, an investigational first-in-class oral therapy with potential launch in 2027. Together with the acquisition of Replay, announced in April 2026, the agreement further strengthens LEO Pharma’s pipeline in rare genetic skin diseases. Financial highlights LEO Pharma’s revenue increased by 7% to DKK 7,257 million, and by 10% at constant exchange rates (CER). The revenue growth was led by North America (38% at CER) and Rest of World (10% at CER), while sales in Europe (0% at CER) were broadly stable compared to H1 2025. Revenue from the Dermatology portfolio grew by 12% (CER), driven by the strategic brands Anzupgo®, Spevigo® and Adtralza®/Adbry®, which combined had a revenue increase of 50% (CER), whereas revenue from the established brands decreased by 1% (CER) adversely impacted by a distributor transition in a single European market. Sales in the Critical Care portfolio grew by 3% (CER). Adjusted EBITDA amounted to DKK 1,247 million in H1 2026 (H1 2025: DKK 1,456 million) reflecting an adjusted EBITDA margin of 17% (H1 2025: 21%) amid increased strategic investments in commercial and innovation activities, which more than offset expansion in the gross margin. Net profit for H1 2026 was DKK 279 million (H1 2025: DKK 1,977 million). Excluding non-recurring items, net profit improved by 52% to DKK 369 million in H1 2026. Free cash flow was DKK 62 million for H1 2026 (H1 2025: DKK 1,469 million), and reduced net interest-bearing debt to DKK 9,319 million (YE 2025: DKK 9,358 million). Excluding M&A, free cash flow improved by DKK 556 million compared to H1 2025. Innovation highlights Agreement to acquire of dersimelagon from Tanabe Pharma, announced on 18 August 2026, adding a first-in-class oral MC1R agonist for erythropoietic protoporphyria (EPP), filed for U.S. regulatory review at the end of June 2026, supporting a potential launch in 2027. The acquisition further strengthens LEO Pharma’s rare dermatology pipeline and builds on recent additions, including Replay’s next-generation HSV gene therapy platform acquired in April 2026 and the exclusive global license for SPEVIGO® obtained in 2025. The transaction is expected to close in H2 2026. In May 2026, the first patient was dosed in the pivotal Phase 3 DELTA CARE 1 trial investigating the safety and efficacy of delgocitinib cream in adults with mild to severe lichen sclerosus, advancing LEO Pharma’s ambition to expand topical pan-JAK inhibition into treatment of additional inflammatory skin diseases with high unmet need. 2026 outlook updated Revenue growth is now expected to be 9-11% at CER (previously: 8-11%), reflecting year-to-date business performance. The adjusted EBITDA margin is now expected to be 14-16% (previously: 15-18%), reflecting increased development and pre-launch activities following the acquisition of dersimelagon, subject to the expected closing of the transaction in H2 2026. "We delivered a strong first half of 2026, reflecting the momentum we are building across our business and the strength of our global platform, while continuing to invest to drive future growth. As Adtralza®/Adbry®, Anzupgo® and Spevigo® together surpassed DKK 1 billion in quarterly revenue for the first time, the acquisition of dersimelagon adds another first-in-class therapy to our late-stage pipeline, with the potential to strengthen our commercial portfolio as early as next year and further expand our ability to address significant unmet needs in dermatology.” CEO Christophe Bourdon About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,400 people worldwide. Together, we reach far beyond the skin. For more information, visit Financial highlights and key figures (DKK million) Q2 2026 Q2 2025 H1 2026 H1 2025 FY 2025 Income statement Revenue 3,736 3,416 7,257 6,789 13,499 Of which dermatology revenue 3,071 2,781 5,946 5,508 10,991 Gross profit 2,469 2,287 4,772 4,253 8,240 Adjusted EBITDA 1 637 911 1,247 1,456 2,107 Non-recurring items 1 (47) 1 (90) 1,733 1,644 Operating profit before depreciation and amortization (EBITDA) 1 590 912 1,157 3,189 3,751 Operating profit (EBIT) 305 576 529 2,512 2,279 Financial items, net (113) (126) (222) (283) (566) Profit before tax 192 450 307 2,229 1,713 Net profit 180 235 279 1,977 2,489 Earnings per share, basic (EPS) (DKK) 0.47 0.61 0.73 5.16 6.49 Earnings per share, diluted (DEPS) (DKK) 2 0.47 0.61 0.73 5.16 6.49 Balance sheet Investments in property, plant and equipment 62 67 93 119 256 Assets 20,873 19,902 20,873 19,902 20,445 Equity 5,518 4,837 5,518 4,837 5,262 Net working capital 3 4,199 4,786 4,199 4,786 3,991 Net interest-bearing debt (NIBD) 4 9,319 9,676 9,319 9,676 9,358 Invested capital 5 14,638 14,248 14,638 14,248 14,380 Cash flow Cash flow from operating activities 137 157 514 (27) 1,255 Cash flow from investing activities (411) (74) (452) 1,496 620 Net cash flow 53 (25) 90 96 (3) Free cash flow (274) 83 62 1,469 1,875 Free cash flow excluding M&A 6 62 83 398 (158) 940 Key ratios Revenue growth 9% 3% 7% 6% 8% Revenue growth at CER 1 11% 4% 10% 7% 10% Dermatology revenue growth at CER 1 12% 6% 12% 8% 12% Gross margin 66% 67% 66% 63% 61% OPEX ratio (% of revenue) 58% 50% 59% 51% 57% EBIT margin 8% 17% 7% 37% 17% EBITDA margin 1 16% 27% 16% 47% 28% Adjusted EBITDA margin 1 17% 27% 17% 21% 16% Effective tax rate 6% 48% 9% 11% (45)% NIBD/Adjusted EBITDA (LTM) 7 4.9 5.5 4.9 5.5 4.4 People Average number of full-time employees (FTE) 4,373 4,023 4,338 4,027 4,104 Number of full-time employees (FTE) at period-end 4,398 4,040 4,398 4,040 4,265 1 See Note 2 Non-IFRS measures. 2 Outstanding warrants did not have a dilutive effect on the outstanding shares in the calculation of DEPS in H1 2026 or H1 2025. The required conditions for equity settlement were not met at the reporting date. Please refer to Note 6.2 Share-based in the Annual Report for 2025 3 Net working capital is a non-IFRS measure and comprises inventories, trade receivables and other receivables less trade payables and other payables. 4 The net interest-bearing debt (NIBD) is a non-IFRS measure and comprises the interest-bearing liabilities less cash and cash equivalents. 5 Invested capital is calculated as the sum of non-current assets, net working capital and tax receivables less deferred tax liabilities and other non-interest-bearing liabilities. 6 M&A cash impact refer to page 8, section ‘Cash flow from investing activities’. 7 Adjusted EBITDA (LTM) is the adjusted EBITDA for the last 12 months. Business Review In H1 2026, reported revenue growth was 7%. At constant exchange rates (CER), revenue increased by 10%, including organic growth of 7%. Dermatology revenue grew by 12% (CER) for the period, including organic growth of 8%, led by strong growth in the strategic brands portfolio while the portfolio of established brands declined by 1% (CER) impacted by a distributor transition in a single market. Critical Care recorded revenue growth of 3% (CER) compared to H1 2025. Exchange rates had a 3-percentage-point negative effect on reported revenue growth for H1 2026. In Q2 2026, reported revenue growth was 9%. Revenue increased by 11% at CER, including organic growth of 7%. Dermatology revenue grew by 12% (CER), including organic growth of 8%, led by strong growth in the strategic brands portfolio while the portfolio of established brands declined by 2% (CER) during the quarter amid a distributor transition in a single market. Critical Care recorded revenue growth of 2% (CER) compared to Q2 2025. Exchange rates had a 2-percentage point negative effect on reported revenue growth for Q2 2026. (DKK million) Q2 2026 Q2 2025 Growth (CER) Growth (DKK) H1 2026 H1 2025 Growth (CER) Growth (DKK) Revenue by area Dermatology 3,071 2,781 12% 10% 5,946 5,508 12% 8% Strategic brands 1,028 676 56% 52% 1,888 1,327 50% 42% Established brands 2,043 2,105 (2)% (3)% 4,058 4,181 (1)% (3)% Critical Care 594 585 2% 2% 1,193 1,170 3% 2% Other 71 50 42% 42% 118 111 6% 6% Total 3,736 3,416 11% 9% 7,257 6,789 10% 7% Revenue by region Europe 1,785 1,773 1% 1% 3,509 3,517 (0)% (0)% North America 913 644 46% 42% 1,669 1,297 38% 29% Rest of World 1,038 999 6% 4% 2,079 1,975 10% 5% Total 3,736 3,416 11% 9% 7,257 6,789 10% 7% Business review by product category Strategic brands revenue grew by 50% (CER) in H1 2026 compared to H1 2025, including organic growth of 30% and a 20-percentage-point contribution from the consolidation of prior-year sales levels for Spevigo®, the IL-36RA biologic for generalized pustular psoriasis (GPP) licensed from Boehringer Ingelheim on 30 September 2025. Organic growth was led by the continued global roll-out of the topical pan-JAK inhibitor Anzupgo® for chronic hand eczema (CHE). Additionally, the IL-13 biologic Adtralza®/Adbry® for the treatment of atopic dermatitis (AD), and Spevigo® also contributed to organic growth compared to H1 2025. The global roll-out of Anzupgo ® continued during the first half of 2026. The product is now launched in 11 markets, and available through early access schemes in an additional nine markets. Sales of Anzupgo® grew strongly compared to H1 2025, driven in particular by the U.S., where the product was launched in September 2025. In the U.S., LEO Pharma continued to expand commercial formulary coverage for Anzupgo® during H1 2026 through focused market access efforts, with the prescriber base also increasing throughout the period. As the first and only FDA-approved treatment specifically indicated for moderate-to-severe CHE in adults, Anzupgo® is well positioned to help address a significant unmet need in what is historically perceived to be an undertreated disease. LEO Pharma remains focused on further expanding market access and raising disease awareness among healthcare providers and patients to support earlier patient identification and appropriate disease management. Outside the U.S., Anzupgo® delivered broad-based growth during the first six months, supported by additional commercial launches. This included Denmark and Sweden, where reimbursement was secured and Anzupgo® was launched commercially in May and June 2026, respectively. Furthermore, early access schemes were initiated in several additional markets during Q2, including South Korea, Norway, Poland and Czechia, as LEO Pharma continues to advance CHE disease awareness initiatives across markets. Spevigo ® delivered strong sales growth in H1 2026 compared to H1 2025, prior to Spevigo® becoming part of the LEO Pharma portfolio of strategic brands, led by the U.S. Spevigo® therefore also contributed to organic revenue growth, reflecting growth compared to the prior-year sales level when the product was marketed by Boehringer Ingelheim. With the addition of Spevigo® to the portfolio, LEO Pharma is leveraging its broad dermatology platform to expand access, raise awareness of GPP among healthcare professionals and supporting patient identification for this rare and potentially life-threatening disease. Following the transfer of marketing authorizations (MA) in Europe and the biologics license application (BLA) transfer in the U.S. during Q1 LEO Pharma is assuming full responsibility commercial and medical activities for Spevigo® across most markets. In the U.S., LEO Pharma is expanding engagement with healthcare professionals and organized provider networks alongside initiatives to improve product availability at key treatment centers and specialist care sites. These initiatives, mostly implemented towards the end of H1, are intended to strengthen disease awareness and patient identification, widen availability of Spevigo® across treatment locations, and support timely treatment initiation in GPP. For Adtralza®/Adbry® , robust growth in H1 2026 was driven by the U.S., Japan and Germany with contributions from several other markets, including the UAE, the Netherlands, the UK and Spain. Across markets, growth continued to be supported by the increasing adoption of biologics for the treatment of AD. During H1 2026, LEO Pharma continued to strengthen Adtralza®/Adbry®’s position through commercial activities and the expanded use of medical education materials highlighting its efficacy in high-burden areas of AD, including the head and neck region and the hands. The messaging, supported by real-world data and results from the Phase 3b ADHAND trial, continued to be well received in the first markets where it has been deployed. Sales growth was also supported by uptake of the pre-filled pen, reflecting patient and prescriber demand for greater convenience and flexibility in AD management. Toward the end of H1 2026, Adtralza® marked its five-year anniversary since European Commission approval and was removed from the European Medicine Agency’s additional monitoring list, reflecting its well-established long-term safety profile. In Q2 2026, Strategic brands grew by 56% (CER), including organic growth of 34% and a 22-percentage-point contribution from the consolidation of prior-year sales levels for Spevigo®. Increased uptake of Anzupgo® in the U.S. was the leading growth driver during the quarter, supported by strong sales growth for both Spevigo® and Adtralza®/Adbry®. Established brands revenues declined by 1% (CER) in H1 2026, adversely impacted by a distributor transition in a European market. Excluding this impact, sales of the Established brands portfolio grew by 2% compared to H2 2025, driven by the Rest of World region. Among individual countries, growth was led by China and Canada, while sales in region Europe detracted from growth. Within the Established brands portfolio, the Daivobet/Daivonex® range of topical treatments for psoriasis, the Fucidin® range of antibiotic topicals for the treatment of skin infections and Skinoren® for the treatment of acne vulgaris contributed positively to growth, while lower sales in Europe of Enstilar®, a topical foam for the treatment of psoriasis, detracted from growth in H1 2026. In Q2 2026, Established brands recorded a 2% (CER) decline in revenues versus the same period last year, adversely impacted by the distributor transition in a European market. Excluding this, the portfolio grew by 3% compared to Q2 2025, driven by increased sales of Skinoren®. Critical Care revenues increased by 3% (CER) compared to H1 2025, with growth driven by Germany, the Nordics and Greece. For H1 2026, growth was supported by both the thrombosis products and the addition of Loqtorzi® to the portfolio. In H1 2026 LEO Pharma began the European roll-out of Loqtorzi®, for the treatment of nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). Following launch in the first five markets during H1 2026, Loqtorzi® was subsequently launched in France via Direct Access on 1 July and has seen steady uptake across markets, contributing to Critical Care revenue growth for the period. In Q2 2026, Critical Care revenues grew by 2% (CER) compared to Q2 2025, driven by Loqtorzi®. Other revenue from contract manufacturing of divested products amounted to DKK 118 million for H1 2026, up from DKK 111 million in H1 2025. The growth was driven by favorable timing which more than offset product discontinuations. Revenue by region Geographically, North America was the fastest-growing region in H1 2026, with revenue increasing 38% (CER) compared to the same period last year. Strong growth for Anzupgo® and the addition of Spevigo® to the portfolio were the key drivers of the revenue growth in H1 2026, with Adtralza®/Adbry® also delivering a robust contribution to growth during the period. In addition, gross-to-net revenue adjustments relating to prior periods had a positive impact on growth for the region. In Europe , revenue during H1 2026 was broadly unchanged compared to the same period last year, adversely impacted by a distributor transition in a European market. Excluding this impact, sales in Europe grew by 3% during the period. Across the region, sales were driven by strong growth of Anzupgo®, Spevigo® and Adtralza®, alongside the Critical Care portfolio, while lower sales of the Established brands portfolio, impacted by the aforementioned distributor transition, detracted from growth. The Rest of World region delivered revenue growth of 10% (CER) in H1 2026, driven by China, South Korea, Japan, Brazil and Mexico, as well as broad-based growth across distributor markets, despite geopolitical turmoil. Strong growth for the Established brands portfolio was the main driver of regional growth, with Adtralza® and Anzupgo® as well as the Critical Care portfolio contributing to the increase in regional revenues versus H1 2025. Financial review Income statement (DKK million) Q2 2026 Q2 2025 Change in value Change % H1 2026 H1 2025 Change in value Change % Revenue 3,736 3,416 320 9% 7,257 6,789 468 7% Cost of sales (1,267) (1,129) (138) 12% (2,485) (2,536) 51 (2)% Gross profit 2,469 2,287 182 8% 4,772 4,253 519 12% Gross margin, % 66% 67% (1)pp N/A 66% 63% 3pp N/A Sales and distribution costs (1,444) (1,124) (320) 28% (2,854) (2,241) (613) 27% Research and development costs (394) (248) (146) 59% (767) (579) (188) 32% Administrative costs (327) (339) 12 (4)% (636) (659) 23 (3)% Other operating income, net 1 0 1 N/A 14 1,738 (1,724) (99)% Operating profit (EBIT) 305 576 (271) (47)% 529 2,512 (1,983) (79)% EBIT margin, % 8% 17% (9)pp N/A 7% 37% (30)pp N/A Adjusted EBITDA 1 637 911 (274) (30)% 1,247 1,456 (209) (14)% Adjusted EBITDA margin, % 17% 27% (10)pp N/A 17% 21% (4)pp N/A 1 See Note 2 Non-IFRS measures. Revenue Revenue increased by 7% to DKK 7,257 million in H1 2026. This reflected revenue growth of 10% (CER), whereas the development in exchange rates had a 3-percentage-point negative impact on revenue growth, due to the appreciation of the DKK versus the USD, the JPY, and the CNY, among others. Gross profit Gross profit increased by 12% to DKK 4,772 million in H1 2026, resulting in a gross margin of 66%, equivalent to a 3-percentage-points improvement over H1 2025. The gross margin expansion was driven by reduced sourcing costs as well as higher volumes and a favorable sales mix. In Q2 2026, the gross margin of 66% was one percentage point lower compared to Q2 2025, which had been positively impacted by timing effects between Q1 and Q2 in 2025. Operating expenditures (OPEX) In H1 2026, OPEX amounted to DKK 4,257 million, excluding other operating income and expenses, representing a 22% increase compared to the same period last year. This development reflected increased commercial investments in support of the ongoing global roll-out of Anzupgo® and the addition of Spevigo® to the portfolio as well as increased investments in the innovation pipeline. Reflecting these investments, the ratio of OPEX to revenue increased to 59% in H1 2026, compared to 51% in H1 2025. In Q2 2026, OPEX increased by DKK 454 million, or 27%, compared with the same period in 2025, driven by commercial and innovation investments. Sales and distribution costs Sales and distribution costs increased by 27% in H1 2026 to DKK 2,854 million, corresponding to 39% of revenue compared to 33% in H1 2025. The increase was driven by the sales force expansion in the U.S. during the second half of 2025 and increased commercial activities globally, including the global roll-out of Anzupgo® and the addition of Spevigo® to the portfolio. In Q2 2026, sales and distribution costs were DKK 1,444 million, corresponding to 39% of revenue, compared to 33% in Q2 2025. Research and development costs Research and development (R&D) costs amounted to DKK 767 million in H1 2026, an increase of DKK 188 million compared to the same period last year, driven by the addition of Spevigo® to the portfolio including ongoing late-stage clinical trial activities as well as late-stage trial initiations for delgocitinib cream (brand name: Anzupgo®), and the addition of the pre-clinical HSV gene therapy platform, acquired with Replay in April 2026. Investments in these new programs were partially offset by trial completions over the past year. R&D costs as a percentage of revenue were 11% in H1 2026, one percentage point higher than in H1 2025. In Q2 2026, R&D costs were DKK 394 million, corresponding to 11% of revenue, compared to 7% in Q2 2025. Administrative costs Administrative costs for H1 2026 amounted to DKK 636 million or 9% as a percentage of revenue. Compared to H1 2025, administrative costs decreased by DKK 23 million despite an increase in non-recurring items. Excluding non-recurring items, administrative costs as a percentage of revenue were 8% in H1 2026, 2 percentage points lower than in H1 2025. In Q2 2026, administrative costs were DKK 327 million, corresponding to 9% of revenue, compared to 10% in Q2 2025. Other operating income, net Other operating income amounted to DKK 14 million in H1 2026 compared to DKK 1,738 million in H1 2025 which included the USD 250 million upfront payment received from Gilead Sciences in January 2025, relating to the strategic partnership for the STAT6 program. Adjusted EBITDA Operating profit before depreciation and amortization, excluding non-recurring items (adjusted EBITDA), amounted to DKK 1,247 million for H1 2026, compared to DKK 1,456 million in H1 2025 as increased investments in sales and distribution and R&D activities more than offset improved gross profit. The adjusted EBITDA margin came to 17% for H1 2026 compared to 21% for H1 2025. In Q2 2026, adjusted EBITDA amounted to DKK 637 million, compared to DKK 911 million in Q2 2025. The adjusted EBITDA margin of 17% for Q2 2026 was 10-percentage points lower compared to Q2 2025, reflecting increased investment and favorable timing effects in the same period last year that benefitted Q2 2025, which more than offset improved gross profit. Non-recurring items Non-recurring items excluded from adjusted EBITDA were an expense of DKK 90 million in H1 2026, reflecting integration costs from the addition of Spevigo® to the portfolio, as well as costs related to strategic corporate initiatives and other non-recurring items. Non-recurring items in H1 2025 constituted an income of DKK 1,733 million reflecting the upfront payment received from Gilead Sciences, net of transaction costs, as well as other non-recurring items. In Q2 2026, non-recurring items excluded from adjusted EBITDA amount to an expense of DKK 47 million compared to an income of DKK 1 million in Q2 2025. Depreciation & amortization Depreciation and amortization for the first six months of 2026 totaled DKK 628 million, equivalent to 9% of revenue, compared to DKK 677 million, or 10% of revenues, in H1 2025. No impairments were recognized in H1 2026, compared to DKK 9 million in H1 2025. In Q2 2026, depreciation and amortization amounted to DKK 285 million, equivalent to 8% of revenue, compared to DKK 336 million, or 10% of revenues, in Q2 2025. EBIT The operating profit (EBIT) for H1 2026 reached DKK 529 million, compared to DKK 2,512 million for the same period in 2025. Contacts Investor Relations: Christian Boas Ryom, telephone +45 4494 5888 Christopher Broe Hansen, telephone +45 5355 3895 Media: Jeppe Ilkjær, telephone +45 3050 2014 Read full story here

AcquisitionPhase 3Drug ApprovalLicense out/in

18 Aug 2026

·www.biospace.com

LEO adds to dermatology portfolio with $435M deal for late-stage rare disease drug

iStock, naratrip boonroung This is the third recent acquisition conducted by Denmark’s LEO Pharma in medical dermatology, a portfolio that marked 12% growth in the first half of the year. LEO Pharma has put up $435 million to acquire a rare disease drug for two conditions that cause photosensitivity, expanding the Danish biotech’s dermatology portfolio. The once-daily oral melanocortin 1 receptor (MC1R) agonist, called dersimelagon, was owned by Tanabe Pharma and has completed Phase 3 development for erythropoietic protoporphyria (EPP) and X-linked proto-porphyria (XLP). The drug was submitted for approval to the FDA for both indications in June, according to LEO’s Tuesday morning announcement . Both conditions cause photosensitivity that can trigger severe reactions to sunlight. These include skin rashes, swelling, redness, burning sensations and sometimes liver damage, and limits a patient’s ability to be outside. Dersimelagon is designed to increase skin melanin to reduce the penetration of sunlight and guard against such reactions. In the Phase 3 INSPIRE trial, which read out in March , dersimelagon prolonged average sun exposure by 23 minutes during weeks 12 through 16 as compared to placebo. The effect grew to 29 minutes by week 16 in a supplementary analysis. The therapy also reduced pain events. Mergers & acquisitions Mid-sized European drugmakers are snapping up US biotechs. Will the surge continue? European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing. May 13, 2026 · 4 min read · Nick Paul Taylor Read more LEO will now take over the worldwide rights to dersimelagon for $435 million, including an upfront payment and additional undisclosed milestones and royalties offered later on. Dersimelagon has been granted fast track and orphan drug designations from the FDA. If approved, the therapy would be the first treatment for EPP and XLP to make it to market, LEO said. LEO plans to launch the drug in 2027, with preparations in 2026 expected to increase the company’s overall investments for the year. The deal with Japan’s Tanabe is the latest conducted by LEO in medical dermatology, after the 2025 partnership with Boehringer Ingelheim for IL-36R antagonist Spevigo. LEO also recently acquired Replay Therapeutics’ next-generation HSV gene therapy platform. Also on Tuesday, LEO reported 10% revenue growth at constant currencies to DKK 7.26 billion ($1.12 billion) for the first half. This was led by growth in the dermatology portfolio, which grew 12%. Key drugs Anzupgo, Spevigo and Adtralza/Adbry had a combined revenue increase of 50%.

Phase 3AcquisitionOrphan DrugFast TrackClinical Result

25 Jun 2026

·www.biospace.com

LEO Pharma to Showcase New Data Highlighting the Burden and Unmet Needs in Chronic Hand Eczema at ESCD 2026 in Copenhagen

New data show that chronic hand eczema can disrupt working lives and school days, with many patients reporting sick leave from work and worsening of symptoms during everyday activities. 1 Findings from the DELTA FORCE and DELTA TEEN phase 3 studies highlight the heavy burden of chronic hand eczema across the life course – from impaired work productivity in adults to an impact on school life in adolescents. 1,2 BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announces its scientific program for the European Society of Contact Dermatitis (ESCD) Congress 2026, taking place in Copenhagen, Denmark. At the congress, hosted on LEO Pharma’s home ground, the company will present new data highlighting the burden, symptom severity and ongoing unmet needs of people living with chronic hand eczema (CHE). 1-5 LEO Pharma will present multiple posters covering patient‑reported outcomes, disease burden in both adolescents and adults, and emerging insights into the skin microbiome in chronic hand eczema, reflecting the company’s continued investment in advancing understanding of this debilitating disease across the life course. 1-5 “ Presenting new data here in Copenhagen, where LEO Pharma was founded more than a century ago, is particularly meaningful to us ,” said Jacob Pontoppidan Thyssen, Chief Scientific Officer at LEO Pharma. “ Across our program, the message is clear: Chronic hand eczema continues to place a heavy burden on patients’ lives with persistent symptoms, and there is still a real need for patients with CHE .” When chronic hand eczema affects working life Data presented at ESCD 2026 show that chronic hand eczema can substantially impair work productivity and daily functioning. In the DELTA FORCE phase 3 study in adults with severe CHE, around one in four patients reported related sick leave from work in the previous 12 months, and almost one in three patients reported worsening of symptoms while at work. 1 Patient reported outcomes from DELTA FORCE further demonstrated greater improvements in self-rated work productivity and daily activities in patients treated with topical delgocitinib compared with patients treated with oral alitretinoin. Improvements were accompanied by greater gains in quality of life, measured using generic (EQ-5D-5L), dermatology specific (DLQI) and CHE specific (HEIS) instruments. 1 “Chronic hand eczema is much more than a disease, it is a societal challenge indeed due to the importance of the hands in daily life activities,” said lead author of the DELTA FORCE poster, Professor Andrea Bauer from the Technical University Dresden, Germany. “When people with chronic hand eczema are unable to work or struggle to remain productive, the impact extends beyond the individual to workplaces and society as a whole. These findings underline the importance of continuing to explore treatment approaches that not only address symptoms but also help people with CHE maintain their ability to work and function in everyday life.” Disease burden in adolescents with chronic hand eczema: DELTA TEEN LEO Pharma will also present baseline data from the DELTA TEEN phase 3 study in adolescents with moderate to severe chronic hand eczema. The findings show a substantial disease burden in adolescence, with persistent symptoms and a clear impact on school life and daily activities. 2 The data highlight that chronic hand eczema can affect more than school attendance, with a notable impact on schoolwork, participation in school activities and everyday functioning during a vulnerable phase of adolescents’ development. 2 Importantly, the findings also show that current standard‑of‑care treatments were associated with limited success, underscoring that effective treatment options for adolescents with moderate to severe chronic hand eczema remain a major unmet need. 2 The key results from the DELTA Teen trial were just published in The Lancet Child & Adolescent Health in early June 2026, coinciding with the poster presentation at ESCD in Copenhagen. 6 The company’s full roster of presentations at the 2026 ESCD congress is listed below. 1-5 Title Author Format & Timing HRQoL and Work Productivity Improvements with Topical Delgocitinib vs Oral Alitretinoin in Chronic Hand Eczema: Phase 3 DELTA FORCE Results Bauer A, Buhl T, Woolf R, et al. Poster P-071 Date: 25 June presented from 16:45–17:20 Baseline burden and treatment history of adolescents with moderate to severe Chronic Hand Eczema (CHE) enrolled in the randomized phase 3 DELTA TEEN trial Molin S, Rubel D, Navarro‑Triviño FJ, et al. Short Talk Session: Free communication 3 Date: 27 June 09:45–10:00 Meaningful score region analysis to define interpretation thresholds for categorizing patients as mild, moderate and severe on the patient-reported hand eczema symptom diary (HESD) Molin S, Skingley G, Arbuckle R, et al. Poster P-125 Date: 25 June presented from 16:45–17:20 Construction and validation of a photographic guide for the validated Investigator’s Global Assessment of Chronic Hand Eczema scale (IGA-CHE) Bauer A, Bissonnette R, Agner T, et al. Poster P-083 Date: 25 June presented from 16:45–17:20 Treatment with delgocitinib cream is associated with reductions in Staphylococcus aureus density and pain, and increased microbial diversity in patients with mild to severe Chronic Hand Eczema Agner T, Wollenberg A, Aytan‑Aktug D, et al. Short Talk Session: Pre-symposium: session 1 Date: 24 June 11:30–11:45 About Chronic Hand Eczema Chronic Hand Eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year. 7,8 CHE is one of the most common skin diseases of the hands with a global prevalence rate of estimated 4.7%. 9,10 In a substantial number of patients, HE can develop into a chronic disease. 9 CHE is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 11 CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 12,13 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the disease. 14 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 15 About Anzupgo® (delgocitinib) Cream Anzupgo® cream is a topical non-steroidal pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. 16 Anzupgo® is approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, and the United Arab Emirates for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Anzupgo® (delgocitinib) cream is FDA approved in the U.S. for moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Use of Anzupgo® in combination with other JAK inhibitors or potent immunosuppressants is not recommended by the U.S. FDA. 17 Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use. Anzupgo® cream is also under review in other markets. In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi & Co., Ltd. owns the rights. About the DELTA FORCE Trial DELTA FORCE was a 24-week, randomised, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of delgocitinib cream twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema. 18 The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied the drug to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks. All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment. 18 About the DELTA TEEN Trial DELTA TEEN was a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel group, multi-site trial to evaluate the efficacy and safety of twice-daily applications of Anzupgo® compared with cream vehicle in adolescents 12-17 years of age with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate. 19 The primary endpoint of DELTA TEEN was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline. 19 About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin. For more information, visit . References Molin S, Nørreslet LB, Thyssen JP, et al. Work productivity, daily activity impairment and quality of life in adults with severe chronic hand eczema: results from the DELTA FORCE phase 3 study. Presented at the 2026 European Society of Contact Dermatitis (ESCD) Congress; Copenhagen, Denmark. Molin S, Rubel D, Navarro‑Triviño FJ, et al. Disease burden, symptoms and functional impact in adolescents with moderate to severe chronic hand eczema: baseline data from the DELTA TEEN phase 3 study. Presented at the 2026 European Society of Contact Dermatitis (ESCD) Congress; Copenhagen, Denmark. Nørreslet LB, Molin S, Thyssen JP, et al.Defining meaningful score ranges for the Hand Eczema Symptom Diary using patient‑reported outcomes from the DELTA clinical program. Presented at the 2026 European Society of Contact Dermatitis (ESCD) Congress; Copenhagen, Denmark. Thyssen JP, Agner T, Molin S, et al. Development and validation of an Investigator’s Global Assessment photo‑guide for chronic hand eczema. Presented at the 2026 European Society of Contact Dermatitis (ESCD) Congress; Copenhagen, Denmark. Agner T, Wollenberg A, Nørreslet LB, et al. Skin microbiome composition and association with disease severity in chronic hand eczema. Presented at the 2026 European Society of Contact Dermatitis (ESCD) Congress; Copenhagen, Denmark. Molin S, Baselga E, Navarro-Triviño F, et al. Delgocitinib cream for adolescents with moderate to severe chronic hand eczema (DELTA TEEN): a multicentre, double-blind, phase 3 randomised controlled trial. Lancet Child Adolesc Health. 2026;0 Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg . 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of chronic hand eczema in adults: a cross-sectional survey of over 60 000 respondents from the general population of Canada, France, Germany, Italy, Spain and the UK. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3 Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378. Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706. Dalgard FJ, Gieler U, Tomas-Aragones L, et al. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015;135(4):984-991. Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233. ANZUPGO® (delgocitinib) cream. Prescribing Information. FDA. July 2025. ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Identifier: NCT05259722. . ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN). Identifier: NCT05355818. . Contacts For further information please contact: Investor Relations: Christian Boas Ryom, telephone +45 4494 5888 Media: Jeppe Ilkjær, telephone +45 3050 2014

Phase 3Clinical ResultLicense out/inDrug Approval

100 Deals associated with Delgocitinib

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KEGG	Wiki	ATC	Drug Bank
D11046	-	D11AH	DB16133

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Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic eczema	United Kingdom	LEO Pharma A/S	29 Nov 2024
Chronic hand eczema	European Union	LEO Pharma A/S	19 Sep 2024
Chronic hand eczema	Iceland	LEO Pharma A/S	19 Sep 2024
Chronic hand eczema	Liechtenstein	LEO Pharma A/S	19 Sep 2024
Chronic hand eczema	Norway	LEO Pharma A/S	19 Sep 2024
Dermatitis, Atopic	Japan	Shionogi & Co., Ltd.	23 Jan 2020
Dermatitis, Atopic	Japan	Japan Tobacco, Inc.	23 Jan 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lichen Sclerosus Et Atrophicus	Phase 3	United States	Leo Pharma, Inc.	11 Feb 2026
Lichen Sclerosus Et Atrophicus	Phase 3	Canada	Leo Pharma, Inc.	11 Feb 2026
Lichen Sclerosus Et Atrophicus	Phase 3	France	Leo Pharma, Inc.	11 Feb 2026
Lichen Sclerosus Et Atrophicus	Phase 3	Germany	Leo Pharma, Inc.	11 Feb 2026
Lichen Sclerosus Et Atrophicus	Phase 3	Italy	Leo Pharma, Inc.	11 Feb 2026
Lichen Sclerosus Et Atrophicus	Phase 3	Poland	Leo Pharma, Inc.	11 Feb 2026
Lichen Sclerosus Et Atrophicus	Phase 3	Spain	Leo Pharma, Inc.	11 Feb 2026
Lichen Sclerosus Et Atrophicus	Phase 3	United Kingdom	Leo Pharma, Inc.	11 Feb 2026
Eczema, Dyshidrotic	Phase 3	Denmark	LEO Pharma A/S	30 Jan 2022
Eczema, Dyshidrotic	Phase 3	Denmark	Japan Tobacco, Inc.	30 Jan 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05355818 (DELTA TEEN, Pubmed \| Lancet Child Adolesc Health)	Phase 3	Chronic hand eczema	98	Delgocitinib cream	jdafskxbkm(dwhpkurdll) = yaybzlytqy rbqmzozkoc (tifsjxruqa ) View more	Positive	01 Aug 2026
				Cream vehicle	jdafskxbkm(dwhpkurdll) = zkeahqeieq rbqmzozkoc (tifsjxruqa ) View more
DELTA-1/2 (AAD2026)	Phase 3	Chronic hand eczema	1,017	Delgocitinib cream	-	Positive	27 Mar 2026
				Delgocitinib cream (systemic-experienced)	ekvgrcoaiw(ggdepdslwx) = pefkgvgfhm cgcbdkedli (pkboklhode )
NCT05355818 (DELTA TEEN, AAD2026)	Phase 3	Chronic hand eczema	98	delgocitinib cream 20 mg/g	mwjgrkwyzt(qulxkuzpmo) = grtahjzvsp jujuaihcun (gjyrowumzh ) View more	Positive	27 Mar 2026
				cream vehicle	mwjgrkwyzt(qulxkuzpmo) = ozktgjrmgy jujuaihcun (gjyrowumzh ) View more
NCT04949841 (DELTA 3, AAD2026)	Phase 3	Chronic hand eczema	560	Delgocitinib 20 mg/g Cream (Chronic Hand Eczema)	eivbklbdrb(zteggekzqv) = nixfuqmouu roaegvpzff (bfempzgncm, 0.18 - 0.22) View more	Positive	27 Mar 2026
NCT04872101 \| NCT04871711 (DELTA 1, Pubmed \| Contact Dermatitis)	Phase 3	Chronic hand eczema	960	Delgocitinib cream 20 mg/g	louledygkf(eiscdebydf) = cgtvlgqkjw sepaalvzlv (asnijhzqeg )	Positive	03 Mar 2026
				Cream vehicle	ldewjzzcbc(idtgsbiplz) = zchnspkbvw cvvgulfpac (vvjyghnvhk ) View more
NCT05332366 (Pubmed \| J Invest Dermatol)	Phase 2	Frontal Fibrosing Alopecia CXCL9 \| CXCL10 \| IFN-γ	30	Delgocitinib cream	kcjcwjvrbb(ermbnnqlzt) = knfhkfxtph yfvjkzinnv (ttepdtncke )	Positive	01 Oct 2025
NCT05486117 \| NCT05050279 (Pubmed \| J Eur Acad Dermatol Venereol)	Phase 1	Chronic hand eczema	16	Delgocitinib cream 20 mg/g	sjeejqyact(iwinekadzv) = oxunqjubqn vhnusurtlh (lalrswzkeq ) View more	Positive	01 Sep 2025
NCT04872101 \| NCT04871711 (FDA_CDER) Manual	Phase 3	Chronic hand eczema	960	ANZUPGO (TRIAL 1)	jahscrdvkw(mngmzckabd) = yhklscarda sjpvmsgsis (dmpxgsasrf ) View more	Positive	23 Jul 2025
				Vehicle (TRIAL 1)	jahscrdvkw(mngmzckabd) = ypmwsoxney sjpvmsgsis (dmpxgsasrf ) View more
NCT05355818 (DELTA TEEN, CTgov)	Phase 3	Chronic hand eczema	98	Delgocitinib (Delgocitinib Cream)	ycinybadbp = tmjhyvdewm xinbxlubnt (whhupqdytl, nombneidym - nmmcrhgcru) View more	-	02 Jul 2025
				Cream vehicle (Cream Vehicle)	ycinybadbp = mjyxvkbctu xinbxlubnt (whhupqdytl, higunwgnif - zlqjghsmlf) View more
NCT04872101 \| NCT04949841 (DELTA 3, Pubmed \| J Am Acad Dermatol)	Phase 3	Chronic hand eczema	801	Delgocitinib cream	dgxbnnwxhp(tbepygfggq) = zxmnqtphak cqcnfrvbom (uydavwwcpz ) View more	Positive	01 Jul 2025

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