A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)

The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:
Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.
Intervention Form: Film-coated tablet.

Start Date10 Mar 2026

Sponsor / Collaborator

EMD Serono Research & Development Institute, Inc.

[+1]

NCT06589713

/ CompletedPhase 1

Phase 1, Open Label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Enpatoran in Male and Female Participants

The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.

Start Date24 Sep 2024

Sponsor / Collaborator

Merck Healthcare KGaA

[+1]

NCT06589726

/ CompletedPhase 1

A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of Enpatoran on the QTc (Corrected QT) Interval in Healthy Adult Participants

The purpose of this study is to assess potential effects of enpatoran on cardiac repolarization (i.e. prolongation of QT interval).

Start Date10 Sep 2024

Sponsor / Collaborator

Merck Healthcare KGaA

[+1]

100 Clinical Results associated with Enpatoran

100 Translational Medicine associated with Enpatoran

100 Patents (Medical) associated with Enpatoran

Literatures (Medical) associated with Enpatoran

01 May 2026·Lancet Rheumatology

Enpatoran: promising mechanism, pharmacodynamic challenge

Article

Author: Arriens, Cristina

01 May 2026·LANCET

Enpatoran, a Toll-like receptor 7/8 inhibitor, in moderate-to-severe systemic lupus erythematosus: findings from Cohort B of a multicentre, international, double-blind, placebo-controlled dose-finding phase 2 trial

Article

Author: Klopp-Schulze, Lena ; Roy, Sanjeev ; Dall'Era, Maria ; Werth, Victoria P ; Fernandez-Ruiz, Ruth ; Kleinmond, Christine ; Moreau, Flavie ; Morand, Eric F ; Sgouroudi, Evridiki ; Pearson, David R ; Furie, Richard ; Gühring, Hans ; Sanchez-Guerrero, Jorge ; Wenzel, Joerg

BACKGROUND:

Toll-like receptors (TLR) 7 and 8 (TLR7/8) are activators of innate and adaptive immunity contributing to lupus pathogenesis. In Cohort B of WILLOW, a phase 2, randomised, placebo-controlled, double-blind, basket, dose-finding study, enpatoran, an oral small molecule inhibitor of TLR7/8, was evaluated in participants with active systemic lupus erythematosus (SLE).

METHODS:

Participants were eligible if they were aged 18-75 years with moderate-to-severe SLE, with or without cutaneous manifestations, had a disease duration of at least 6 months, and were receiving a stable dose of medication before the screening period. Participants were recruited from 132 centres in 22 countries. In Part 1, participants were randomly allocated in a 1:2 ratio to receive either placebo or 100 mg enpatoran, both twice-daily. Following the enrolment of 60 participants, Part 2 was activated and additional participants were randomly allocated in a 1:1:1:1 ratio to 25 mg, 50 mg, or 100 mg of enpatoran or placebo, all twice-daily, for 24 weeks. Random allocation was stratified by region, biomarker status, and hybrid Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index score. The primary objective was to evaluate the dose-response relationship of enpatoran, using British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rate at week 24, based on multiple comparison procedure-modelling analysis. Study visits were scheduled from week 0 to week 24, followed by a 2-week safety follow-up period for participants who chose not to enter the long-term extension. From weeks 2 to 12, glucocorticoid doses were tapered to a prednisone-equivalent dose of no more than 5 mg/day, as clinically tolerated. Adverse events were monitored continuously throughout the study; safety parameters (including physical examination, vital signs, and routine chemistry and haematology) were assessed at all study visits. The trial was registered at ClinicalTrials.gov (NCT05162586) and a long-term extension study is ongoing.

FINDINGS:

Between May 4, 2022, and Feb 6, 2024, participants were screened for eligibility for WILLOW cohorts A and B; 715 participants were screened and 354 were randomly allocated and included in the Cohort B safety population (95 to placebo, 71 to 25 mg enpatoran, 74 to 50 mg enpatoran, and 114 to 100 mg enpatoran). One patient allocated to the placebo group was found to be ineligible and was excluded from the full analysis set for the efficacy analyses. 335 (95%) of 353 participants were female, 18 (5%) were male, and median age was 41 years (IQR 33-51). At week 24, the study did not meet its primary objective of identifying a statistically significant dose-response relationship for enpatoran in BICLA response rate (p=0·14). BICLA response rates at week 24 were higher with all doses of enpatoran (25 mg: 41 [58%] of 71; odds ratio [OR] vs placebo 2·2 [95% CI 1·1-4·0], 50 mg: 36 [49%] of 74; OR 1·5 [95% CI 0·8-2·8], and 100 mg: 56 [49%] of 114; OR 1·6 [95% CI 0·9-2·8]) versus placebo (37 [39%] of 94). The most common treatment-emergent adverse event was diarrhoea, in four (6%) of 71, two (3%) of 74, and two (2%) of 114 participants in the 25 mg, 50 mg, and 100 mg enpatoran groups, respectively, and seven (7%) of 95 participants in the placebo group. Serious adverse events were reported in one (1%) of 71, three (4%) of 74, five (4%) of 114, and three (3%) of 95 participants treated with 25 mg, 50 mg, and 100 mg enpatoran and placebo, respectively.

INTERPRETATION:

In this study of participants with moderate-to-severe SLE, enpatoran improved BICLA response rates versus placebo; however, the primary objective of a statistically significant dose-dependent effect on disease activity based on BICLA response was not met. Enpatoran was well tolerated across all dose groups.

FUNDING:

Merck Healthcare (Darmstadt, Germany).

01 May 2026·LANCET

Could enpatoran add to our therapeutic toolbox in SLE?

Article

Author: McCann, Lia ; Durcan, Laura

News (Medical) associated with Enpatoran

13 May 2026

·www.emdgroup.com

Merck KGaA, Darmstadt, Germany, Delivers Solid Start to the Year and Upgrades Full-Year Guidance

Solid first-quarter performance driven by Process Solutions and Semiconductor Materials Strong foreign exchange effects remain a headwind Group net sales of € 5.1 billion (organic growth +2.9%) EBITDA pre of € 1.5 billion (organic growth +5.3%) Company upgrades full-year 2026 guidance Building from a position of strength, the Group sharpens its strategic direction to create mid- to long-term value and growth – and confirms its mid-term guidance Merck KGaA, Darmstadt, Germany, a leading science and technology company, delivered a solid start to fiscal 2026. In the first quarter, the Group generated moderate organic sales growth and sustained profitability. This was driven by Process Solutions and Semiconductor Materials, while strong foreign exchange effects continued to weigh on reported figures. “Our first-quarter performance underlines the strength of the company’s diversified portfolio and its clear focus on complementary science and technology businesses,” said Kai Beckmann, Chairman of the Executive Board and Group CEO of Merck KGaA, Darmstadt, Germany, since May 1. “Based on our performance in the first quarter and our current market conditions, we upgrade our full-year 2026 financial guidance. At the same time, we sharpen the strategic direction of the company for the long-term. As markets, technologies and customer needs evolve, we will adapt our operating model and move towards a stronger focus on integrated workflow solutions for customers, expanding our offerings for customers and patients and bundling capabilities across our businesses.” First-quarter results In the first quarter of 2026, reported Group net sales reached € 5.1 billion (Q1 2025: € 5.3 billion). Despite organic growth of 2.9% compared with the year-earlier quarter, strong foreign exchange effects had an impact of –5.5%, resulting in a 2.8% decline in reported net sales. EBITDA pre grew by 5.3% organically and amounted to € 1.5 billion (Q1 2025: € 1.5 billion), with foreign exchange effects of –5.7%. This corresponds to an improved EBITDA pre margin of 29.8% (Q1 2025: 29.1%), supported by one-time effects in the Electronics business sector. Earnings per share pre came in at € 2.11, in line with the year-earlier quarter (Q1 2025: € 2.12). The development reflects disciplined cost management and differing contributions from all three business sectors, offset by negative foreign exchange effects. Group performance shaped by solid demand In the first quarter of 2026, Merck KGaA, Darmstadt, Germany, recorded solid demand across its portfolio. Despite ongoing macroeconomic uncertainty and geopolitical tensions, this development reflects resilience in the company’s attractive growth markets. Demand trends varied across regions and applications, underscoring the value of the Group’s diversified business model and global footprint. Foreign exchange effects significantly weighed on reported sales and earnings at Group level, driven primarily by the development of the U.S. dollar against the euro as well as foreign exchange effects in key Asian markets. These effects are in line with the assumptions underlying the company’s guidance for the year. Life Science benefits from growth across the business with innovation at its core Life Science delivered a strong start to 2026, with organic growth across the business led by Process Solutions. The performance reflected the business sector’s breadth across research, development, manufacturing, and regulated applications, as well as a sharpened focus on operational effectiveness. Effective January 1, 2026, a new go-to-market model aligned the organization more closely with customer needs and purchasing journeys through three distinct business units: Process Solutions, Discovery Solutions and Advanced Solutions. Net sales of Life Science grew by 2.2% to € 2.3 billion. Strong organic growth of 8.3% overcame foreign exchange effects of –6.0%. EBITDA pre was € 649 million, an increase of 4.2% year-on-year. Organic growth of 7.4% and portfolio effects of 1.6% surpassed foreign exchange effects of –4.8%. Process Solutions, which offers solutions for every step of pharmaceutical manufacturing, remained the growth driver in the first quarter. Net sales grew organically by 16.2% and surpassed the threshold of € 1 billion. Growth was supported by strong momentum in downstream processing and single-use solutions, alongside limited safety stock building in response to regional developments as well as contributions from new customer projects. Order intake remained strong across the portfolio. On March 31, 2026, Life Science also closed the acquisition of JSR Life Sciences’ chromatography business. These technologies help improve productivity and support scalable biologics manufacturing. Discovery Solutions, with its digital-first portfolio of biology and chemistry products for research and early-stage workflows, grew organically by 1.6%. Due to foreign exchange effects, net sales declined to € 692 million. The business unit’s performance was supported by continued demand from academic, biotech and pharmaceutical customers in a gradually improving research spending environment. Advanced Solutions saw organic growth of 4.0%. However, foreign exchange effects and a small portfolio effect led to an overall decline of 2.7% to € 563 million. The business unit delivers tailored products and services that help customers address unique needs in high-touch and regulated environments. Performance was supported by demand for key solutions across the portfolio in quality-critical end markets such as diagnostics, testing and regulated manufacturing. Life Science continued to increase its investment in R&D, expanding its portfolio with solutions for improved performance across research and biopharmaceutical manufacturing. Recent launches include the digitally enabled Milli-Q® CLX 8Series systems, which enable clinical labs to target 99.9% uptime of high-quality purified water. The FemtoQuest™ system enhances capabilities for ultrasensitive biomarker detection with up to 1,000 times greater sensitivity than traditional methods. Furthermore, Millipore Express® Ace supports more efficient and sustainable sterilizing-grade filtration, underlining the company’s commitment to bringing greener alternatives to the market. These innovations help customers improve efficiency and performance across crucial research and manufacturing workflows. Healthcare delivers stable performance amid portfolio dynamics Sales in Healthcare were supported by treatments addressing rare diseases and cardiovascular, metabolic and endocrine diseases, while pricing and lifecycle effects continued to impact mature franchises. The business sector delivered net sales of € 2.1 billion and EBITDA pre of € 718 million in the first quarter of 2026. Overall, net sales declined organically by 3.4%. Positive portfolio effects added 4.4 percentage points, while foreign exchange effects had an impact of –4.0%. EBITDA pre was down 9.7% year-on-year, due mainly to foreign exchange effects of –8.5% and follow-on costs associated with the acquisition of SpringWorks Therapeutics Inc., USA, in 2025. The Rare Diseases franchise contributed significantly to the results, reflected as a portfolio effect of 4.4%. Net sales mainly include Ogsiveo®, which treats progressing desmoid tumors, and Gomekli®, approved for neurofibromatosis type 1. Following approval in China for the treatment of tenosynovial giant cell tumor (TGCT), pimicotinib has had an encouraging start and recorded its first sales in the first quarter of 2026. The Cardiovascular, Metabolism & Endocrinology franchise grew by 1.2% organically against a tough comparative base in the year-earlier quarter. Main drivers were the diabetes medicine Glucophage® with organic growth of 6.3% and the thyroid medicine Euthyrox®, which grew by 5.8% organically. In the Fertility franchise, Pergoveris®, indicated for the stimulation of follicular development in women, grew organically by 19.5% across all regions. This was more than offset by the organic decline of Gonal-f®, a follicle-stimulating hormone treatment, amid remaining net price effects in the United States. Net sales of the Oncology franchise declined organically by 4.9% compared with the year-earlier quarter. Erbitux®, a treatment for metastatic colorectal cancer and for cancer of the head and neck, saw an organic decline of 3.3% due to competition from non-comparable biologics in China. Bavencio®, which is used to treat locally advanced or metastatic urothelial carcinoma, declined organically by 13.5% amid increasing competition. In the Neurology & Immunology (N&I) franchise, Mavenclad®, indicated for relapsing forms of multiple sclerosis, saw an organic decline of 6.8% due to weaker demand in North America following the loss of market exclusivity in the United States. By contrast, organic sales continued to grow in Europe, the Middle East and Africa, and Latin America. Healthcare continues to focus on strengthening its position in rare diseases, advancing its pipeline through both internal and external innovation, and building its portfolio for sustainable profitable growth. Recent progress includes the first patient dosed in the Phase III program, ELOWEN‑1 (NCT07332481) and ELOWEN‑2 (NCT07355218), evaluating enpatoran in people living with lupus who experience active skin manifestations. In addition, ongoing regulatory filings include pimicotinib in the United States and Europe; and the company is filing Pergoveris® for review under the U.S. FDA Commissioner's National Priority Voucher (CNPV) program. Electronics supported by structural semiconductor trends Electronics recorded continued solid performance in the first quarter of 2026, with net sales of € 817 million and EBITDA pre of € 282 million. Demand was supported by advanced semiconductor applications, including materials used in artificial intelligence and high‑performance computing. Net sales grew organically by 4.2%. Due to portfolio effects of –10.6% and foreign exchange effects of –7.5%, reported net sales were lower year-on-year. EBITDA pre increased by 30.1% organically. This strong growth was driven by one-time effects from a reimbursement reflecting the recovery of costs incurred in connection with a non-quality-related supplier mislabeling dispute as well as the sale of OLED patents to Universal Display Corporation, USA. Foreign exchange effects had an impact of –‍9.2% and portfolio effects of –5.4%. Semiconductor Solutions achieved strong organic growth of 7.5%. However, net sales declined slightly to € 640 million due to foreign exchange effects of –9.1%. Semiconductor Materials grew organically in the low-teens percentage range on the back of continued demand for high-value materials for AI chip systems and advanced nodes. Advanced nodes are the latest semiconductor manufacturing processes that enable smaller feature sizes and the most powerful chips. Net sales in Delivery Systems & Services (DS&S) declined compared with the year-earlier quarter but stabilized sequentially. Net sales in Optronics were € 177 million. The Metrology & Inspection business, which provides equipment for semiconductor and optoelectronic manufacturing, grew organically in the mid-double-digit percentage range. The businesses with liquid crystals, photoresists for display applications and OLED materials declined organically due to lower demand. Merck KGaA, Darmstadt, Germany, offers one of the broadest portfolios of materials and material-related tools and equipment for the semiconductor industry. With its system know-how, the Electronics business sector is driving the convergence of optics and semiconductors to meet the demands of next-generation technologies for advanced chip systems. These tools are crucial for highly accurate wafer measurements, enabling process control and defect detection to enhance production yields and accelerate time-to-market. The company's integrated semiconductor solutions are enabling faster, smarter and more energy-efficient devices. Positioning Merck KGaA, Darmstadt, Germany, for evolving markets and future growth opportunities Against a dynamic market backdrop, Merck KGaA, Darmstadt, Germany, is sharpening its strategic direction to strengthen resilience and capture future growth opportunities. Building on its established positions across attractive markets and along the value chain, the company is continuing to align its portfolio, innovation priorities and operating model with areas of highest long-term value creation. This includes the continued development of differentiated, high-growth businesses and a stronger focus on integrated solutions across customer processes. It includes the increased use of platformed capabilities and AI to enhance speed, scalability and execution across the enterprise, and a disciplined approach to external innovation through partnerships, in-licensing and selective acquisitions. Through this approach, Merck KGaA, Darmstadt, Germany, aims to further strengthen its competitive position while advancing the foundations for sustainable, profitable growth over time. At the same time, the company confirms its mid-term guidance, while the multi-year measures outlined today are expected to be implemented progressively and to strengthen the foundation for higher long-term growth while sustaining attractive margins. Kai Beckmann, Chairman of the Executive Board and Group CEO of Merck KGaA, Darmstadt, Germany, said: “Merck KGaA, Darmstadt, Germany, is operating from a position of strength, building on more than 350 years of science-driven innovation. Our unique expertise in biology, chemistry, and physics enables us to play a leading role in translating the digital world into the real world. From the laboratory to our customers and patients, we are active along the entire industrial value chain. Our strategic direction aims to increase focus across our diversified portfolio, strengthen the company’s innovation engine and enhance the scalability of its operating model. This will enable us to respond to changing market conditions, increase implementation speed, flexibility and scalability, and drive growth and sustainable value over the long term.” Guidance for 2026 Based on the Group’s performance in the first quarter and current market conditions, Merck KGaA, Darmstadt, Germany, has upgraded the target corridors for its full‑year 2026 guidance. The company now expects net sales between € 20.4 billion and € 21.4 billion and EBITDA pre between € 5.7 billion and € 6.1 billion. This adjustment primarily reflects assumptions of stronger momentum in Life Science and Healthcare's resilience in a challenging environment. The guidance assumes no sales of Mavenclad® in the United Sates from May 2026 (previous forecast: from March 2026) amid generic competition and furthermore excludes the potential commercialization of Pergoveris® in the United States. As a result, the implied organic growth corridor for Group net sales shifts to 0% to +3%. Organic EBITDA pre growth is now expected at –2% to +2%. The company anticipates foreign exchange effects to impact net sales between –3% to –1%; for EBITDA pre, the range is –5% to –2%. This translates to an EPS pre between € 7.50 and € 8.20. At the same time, the company confirms its previous mid-term guidance. Merck KGaA, Darmstadt, Germany, targets annual organic sales growth in the mid-single-digit percentage range. For the EBITDA pre margin, the company sees potential for a step-up to approximately 30%, while the multi-year measures outlined today are expected to be implemented progressively and to strengthen the foundation for higher long-term growth while sustaining attractive margins. Overview of the key figures for Q1 2026 Merck KGaA, Darmstadt, Germany Key figures € million Q1 2026 Q1 2025 Change Net sales 5,134 5,280 -2.8% Operating result (EBIT)1 937 1,006 -6.8% Margin (% of net sales)1 18.3% 19.0% EBITDA2 1,434 1,479 -3.0% Margin (% of net sales)1 27.9% 28.0% EBITDA pre1 1,530 1,535 -0.3% Margin (% of net sales)1 29.8% 29.1% Profit after income tax 669 738 -9.4% Earnings per share (€) 1.52 1.69 -10.1% Earnings per share pre (€)1 2.11 2.12 -0.5% Operating cash flow 818 556 47.2% Net financial debt1, 3 8,318 8,619 -3.5% Number of employees4 62,477 62,604 -0.2% 1 Not defined by IFRS® Accounting Standards (IFRS Accounting Standards). 2 Not defined by IFRS Accounting Standards; EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 3 Figures for the reporting period ending on March 31, 2026, prior-year figures as of December 31, 2025. Life Science Net sales by business unit € million Q1 2026 Share Organic growth1 Exchange rate effects1 Acquisitions/ divestments1 Total change Q1 20252 Share Process Solutions 1,011 45% 16.2% -6.1% – -10.1% 919 41% Discovery Solutions 692 30% 1.6% -5.6% – -4.0% 721 33% Advanced Solutions 563 25% 4.0% -6.2% -0.5% -2.7% 578 26% Life Science 2,266 100% 8.3% -6.0% -0.1% 2.2% 2,218 100% 1 Not defined by IFRS Accounting Standards. 2 Prior-year figures have been adjusted to reflect the transformation of the three business units. Forecast for the Group Forecast for FY 2026 € million Net sales EBITDA pre1 Free cash flow Group ~20,400 to 21,400 Organic 0% to +3% Foreign exchange effect -3% to -1% Portfolio ~0% ~5,700 to 6,100 Organic -2% to +2% Foreign exchange effect -5% to -2% Portfolio ~0% ~1,600 to 2,100 Life Science ~9,100 to 9,500 Organic +4% to +7% Foreign exchange effect -3% to -1% Portfolio ~0% ~2,600 to 2,800 Organic +4% to +8% Foreign exchange effect -4% to -1% Portfolio ~+1% n/a Healthcare ~8,100 to 8,500 Organic -6% to -3% Foreign exchange effect -3% to 0% Portfolio ~+2% ~2,600 to 2,800 Organic -12% to -8% Foreign exchange effect -5% to -2% Portfolio ~0% n/a Electronics ~3,200 to 3,400 Organic +3% to +7% Foreign exchange effect -4% to -2% Portfolio ~-7% ~900 to 1,000 Organic +21% to +27% Foreign exchange effect -4% to -1% Portfolio ~-4% n/a Corporate and Other n/a ~-450 n/a Notes to editors: The press conference for media representatives will take place at 9:30 a.m. (CEST). The respective presentation and further information for journalists, including a digital press kit, can be found here. The quarterly statement can be found here. Merck KGaA, Darmstadt, Germany, on LinkedIn. Company photos and videos can be found here. Merck KGaA, Darmstadt, Germany, stock symbols: Reuters: MRCG, Bloomberg: MRK GY, Dow Jones: MRK.DE Frankfurt Stock Exchange: ISIN: DE 000 659 9905 – WKN: 659 990

AcquisitionDrug ApprovalPhase 3

06 May 2026

·www.biospace.com

Merck Announces First Dose in Phase 3 Study with Enpatoran for Lupus Patients with Active Skin Manifestations

Significant unmet need remains for 85% of lupus patients whose disease includes skin manifestations, often associated with substantial physical and psychosocial burden Enpatoran, an oral TLR7/8 inhibitor, is designed for lupus patients with active cutaneous manifestations, with the goal of broadening the treatment paradigm beyond the current standards ELOWEN is a global Phase 3 program evaluating enpatoran’s impact on both skin and systemic symptoms in patients with lupus and potential links between skin and systemic disease activity Merck, a leading global science and technology company, today announced the first patient was dosed in the Phase 3 program, ELOWEN-1 (NCT07332481) and ELOWEN-2 (NCT07355218), evaluating enpatoran in people living with lupus who experience active skin manifestations. “People living with lupus continue to face significant challenges in achieving disease control and are very often affected by itchy, painful and stigmatized skin manifestations,” said David Weinreich, Global Head of R&D, Merck. “With enpatoran, we aim to target the underlying drivers of lupus and redefine how to approach the disease by understanding both visible skin manifestations and systemic activity.” Enpatoran is an oral selective toll-like receptor (TLR) 7/8 inhibitor designed to modulate pathways central to lupus-related inflammation.1 By targeting these upstream drivers, enpatoran has the potential to impact disease activity and address a key aspect of the lupus mechanism that remains difficult to manage with current treatment approaches, while preserving the body’s broader immune function.1 “The ELOWEN program builds on Phase 2 findings, where enpatoran demonstrated clinically meaningful improvements in patients with active cutaneous manifestations, regardless of their underlying lupus diagnosis,” said Professor Eric Morand, principal investigator. “These studies are designed to further explore how targeting shared inflammatory pathways may benefit patients across the lupus spectrum.” Lupus is a chronic autoimmune disease that can affect multiple organ systems, including the skin, joints, kidneys and central nervous system.2 Up to 85% of patients experience skin manifestations, which are among the most visible signs of disease and may reflect underlying immune-driven inflammation.1 Skin manifestations can be life-altering and sometimes are irreversible on their own.3,4 They can present as inflamed, photosensitive lesions on the face, scalp and other areas, and may lead to scarring or pigment changes.5 Despite their prevalence and the fact that skin manifestations are the first sign of disease in nearly one third (29%) of cases,1 many patients still do not achieve adequate disease control.6 “Skin symptoms impose a profound and multilayered burden that lingers long after flares subside. The lesions are visible, disfiguring and often painful, and the psychological weight can be equally debilitating, breeding a loss of identity that standard clinical assessments often fail to capture,” said Dr. Joy Buie, PhD, VP of Research at the Lupus Foundation of America. “These consequences erode participation in work, social life, and intimate relationships as self-consciousness and deliberate avoidance quietly reshape how patients navigate the world around them. It is vital we recognize skin manifestations as a visible and clinically actionable signal of underlying systemic disease " ELOWEN-1 and ELOWEN-2 are two global randomized, double-blind, placebo-controlled Phase 3 studies evaluating enpatoran taken twice daily versus placebo, on top of standard of care, in patients with lupus who have active cutaneous manifestations. The ELOWEN studies will be conducted in 266 sites in 26 countries. Each study will recruit approximately 200 lupus participants, and the primary endpoint will be a change in CLASI-A from baseline. Enpatoran is an investigational, oral, selective inhibitor of toll-like receptors 7 and 8 (TLR7/8), which play a key role in immune pathways involved in lupus. Enpatoran has the potential to be the first targeted therapy for lupus patients with active cutaneous manifestations, with the goal of broadening the treatment paradigm beyond the current standards of care for patients with CLE and SLE. Enpatoran is currently under clinical investigation and has not been approved for any use anywhere in the world. ELOWEN-1 (NCT07332481) and ELOWEN-2 (NCT07355218) are two global randomized, double-blind, placebo-controlled Phase 3 studies evaluating enpatoran taken twice daily versus placebo, on top of standard of care, in patients with lupus who have active cutaneous manifestations. The ELOWEN studies will be conducted in 266 sites in 26 countries. Each study will recruit approximately 200 lupus participants, and the primary endpoint will be a change in CLASI-A from baseline. Lupus erythematosus is a chronic autoimmune disease characterized by inflammation that can affect multiple organs and systems in the body. The disease is heterogeneous, with symptoms ranging from mild to life-threatening, and often follows a relapsing-remitting course. Cutaneous manifestations are common (72-85%) of patients and can occur alongside or independently of systemic involvement. Beyond their physical presentation, they are associated with increased disease burden, including scarring, psychological impact and reduced quality of life. Lupus disproportionately affects women and people of color, and many patients continue to experience unmet medical needs due to insufficient disease control or treatment-related side effects. Merck has a long-standing legacy in neurology and immunology. The company’s current neurology portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine) tablets. Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck’s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including lupus and generalized myasthenia gravis (gMG). Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2025, Merck generated sales of € 21.1 billion in 65 countries. Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics. All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to to register online, change your selection or discontinue this service. 1 Childs B and Merola JF. From the Masterclasses in Dermatology 2025 Meeting: Practical Approaches to Cutaneous and Systemic Lupus for Dermatologists. J Clin Aesthet Dermatol. 2025;18(10):40–47. 2 Lupus Research Alliance. What Is Lupus? Available at: . Last accessed: April 2026. 3 Klein R, Moghadam-Kia S, Taylor L, et al. Quality of Life in Cutaneous Lupus Erythematosus. J Am Acad Dermatol. 2011 Mar 12;64(5):849–858. 4 Chambers S, On A, Yang X, et al. Dyspigmentation and scarring in cutaneous lupus erythematosus. Lupus Sci Med. 2025;12(2). 5 Lupus Foundation of America. What is lupus? Available at: . Last accessed: April 2026. 6 Kandane-Rathnayake, Louthrenoo W, Hoi A, et al. ‘Not at target’: prevalence and consequences of inadequate disease control in systemic lupus erythematosus—a multinational observational cohort study. Arthritis Res Ther. 2022;24:70. The content above comes from the network. if any infringement, please contact us to modify.

30 Apr 2026

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Merck KGaA, Darmstadt, Germany, Announces First Dose in Phase 3 Study with Enpatoran for Lupus Patients with Active Skin Manifestations

Significant unmet need remains for 85% of lupus patients whose disease includes skin manifestations, often associated with substantial physical and psychosocial burden Enpatoran, an oral TLR7/8 inhibitor, is designed for lupus patients with active cutaneous manifestations, with the goal of broadening the treatment paradigm beyond the current standards ELOWEN is a global Phase 3 program evaluating enpatoran’s impact on both skin and systemic symptoms in patients with lupus and potential links between skin and systemic disease activity Not intended for UK-based media DARMSTADT, Germany--(BUSINESS WIRE)--Merck KGaA, Darmstadt, Germany, a leading global science and technology company, today announced the first patient was dosed in the Phase 3 program, ELOWEN-1 ( NCT07332481 ) and ELOWEN-2 ( NCT07355218 ), evaluating enpatoran in people living with lupus who experience active skin manifestations. “People living with lupus continue to face significant challenges in achieving disease control and are very often affected by itchy, painful and stigmatized skin manifestations,” said David Weinreich, Global Head of R&D, Merck KGaA, Darmstadt, Germany. “With enpatoran, we aim to target the underlying drivers of lupus and redefine how to approach the disease by understanding both visible skin manifestations and systemic activity.” Enpatoran is an oral selective toll-like receptor (TLR) 7/8 inhibitor designed to modulate pathways central to lupus-related inflammation. 1 By targeting these upstream drivers, enpatoran has the potential to impact disease activity and address a key aspect of the lupus mechanism that remains difficult to manage with current treatment approaches, while preserving the body’s broader immune function. 1 “The ELOWEN program builds on Phase 2 findings, where enpatoran demonstrated clinically meaningful improvements in patients with active cutaneous manifestations, regardless of their underlying lupus diagnosis,” said Professor Eric Morand, principal investigator. “These studies are designed to further explore how targeting shared inflammatory pathways may benefit patients across the lupus spectrum.” Lupus is a chronic autoimmune disease that can affect multiple organ systems, including the skin, joints, kidneys and central nervous system. 2 Up to 85% of patients experience skin manifestations, which are among the most visible signs of disease and may reflect underlying immune-driven inflammation. 1 Skin manifestations can be life-altering and sometimes are irreversible on their own. 3,4 They can present as inflamed, photosensitive lesions on the face, scalp and other areas, and may lead to scarring or pigment changes. 5 Despite their prevalence and the fact that skin manifestations are the first sign of disease in nearly one third (29%) of cases, 1 many patients still do not achieve adequate disease control. 6 “Skin symptoms impose a profound and multilayered burden that lingers long after flares subside. The lesions are visible, disfiguring and often painful, and the psychological weight can be equally debilitating, breeding a loss of identity that standard clinical assessments often fail to capture”, said Dr. Joy Buie, PhD, VP of Research at the Lupus Foundation of America. “These consequences erode participation in work, social life, and intimate relationships as self-consciousness and deliberate avoidance quietly reshape how patients navigate the world around them. It is vital we recognize skin manifestations as a visible and clinically actionable signal of underlying systemic disease " ELOWEN-1 and ELOWEN-2 are two global randomized, double-blind, placebo-controlled Phase 3 studies evaluating enpatoran taken twice daily versus placebo, on top of standard of care, in patients with lupus who have active cutaneous manifestations. The ELOWEN studies will be conducted in 266 sites in 26 countries. Each study will recruit approximately 200 lupus participants, and the primary endpoint will be a change in CLASI-A from baseline. About Enpatoran Enpatoran is an investigational, oral, selective inhibitor of toll-like receptors 7 and 8 (TLR7/8), which play a key role in immune pathways involved in lupus. Enpatoran has the potential to be the first targeted therapy for lupus patients with active cutaneous manifestations, with the goal of broadening the treatment paradigm beyond the current standards of care for patients with CLE and SLE. Enpatoran is currently under clinical investigation and has not been approved for any use anywhere in the world. About the Phase 3 ELOWEN Program ELOWEN-1 ( NCT07332481 ) and ELOWEN-2 ( NCT07355218 ) are two global randomized, double-blind, placebo-controlled Phase 3 studies evaluating enpatoran taken twice daily versus placebo, on top of standard of care, in patients with lupus who have active cutaneous manifestations. The ELOWEN studies will be conducted in 266 sites in 26 countries. Each study will recruit approximately 200 lupus participants, and the primary endpoint will be a change in CLASI-A from baseline. About Lupus Erythematosus Lupus erythematosus is a chronic autoimmune disease characterized by inflammation that can affect multiple organs and systems in the body. The disease is heterogeneous, with symptoms ranging from mild to life-threatening, and often follows a relapsing-remitting course. Cutaneous manifestations are common (72-85%) of patients and can occur alongside or independently of systemic involvement. Beyond their physical presentation, they are associated with increased disease burden, including scarring, psychological impact and reduced quality of life. Lupus disproportionately affects women and people of color, and many patients continue to experience unmet medical needs due to insufficient disease control or treatment-related side effects. Merck KGaA, Darmstadt, Germany in Neurology and Immunology Merck KGaA, Darmstadt, Germany has a long-standing legacy in neurology and immunology. The company’s current neurology portfolio includes two products for the treatment of relapsing MS – Rebif ® (interferon beta-1a) and MAVENCLAD ® (cladribine) tablets. Merck KGaA, Darmstadt, Germany aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck KGaA, Darmstadt, Germany’s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including lupus and generalized myasthenia gravis (gMG). About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2025, Merck KGaA, Darmstadt, Germany, generated sales of € 21.1 billion in 65 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to to register for your online, change your selection or discontinue this service. ____________________ 1 Childs B and Merola JF. From the Masterclasses in Dermatology 2025 Meeting: Practical Approaches to Cutaneous and Systemic Lupus for Dermatologists. J Clin Aesthet Dermatol . 2025;18(10):40–47. 2 Lupus Research Alliance. What Is Lupus? Available at: . Last accessed: April 2026. 3 Klein R, Moghadam-Kia S, Taylor L, et al. Quality of Life in Cutaneous Lupus Erythematosus. J Am Acad Dermatol . 2011 Mar 12;64(5):849–858. 4 Chambers S, On A, Yang X, et al. Dyspigmentation and scarring in cutaneous lupus erythematosus. Lupus Sci Med . 2025;12(2). 5 Lupus Foundation of America. What is lupus? Available at: . Last accessed: April 2026. 6 Kandane-Rathnayake, Louthrenoo W, Hoi A, et al. ‘Not at target’: prevalence and consequences of inadequate disease control in systemic lupus erythematosus—a multinational observational cohort study. Arthritis Res Ther. 2022;24:70. Contacts Media Relations flavia.felix@emdserono.com Phone: +1 781 427 1892

Phase 3Phase 2

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Erythematosus, Discoid	Phase 3	United States	EMD Serono Research & Development Institute, Inc.	10 Mar 2026
Systemic Lupus Erythematosus	Phase 3	United States	EMD Serono Research & Development Institute, Inc.	10 Mar 2026
Dermatomyositis	Phase 2	United States	Merck KGaA	19 Jan 2023
Dermatomyositis	Phase 2	Czechia	Merck KGaA	19 Jan 2023
Dermatomyositis	Phase 2	Greece	Merck KGaA	19 Jan 2023
Dermatomyositis	Phase 2	Italy	Merck KGaA	19 Jan 2023
Dermatomyositis	Phase 2	Poland	Merck KGaA	19 Jan 2023
Dermatomyositis	Phase 2	Spain	Merck KGaA	19 Jan 2023
Dermatomyositis	Phase 2	United Kingdom	Merck KGaA	19 Jan 2023
COVID-19	Phase 2	United States	Merck KGaA	29 Jul 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05162586 (WILLOW, Pubmed \| Lancet)	Phase 2	Systemic Lupus Erythematosus	353	Enpatoran 25 mg	dykrkcobtl(gzpmokweku) = tlrswoqkfj fmsybkfpcn (gkfpujeatb ) View more	Negative	01 May 2026
				Enpatoran 50 mg	dykrkcobtl(gzpmokweku) = tcuxzfscij fmsybkfpcn (gkfpujeatb ) View more
NCT05162586 (WILLOW, Pubmed \| Lancet Rheumatol)	Phase 2	Lupus Erythematosus, Cutaneous \| Systemic Lupus Erythematosus	100	Enpatoran 25 mg	kilzqxpjsq(yazbnfrfrv) = bgnsuimhkg iakmrfpxyd (wwckzrsjgs, -70 to -58) View more	Positive	01 May 2026
				Enpatoran 50 mg	kilzqxpjsq(yazbnfrfrv) = efgutavgkt iakmrfpxyd (wwckzrsjgs, -75 to -61)
NCT05162586 (WILLOW, CTgov)	Phase 2	Lupus Erythematosus, Cutaneous \| Systemic Lupus Erythematosus \| Lupus Erythematosus, Discoid	456	Placebo (Cohort A: Placebo)	hugvdopkho(dgiduhtvfv) = anpibahert fdwqmlskje (xghlwwwqjp, 3.94) View more	-	01 Dec 2025
				Placebo (Cohort B (Part 1 + Part 2): Placebo)	rnzjimsbmr = ffmxpwwfjy flnqeqynth (mwmtxdptla, oydlpgtfnp - nmzjorazrw) View more
NCT05162586 (WILLOW, ACR2025)	Phase 2	Lupus Erythematosus, Cutaneous	262	Enpatoran	cayfpvfsvi(nmkslfgxjz) = dgaiqqpirj lamkuffndi (ooxwcekxzl ) View more	Positive	24 Oct 2025
				Placebo	cayfpvfsvi(nmkslfgxjz) = wryabqdxra lamkuffndi (ooxwcekxzl ) View more
NCT05162586 (WILLOW, EULAR2025) Manual	Phase 2	Systemic Lupus Erythematosus	354	Placebo	dxryqljejz(xwxypohavu) = gubodgxzcd eeqwucjzca (vsxvplthwo ) View more	Positive	11 Jun 2025
				Enpatoran 25mg BID	dxryqljejz(xwxypohavu) = podwteuywm eeqwucjzca (vsxvplthwo ) View more
NCT05162586 (WILLOW, EULAR 12025 \| EULAR 22025)	Phase 2	Systemic Lupus Erythematosus	353	ENPATORAN 25 mg BID	solcoaibyu(vcfdhtxnzf) = ojbzhitrcu wojgiayvkk (dqbxboedpf ) View more	Positive	11 Jun 2025
				ENPATORAN 50 mg BID	solcoaibyu(vcfdhtxnzf) = yqbqwxclwz wojgiayvkk (dqbxboedpf )
NCT05162586 (ACR2022) Manual	Phase 1	-	36	Enpatoran	gputkpowxo(igzpiwvtsm) = Cmax: 0.9409 [0.7855–1.1270]; AUC0-inf: 0.8959 [0.7497–1.0704] and AUC0-tlast: 0.8963 [0.7511–1.0695]). zjmroyrrfy (axilnosvto ) View more	Positive	12 Sep 2022
NCT04448756 (ANEMONE, CTgov)	Phase 2	COVID-19	149	Placebo (Placebo)	ytyrwbqvtu(jrarwzdowc) = dqcpasmgzj ouivvijctl (uqfflfhjim, cdfptbveqj - xaykjrljym) View more	-	06 Jun 2022
				M5049 (M5049 100 mg)	ytyrwbqvtu(jrarwzdowc) = rptmbglxxu ouivvijctl (uqfflfhjim, qlkofbtbew - daeqlzvnwj) View more
NCT04448756 (ANEMONE, EULAR2022)	Phase 2	COVID-19 cytokines \| C-reactive protein \| D-dimer ... View more	149	Enpatoran 50 mg BID	jcieuzyntg(tdrfmbgebi) = brmuctakbq kqkgxejeew (honwttbxuj ) View more	Positive	01 Jun 2022
				Enpatoran 100 mg BID	jcieuzyntg(tdrfmbgebi) = nblverldvw kqkgxejeew (honwttbxuj ) View more
NCT03676322 (Pubmed) Manual	Phase 1	Autoimmune Diseases	96	M5049 (single-dose)	ymjkrbunwx(vyihrhekez) = tstlltykka imldtmtpfz (zrzymmtuqk ) View more	Positive	01 Oct 2021
				M5049 (multiple-dose)	ymjkrbunwx(vyihrhekez) = wgsfsijmtr imldtmtpfz (zrzymmtuqk )

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