Request Demo
Last update 17 Aug 2026
Enpatoran
Last update 17 Aug 2026
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms M 5049, M-5049, M0549 |
Target |
Action antagonists |
Mechanism TLR7 antagonists(Toll like receptor 7 antagonists), TLR8 antagonists(Toll like receptor 8 antagonists) |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
Login to view timeline
Structure/Sequence
Molecular FormulaC16H15F3N4 |
InChIKeyBJXYHBKEQFQVES-NWDGAFQWSA-N |
CAS Registry2101938-42-3 |
Related
12
Clinical Trials associated with EnpatoranNCT07332481
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.
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 |
NCT06589713
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 |
NCT06589726
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 |
100 Clinical Results associated with Enpatoran
Login to view more data
100 Translational Medicine associated with Enpatoran
Login to view more data
100 Patents (Medical) associated with Enpatoran
Login to view more data
21
Literatures (Medical) associated with Enpatoran01 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
24
News (Medical) associated with Enpatoran08 Jul 2026
DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading science and technology company, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enpatoran for the treatment of lupus with active cutaneous manifestations. Enpatoran is an oral selective toll-like receptor (TLR) 7/8 inhibitor, designed to modulate pathways central to lupus-related inflammation.
“For the 85% of lupus patients whose disease includes skin manifestations, often associated with substantial physical and psychosocial burden, the lack of targeted treatment makes the disease hard to control,” said David Weinreich, MD, MBA, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck. “This Breakthrough Therapy designation demonstrates that enpatoran has the potential to redefine how we approach lupus, by addressing the visible burden of rash, while potentially driving benefit beyond the skin. We look forward to working with the FDA to potentially bring this much-needed option to patients as quickly as possible.”
The FDA Breakthrough Therapy designation is supported by results from the Phase 2 WILLOW study, a multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety and efficacy of orally administered enpatoran. The trial used an innovative basket and adaptive study design including patients with both CLE (Cutaneous Lupus Erythematosus) and SLE (Systemic Lupus Erythematosus). The results demonstrated that enpatoran delivered clinically meaningful improvements of lupus symptoms, particularly in patients with active cutaneous manifestations.
Additionally, Merck recently initiated the ELOWEN 1 and ELOWEN 2 studies, a global Phase 3 program evaluating the therapy’s impact on both cutaneous and systemic symptoms in patients with lupus and potential links between skin and systemic disease activity.
Lupus is a chronic autoimmune disease that can affect multiple organ systems, including the skin, joints, kidneys, and central nervous system. Skin manifestations, which can present as inflamed, photosensitive lesions on the face, scalp and other areas, may be life-altering and are sometimes irreversible on their own. But, despite skin manifestations being the first sign of disease in nearly one-third (29%) of lupus cases,1 many patients still do not achieve adequate disease control.2
FDA Breakthrough Therapy designation is a process aimed at expediting the development and review of drugs for serious conditions, where the preliminary clinical evidence indicates that the drug may offer a substantial improvement over available therapy.
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%) in 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 in Neurology and Immunology
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. 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).
About Merck
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 www.merckgroup.com/subscribe 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 Kandane-Rathnayake R, 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(1):70.
Phase 3Clinical ResultPhase 2Breakthrough Therapy
08 Jul 2026
Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies
FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations
Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA’s breakthrough designation, which is designed to expedite drug development and review
Merck, a leading science and technology company, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enpatoran for the treatment of lupus with active cutaneous manifestations. Enpatoran is an oral selective toll-like receptor (TLR) 7/8 inhibitor, designed to modulate pathways central to lupus-related inflammation.
“For the 85% of lupus patients whose disease includes skin manifestations, often associated with substantial physical and psychosocial burden, the lack of targeted treatment makes the disease hard to control,” said David Weinreich, MD, MBA, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck. “This Breakthrough Therapy designation demonstrates that enpatoran has the potential to redefine how we approach lupus, by addressing the visible burden of rash, while potentially driving benefit beyond the skin. We look forward to working with the FDA to potentially bring this much-needed option to patients as quickly as possible.”
The FDA Breakthrough Therapy designation is supported by results from the Phase 2 WILLOW study, a multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety and efficacy of orally administered enpatoran. The trial used an innovative basket and adaptive study design including patients with both CLE (Cutaneous Lupus Erythematosus) and SLE (Systemic Lupus Erythematosus). The results demonstrated that enpatoran delivered clinically meaningful improvements of lupus symptoms, particularly in patients with active cutaneous manifestations.
Additionally, Merck recently initiated the ELOWEN 1 and ELOWEN 2 studies, a global Phase 3 program evaluating the therapy’s impact on both cutaneous and systemic symptoms in patients with lupus and potential links between skin and systemic disease activity.
Lupus is a chronic autoimmune disease that can affect multiple organ systems, including the skin, joints, kidneys, and central nervous system. Skin manifestations, which can present as inflamed, photosensitive lesions on the face, scalp and other areas, may be life-altering and are sometimes irreversible on their own. But, despite skin manifestations being the first sign of disease in nearly one-third (29%) of lupus cases,[1] many patients still do not achieve adequate disease control.[2]
FDA Breakthrough Therapy designation is a process aimed at expediting the development and review of drugs for serious conditions, where the preliminary clinical evidence indicates that the drug may offer a substantial improvement over available therapy.
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%) in 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.
Phase 3Clinical ResultPhase 2Breakthrough TherapyDrug Approval
13 May 2026
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
100 Deals associated with Enpatoran
Login to view more data
R&D Status
10 top R&D records. to view more data
Login
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Lupus Erythematosus, Discoid | Phase 3 | United States | 10 Mar 2026 | |
| Lupus Erythematosus, Discoid | Phase 3 | Japan | 10 Mar 2026 | |
| Lupus Erythematosus, Discoid | Phase 3 | Switzerland | 10 Mar 2026 | |
| Systemic Lupus Erythematosus | Phase 3 | United States | 10 Mar 2026 | |
| Systemic Lupus Erythematosus | Phase 3 | Japan | 10 Mar 2026 | |
| Systemic Lupus Erythematosus | Phase 3 | Switzerland | 10 Mar 2026 | |
| Dermatomyositis | Phase 2 | United States | 19 Jan 2023 | |
| Dermatomyositis | Phase 2 | Czechia | 19 Jan 2023 | |
| Dermatomyositis | Phase 2 | Greece | 19 Jan 2023 | |
| Dermatomyositis | Phase 2 | Italy | 19 Jan 2023 |
Login to view more data
Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2 | 100 | wfrjetarue(kgpjuwmart) = oznjjthuwf bbiuztyhhj (omsgsdudeo, -70 to -58) View more | Positive | 01 Jul 2026 | |||
wfrjetarue(kgpjuwmart) = wvqsucbiub bbiuztyhhj (omsgsdudeo, -75 to -61) | |||||||
Phase 2 | 379 | tmtvhvihgi(ljmffyzwib) = mxusydxvqe yrzbzjhryr (sddosrvnba ) View more | Positive | 11 Jun 2026 | |||
tmtvhvihgi(ljmffyzwib) = uuzzaxuwaw yrzbzjhryr (sddosrvnba ) View more | |||||||
Phase 2 | 262 | (CLE) | dcbdhrxpvv(skxcefyvkp) = ergpdtxssa egqjpaeivp (ytgkegqpjh ) | Positive | 11 Jun 2026 | ||
(SLE) | ggbmhidqtv(hikjnyvdvx) = lfxxistjnz mxauhwnrhm (xogmlsechp ) | ||||||
Phase 3 | 298 | (Standard of care (corticosteroid taper)) | sfemwtkbat(psviotcovz) = yajzrondxt qbldswxprp (wevvmqglhs ) View more | Positive | 11 Jun 2026 | ||
Placebo (Standard of care (corticosteroid taper)) | axyenrwboy(hinwarkege) = peyfyxcfrb qcxwweprnd (bmkhjedvrw ) View more | ||||||
Phase 2 | 353 | nghysrdifs(vncgetthve) = nmimrijsce yqkiaabgio (chvmxoqgta ) View more | Negative | 01 May 2026 | |||
nghysrdifs(vncgetthve) = ngylgyoiel yqkiaabgio (chvmxoqgta ) View more | |||||||
Phase 2 | 456 | Placebo (Cohort A: Placebo) | viuconsvdd(inzzmherlu) = ojkazhtfbv srzvxspfpa (naesbqmdqi, 3.94) View more | - | 01 Dec 2025 | ||
Placebo (Cohort B (Part 1 + Part 2): Placebo) | qnsmfrzwrn = cvohlwhoay ystngpxbzt (fsmllfgpaz, tsdrdotpyd - rjiuzcfeaa) View more | ||||||
Phase 2 | 262 | ldykixdmoo(lrlqwnmlfs) = ustknsazft gwpzzlkcxn (xjbphqjwoe ) View more | Positive | 24 Oct 2025 | |||
Placebo | ldykixdmoo(lrlqwnmlfs) = czvhkfuevf gwpzzlkcxn (xjbphqjwoe ) View more | ||||||
Phase 2 | 354 | Placebo | pkjfnjahit(quroaysquo) = tfqkddkdyj iwqmkmtkqr (arabozfiqq ) View more | Positive | 11 Jun 2025 | ||
pkjfnjahit(quroaysquo) = fjxwkxzqvj iwqmkmtkqr (arabozfiqq ) View more | |||||||
Phase 2 | 353 | ezsrpubhny(oxpxvmbqtk) = gaodkovsaf fvoncqncdy (acecomqtwe ) View more | Positive | 11 Jun 2025 | |||
ezsrpubhny(oxpxvmbqtk) = epufohazcy fvoncqncdy (acecomqtwe ) | |||||||
NCT05162586 (ACR2022) Manual  | Phase 1 | - | 36 | omjstfabxi(yrxziymccw) = Cmax: 0.9409 [0.7855–1.1270]; AUC0-inf: 0.8959 [0.7497–1.0704] and AUC0-tlast: 0.8963 [0.7511–1.0695]). iqoapewpxz (voczxjnxie ) View more | Positive | 12 Sep 2022 |
Login to view more data
Translational Medicine
Boost your research with our translational medicine data.
login
or
Deal
Boost your decision using our deal data.
login
or
Core Patent
Boost your research with our Core Patent data.
login
or
Clinical Trial
Identify the latest clinical trials across global registries.
login
or
Approval
Accelerate your research with the latest regulatory approval information.
login
or
Regulation
Understand key drug designations in just a few clicks with Synapse.
login
or
Hiro LS Researcher
The AI Search Engine Built to Accelerate Biopharma Decisions
Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.
Ask any biopharma research question→
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Discover Synapse Data Servers
Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free