Almirall performed even better than anticipated in 2024 and further grew its European dermatology business, according to a Company press release.

After the approval of lebrikizumab (Ebglyss) by the European Commission (EC), the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, and Switzerland, the product has now launched in 11 countries in Europe (in 2023: Germany, in 2024: Norway, UK, Spain, Denmark, the Czech Republic, the Netherlands, and in 2025: Italy, Switzerland, Austria, Belgium, and Sweden).

The rollout in the remaining European countries is expected throughout 2025. In 2024, Almirall’s collaborator Lilly received US FDA approval for lebrikizumab and subsequently launched the product in the US.

Lebrikizumab is an anti-IL13 monoclonal antibody for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

Tildrakizumab (Ilumetri), an anti-IL-23 high-affinity humanized monoclonal antibody indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis, delivered very strong growth across all regions and achieved €209 MM in 2024, a year-on-year growth of 26% after an already strong performance in 2023.

This performance is further supported by the recent launch of the 200mg dose option as an alternative to the 100mg dose. Almirall anticipates sustaining the momentum of tildrakizumab in the short to mid-term.

Additionally, Wynzora cream, a once-daily aqueous cream with a fixed combination of calcipotriene and betamethasone dipropionate (CAL/BDP), indicated for the topical treatment of mild-to-moderate psoriasis vulgaris in adults, including scalp, experienced a continued significant sales increase driven by a combination of in-market growth and recent country launches.

Tirbanibulin (Klisyri), a microtubule inhibitor for the topical treatment of actinic keratosis (AK) of the face or scalp, continued to grow significantly across major markets. The company anticipates that the favorable growth trend for this product will continue in Europe and will be further fueled by the recent approval of the large field application in the US which opens up opportunities for dermatologists to treat a wide range of patients.

What’s in the Pipeline?

Almirall’s R&D pipeline is solely focused on medical dermatology.

In Almirall’s late-stage pipeline, it successfully completed the decentralized regulatory approval procedure for efinaconazole (Jublia) in Europe and is expecting national marketing authorizations in Europe during the first half of 2025.

Sarecycline’s (Seysara) regulatory review in China is ongoing, with an anticipated approval in the second half of 2025.

To expand the label for Klisyri to include large field application also in Europe, a current clinical study is aimed at enabling approval for an anticipated launch in 2026.

Almirall’s strategy of providing more value to the established biologic products – tildrakizumab and lebrikizumab – is focused on close collaborations with its partners. Sun Pharma is running two Phase III studies to assess the efficacy and safety of tildrakizumab in patients with psoriatic arthritis. The first results are expected in the second half of 2025.

Almirall, together with its collaborator Eli Lilly, are running a comprehensive program of clinical trials with the aim of further expanding the indications for Lebrikizumab. This includes a Phase III study run by Lilly which explores its safety and efficacy in patients from 6 months to under 18 years to make the benefits of lebrikizumab accessible to the pediatric population.

Almirall is currently conducting the ADTrust study, a 1200 patient pan-European, prospective observational 2-year study that aims to explore the physical, psychological and social impact of Atopic Dermatitis and the treatment with lebrikizumab on patient’s lives over 24 months in real-world clinical practice settings. The first patient was recruited into the study in January 2025, and its conclusion is forecasted for 2028.

In the next 15 months, the start of four Proof of Concept (PoC) clinical studies across a spectrum of different diseases is planned.

The company is continuing to advance the asset ALM27134, a first-in-class fully human, high-affinity monoclonal antibody that targets IL-1RAP (Interleukin-1 Receptor Accessory Protein) for the treatment of autoimmune dermatological diseases. This monoclonal antibody has the potential to address the unmet needs in several autoimmune dermatology indications. The phase I study of ALM27134 is ongoing, with single and multiple ascending doses in healthy volunteers completed, and now advancing to explore the pharmacokinetics and safety of this novel treatment candidate. The start of a Phase II study is planned for later this year in patients suffering from Hidradenitis Suppurativa.

Phase I of ALM223, an IL-2 mutant fusion protein (IL-2muFc) drug candidate developed in collaboration with Simcere is ongoing. This molecule is designed to activate regulatory T-cells and has the potential to rebalance the immune system in several autoimmune diseases^.

Clinical supply manufacturing of the company’s anti-IL-21 monoclonal antibody is ongoing to prepare for the launch of phase II testing. IL-21 is a cytokine involved both in B- and T-cell biology and likely to be involved in several immune-mediated skin diseases.

ZKN-013 is an oral readthrough inducer designed to overcome nonsense mutations that cause a premature stop codon. ZKN-013 has promising potential in several rare indications, such as Dystrophic Epidermolysis Bullosa (RDEB), Junctional Epidermolysis Bullosa (JEB), and familial adenomatous polyposis (FAP). The phase I clinical study with ZKN-013 in healthy volunteers is currently ongoing.

New Partnerships

In January 2024, Almirall announced a collaboration with Microsoft to advance its capabilities in the area of generative Artificial Intelligence (genAI) for the rapid analysis of extensive datasets creating a digital, agile, and patient-centric approach. Within Almirall R&D, the focus includes accelerating the discovery of new therapeutic targets, and to generate new product technologies for Almirall’s dermatology pipeline. Furthermore, Almirall will establish a new approach to technology-aided data management to optimize access to high-quality data, including data governance, quality processes, and digital identity management.

In February, the company announced a partnership with the Centre for Genomic Regulation (CRG) to identify biomarkers to build new disease models for atopic dermatitis, which will lead to the development of new treatment options for AD. This new collaboration is complementary to the ongoing partnership with CRG aimed at developing and characterizing novel preclinical models as the basis for developing new treatment options for non-melanoma skin cancer (NMSC).