The aim of the study is to evaluate the efficacy and safety of a combined approach of cryotherapy and tirbanibulin for the treatment of actinic keratosis of the scalp and forehead, repeated every 4 months. A higher rate of complete response is expected with this combination compared to cryotherapy alone, as well as a better response with repeated treatment cycles.

Start Date30 Nov 2025

Sponsor / Collaborator

Almirall SAS

NCT07010692

/ RecruitingPhase 1/2

Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas

The investigators seek to evaluate the effectiveness of fractional laser therapy and tirbanibulin ointment to treat squamous and basal cell carcinomas. This will be executed by using both thulium and erbium lasers on previously biopsy-confirmed SCCs and BCCs and applying bulk heating methods. Then, depending on the level of invasiveness, subjects may be instructed to apply the ointment over the course of five nights immediately following the treatment. The intention of this study is to minimize the need for invasive surgical procedures so as to optimize the cosmetic appearance, and provide a treatment option that is beneficial for a wide range of individuals.

Start Date16 May 2025

Sponsor / Collaborator

Robinson MD

NCT06791525

/ RecruitingPhase 4

Single-arm, Open-label Study of Tirbanibulin 1% Ointment to Treat Warts on the Hands in Pediatric Patients

Warts are common, benign skin lesions caused by the human papillomavirus (HPV). Treatment is challenging, particularly in the pediatric population, where standard modalities such as cryotherapy and intralesional immunotherapy are poorly tolerated. Existing topical treatments, such as imiquimod and 5-fluorouracil, have low efficacy and require prolonged use. Case reports suggest tirbanibulin ointment may provide an effective and well-tolerated alternative for pediatric warts. This study will evaluate the efficacy and safety of tirbanibulin ointment in treating pediatric hand warts.

Start Date01 May 2025

Sponsor / Collaborator

The Skin Center Dermatology Group

100 Clinical Results associated with Tirbanibulin

100 Translational Medicine associated with Tirbanibulin

100 Patents (Medical) associated with Tirbanibulin

165

Literatures (Medical) associated with Tirbanibulin

01 Apr 2026·Photodiagnosis and Photodynamic Therapy

Randomized comparative study of 5-Fluorouracil 4%, tirbanibulin, and photodynamic therapy for relapsing actinic keratoses

Article

Author: Dika, Emi ; Gualandi, Alberto ; Alessandrini, Aurora ; Magnaterra, Elisabetta ; Vaccari, Sabina ; Scotti, Biagio ; Baraldi, Carlotta ; Venturi, Federico

BACKGROUND:

Actinic keratosis (AK) reflects a field cancerization process in chronically sun-damaged skin, and relapse after diclofenac therapy is a frequent clinical scenario. Field-directed treatments such as 5-fluorouracil (5-FU), tirbanibulin, and photodynamic therapy (PDT) are widely used, yet comparative data in post-diclofenac relapse and the contribution of reflectance confocal microscopy (RCM) to therapeutic monitoring remain limited.

OBJECTIVES:

To compare the clinical efficacy, tolerability, and subclinical response of 5-FU 4%, tirbanibulin 1%, and PDT in relapsing AK of the scalp, integrating RCM imaging to assess field response.

METHODS:

A prospective randomized (1:1:1) study was conducted in 45 patients who previously achieved complete clearance with diclofenac 3% and relapsed within 12 months. Endpoints included clinical clearance at 12 weeks, RCM normalization, recurrence at 6 months, and local skin response (LSR) severity.

RESULTS:

Twelve-week clearance rates were 73.3% for 5-FU, 66.7% for tirbanibulin, and 80.0% for PDT (p=0.711). RCM normalization occurred in 66.7%, 60.0%, and 73.3% of patients, respectively (p=0.741). Recurrence among responders at 6 months was low and comparable (9.1%, 10.0%, and 8.3%; p=0.991). Tirbanibulin showed significantly lower LSR scores versus 5-FU and PDT (p<0.001), indicating superior tolerability.

CONCLUSIONS:

Short-term efficacy of 5-FU, tirbanibulin, and PDT was comparable, while tolerability differed markedly. Tirbanibulin demonstrated the most favorable inflammatory and cosmetic profile, whereas 5-FU and PDT may be preferred when a more intense field effect is desired. RCM detected subclinical persistence in select cases and may serve as an adjunctive imaging tool for monitoring and guiding retreatment in field cancerization.

01 Apr 2026·MECHANISMS OF AGEING AND DEVELOPMENT

SRC suppression attenuates vascular aging by activating FUNDC1-dependent mitophagy

Article

Author: Wang, Linghuan ; Zhang, Weiwei ; Fang, Yan ; Cao, Feng ; Zhang, Yingjie ; Lu, Tingting ; Sun, Ting ; Ma, Yan ; Han, Dong ; Wang, Tianhu ; Fang, Zhiyi

Vascular smooth muscle cell senescence contributes critically to vascular remodeling and atherosclerosis, with mitochondrial dysfunction and impaired mitophagy recognized as major contributors. SRC, a stress-responsive tyrosine kinase, has been linked to aging, yet its role in vascular aging remains unclear. Here, we examined the role of SRC in regulating autophagy/mitophagy using in vitro and in vivo models. An accelerated vascular aging model was established using a high-fat diet and streptozotocin injection in ApoE^-/- mice, while senescence in mouse aortic vascular smooth muscle cells (MOVASs) was induced by doxorubicin. Elevated expression of SRC and phosphorylated SRC (Tyr418) was confirmed in both models. Pharmacological inhibition of SRC with KX2-391 partially mitigated features of vascular aging, improved mitochondrial morphology, reduced plaque burden, and enhanced fibrous cap stability. In senescent MOVASs, SRC knockdown decreased FUNDC1 Tyr18 phosphorylation, enhanced mitophagic flux, and reduced senescence, whereas SRC overexpression produced opposite effects and impaired KX2-391-mediated protection. Moreover, FUNDC1 knockdown abolished the anti-senescence effects of KX2-391, confirming that FUNDC1 is essential for SRC-mediated regulation. Together, these findings establish the SRC-FUNDC1 axis as an important regulator of mitophagy and vascular aging, suggesting that SRC inhibition may offer therapeutic benefit against vascular senescence and atherosclerosis.

01 Feb 2026·JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT

Real‐world evidence of tirbanibulin in the treatment of actinic keratosis in Germany – prospective, multicenter, non‐interventional KLIR study

Article

Author: Hadshiew, Ina ; Kempf, Afra ; Berking, Carola ; Heppt, Markus V. ; Melzer, Antje

Summary:

Background:

Tirbanibulin is an approved topical treatment for actinic keratosis (AK). This non‐interventional study investigated effectiveness and safety of tirbanibulin for AK.

Patients and Methods:

The prospective KLIR‐study was conducted at 58 German dermatology centers (02/2022–09/2023). Patients received tirbanibulin once daily for 5 consecutive days. Lesion count reduction, clearance rates, safety, and treatment satisfaction were assessed at day 57 (visit 3) after treatment. Visits on days 0, 8–29, and 240 allowed for the evaluation of baseline data, local skin reaction (LSR) peaks, and lesion recurrence, respectively.

Results:

In total, 545 AK patients were included in the study. The mean number of AK lesions decreased from 5.9 (baseline) to 1.9 at visit 3, representing a 70% lesion count reduction ( p < 0.0001). Clearance rates at visit 3 were 37.4% (complete clearance) and 55.0% (partial clearance ≥ 75% reduction). Among patients with complete clearance at visit 3, 21.9% experienced recurrent AK lesions at visit 4. The majority of LSRs were mild or moderate. Erythema (97.6%) was the most common LSR. Overall, 91.5% of patients rated their AK lesions as improved and 99% would consider future tirbanibulin treatment (“definitely”, “certainly”, “probably”, “maybe”).

Conclusions:

Tirbanibulin showed high lesion clearance and a high level of acceptance in real‐life conditions.

News (Medical) associated with Tirbanibulin

14 Jan 2026

·www.biospace.com

Almirall Presents R&D Pipeline Advances Supported by Sustained Growth and Leadership in Medical Dermatology at J.P. Morgan Healthcare Conference

Pipeline advances in 2026 span a range of dermatology disease areas, including atopic dermatitis, hidradenitis suppurativa, and alopecia areata, with 3 ongoing PoC/Phase II clinical studies* and 3 additional studies to be initiated in 2026. Almirall’s sustained trajectory of growth and profitability enables the company to reach more patients and supports a growth outlook of double-digit net sales through 2030, combined biologics peak sales of approximately €800 MM (Ebglyss ® and Ilumetri ® ), and a 25% EBITDA margin by 2028. Almirall's leadership in medical dermatology, biologics growth, and continued strong performance of its broad product portfolio fuel advancement of a diversified and innovative R&D pipeline addressing skin diseases with high unmet need. SAN FRANCISCO--(BUSINESS WIRE)-- Almirall, S.A. (ALM) , a global pharmaceutical company dedicated to medical dermatology, is participating in the 44 th J.P. Morgan Healthcare Conference 2026, taking place from 12 th to 14 th January 2026 in San Francisco, to provide an update on its business strategy, pipeline advancement, and business outlook. The company’s CEO and president, Carlos Gallardo, presents an update on the progress of the R&D pipeline in medical dermatology which is focused on developing impactful novel treatments for high unmet medical need skin diseases utilising a variety of different technology approaches. Advancing a broad Medical Dermatology pipeline Almirall’s continued investment in advancing its R&D capabilities and its medical dermatology pipeline are closely aligned with the company’s long-term perspective and commitment to positively impact patients and society, and further expansion of its leadership in medical dermatology. The company’s R&D pipeline strategy is based on Almirall’s strong capabilities, advancing the scientific understanding of skin diseases through collaborations with global leading experts and organisations. Almirall utilises a variety of modalities and novel technologies to address some of the most important unmet needs that often have a debilitating effect on patients. Almirall’s clinical development program currently features 3 ongoing proof-of-concept (PoC)/Phase II studies including an anti-IL-1RAP monoclonal antibody (mAb) targeting hidradenitis suppurativa, an IL-2muFc mutant fusion protein targeting alopecia areata and targeting atopic dermatitis - the latter led by Almirall's partner Simcere. In 2026, Almirall plans to initiate 3 additional PoC clinical studies with an anti-IL-21 mAb targeting hidradenitis suppurativa and one additional inflammatory skin disease for the anti-IL-1RAP and the IL-2muFc mutant fusion protein, respectively. Furthermore, Almirall plans to advance a bispecific antibody targeting both IL-13 and OX-40L for the treatment of atopic dermatitis into Phase I in the first half of 2026. In addition to the early-stage clinical pipeline, and as part of the ongoing lifecycle management activities, Almirall is also conducting – together with its partners – a variety of additional studies to enable further patient populations’ access to their biologics portfolio, specifically lebrikizumab and tildrakizumab. As part of this work Almirall is initiating a Phase III study with lebrikizumab in patients with nummular eczema. Nummular eczema is a debilitating condition that is distinct from atopic dermatitis but is thought to involve similar disease mechanisms and therefore makes targeting IL-13 by lebrikizumab a potentially promising therapy option. Several other ongoing clinical studies supporting Ebglyss ® and Ilumetri ® will further increase the body of evidence for these important biologics. Sustained growth and business performance fuel long-term investment in pipeline Almirall’s strong business performance and growth trajectory allow for sustained investment in its leading R&D capabilities following the previous investments into the commercial execution for the launch of breakthrough assets, as well as capabilities, expertise, and infrastructure. The company entered a new era for its business at the beginning of 2025 – and is advancing against its forecasted sustained double-digit growth of net sales (CAGR to 2030) and a substantial margin expansion. This new business era is driven by Almirall’s focus on medical dermatology, growth of its broad product portfolio, and commercial excellence across key markets. Throughout 2025, Almirall has demonstrated that it is on track to deliver against the business goals and has confirmed its guidance for the year based on the successful strategy of combining the advancement of its growth drivers, particularly the biologics portfolio, with the continued growth of its broad portfolio of medical dermatology solutions, including Klisyri ® , Wynzora ® , and Seysara ® . Almirall has shown the success of its recent biologics launches across key markets in Europe and is on track to deliver above €800 MM combined peak sales with expected peak sales for Ebglyss ® of above €450 MM, and Ilumetri ® of above €300 MM. This growth trajectory enables Almirall to continue to invest sustainably into its leading R&D capabilities and pipeline dedicated to medical dermatology, especially immune-modulated skin diseases. Based on the sustained significant investment in its R&D pipeline, Almirall will further drive science leadership enabling the company to develop disruptive and innovative products that build sustained future growth as leader in medical dermatology. Medical Dermatology: Significant unmet needs and growth potential Significant unmet needs continue to persist in medical dermatology based on the severe patient impact of a wide range of dermatological diseases with many patients, especially with chronic diseases still being uncontrolled. Despite significant scientific progress, and the continuously increasing numbers of patients diagnosed with skin diseases, and the transition of more patients to advanced treatments, many patients still suffer from debilitating skin conditions. Therefore, Almirall has significant potential to deliver more and better treatments to many dermatology patients, and – based on its unique dedication to medical dermatology, commercial capabilities, close collaboration with the medical community, and its proven end-to-end capabilities across the entire value chain – has the opportunity for further business growth. This enables Almirall to give patients and the medical community access to innovative and relevant solutions and contribute to improving their lives. " We are excited about the opportunities our broad R&D pipeline offers – to patients, the medical community, and for the future growth of Almirall. In addition to the three ongoing Proof-of-Concept studies we are planning to initiate another three this year which makes this a first in Almirall’s long history and is testament to our dedication to medical dermatology. Progressing a number of promising assets to address high impact skin diseases is made possible by the sustained previous investments we have made into commercial excellence for the launch of breakthrough assets, as well as our expertise, scientific capabilities, and infrastructure which are key factors for our leadership in medical dermatology,” stated Carlos Gallardo, CEO and President of Almirall. Karl Ziegelbauer, Chief Scientific Officer, commented, " Our continued investment in our R&D expertise, infrastructure, and our collaborations has translated into the significant advancement of our pipeline we are seeing today. Our plans to have initiated six Proof-of-Concept studies before the end of 2026 is a demonstration of our ability to create meaningful innovation in medical dermatology, based on our track record of success across the entire R&D value chain ." “ Our sustained investment in R&D combined with Almirall’s robust financial situation are the foundation for our long-term perspective and our confidence in achieving our business ambition. Our commercial execution, the strength of our position in Europe, and our successful business model and execution enable us to continue to grow our business and further drive the future trajectory of Almirall in medical dermatology,” added Jon Uguzne Garay, Almirall’s Chief Financial Officer. About Almirall Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life . We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. For more information, please visit Legal notice: This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law. *including the clinical development program for IL-2muFc in Atopic Dermatitis which is led by Almirall’s partner Simcere Contacts Corporate Communications: corporate.communication@almirall.com Phone: +34 93 291 35 08 Investor Relations investors@almirall.com Phone: +34 93 291 30 87

Phase 2

17 Sep 2025

·www.businesswire.com

EADV 2025: Almirall Advances Skin Science and Leads Innovation for Holistic Patient Care in Medical Dermatology

PARIS--(BUSINESS WIRE)--Almirall, S.A. (ALM) a global biopharmaceutical company dedicated to medical dermatology, is a major contributor to the 2025 European Academy of Dermatology and Venereology Congress (EADV) presenting new data across its broad portfolio of dermatological treatments including new real-world data of lebrikizumab on atopic dermatitis, new clinical data of tildrakizumab on psoriasis and tirbanibulin on actinic keratosis. The 34th EADV congress will take place from September 17 to 20 in Paris, France. At the congress, Almirall contributes a total of 44 scientific abstracts focused on advancing patient care across the company’s broad portfolio of dermatological treatments including atopic dermatitis, psoriasis, actinic keratosis, and hidradenitis suppurativa. With a strong emphasis on real-world evidence, patient-reported outcomes, and well-being, Almirall’s scientific programme includes multiple presentations, two expert-led symposia on psoriasis and atopic dermatitis, and an interactive exhibition booth supporting dermatologists in their daily practice and effective treatment choices for their patients. “The EADV congress is one of the most important platforms for exchange and learning about scientific and clinical advances in Dermatology. The Almirall team is excited to engage in conversations with leading experts and researchers to advance skin science and to develop meaningful solutions for patients. We are looking forward to discussing our new real-world evidence and clinical data for treatments across our broad portfolio to improve health outcomes for patients and support dermatologists in everyday practice,” said Dr. Volker Koscielny, Almirall’s Chief Medical Officer. Atopic Dermatitis: first real-world evidence study and new data on long-term efficacy and well-being of lebrikizumab Almirall presents interim results from the ADlife study, offering – for the first time - real-world evidence on the treatment of atopic dermatitis with lebrikizumab, featuring 100 patients treated for 16 weeks. The ADlife study demonstrates lebrikizumab is highly effective in treating moderate to severe atopic dermatitis with clinically relevant improvements in AD symptoms, already after 4 weeks of treatment, and a consistent safety profile. This data suggests that efficacy seen in randomized clinical trials translates well into the real-world setting - even in a more complex patient population. New data from the long-term extension ADjoin study shows that out of the patients showing significant improvement of their AD symptoms at week 16, those responses remained sustained after two-years of continuous treatment with lebrikizumab, as measured by absolute scores which are considered clinically relevant as they show response regardless of baseline severity. Further supporting its long-term efficacy, improvements in patient reported outcomes, such as itch and sleep (measured by POEM) were also observed up to 3 years of treatment with lebrikizumab. The ADvantage study – the first trial to utilize the WHO-5 Well-being Index in the assessment of an atopic dermatitis treatment – demonstrates the positive impact of lebrikizumab on holistic care for patients with moderate-to-severe atopic dermatitis who often show a significant impairment of their psychological well-being. Treatment with lebrikizumab was associated with improved psychological well-being in adult and adolescent patients to levels similar to a healthy population – already after 16 weeks - and were maintained for up to 52 weeks of treatment. Results from the ADvocate 1 and 2 studies reinforce lebrikizumab’s ability to deliver high rates of both skin clearance and itch relief after 16 weeks of treatment. First results were observed as early as week 4 compared to placebo and were maintained through to 52 weeks after treatment was initiated. Improvements in both the severity of the skin condition and itch translate into meaningful improvements in patient‑reported outcomes in atopic dermatitis1. Almirall’s symposium on atopic dermatitis, “Long-term control in Atopic Dermatitis: Elevating Therapeutic Goals” will be chaired by Prof. Sébastien Barbarot (France), and feature Prof. Tilo Biedermann (Germany), Prof. Richard Warren (UK), and Dr. Alessandra Narcisi (Italy). It will showcase new evidence on the role of IL-13 in AD pathogenesis, supporting the real-world evidence and the long-term efficacy of lebrikizumab delivering meaningful health benefits for patients. “Our symposium will highlight the unmet needs in atopic dermatitis and the pivotal role of IL-13 in disease pathophysiology. Through long-term data from clinical trials, real-world evidence and clinical cases, we’ll discuss how systemic biologic therapies like lebrikizumab are transforming care for patients and healthcare professionals”, commented Prof. Sébastien Barbarot. Psoriasis: advancing disease management and patient outcomes Almirall will present new effectiveness data on tildrakizumab for the treatment of moderate-to-severe plaque psoriasis from the real world ZODIPSO and CzATCH studies. These studies demonstrate high effectiveness of the treatment in high impact areas including nails, scalp, and the genital area. The TIL-SENIOR study explores the needs of elderly patients and how treatment with biologics like tildrakizumab can address these and offer a meaningful therapeutic option, while the TIL-TWO study shows how patients with elevated body weight or high-burden of disease can benefit from treatment with tildrakizumab 200 mg. The PROCARE-t study demonstrates high patient satisfaction with the psoriasis care provided by both hospital pharmacists and dermatologists during the treatment with tildrakizumab. Healthcare Professionals (HPCs) also expressed high satisfaction with the treatment showing the importance of multidisciplinary care in dermatology involving dermatologists and pharmacists. New data from the PRO-SCALP study show that CAL/BPD PAD(TM) cream delivers significant symptom relief of mild-to-moderate psoriasis of the scalp – which is particularly challenging to treat. It also demonstrated the treatment achieving enhanced emotional well-being, and overall improvements in daily life for patients. Almirall will also host a focused symposium on remaining unmet needs in psoriasis, “Psoriasis: Is there anything left to solve?”, Chaired by Prof. Jo Lambert (Belgium), with Dr. Andreas Pinter (Germany) and Dr. Pedro Mendes Bastos (Portugal). R&D pipeline: new insights on the treatment of large areas affected by Actinic Keratosis (AK), and phase I data on novel treatment for Hidradenitis Suppurativa (HS) Almirall will share new data from the TirbAKare study demonstrating tirbanibulin’s suitability for treating large skin areas of up to 100 cm2 affected by actinic keratosis. The results show that tirbanibulin provides statistically significant and clinically meaningful reduction in AK lesion count compared to vehicle at day 57 while offering a favorable safety profile. These results confirm tirbanibulin’s efficacy and tolerability, consistent with previous findings in controlled trials and real-world evidence when treating larger AK areas. Late-breaker: Phase I data on LAD191, a monoclonal antibody targeting the Interleukin-1 Receptor Accessory Protein (IL-1RAP), in patients affected by Hidradenitis Suppurativa suggest a favorable safety and tolerability profile, along with early signs of clinical improvement supporting the continued development of this asset. Advancing skin science at EADV 2025 Almirall’s booth at EADV (Pavilion 7.2, Booth D06) will offer visitors the opportunity to explore the latest innovations in dermatology and insights into patient needs through interactive educational content and global disease awareness initiatives. Highlights include: the global campaign, “Sanctuary Salon”, which educates about the impact of skin conditions on daily life and self-care, especially in the scalp area, a spotlight on the emotional burden experienced by AD patients, and the possibility for visitors contribute to a psoriasis patient association. About Almirall Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. For more information, please visit https://www.almirall.com/ Legal notice: This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law. ANNEX: 34th EADV Congress presentations and poster details Satellite Symposium on psoriasis: Psoriasis: is there anything left to solve? Chair: Prof. Jo Lambert, Belgium Speakers: Dr. Andreas Pinter, Germany; Dr. Pedro Mendes Bastos, Portugal Thursday 18th September at 17:45 (CEST) / Room S06. Pavilion 7.3. Satellite Symposium on atopic dermatitis: Long-term control in Atopic Dermatitis: Elevating Therapeutic Goals. Chair: Prof. Sébastien Barbarot, France Speakers: Prof. Tilo Biedermann, Germany; Prof. Richard Warren, United Kingdom; Dr. Alessandra Narcisi, Italy. Friday, 19th September at 13:00 (CEST)/ Room S05, Pavilion 7.3. Full abstracts will be available on the EADV 2025 Congress platform from 07:00 CEST on 17 September 2025 – see full list of accepted abstracts below: Ebglyss® (lebrikizumab) Ilumetri® (tildrakizumab) Wynzora® (CAL/BDP) PAD™ Cream Klisyri® (tirbanibulin) and actinic keratosis LAD191 and Hidradenitis Suppurativa 1 Silverberg et al. J Dermatolog Treat 2024; 35(1):2428729.

Clinical ResultPhase 1

07 Mar 2025

·www.businesswire.com

AAD 2025: Almirall presents early-stage pipeline progress and real-world evidence on demonstrating AK treatment success and patient satisfaction with Tirbanibulin

ORLANDO, Fla.--(BUSINESS WIRE)--Almirall, S.A. (ALM), a global pharmaceutical company dedicated to medical dermatology presents five scientific posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting - including new data on tirbanibulin, a topical treatment for actinic keratosis (AK) and progress of its early-stage asset LAD191, a high-affinity monoclonal antibody targeting interleukin-1 receptor accessory protein (IL-1RAP). These presentations provide valuable insights into patient outcomes, safety, and real-world effectiveness of tirbanibulin for the treatment of AK and demonstrate the ongoing commitment of Almirall to finding novel solutions for skin diseases through progressing its early-stage clinical development pipeline. "Our close collaboration with the dermatology community and patients allows us to better understand their needs and develop effective solutions. The findings presented at AAD 2025 show our focus on delivering impactful data on our established products as well as progressing our early-stage pipeline. The data on tirbanibulin for the treatment of actinic keratosis highlight the importance of a patient-centered approach to achieve treatment success. Presenting data from the phase I study of our early-stage asset LAD191 is an important step towards adding new impactful treatments to our dermatology portfolio in the future," stated Dr. Volker Koscielny, Almirall’s Chief Medical Officer. Tirbanibulin data: The new data analysis presented at the AAD demonstrates the impact of tirbanibulin on overall AK treatment success and clearance while also assessing patient satisfaction and willingness to continue the treatment. The data show the product´s demonstrated safety and tolerability profile through a combination of clinical trial data and real-world evidence. The analysis from Phase III, phase IV, and real-world studies provide further evidence for tirbanibulin´s tolerability, safety profile and patient satisfaction. According to Dr. Darrell Rigel, MD MS and Clinical Professor, Mount Sinai Icahn School of Medicine, "Patient satisfaction is a significant aspect of treatment outcomes. The results of these studies with tirbanibulin indicate notable improvements in patient satisfaction in real-world scenarios, which supports adherence to AK treatment protocols thus paving the way for more sustainable outcomes. By prioritizing patient experience and addressing their needs, the effectiveness of therapies can be enhanced, which can lead to an overall improvement in the quality of care." LAD191 data: Almirall also presents progress on its early-stage pipeline showing data from the Phase I clinical study with LAD191, a high-affinity monoclonal antibody targeting interleukin-1 receptor accessory protein (IL-1RAP), which is in development for the treatment of immune-modulated skin diseases such as Hidradenitis suppurutiva. The results in healthy volunteers support the safety and tolerability and add to previous pre-clinical studies that have demonstrated LAD191’s ability to inhibit pro-inflammatory cytokines. Blocking multiple pathways through IL-1RaP inhibition is anticipated to provide greater clinical benefit in attenuating proinflammatory responses compared to single cytokine inhibition. Addressing Unmet Needs in Medical Dermatology Medical dermatology remains a field with significant unmet needs, as many skin conditions still have limited treatment options. Dermatological diseases not only impact physical health but also affect emotional wellbeing and quality of life of patients. As a key participant in AAD 2025, Almirall continues to foster knowledge exchange and collaboration, reinforcing its commitment to deliver transformative dermatological solutions that improve patient lives. With over 80 years of experience in healthcare, Almirall is committed to advancing science in dermatology through continuous investment in research and development and by fostering strong partnerships with the medical and scientific communities. The company's expanding portfolio in medical dermatology, particularly its focus on advanced biologic solutions for psoriasis and atopic dermatitis, underscores its dedication to improving dermatological treatments and enhancing patient outcomes. Almirall´s presence at the AAD 2025 is an important opportunity to connect with healthcare professionals, partners, and industry peers at AAD 2025, a leading international forum for medical dermatology expertise and collaboration. 2025 AAD Annual Meeting poster details: Five Almirall abstracts have been accepted by the AAD for their annual meeting. Patient outcomes and satisfaction with tirbanibulin for the treatment of actinic keratosis (AK): Results from real-world studies 2. Relating patient-reported treatment satisfaction and clinical outcomes in real-world studies of tirbanibulin for actinic keratosis (AK) 3. Safety and tolerability of tirbanibulin for the treatment of actinic keratosis (AK): Results from clinical trials and real-world studies 4. Clearance of actinic keratosis (AK) with tirbanibulin: Comparing results from controlled trials with real-world clinical studies Phase I single and multiple ascending-dose study to assess the safety, tolerability and pharmacokinetics of LAD191, a monoclonal antibody against the interleukin-1 receptor accessory protein (IL-1RaP), in healthy volunteers. About Klisyri: Klisyri tirbanibulin ointment, 1% is a novel microtubule inhibitor indicated for the topical field treatment of actinic keratosis (AK) of the face or scalp. Klisyri has a demonstrated efficacy and safety profile, and a convenient 5-day application period, which is the shortest of any topical treatment for AK.1 IMPORTANT SAFETY INFORMATION INDICATION KLISYRI is a microtubule inhibitor indicated for the topical field treatment of actinic keratosis on the face or scalp. WARNINGS AND PRECAUTIONS Ophthalmic Adverse Reactions Klisyri may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible. Local Skin Reactions Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) in the treated area can occur after topical application of Klisyri. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of Klisyri is more likely to result in irritation. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain. Click here to view Full Prescribing Information. Reference: Klisyri [package insert]. Malvern, PA: Almirall, LLC. Content addressed for US audience only. About Almirall Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. For more information, please visit https://www.almirall.com/

Phase 1Phase 3Clinical Result

100 Deals associated with Tirbanibulin

External Link

KEGG	Wiki	ATC	Drug Bank
D11691	Tirbanibulin	D06BX	DB06137

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Actinic Keratosis	United States	Almirall LLC	14 Dec 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Psoriasis	Phase 2	Malaysia	PharmaEssentia Corp.	09 Aug 2019
Advanced Malignant Solid Neoplasm	Phase 2	South Korea	Hanmi Pharmaceutical Co., Ltd.	01 Dec 2012
Breast Cancer	Phase 2	South Korea	Hanmi Pharmaceutical Co., Ltd.	01 Dec 2012
recurrent gastric cancer	Phase 2	South Korea	Hanmi Pharmaceutical Co., Ltd.	01 Dec 2012
Stomach Cancer	Phase 2	South Korea	Hanmi Pharmaceutical Co., Ltd.	01 Dec 2012
Castration-Resistant Prostatic Cancer	Phase 2	United States	Athenex, Inc.	01 Feb 2010
Pruritus	Phase 1	Japan	PharmaEssentia Corp.	16 Nov 2021
Photodamaged skin	Phase 1	United States	Athenex, Inc.	09 Dec 2018
Plaque psoriasis	Phase 1	-	PharmaEssentia Corp.	27 Oct 2015
Acute Myeloid Leukemia	Phase 1	United States	Athenex, Inc.	01 Dec 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05260073 (PROAK, AAD2025)	Phase 4	Actinic Keratosis	606	Tirbanibulin	wkiglepwrv(zxkkykzidv) = Adverse events and local skin tolerability were comparable to those in the Phase III studies xpruilenhm (ggrynykbuq )	Positive	07 Mar 2025
NCT05741294 (CTgov)	Phase 4	Actinic Keratosis	334	Tirbanibulin	gkrgaunsyr(huunzhqhsq) = upsxehqjhw tzmdnagcui (stwzozjybz, qcnhhtyonl - kenrhopvlh) View more	-	20 Feb 2025
NCT05260073 (PROAK, AAD2024)	Phase 3	Actinic Keratosis	290	tirbanibulin	htnftxrlrz(gieefsyjen) = wpeavmnazw zeqgrhdwno (lahjhjnjta ) View more	Positive	08 Mar 2024
NCT05260073 (PROAK, AAD2024)	Phase 3	Actinic Keratosis	290	vehicle	htnftxrlrz(gieefsyjen) = hweavtlydv zeqgrhdwno (lahjhjnjta ) View more	Positive	08 Mar 2024
NCT05279131 (AAD2024)	Phase 3	Actinic Keratosis	105	Tirbanibulin	rawvrhovnx(gpphuwezpm) = gegzdgorqv gzsmrdsngb (dvwuvlvtdt ) View more	Positive	08 Mar 2024
NCT05279131 (CTgov)	Phase 3	Actinic Keratosis	105	Tirbanibulin ointment 1%	vjvawgmzgy(rhjshsdmee) = fukxwkqiuz xpynmmcqyk (oserrvlehx, kzacmpomlt - bptnnvdeow) View more	-	23 Jan 2024
EADV2023	Phase 3	Actinic Keratosis	320	Tirbanibulin 1% ointment	juyzdanupl(lonuizfphm) = umzshjjisi tieyhruflx (krxxfkoxyc ) View more	Positive	11 Oct 2023
EADV2022	Phase 3	Actinic Keratosis	353	Tirbanibulin 1% ointment	szgbmjocdg(bhzfpcmlhv) = few of the six local skin reactions assessed were severe (0%-9%) and only 16% of patients reported adverse events, mostly mild application site pain (10%) and/or pruritus (9%) lgfhpfklat (gyzmvdsoec )	-	07 Sep 2022
EADV2022	Not Applicable	-	12	Tirbanibulin 1% ointment	kxwxyhcxtp(hbbkekqnmx) = yvugwtpqlu ofzaulnstz (bjhrkknmvc ) View more	-	07 Sep 2022
EADV2022	Phase 3	Actinic Keratosis	-	Tirbanibulin 1% ointment	nzigyokkdz(enibwflgvp) = Most cases of application site pain with tirbanibulin or vehicle were mild (77% vs. 91%) or moderate (23% vs. 9%) cmrzqjadgc (djiorhzwes ) View more	-	07 Sep 2022
EADV2022	Phase 3	Actinic Keratosis	-	Vehicle		-	07 Sep 2022
NCT01397799 (Pubmed \| Invest New Drugs)	Phase 1	Acute Myeloid Leukemia	24	KX2-391 120 mg	vmverdbyai(hpnvxzrnqr) = occurred in 1 patient at 140 mg dose jqaheqzfxp (zamsglfbse ) View more	Positive	17 May 2022
NCT01397799 (Pubmed \| Invest New Drugs)	Phase 1	Acute Myeloid Leukemia	24	KX2-391 140 mg		Positive	17 May 2022

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