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 2026

Sponsor / Collaborator

Almirall SAS

NCT07657988

/ RecruitingNot Applicable

Patient and Clinician Reported Outcomes Among Patients With Actinic Keratosis Receiving Tirbanibulin for Large fiEld Application on the Face, in U.S Clinical pRactice Settings: A Pilot Initiative (CLEAR)

The goal of this observational study is to learn about the effectiveness of tirbanibulin among adult subjects with actinic keratosis (AK) lesions in the face. The main question it aim to answer is:
How does tirbanibulin improve subject's overall appearance of the skin, improve how patient's skin looks, and improve patient's skin texture, in a 57-day observation period.
Participants already taking tirbanibulin as part of their regular medical care for AK will answer online survey questions at the beginning of the study and at Day 57.

Start Date02 Apr 2026

Sponsor / Collaborator

Avant Health LLC

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

100 Clinical Results associated with Tirbanibulin

100 Translational Medicine associated with Tirbanibulin

100 Patents (Medical) associated with Tirbanibulin

186

Literatures (Medical) associated with Tirbanibulin

01 Jan 2027·Journal of Geriatric Oncology

Non-surgical therapies for localized non-melanoma skin cancer in older adults: A review

Review

Author: Caudill, Jennifer ; Kizy, Selene M ; Gardner, Kenzie ; Baylis, Luke T ; Nellis, Julia

Non-melanoma skin cancers (NMSCs) represent the most common malignancies in the United States, with a rapidly rising incidence that disproportionately affects older adults. While surgery remains the gold-standard treatment for NMSCs, an often-overlooked reality is that many affected older adults face a combination of comorbidities, cognitive impairment, functional limitations, and logistical barriers that make surgical treatment impractical or unrealistic. Accordingly, this review examines the role of non-surgical therapies (NSTs) as essential alternatives for older patients, highlighting their mechanisms, clinical utility, and older adult-specific considerations. Specifically, topical agents such as 5-fluorouracil, imiquimod, tirbanibulin, retinoids, and trichloroacetic acid offer effective, less-invasive options for superficial lesions but rely heavily on adherence, which may be compromised in cognitively impaired or functionally-limited individuals. Intralesional therapies (including 5-fluorouracil and methotrexate), on the other hand, provide high clearance rates with minimal systemic toxicity, while also reducing patient responsibility and daily application. Mechanical techniques like cryosurgery and electrodessication and curettage offer efficient, cost-effective treatments but require wound care that may be difficult for some older adults to manage. Photodynamic therapy and radiation modalities (SRT, IGSRT, brachytherapy, and EBRT) demonstrate strong short-term efficacy but may be limited by treatment-related discomfort of the need for multiple visits, posing challenges for those with transportation barriers. Importantly, systemic therapies such as hedgehog pathway inhibitors and PD-1 inhibitors are effective for advanced or inoperable disease, but carry significant toxicities and treatment burdens that limit their suitability for older patients, especially those with polypharmacy concerns. Furthermore, this review emphasizes that across all modalities, NST selection must prioritize geriatric principles, balancing efficacy with safety, comfort, functional status, cognitive capacity, support systems, and patient preferences. As the aging population grows and NMSC numbers expand in parallel, individualized, patient-centered care and expanded older adult-focused research are essential to optimizing treatment outcomes for older adults.

01 Nov 2026·British Journal of Pharmacology

Repurposing tirbanibulin as an orally active E2‐targeting entry inhibitor against Chikungunya virus

Article

Author: Luo, Shu‐dan ; He, Yan‐hua ; Yang, Yan‐yong ; Zhao, Ping ; Gao, Fu ; Gu, Jing‐wen ; Ma, Yu‐qing ; Tang, Hai‐lin ; Tang, Wan‐da

Background and purpose:

Chikungunya virus (CHIKV) causes severe acute and chronic disease, yet no approved specific antiviral treatment exists. To rapidly identify potential treatments, we aimed to screen an FDA‐approved drug library for inhibitors of CHIKV infection. Tirbanibulin, a dual‐microtubule polymerization and Src kinase inhibitor, was assessed for its potential anti‐CHIKV activity.

Methods:

We performed a high‐throughput screen of an FDA‐approved drug library. Mechanism‐of‐action studies included entry‐step analysis, surface plasmon resonance (SPR) binding assays and molecular docking. In vivo efficacy was evaluated in lethal murine neuroinfection and CHIKV‐induced arthritis models following oral administration of the candidate compound.

Experimental approach:

Tirbanibulin exhibited nanomolar to low‐micromolar antiviral activity (EC 50 range: 0.035–75.64 μM) across multiple cell lines, with high selective indices in key target HT22 and Huh7 cells. It acted at a post‐attachment entry step, inhibiting clathrin‐mediated endocytosis and potentially viral fusion. Surface plasmon resonance confirmed direct, high‐affinity binding to the CHIKV E1 and E2 glycoprotein complex (K_D = 73 nM). In the lethal neuroinfection model, oral tirbanibulin significantly improved survival and reduced brain viral loads; in the arthritis model, it markedly attenuated footpad swelling and inflammatory pathology.

Conclusion and implications:

Tirbanibulin is a novel, orally bioavailable entry‐stage inhibitor that directly targets the E2 glycoprotein. Multiple preclinical and clinical studies have confirmed its favourable oral bioavailability and safety. Given its established clinical safety profile, it represents a promising repurposing candidate for clinical evaluation against Chikungunya fever.

01 Aug 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Structure-based design and synthesis of KX-01 analogs as potent antitumor agents targeting the tubulin colchicine binding site

Article

Author: Yang, Zhuang ; Li, Qingqing ; Wang, Fang ; Cui, Xue ; Yang, Jianhong ; Gao, Chenke ; Li, Yong ; Zhang, Shuai ; Tang, Minghai ; Zhang, Chufeng ; Liu, Li ; Hu, Xiuying ; Wang, Yilin ; Chen, Hongxiu ; Sun, Maoru

Our preliminary studies indicated that KX-01 inhibits tubulin polymerization in a reversible and concentration-dependent manner, resulting in dramatically low toxicity across various solid and liquid tumor types. However, KX-01 has not yet been approved as an anticancer agent due to its insufficient efficacy, and research on its derivatives remains limited. To improve its antitumor activity and investigate the structure-activity relationships (SARs), sixty-seven KX-01 analogs were designed and synthesized based on the KX-01-tubulin cocrystal structure. Among them, compound 8h exhibited the most potent antiproliferative activity, with IC₅₀ values of 3.5 ± 0.6, 2.4 ± 0.2, 15.7 ± 3.1, 22.1 ± 1.9, and 7.3 ± 1.1 nM against HCT116, HeLa, A2780S, A2780T, and HT29 cells, respectively, indicating its potential to overcome multidrug resistance. Replacing the endocyclic nitrogen atom in the pyridine ring of KX-01 with an exocyclic fluorine atom directly results in the loss of Src inhibitory activity. The cocrystal of 8h-tubulin complex revealed that it simultaneously occupies the colchicine site in β-tubulin and a cavity in α-tubulin. In the HT29 xenograft model, orally administered 8h (5 mg/kg, once daily) showed marginally superior in vivo antitumor efficacy than KX-01.

News (Medical) associated with Tirbanibulin

30 Sep 2026

·www.biospace.com

Almirall Advances Skin Science and Shares New Evidence Across Its Dermatology Portfolio at EADV 2026

Almirall’s scientific programme at EADV 2026 showcases advances in critical skin diseases, including atopic dermatitis, psoriasis and actinic keratosis, through more than 20 abstracts, including a late-breaking abstracts, alongside two expert-led symposia and an interactive industry AD hub session. New clinical data show consistent efficacy and effectiveness in atopic dermatitis treatment across body regions with lebrikizumab, including high-impact areas such as the face and neck 1,2 , while late-breaking ADlong results highlight sustained improvements in skin signs and itch with up to five years of treatment 3 . Final two-year data from the POSITIVE clinical study demonstrate the benefits on patient overall well-being and quality of life during tildrakizumab treatment 4,5 , and further data show evidence in patients with high disease burden and previous biologic treatment 6,7 . Almirall’s commitment to medical dermatology is reflected by its Gold Sponsorship of EADV 2026 and the launch of the ‘Face It’-campaign to raise awareness of the burden of atopic dermatitis with face and neck involvement, addressing the broader impact of skin diseases on patients. VIENNA--(BUSINESS WIRE)--Almirall, S.A. (ALM), a global biopharmaceutical company dedicated to medical dermatology, today announced its scientific programme at the 35th European Academy of Dermatology and Venereology (EADV) Congress, taking place in Vienna from 30 September to 3 October 2026. As Gold Sponsor of this year’s congress, Almirall will present more than 20 abstracts on clinical and real-world evidence spanning atopic dermatitis (AD), psoriasis (PsO) and actinic keratosis (AK), and a late-breaking abstract on the ADlong 5-year long-term extension trial of AD, presenting clinical and real-world evidence across its broad commercial portfolio to support patients and dermatologists. Almirall is sharing new data for its biologic treatments, lebrikizumab in AD and tildrakizumab in PsO, with a focus on strengthening the evidence base in areas of high unmet patient need. These new data demonstrate positive treatment outcomes across different patient populations and body regions, including high-impact areas, alongside sustained, holistic disease control– in line with Almirall’s commitment to impactful innovation that makes a real difference to patients. Evidence for topical treatments further underscores the value of a broad product portfolio for patients and dermatologists, with data showing adherence and effectiveness of CAL/BDP PAD cream in psoriasis 8,9 , as well as one-year safety and efficacy data of tirbanibulin when applied to up to 100 cm2 in patients with AK on face or scalp 10 . Two expert-led, educational symposia on AD and PsO, an interactive industry hub session focused on AD and a dedicated R&D corner at the exhibition booth which features Almirall’s medical dermatology pipeline, provide opportunities for scientific exchange on the new evidence and its relevance to clinical practice. “We are advancing the scientific understanding of skin diseases to develop innovative treatments aimed at addressing real patient needs. Our EADV programme shows the breadth and depth of our work in research and development and is testament to our focus on generating evidence across our broad dermatology portfolio addressing areas of high unmet need,” said Dr Karl Ziegelbauer, Chief Scientific Officer at Almirall. “Through our close collaborations with patients and dermatologists and a pipeline solely dedicated to medical dermatology, we deepen our understanding of the broader burden of skin disease and show where science can make a meaningful difference to patients and the medical community.” Atopic dermatitis: consistent evidence across body regions including high-impact areas like the face and neck Almirall’s AD programme expands the clinical and real-world evidence for lebrikizumab, a high affinity, selective interleukin-13 inhibitor, with a focus on generating robust clinical evidence across body regions, high-impact areas and treatment outcomes in different patient populations. The Phase 3b ADhope trial 11,12,13, the European observational ADtrust study 14,15,16 , and the German real-world evidence study ADlife contribute findings on skin symptoms, itch and other patient-reported outcomes 17,18,19 . Together, they build understanding of the treatment’s potential efficacy and effectiveness across clinical-trial and routine-practice settings. Analyses from the ADhope and ADtrust studies specifically examine outcomes in patients with face, neck or hand involvement, addressing skin areas where disease can have a substantial impact on daily life 1,2 . Findings from the ADjoin clinical long-term extension study assess skin responses with up to three years of treatment 20 . In addition, late-breaking results from the Phase 3b ADlong extension study show sustained skin and itch responses in patients with up to five years of lebrikizumab exposure 3 . Almirall will also host two AD expert meetings exploring visible disease burden, sustained responses and practical approaches to everyday management, with a particular focus on face and neck involvement: Interactive Industry AD Hub, Thursday 1 October, 9:15 to 10 am CEST: “Looking Into the Face of AD: Tackling Clinical Cases in Moderate-to-Severe Atopic Dermatitis with Face and Neck Involvement including lebrikizumab.” Chaired by Prof. Christian Vestergaard. AD symposium, Friday 2 October, 1 to 2 pm CEST: “The Many Faces of AD – Spotlight on Visible Burden, Deep Response, and Simplicity in Everyday Care with Lebrikizumab.” Chaired by Dr. Christine Bangert. Psoriasis: sustained disease control and treatment outcomes beyond skin clearance New data on tildrakizumab increases the body of scientific evidence demonstrating robust and durable efficacy across the moderate-to-severe psoriasis journey. New analyses from reSURFACE 1 suggest that earlier intervention may contribute to better outcomes and long-term disease control in psoriasis, reinforcing the value of targeted, sustained IL-23p19 inhibition 21 . Beyond skin clearance, final two-year analyses from POSITIVE report benefits in patients with psoriasis affecting high-impact areas or causing high burden symptoms. Findings include improvements in psychological well-being, quality of life, work productivity and treatment satisfaction, supporting a broader view of treatment outcome and its impact on patients’ daily lives 4,5,22,23 . The data presented by Almirall at this year’s EADV conference further demonstrates the treatment outcomes of tildrakizumab across diverse and challenging patient populations. PROCARE-T highlights consistent effectiveness regardless of prior biologic exposure or disease duration 6 , while PATH-T demonstrates positive treatment outcomes even in patients with high-impact area involvement, and previous biologic failure 7 . Almirall’s psoriasis symposium will explore patient perspectives, psychological well-being and treatment considerations in specific populations that represent higher treatment challenges, including older patients and those with obesity: Psoriasis Symposium, Thursday 1 October, 5:45 to 6:45 pm CEST: “Redefining Treatment Success in Psoriasis: Moving beyond PASI to sustained disease control,” chaired by Professor Ulrich Mrowietz . Bringing scientific breakthroughs closer to patients and dermatologists Beyond the scientific programme, Almirall will raise awareness of the burden of AD with face and neck involvement in patients’ daily lives through its Face It campaign and dedicated booth, and a virtual reality medical training for dermatologists. Visitors to Almirall’s congress booth ( X304, X306 ) will also be able to explore its research and development pipeline through interactive displays. Together, these activities reflect the company’s commitment to advancing the scientific understanding of skin diseases and bringing breakthrough innovation to patients and dermatologists. Further information on Almirall’s scientific presentations and congress activities is available at EADV 2026 Media Page | Almirall 1 About Almirall Almirall is a global biopharmaceutical 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 advance the scientific understanding of skin diseases to develop innovative and differentiated treatments and solutions that address patients’ needs. Our clinical development portfolio includes four ongoing proof-of-concept (PoC)/Phase II studies and two further PoC studies planned across key areas of medical dermatology. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2025: €1114.5 MM, over 2100 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 almirall.com Media landing page: EADV 2026 Media Page | Almirall Media password: EADV 2026 Media Page Legal warning 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. ____________________ 1 Password for the media page: EADV 2026 Media Page ANNEX: EADV 2026 abstracts list Tildrakizumab Association Between Psoriasis Duration and Maintenance of Control (PASI ≤2) after Tildrakizumab Withdrawal: Post Hoc Analyses from reSURFACE 1 Psycholag in Moderate-to-Severe Psoriasis: Insights from the POSITIVE Study on Psychological Well-being and Treatment with Tildrakizumab Beyond Skin Clearance: Long Term Improvement of Psychological Well-Being and Health-Related Quality of Life in High-Impact Area Psoriasis Treated with Tildrakizumab (POSITIVE Study) A Holistic View of Treatment Success in Psoriasis: Long-Term Real-World Improvements in Psychological Well-Being and Health-Related Quality of Life With Tildrakizumab Patients with Psoriasis and Burdensome Symptoms (POSITIVE study) Health-Related Quality of Life, Work Productivity and Treatment Satisfaction with Tildrakizumab for Up to 2 Years in Patients with Moderate-to-Severe Psoriasis in the POSITIVE Study Holistic Treatment Success with Tildrakizumab: Combined Evidence of WHO 5, PASI and DLQI Outcomes from the POSITIVE, BLUE, TiGER, TIL TWO and TIL Senior Studies BADBIR Patient characteristics of biologic-experienced and biologic-naive patients with chronic plaque psoriasis receiving tildrakizumab High effectiveness of tildrakizumab in moderate-to-severe psoriasis regardless of prior biologic therapy or disease duration: 28-week interim data from the PROCARE-T study High effectiveness of tildrakizumab in moderate-to-severe psoriasis involving high-impact areas after failure of prior biologics: 28-week interim data from the PATH-T study Lebrikizumab Late-breaker: Lebrikizumab Showed Sustained Efficacy and Safety Through 5 Years in Patients with Moderate-to-Severe Atopic Dermatitis: Results from the ADlong Long-Term Extension Trial Lebrikizumab Treatment Led to Low Disease Activity in the Majority of Patients with Moderate-to-Severe Atopic Dermatitis: Findings from the ADhope 1 Trial Lebrikizumab Delivers Improvements Across Patient-Reported Itch, Sleep, Overall Assessment of Disease Severity and Treatment Satisfaction in ADhope 1 Lebrikizumab Achieved High Levels of Absolute EASI Optimal Response in Patients with Moderate-to-Severe Atopic Dermatitis for Up to 3 Years (ADvocate 1 & 2 to ADjoin) Lebrikizumab Provided High Levels of Effectiveness in Patients with Moderate-to-Severe Atopic Dermatitis: Results from ADlife, A Real-World Study Lebrikizumab Treatment Leads to Relevant Improvements in Patient-Reported Outcomes for Moderate-to-Severe Atopic Dermatitis in a Real-Life Setting: Findings from ADlife Lebrikizumab Provided Meaningful Improvements in Patient-Reported Disease Control and Reduced the Number of Flares in Patients with Moderate-to-Severe Atopic Dermatitis: ADlife Real-World Study Baseline Demographics, Clinical Characteristics and Disease Burden Among Patients with Atopic Dermatitis (AD) Treated with Lebrikizumab in Real-World Clinical Practice: Interim Results from a European Prospective Observational Study (ADtrust) Lebrikizumab Impact on Alleviating Disease Severity, Itch Burden and Quality of Life, in Patients with Moderate-to-Severe Atopic Dermatitis (AD): 16-Week Interim Results from a European Prospective Observational Study (ADtrust) Lebrikizumab Impact on Patient-Reported Outcomes (PROs) Among Patients with Atopic Dermatitis (AD) in Real-World Clinical Practice: 16-Week Interim Results from a European Prospective Observational Study (ADtrust) Lebrikizumab Real-World Effectiveness and Patient Satisfaction in Patients with Moderate-to-Severe Atopic Dermatitis (AD) and Face or Hand Involvement: 16-Week Interim Results from a European Prospective Observational Study (ADtrust) Lebrikizumab Provides Clinically Meaningful Response in Face and Hands in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: ADhope 1 Study Lebrikizumab Shows Efficacy in Patients with Moderate-to-Severe Atopic Dermatitis, Including Patients with Predominantly Moderate Disease (ADhope 1) Tirbanibulin Efficacy, tolerability and 1-year long term safety with tirbanibulin 1% ointment in patients with actinic keratosis applied over a field up to 100 cm² and up to 2 treatment courses CAL/BDP PAD cream Adherence to Wynzora in adults with mild-to-moderate psoriasis: Results from the ADHER-TOP study Effectiveness and PROs of Wynzora in adults with mild-to-moderate psoriasis: Results from the ADHER-TOP study ____________________ 1 Vestergaard C et al. Lebrikizumab Real-World Effectiveness and Patient Satisfaction in Patients with Moderate-to-Severe Atopic Dermatitis (AD) and Face or Hand Involvement: 16-Week Interim Results from a European Prospective Observational Study (ADtrust) . EADV Congress 2026. 2 Vestergaard C et al. Lebrikizumab Provides Clinically Meaningful Response in Face and Hands in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: ADhope 1 Study . EADV Congress 2026 (Encore abstract). 3 [ADlong Study] Late-Breaking Abstract: Lebrikizumab 5-Year Long-Term Extension Results in Moderate-to-Severe Atopic Dermatitis (ADlong). EADV Congress 2026 (Late-breaker). 4 [POSITIVE Study - HRQoL 2-Year] Health-Related Quality of Life, Work Productivity and Treatment Satisfaction with Tildrakizumab for Up to 2 Years in Patients with Moderate-to-Severe Psoriasis in the POSITIVE Study . EADV Congress 2026 (Almirall De novo publication). 5 [POSITIVE Study - High-Impact] Beyond Skin Clearance: Long Term Improvement of Psychological Well-Being and Health-Related Quality of Life in High-Impact Area Psoriasis Treated with Tildrakizumab (POSITIVE Study) . EADV Congress 2026 (Almirall Encore publication). 6 [PROCARE-T Study] High effectiveness of tildrakizumab in moderate-to-severe psoriasis regardless of prior biologic therapy or disease duration: 28-week interim data from the PROCARE-T study . EADV Congress 2026 (Almirall publication). 7 [PATH-T Study] High effectiveness of tildrakizumab in moderate-to-severe psoriasis involving high-impact areas after failure of prior biologics: 28-week interim data from the PATH-T study . EADV Congress 2026 (Almirall publication). 8 Torres T, Fernández-Armenteros JM, Castilla-Fernández G, Asensio D, Galván J. Adherence to Wynzora in adults with mild-to-moderate psoriasis: Results from the ADHER-TOP study . EADV Congress 2026. 9 Torres T, Fernández-Armenteros JM, Castilla-Fernández G, Asensio D, Galván J. Effectiveness and PROs of Wynzora in adults with mild-to-moderate psoriasis: Results from the ADHER-TOP study . EADV Congress 2026. 10 Welzel J, Szepietowski JC, Ferrandiz Pulido C, Pellacani G, Mosterd K, Otero R, Perez Fierro AM, Castilla-Fernández G, Siddall H, Pau-Charles I, Dirschka T. Efficacy, tolerability and 1-year long term safety with tirbanibulin 1% ointment in patients with actinic keratosis applied over a field up to 100 cm² and up to 2 treatment courses . EADV Congress 2026 (Abstract N°: AS-554). 11 Irvine A et al. Lebrikizumab Treatment Led to Low Disease Activity in the Majority of Patients with Moderate-to-Severe Atopic Dermatitis: Findings from the ADhope 1 Trial . EADV Congress 2026. 12 Zeidler C et al. Lebrikizumab Delivers Improvements Across Patient-Reported Itch, Sleep, Overall Assessment of Disease Severity and Treatment Satisfaction in ADhope 1 . EADV Congress 2026. 13 Munera-Campos M et al. Lebrikizumab Shows Efficacy in Patients with Moderate-to-Severe Atopic Dermatitis, Including Patients with Predominantly Moderate Disease (ADhope 1) . EADV Congress 2026 (Encore abstract). 14 Augustin M et al. Baseline Demographics, Clinical Characteristics and Disease Burden Among Patients with Atopic Dermatitis (AD) Treated with Lebrikizumab in Real-World Clinical Practice: Interim Results from a European Prospective Observational Study (ADtrust) . EADV Congress 2026. 15 Gutermuth J et al. Lebrikizumab Impact on Alleviating Disease Severity, Itch Burden and Quality of Life, in Patients with Moderate-to-Severe Atopic Dermatitis (AD): 16-Week Interim Results from a European Prospective Observational Study (ADtrust) . EADV Congress 2026. 16 Augustin M et al. Lebrikizumab Impact on Patient-Reported Outcomes (PROs) Among Patients with Atopic Dermatitis (AD) in Real-World Clinical Practice: 16-Week Interim Results from a European Prospective Observational Study (ADtrust) . EADV Congress 2026. 17 Lauffer F et al. Lebrikizumab Provided High Levels of Effectiveness in Patients with Moderate-to-Severe Atopic Dermatitis: Results from ADlife, A Real-World Study . EADV Congress 2026. 18 Lauffer F et al. Lebrikizumab Treatment Leads to Relevant Improvements in Patient-Reported Outcomes for Moderate-to-Severe Atopic Dermatitis in a Real-Life Setting: Findings from ADlife . EADV Congress 2026. 19 Lauffer F et al. Lebrikizumab Provided Meaningful Improvements in Patient-Reported Disease Control and Reduced the Number of Flares in Patients with Moderate-to-Severe Atopic Dermatitis: ADlife Real-World Study . EADV Congress 2026. 20 Thaçi D et al. Lebrikizumab Achieved High Levels of Absolute EASI Optimal Response in Patients with Moderate-to-Severe Atopic Dermatitis for Up to 3 Years (ADvocate 1 & 2 to ADjoin). EADV Congress 2026. 21 [reSURFACE 1 Post Hoc] Association Between Psoriasis Duration and Maintenance of Control (PASI ≤2) after Tildrakizumab Withdrawal: Post Hoc Analyses from reSURFACE 1. EADV Congress 2026 (Almirall De novo publication). 22 [POSITIVE Study - Holistic View] A Holistic View of Treatment Success in Psoriasis: Long-Term Real-World Improvements in Psychological Well-Being and Health-Related Quality of Life With Tildrakizumab Patients with Psoriasis and Burdensome Symptoms (POSITIVE study). EADV Congress 2026 (Almirall De novo publication). 23 [POSITIVE Study - Psycholag] Psycholag in Moderate-to-Severe Psoriasis: Insights from the POSITIVE Study on Psychological Well-being and Treatment with Tildrakizumab. EADV Congress 2026 (Almirall De novo publication). Contacts Corporate Communications: Corporate.communication@almirall.com Phone: (+34) 659 614 173 Investor Relations investors@almirall.com Phone: (+34) 93 291 30 87

Clinical ResultPhase 3Phase 2

11 May 2026

·www.biospace.com

Almirall Continues Its Positive Trajectory in Q1 2026 in Line With Expectations – Led by 19.3% YoY Growth of Its European Dermatology Business

Almirall's European Dermatology business delivered solid growth of 19.3% YoY, reaching €166.3 MM in Q1 2026, driven by strong momentum across key growth drivers. This contributed to overall Net Sales of €291 MM, up 2.2% YoY and reflecting 9% growth on a Last-Twelve-Months (LTM) basis. Performance continues to be driven by the biologics portfolio, with Ilumetri ® showing 11.8% increase in sales vs Q1 2025 (total of €61.6 MM), and Ebglyss ® delivering €41.9 MM quarterly sales – more than 2x YoY – boosted by sustained growth in recent launch countries. Strong performance of the broad dermatology product portfolio in line with expectations – products driving relevance of Almirall in medical dermatology, including Wynzora ® (20.8%, total of €9.3 MM) and Klisyri ® (7.2%, total of €7.4 MM). Total EBITDA was €67.5 MM, corresponding to 23.2% over Net Sales – improvement versus FY 2025 (21%). Continued R&D pipeline progress includes the start of phase I of anti-IL-13/OX40L bispecific antibody, and a new collaboration with China-based biotech Huaota for the development of a novel monoclonal antibody in medical dermatology. Reiterated guidance for the full year 2026: 9-12% growth and € 270MM to € 290MM EBITDA – scrip dividend of €0.19 per share approved by the AGM on 8 th May 2026. BARCELONA--(BUSINESS WIRE)-- Almirall, S.A. (ALM), a global pharmaceutical company dedicated to medical dermatology, today announced its financial results for the first quarter of 2026. Almirall continued to deliver on the company’s growth trajectory in line with expectations and the long-term strategy, led by 19.3% YoY growth of its European Dermatology business to €166.3 MM. During Q1 2026, total Net Sales increased by 2.2% YoY to €291 MM, with growth mainly driven by the biologics and continuously increasing contributions from the broader dermatology portfolio. EBITDA was €67.5 MM, corresponding to 23.2% over Net Sales, representing an improvement versus FY 2025 (21%) and aligned with full year guidance (the YoY comparison includes a divestment/outlicencing in Q1 2025. Ebglyss ® (lebrikizumab, for the systemic treatment of moderate to severe atopic dermatitis) continued its strong growth, delivering total Net Sales of €41.9 MM, representing more than a twofold increase YoY. The brand´s performance was driven by the continued strong trajectory in recent launch countries, reflecting sustained patient need and growing access. Ilumetri ® (tildrakizumab, for the systemic treatment of moderate to severe psoriasis), continued to deliver double digit growth in Q1 2026 representing an increase of 11.8% YoY, with total Net Sales of €61.6 MM, demonstrating the strong market position of Ilumetri ® and the continued relevance of anti IL23 therapies in the competitive psoriasis market segment. The broad dermatology product portfolio continued to grow in line with expectations, reinforcing Almirall’s relevance as a leading medical dermatology partner in Europe. Wynzora ® (psoriasis) delivered €9.3 MM in Net Sales, representing 20.8% growth YoY, and Klisyri ® (actinic keratosis) achieved €7.4 MM in Net Sales, growing 7.2% YoY. Almirall continued to advance its medical dermatology pipeline during the quarter, reinforcing the company’s commitment to long-term innovation in medical dermatology. Progress in Q1 2026 included the initiation of a Phase I clinical study for an anti IL 13/OX40L bispecific antibody, supporting Almirall’s ambition to develop differentiated immunology assets. The company also announced a new collaboration with China-based biotech company Huaota, focused on the co-development of a novel monoclonal antibody for medical dermatology, which demonstrates Almirall’s approach to partnerships to further strengthen the company´s innovation strategy. “We continue to advance our leadership in medical dermatology, delivering Q1 results in line with expectations and consensus, led by strong, sustained growth in our European Dermatology business. The continued performance of Ebglyss ® and Ilumetri ® , together with the strong growth of our broader portfolio, highlight the benefits of our focus on medical dermatology and our commercial excellence. Our underlying business momentum remains strong which enables us to advance our pipeline and expand our innovation footprint through new collaborations. This positions Almirall well to deliver against our mid-term guidance and our long-term ambition to deliver sustained growth as a leader in medical dermatology.” Carlos Gallardo, Almirall Chairman and CEO Q1 2026 Q1 2025 Variation Total Revenue 292.4 286.1 2.2% Net Sales 291.0 284.6 2.2% Other Income 1.4 1.5 (6.7%) Gross Profit 186.7 190.4 (1.9%) % of sales 64.2% 66.9% Total EBITDA 67.5 70.9 (4.8%) Net Income 15.3 21.6 (29.2%) Normalised Net Income 16.1 22.1 (27.1%) 2026 Full Year Guidance Full year guidance for 2026: Net Sales: 9% to 12% growth. EBITDA between € 270MM to € 290MM R&D pipeline Almirall’s continued investment in its leading R&D capabilities and medical dermatology pipeline remains closely aligned with the company’s long-term commitment to positively impact patients and society, while further strengthening its leadership in medical dermatology. Continued R&D pipeline progress in Q1 2026 included the initiation of a Phase I clinical study for an anti IL-13/OX40L bispecific antibody, supporting Almirall’s focus on advancing next-generation biologics in medical dermatology. Almirall´s partner Lilly presented positive top-line results from the pivotal Phase 3 ADorable-1 trial evaluating efficacy and safety of lebrikizumab for children and adolescents with moderate-to-severe atopic dermatitis. At the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, Almirall presented long-term interim results from the ongoing Phase 3b ADlong study, where lebrikizumab delivered long-term disease control for up to four years in patients with moderate-to-severe atopic dermatitis. In parallel, ongoing clinical development includes the recently initiated Phase III study evaluating lebrikizumab in patients with nummular eczema, a distinct and burdensome condition with biological overlap with atopic dermatitis. Almirall also announced a new collaboration with China-based biotech Huaota for the development of a novel monoclonal antibody in medical dermatology. Almirall continues to expand the clinical and real-world evidence base supporting its key biologics, Ebglyss ® (lebrikizumab) and Ilumetri ® (tildrakizumab). Lifecycle management activities will continue to strengthen Almirall’s key priority products with several ongoing clinical studies supporting the biologics in AD and PSO as part of ongoing collaborative programs with its partners Lilly and Sun Pharma, respectively, to grow patient access and product value. Additional pipeline programs are expected to progress into phase II/PoC studies during 2026, including an anti-IL-21 monoclonal antibody targeting hidradenitis suppurativa. Partnership with the dermatology community Collaboration with dermatologists and life-science experts remains fundamental to Almirall’s commitment to advancing medical dermatology. Through these partnerships, the company continues to drive scientific exchange and deepen the understanding of skin diseases, therapeutic approaches, and their impact on patients, with a clear focus on delivering evidence-based, patient-centred care. In March, at the 2026 AAD, Almirall presented a broad range of new clinical and real-world evidence across atopic dermatitis, psoriasis, actinic keratosis, and acne. More than 15 posters were presented, leading with 9 on lebrikizumab, two on tildrakizumab showing the final 2-year results of the POSITIVE study on patient wellbeing, and new analyses for tirbanibulin, and new results and analysis for sarecycline. In March, Almirall hosted the 17th edition of its Skin Academy in Prague, bringing together leading dermatology experts from around the world. As a key scientific platform in medical dermatology, Skin Academy continues to foster collaboration, exchange on best practices, and innovation to address some of the most complex health challenges in the field of dermatology. Dividend and Investor Calendar 2026 On 8th May, the Annual General Shareholder Meeting approved the distribution of a dividend, for the amount of €0.19 per share. This will be applied using the flexible dividend system in line with prior years, which will offer shareholders the option to receive the agreed dividend in cash and/or in shares. H1 2026 Financial Results – 24th July 2026 9M 2026 Financial Results – 9th November 2026 About Almirall Almirall is a global biopharmaceutical 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 2025: €1114.5 MM, over 2100 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 disclaims 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. Contacts Corporate Communications: corporate.communication@almirall.com Phone: +34 93 291 35 08 Investor Relations investors@almirall.com Phone: (+34) 93 291 30 87

Clinical ResultPhase 3Drug ApprovalPhase 1Financial Statement

26 Mar 2026

·www.businesswire.com

AAD 2026: Almirall Presents New Clinical and Real‑world Evidence Across Atopic Dermatitis, Psoriasis, Actinic Keratosis and Acne

DENVER--(BUSINESS WIRE)--Almirall S.A. (ALM), a global biopharmaceutical company dedicated to medical dermatology, is presenting a broad range of clinical and real‑world data across its portfolio at the 2026 American Academy of Dermatology (AAD) Annual Meeting. The company’s presence includes more than 15 scientific posters, led by 9 lebrikizumab presentations in atopic dermatitis (AD), new analyses on tirbanibulin (AK), two on tildrakizumab from the POSITIVE study, and two sarecycline pooled Phase 3 evaluations in acne. "Our goal is to bring meaningful, evidence‑based treatment options to people living with skin diseases. The breadth of data we are sharing at AAD 2026 – from long‑term results and real‑world evidence for lebrikizumab to clinically relevant AK endpoints with tirbanibulin – reflects our commitment to rigorous science, patient‑centred outcomes, and strong collaboration with dermatology partners,” said Dr. Volker Koscielny, Almirall’s Chief Medical Officer. “AAD is an important moment each year to demonstrate our dedication to advancing medical dermatology and patient care. The new data we are sharing underline the real progress made across multiple skin diseases, and our commitment to bringing dermatologists evidence that supports better decision‑making and better care for their patients,” said Paul Rittman, President & General Manager, Almirall U.S. Almirall’s presence at AAD 2026 is an important opportunity to connect with healthcare professionals, partners, and industry peers. AAD 2026 is a leading international forum for medical dermatology expertise and collaboration and takes place March 27–31 in Denver, Colorado. Addressing Unmet Needs in Medical Dermatology Dermatological diseases can exert a profound physical and emotional burden. With a portfolio spanning inflammatory and proliferative skin conditions and an expanding evidence base across both controlled and real‑world settings, Almirall continues to partner with the dermatology community to improve outcomes, experience and long‑term disease control. 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 providing innovative dermatological treatments and enhancing patient outcomes. 2026 AAD Annual Meeting poster overview: Almirall and its partners will present more than 15 scientific posters across atopic dermatitis, psoriasis, actinic keratosis and acne, including: Lebrikizumab (Atopic Dermatitis) – 3 Almirall Posters + 6 Eli Lilly Posters Head, neck and face AD in patients with skin of color (ADmirable) 4 year long-term safety and efficacy (ADlong) Real-world effectiveness and advanced systemic pretreated populations (ADLIFE) Improvements in absolute endpoints in real-world settings (ADLIFE) EASI clinical responses across body regions in patients needing >16 weeks to reach EASI 75/IGA 0–1 Clinical feature improvements in skin of color Allergic rhinitis comorbidity and PREPARED‑1 study design Reasons for initiating lebrikizumab in adolescents with moderate-to-severe AD Exposure–response modelling supporting every 8 week maintenance dosing Tildrakizumab (Psoriasis) – 2 Almirall Posters + 4 Sun Pharma Posters Effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis overall and in high-impact areas: 2-year results from the POSITIVE study Beyond skin clearance: Tildrakizumab in moderate-to-severe psoriasis patients – 2-year POSITIVE study results Efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis affecting the nails: A multicenter, randomized, double-blind, placebo-controlled, Phase 3b trial Real-World Tildrakizumab Effectiveness in the US by Biologic Experience and Geographic Region in the PPD CorEvitas Psoriasis Registry Real-World Tildrakizumab Persistence in the US by Biologic Experience and Insurance Coverage in the PPD CorEvitas Psoriasis Registry Regional Differences in Patient Characteristics Among US Biologic Initiators from the PPD CorEvitas Psoriasis Registry Tirbanibulin (Actinic Keratosis) – 3 Posters Efficacy beyond complete clearance: percent lesion reduction as a meaningful endpoint Efficacy, safety and tolerability of up to two 5-day treatment courses Achieving complete clearance with mild-to-moderate LSRs: pooled Phase III analysis Sarecycline (Acne) – 2 Posters Truncal acne outcomes: multinational pooled Phase 3 analysis Pooled Phase 3 results in moderate-to-severe facial acne About Klisyri (tirbanibulin) ointment, 1%: INDICATION KLISYRI is a microtubule inhibitor indicated for the topical field treatment of actinic keratosis on the face or scalp. IMPORTANT SAFETY INFORMATION 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 About Seysara (sarecycline) tablets: INDICATIONS AND USAGE SEYSARA (sarecycline) tablet 60/100/150 mg, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of Use: Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. WARNINGS AND PRECAUTIONS Like other tetracyclines, SEYSARA can cause fetal harm when administered to a pregnant woman. If SEYSARA is used during pregnancy, or if the patient becomes pregnant while taking SEYSARA, the patient should be informed of the potential hazard to the fetus and treatment should be stopped immediately. The use of SEYSARA during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA. Central nervous system side effects , including light-headedness, dizziness or vertigo, have been reported with tetracycline use. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued. Intracranial hypertension in adults and adolescents has been associated with the use of tetracyclines. Clinical manifestations include headache, blurred vision and papilledema. Although signs and symptoms of intracranial hypertension resolve after discontinuation of treatment, the possibility for sequelae such as visual loss that may be permanent or severe exists. Concomitant use of isotretinoin and SEYSARA should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using SEYSARA. Bacterial resistance to tetracyclines may develop in patients using SEYSARA. Because of the potential for drug-resistant bacteria to develop during the use of SEYSARA, it should only be used as indicated. As with other antibiotic preparations, use of SEYSARA may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, SEYSARA should be discontinued and appropriate therapy instituted. ADVERSE REACTIONS The most common adverse reaction (incidence ≥1%) was nausea: SEYSARA 3.1% vs placebo 2.0%. Please see full Prescribing Information. About Ilumya (tildrakizumab-asmn): INDICATION AND IMPORTANT SAFETY INFORMATION ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. Infections ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves. Pretreatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment. Immunizations Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines. Adverse Reactions The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea. Please see full Prescribing Information. About Ebglyss (lebrikizumab-lbkz): INDICATION AND SAFETY SUMMARY EBGLYSS is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids. It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg). Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients. Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you: Have a parasitic (helminth) infection. Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with EBGLYSS. Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy. Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Possible side effects EBGLYSS can cause serious side effects, including: Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. The most common side effects of EBGLYSS include: eye and eyelid inflammation, including redness, swelling, and itching injection site reactions shingles (herpes zoster) These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. How to take Use EBGLYSS exactly as prescribed by your healthcare provider. EBGLYSS is given as an injection under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver. If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time. Learn more EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you. Content addressed for US audience only. About Almirall Almirall is a global biopharmaceutical 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 2025: €1114.5 MM, over 2100 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 3Clinical Result

100 Deals associated with Tirbanibulin

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KEGG	Wiki	ATC	Drug Bank
D11691	Tirbanibulin	D06BX03 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

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06135415 (TirbAKare, CTgov)	Phase 3	Actinic Keratosis	280	Vehicle ointment (Vehicle Ointment)	cxygpbpkbn(aadsknvnby) = uxbksamksi mfmsgivcis (atpobhqeor, 3.96) View more	-	30 Jun 2026
NCT06135415 (TirbAKare, CTgov)	Phase 3	Actinic Keratosis	280	Tirbanibulin (Tirbanibulin 10 mg/g)	cxygpbpkbn(aadsknvnby) = vlahtqihtp mfmsgivcis (atpobhqeor, 2.87) View more	-	30 Jun 2026
AAD2026	Not Applicable	Actinic Keratosis	38	Tirbanibulin 1% ointment (Actinic Keratosis)	lnaubeyoot(ryffeciuvo) = jbsfcjwwox zbvkdywcjd (bfaxmqghsr ) View more	Positive	27 Mar 2026
AAD2026	Not Applicable	Actinic Cheilitis	20	Tirbanibulin 1% ointment	dqtdjpxqfa(ymcbvlagkr) = rbkvefkdkj ysnutsvqff (zywldigdfb ) View more	Positive	27 Mar 2026
AAD2026	Not Applicable	Actinic Keratosis	966	Tirbanibulin 1% ointment	iosylwpaqu(mshczpgdxo) = taeabltxog vfaifrkctm (iscvzghkrb ) View more	Positive	27 Mar 2026
NCT06135415 (AAD2026)	Phase 3	Actinic Keratosis	280	Tirbanibulin 1% ointment	wtbmgruuah(bujbzzoysj) = zjevtnoqwb gmxjyrgkih (ixfoquhjiu ) View more	Positive	27 Mar 2026
NCT06135415 (AAD2026)	Phase 3	Actinic Keratosis	280	Vehicle	wtbmgruuah(bujbzzoysj) = sywfmxboit gmxjyrgkih (ixfoquhjiu ) View more	Positive	27 Mar 2026
NCT05260073 (PROAK, AAD2025)	Phase 4	Actinic Keratosis	606	Tirbanibulin	midiosvswy(udbagzmzlu) = Adverse events and local skin tolerability were comparable to those in the Phase III studies uvvdiwkaap (eduysylkbf )	Positive	07 Mar 2025
NCT05741294 (CTgov)	Phase 4	Actinic Keratosis	334	Tirbanibulin	wjyplgouet(vuabxceapo) = ekbcbcauwv dczgwddrdp (yihzhlpazd, udedgsrkhy - kgdcyejfoo) View more	-	20 Feb 2025
NCT05260073 (PROAK, AAD2024)	Phase 3	Actinic Keratosis	290	tirbanibulin	grfummuuhq(ashghpmavi) = ycxifwoydg jjcsbedigq (fxpgskrwuq ) View more	Positive	08 Mar 2024
NCT05260073 (PROAK, AAD2024)	Phase 3	Actinic Keratosis	290	vehicle	grfummuuhq(ashghpmavi) = jfclvidaet jjcsbedigq (fxpgskrwuq ) View more	Positive	08 Mar 2024
NCT05279131 (AAD2024)	Phase 3	Actinic Keratosis	105	Tirbanibulin	bgeztrxlkz(jlsajwhrbu) = yzxuhjctba fsxsiijqdl (jbctwwnfpk ) View more	Positive	08 Mar 2024
NCT05279131 (CTgov)	Phase 3	Actinic Keratosis	105	Tirbanibulin ointment 1%	xoatsmhdgy(zmnchfkblj) = rezetzjvci utgoottnfj (jcmbmkptyi, eamaqnslrt - sgzrzqvmbz) View more	-	23 Jan 2024

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