Klisyri (tirbanibulin ointment) / Guangzhou Xiangxue Pharma, Almirall, Athenex, PharmaEssentia - LARVOL DELTA

Achieving complete clearance (CC) in actinic keratosis (AK) after treatment with tirbanibulin 1% with mild to moderate local skin reactions (LSRs): a pooled post-hoc analysis of three Phase III studies (AAD 2026) - P3 | "Background: Tirbanibulin 1% ointment is effective and safe for the treatment of patients with AK when applied to areas up to 100 cm2 [1,2]. Most patients who achieved CC experienced absent or mild/moderate LSRs, supporting the favorable and balanced efficacy and tolerability profile of tirbanibulin treatment in patients with AK."

P3 data • Retrospective data • Actinic Keratosis • Dermatology

Successful treatment of actinic cheilitis with Tirbanibulin 1% ointment: A monocentric proof-of-concept study (AAD 2026) - "Topical Tirbanibulin appears to be an effective and safe treatment option for AC."

Lip Cancer • Oral Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Efficacy and Safety of Tirbanibulin 1% Ointment for Actinic Keratosis At 1-Year Follow-Up: A Real-Life Extension Study (AAD 2026) - "Tirbanibulin demonstrated durable one-year efficacy. Although recurrences were relatively common, the treatment was well tolerated, with no delayed adverse effects. Its short regimen and favorable safety profile support its role in the long-term management of field cancerization."

Clinical • Actinic Keratosis • Dermatology

A phase 3 study assessing the efficacy, safety and tolerability of up to two 5-day treatment courses of tirbanibulin 1% ointment in patients with actinic keratosis (AK) over a treatment field up to approximately 100 cm² (AAD 2026) - P3 | "At D57 tirbanibulin showed significant and clinically meaningful efficacy and additional benefit up to 2 courses on fields of up to approximately 100 cm2, and a favorable cosmetic outcome. Safety and tolerability were consistent with previous studies [1,2]."

Clinical • P3 data • Actinic Keratosis • Basal Cell Carcinoma • Dermatology • Non-melanoma Skin Cancer • Squamous Cell Carcinoma

Efficacy and Safety of Tirbanibulin 1% Ointment for Actinic Keratosis: A Systematic Review and Meta-analysis (AAD 2026) - "Tirbanibulin 1% ointment demonstrated high rates of complete and partial lesion clearance, with a low incidence of severe LSR. Its convenient 5-day regimen supports patient adherence, positioning it as a therapeutic option for AK."

Retrospective data • Review • Actinic Keratosis • Dermatology

Holistic Value Assessment of Tirbanibulin for Actinic Keratosis: European Multi-Criteria Decision Analysis. (PubMed, Dermatol Ther (Heidelb)) - "Overall, participants recognized tirbanibulin as a valuable treatment for AK, on the basis of robust evidence, favorable safety/tolerability and patient-reported outcomes (PRO) profiles, and alignment with clinical guidelines, with similar efficacy compared with 5FU-4%."

Journal • Actinic Keratosis • Dermatology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Almirall’s 2025 Results (Businesswire) - "Ebglyss, for the treatment of moderate to severe atopic dermatitis, generated €110.8 MM of sales during 2025 – demonstrating a solid increase of its market share after successful launches across European markets. The product’s growth trajectory remains in line with the expected peak sales in Europe of above €450 MM. Ilumetri, for the treatment of psoriasis, continued to grow in line with expectations in 2025, with net sales increasing 12.3% YoY, to a total of €234.4 MM....In 2025...Klisyri grew 33.9% YoY to a total of €32.8 MM."

Sales • Actinic Keratosis • Atopic Dermatitis • Psoriasis

TirbAKare: A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (clinicaltrials.gov) - P3 | N=280 | Completed | Sponsor: Almirall, S.A. | Trial completion date: Apr 2025 ➔ Nov 2025

Trial completion date • Actinic Keratosis • Dermatology

TIRBACRYO: Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead (clinicaltrials.gov) - P3 | N=59 | Not yet recruiting | Sponsor: University Hospital, Lille

New P3 trial • Actinic Keratosis • Dermatology

Almirall continues its sustained growth trajectory in 9M 2025 - delivering 12.8% net sales growth, strong dermatology performance, solid commercial execution in Europe, and further pipeline progress (PharmiWeb) - "Ebglyss, for the treatment of moderate to severe atopic dermatitis, generated €75.5 MM of sales during 9M 2025 – representing more than a 3x increase YoY, as European markets are ramping up after launch...Ilumetri, for the treatment of psoriasis, grew steadily in 9M 2025, with net sales increasing 12% YoY, to a total of €170.9 MM and remaining on track to meet the €300 MM peak sales target....Almirall’s broad dermatology product portfolio continues to show strong performance, further enhancing the company´s relevance to patients and dermatologists. In 9M 2025 Wynzora grew 32.3% YoY to a total of €25.4 MM, and Klisyri grew 22.6% YoY to a total of €20.1 MM."

Sales • Actinic Keratosis • Atopic Dermatitis • Psoriasis

Clearance of actinic keratosis with tirbanibulin: Comparing results from controlled trials with real-world/low interventional clinical studies (EADV 2025) - P, P3 | "Materials & Efficacy of tirbanibulin 1% ointment in the treatment of actinic keratosis (AK) has been evaluated in three phase III clinical trials; two [NCT03285477, NCT03285490] [3] in which tirbanibulin was applied to an area of 25 cm2 and one to an area of 100 cm2 [NCT05279131] [4] (N=458 total patients). These results indicate that clearance rates and reductions in AK lesion counts achieved with tirbanibulin in RCTs approximated results achieved in an open-label phase IV study and in real-world clinical practice."

Clinical • Real-world • Real-world evidence • Actinic Keratosis • Dermatology

Safety and tolerability of tirbanibulin for the treatment of actinic keratosis: Results from clinical trials and post-registration (EADV 2025) - P, P3 | "Materials & Information regarding safety and tolerability of tirbanibulin 1% ointment has been obtained in (i) three phase III trials, in two tirbanibulin was applied to an area of 25 cm2 (NCT03285477, NCT03285490) [3] and in one, to an area of 100 cm2 (NCT05279131) [4] (N=458 total patients), (ii) one open phase IV multicenter, single-cohort, low-interventional study (TirbaSkin [EU2022-001251-16] [5], N=334) and (iii) two real-world/low interventional studies, KLIR (DRKS00027120) [6] (N=543) and PROAK (NCT05260073) [7] (N=300), in which tirbanibulin was applied to an area of 25 cm2. These combined results indicate that tirbanibulin has low occurrence for serious or severe AEs, and severe LSRs were uncommon. The safety/tolerability profile for tirbanibulin in real-world clinical practice was comparable to the one reported in clinical trials."

Clinical • Actinic Keratosis • Dermatology • Pruritus

Tirbanibulin Ointment 1% over a Treatment Field up to 100 cm2 in Actinic Keratosis: A Phase 3 Study (EADV 2025) - "The aim of this study is to evaluate the efficacy, safety, and tolerability of tirbanibulin 10 mg/g ointment, compared to vehicle, in adult patients with AK on the face or scalp in a field larger than 25 cm2 and up to approximately 100 cm2, as well as examining the effects of up to two 5-day treatment courses. Figure 1 Study Design CC, complete clearance; PC, partial clearance."

P3 data • Actinic Keratosis • Alopecia • Dermatology • Squamous Cell Carcinoma

Efficacy and tolerability of tirbanibulin 1% ointment in basal cell carcinoma: real-life experience in Italy (EADV 2025) - "Tirbanibulin 1% ointment was effective and well tolerated in patients with BCC. Tirbanibulin could represent a potential new therapeutic option in BCC with promising outcomes."

Clinical • Actinic Keratosis • Basal Cell Carcinoma • Dermatology • Non-melanoma Skin Cancer • Oncology • Skin Nodular Basal Cell Carcinoma

Clinical response to topical tirbanibulin in actinic keratoses of the scalp: potential predictive factors (EADV 2025) - "Topical tirbanibulin is effective in treating AKs, particularly those located on the scalp. Although no clinical variables reached statistical significance as predictors of response, the anatomical site may influence treatment outcomes. Multicenter studies with larger cohorts are needed to better characterize the clinical profile of responders."

Biomarker • Clinical • Actinic Keratosis • Dermatology • Genetic Disorders • Melanoma • Skin Cancer • Solid Tumor

Split-face case series of tirbanibulin 1% ointment versus photolyase-based repair cream in actinic keratosis: clinical outcomes and cosmetic field improvements (EADV 2025) - "This split-face case series suggests that tirbanibulin 1% ointment is not only effective in clearing AKs but may also confer additional cosmetic benefits in photodamaged skin when compared to a repair cream with photolyase. These findings support further investigation into tirbanibulin's broader field-directed potential."

Clinical • Clinical data • Actinic Keratosis • Dermatology

Pre-treatment with topical tirbanibulin of surrounding NMSCs cancerization field to improve the surgical outcome. A case-control study. (EADV 2025) - "Pretreatment with tirbanibulin, improves surgical outcome and reduces NMSC diameters. Our data suggest that the pre-treatment with tirbanibulin, cleaning perilesional skin and reducing tumoral lesions, could help in the management of surgical patients affected by NMSC."

Clinical • Actinic Keratosis • Dermatology • Oncology • Squamous Cell Carcinoma

Topical treatment of actinic cheilitis with Tirbanibulin: Results of a monocentric phase II study to investigate efficacy and tolerability (EADV 2025) - "Introduction & Objectives: Tirbanibulin 1% ointment is licensed for treatment of actinic keratoses. These results suggest, that treatment of actinic cheilitis with Tirbanibulin appeared to be safe and effective."

Clinical • P2 data • Actinic Keratosis • Dermatology

Tirbanibulin 1% ointment for solar lentigines on the dorsal hands (EADV 2025) - "To our knowledge, this is the first case of complete solar lentigo clearance on the hands following tirbanibulin therapy. These preliminary findings warrant further investigation about the cosmetic and dermatological potential of tirbanibulin for pigmentary disorders and photoaging."

Actinic Keratosis • Dermatology

Tirbanibulin ointment: a viable therapeutic approach for superficial basal cell carcinoma (EADV 2025) - "Erythema does not seem then to be a reliable clinical sign to evaluate for disease persistence. Furthermore, the clinical outcome was correlated with the histological report and any further biopsies would not be justified. No statistically significant difference related to the therapeutic outcome for the two groups was found."

Actinic Keratosis • Basal Cell Carcinoma • Dermatology • Non-melanoma Skin Cancer • Oncology

Eficacia de la tirbanibulina al 1% en el tratamiento de la queratosis actínica pigmentada: un estudio ambispectivo en la vida real (EADV 2025) - "Tirbanibulin 1% ointment is an approved topical treatment for grade I AK, with proven efficacy and a favorable tolerability profile. In conclusion, 1% tirbanibulin appears to be an effective and safe therapeutic option for pAKs, with additional benefits in pigmentation and overall skin appearance. Further studies are needed to better understand the role of pigmentation in treatment response."

Actinic Keratosis • Aesthetic Medicine • Dermatology

Almirall will share new data from the TirbAKare study... (Almirall Press Release) - "...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."

P3 data • Actinic Keratosis

Real-World Efficacy of Tirbanibulin in Actinic Keratosis Treatment: Expert Consensus and Clinical Insights. (PubMed, Dermatol Pract Concept) - "Tirbanibulin should be considered as a first-line option for most patients with AK owing to its proven efficacy, good local and systemic tolerability, and a short treatment regimen of five days. All these factors encourage patient acceptability and treatment compliance. The favorable safety profile and tolerability of tirbanibulin also enable flexible therapeutic schedules, including repeated treatment cycles, if needed."

Journal • Real-world evidence • Review • Actinic Keratosis • Dermatology

TirbAKare: A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (clinicaltrials.gov) - P3 | N=280 | Completed | Sponsor: Almirall, S.A. | Active, not recruiting ➔ Completed | Trial completion date: Nov 2026 ➔ Apr 2025 | Trial primary completion date: Apr 2026 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Actinic Keratosis • Dermatology

Efficacy and safety of sequential treatment with cryotherapy followed by 1% topical tirbanibulin for actinic keratoses in organ transplant recipients: a randomized clinical trial. (PubMed, J Am Acad Dermatol) - "Sequential cryotherapy and tirbanibulin appears effective and safe for AK in SOTRs, improving lesion clearance and reducing new AK development."

Clinical • Journal • Actinic Keratosis • Dermatology • Solid Organ Transplantation • Transplantation