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

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

Tirbanibulin 1% Ointment: Clinical Trial and Real-World Evidence on Efficacy, Tolerability, Safety, and Patient-Reported Outcomes. (PubMed, J Drugs Dermatol) - "In addition to its convenience of use, tirbanibulin 1% ointment has demonstrated efficacy and safety in phases 1 to 3 clinical trials and favorable clinical outcomes in real-world clinical studies. This paper summarizes the comprehensive evidence from clinical trials and global clinical studies to guide clinical consideration of tirbanibulin 1% ointment in AK management."

HEOR • Journal • Real-world evidence • Review • Actinic Keratosis • Dermatology • Oncology • Squamous Cell Carcinoma

Tirbanibulin 1% ointment for the treatment of superficial basal cell carcinoma: A retrospective study. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Retrospective data • Basal Cell Carcinoma • Dermatology • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer

Tirbanibulin 1% Ointment: The Mechanism of Action of a Novel Topical Therapy for Actinic Keratosis. (PubMed, J Drugs Dermatol) - "J Drugs Dermatol. 2025;24:7(Suppl 1):s13-18."

Journal • Review • Actinic Keratosis • Dermatology • Oncology • Squamous Cell Carcinoma

Tirbanibulin 1% Ointment for the Treatment of Hyperkeratotic Actinic Keratosis. (PubMed, J Dermatol) - "No patient discontinued the treatment due to the onset of adverse events. Our real-world experience suggests the effectiveness and safety of tirbanibulin ointment for the treatment of hyperkeratotic AKs."

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

Field Cancerization Treatment with Tirbanibulin 1% Ointment: Results in Real-World Practice. (PubMed, Acta Derm Venereol) - No abstract available

Journal • Real-world evidence • Oncology

Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Bruce Robinson, MD

New P1/2 trial • Aesthetic Medicine • Basal Cell Carcinoma • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Treatment of Condyloma Acuminata with Tirbanibulin 1% Ointment in People Living with HIV: A Case Series with Literature Review. (PubMed, Infect Dis Rep) - "While in need of larger studies, it is possible to hypothesize tirbanibulin 1% ointment as a therapeutic alternative for people living with HIV, especially for condylomas smaller than 1 cm in size."

Journal • Review • Actinic Keratosis • Dermatology • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • Oncology

Tirbanibulin for Pediatric Warts (clinicaltrials.gov) - P4 | N=10 | Recruiting | Sponsor: The Skin Center Dermatology Group | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Pediatrics