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

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

Split-face case series of tirbanibulin 1% ointment versus photolyase-based repair cream in actinic keratosis: clinical outcomes and cosmetic field improvements (EADV 2025) - No abstract available

Clinical • Clinical data • Actinic Keratosis • Dermatology

Efficacy and tolerability of tirbanibulin 1% ointment in basal cell carcinoma: real-life experience in Italy (EADV 2025) - No abstract available

Clinical • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Tirbanibulin Ointment 1% over a Treatment Field up to 100 cm2 in Actinic Keratosis: A Phase 3 Study (EADV 2025) - No abstract available

P3 data • Actinic Keratosis • Dermatology

Clinical response to topical tirbanibulin in actinic keratoses of the scalp: potential predictive factors (EADV 2025) - No abstract available

Biomarker • Clinical • Actinic Keratosis • Dermatology

Pre-treatment with topical tirbanibulin of surrounding NMSCs cancerization field to improve the surgical outcome. A case-control study. (EADV 2025) - No abstract available

Clinical • Oncology

Tirbanibulin ointment: a viable therapeutic approach for superficial basal cell carcinoma (EADV 2025) - No abstract available

Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Tirbanibulin 1% ointment for solar lentigines on the dorsal hands (EADV 2025) - No abstract available

Oncology

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

Almirall Q1 2025 Results (Businesswire) - "Ilumetri (tildrakizumab for the systemic treatment of moderate-to-severe psoriasis) delivered double digit growth in Q1 2025 (12.7% increase YoY) and delivered solid Net Sales of €55.1 MM despite growing competition in the psoriasis market and some quarterly phasing impacts. Wynzora continued to grow in its main markets and delivered total Net Sales of €7.7 MM representing a 22.2% increase vs Q1 2024. The strong double-digit growth performance of Klisyri in Q1 2025 (€6.9 MM +25.5% YoY) is aligned with expectations of its increasing market share in key regions and was further supported by the US large field launch following the approval of the label extension by the FDA in 2024."

Sales • Psoriasis

Optimising Actinic Cheilitis Management: Balancing Efficacy, Safety, and Patient Adherence With Topical Tirbanibulin. (PubMed, Australas J Dermatol) - No abstract available

Journal

Treatment of actinic keratosis with tirbanibulin in private practice dermatology. Our experience in terms of efficacy and patient perception. (EADO-WCM 2025) - "Conclusions Tirbanibulin 1% ointment is a good treatment option for AK in private dermatology clinics, with a very easy posology, low rate of local side effects and good level of efficiency. The relative affordable price, the lack of need of any equipment to do the therapy and patient satisfaction makes it a very useful treatment in this clinical context."

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

Efficacy of Tirbanibulin 1% ointmet in the treatment of Actinic Keratosis, and surrounding solar-damaged skin (field therapy): Results from a Real-Life Study and our experience with pigmented lesions. (EADO-WCM 2025) - "Tirbanibulin 1% ointment is approved for the field treatment of Olsen grade I actinic keratosis of the face and scalp. Furthermore, our study suggests the potential anti-aging and pigment-clearance efficacy of this agent. More studies are needed to understand the mechanisms causing this improvement."

Clinical • Actinic Keratosis • Aesthetic Medicine • CNS Disorders • Dermatology • Genetic Disorders • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Efficacy of Tirbanibulin in Lentigo Maligna: Case Report and Therapeutic Considerations (EADO-WCM 2025) - "The patient declined surgical excision and radiotherapy and was initiated on a 6-week course of imiquimod cream, which showed limited benefit. Subsequently, we administered topical tirbanibulin for 10 consecutive days...In our case, tirbanibulin demonstrated excellent results in treating lentigo maligna following the failure of conventional therapies. Further studies are necessary to define its long-term efficacy and application protocols, but it represents a promising addition to the therapeutic options for lentigo maligna, particularly in cases where surgery is contraindicated."

Case report • Clinical • Actinic Keratosis • Dermatology • Melanoma • Oncology • Pruritus • Solid Tumor • Squamous Cell Carcinoma

Clinical and experimental aspects of tirbanibulin treatments. (PubMed, Arch Dermatol Res) - "Tirbanibulin is a topical medication approved in 2020 as a 5 day topical treatment for actinic keratosis, a precancerous skin lesion characterized by the hyperproliferation of atypical keratinocytes. In summary, we highlighted the preclinical and clinical evidence on the use of tirbanibulin as an effective and safe treatment option beyond AK. Graphical Abstract."

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

Efficacy and safety of tirbanibulin 1% ointment for the treatment of actinic keratosis under conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study) (EADO-WCM 2025) - "CC at Day 57 Conclusions Tirbanibulin 1% ointment is effective, safe, and well tolerated in AK patients regardless OG. Although in a limited sample size, immunosuppressed patients (N=6) in this study can benefit from tirbanibulin with comparable efficacy/safety and tolerability to immunocompetent population."

Clinical • Actinic Keratosis • Dermatology • Pruritus

Topical Tirbanibulin for the treatment of actinic cheilitis (EADO-WCM 2025) - "The oral health DLQI improved significantly between baseline and follow-up (6 vs. 3, p= 0.032). Conclusions Topical treatment with Tirbanibulin may be an effective and well-tolerated option for the treatment of AC, although further investigation including long-term follow-up need to be performed."

Dermatology • Oncology • Squamous Cell Carcinoma

Tirbanibulin 1% Ointment for the Treatment of Hypertrophic Actinic Keratosis (EADO-WCM 2025) - "Figure 1: (A) AK in the nasal bridge in an 80-year-old woman; (B) dermoscopy (10×) highlights Olsen 3 AK; (C) clinical complete resolution of AK at eight-week follow-up; (D) resolution of the AK dermoscopic patterns. Conclusions Our real-life experience confirms the effectiveness and safety of tirbanibulin ointment for treating this difficult-to-treat subset of AKs."

Actinic Keratosis • Dermatology • Oncology