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

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

Patient and physician-reported outcomes with tirbanibulin 1% ointment for actinic keratosis under conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study) (EADO-WCM 2025) - "Conclusions Physicians' and patients' overall satisfaction with tirbanibulin was high, and both reported great likelihood to use tirbanibulin in future. These results are comparable to previous ones[2]."

Clinical • Actinic Keratosis • Dermatology

Tolerability and local skin response of 1% topical tirbanibulin for actinic keratosis in organ transplant recipients. (EADO-WCM 2025) - "While all patients experienced local adverse effects, they were generally mild in severity, as reflected in the low pain reports, with only 9 patients experiencing pain at all. This suggests that tirbanibulin can be safely used in this immunosuppressed patient population."

Clinical • Actinic Keratosis • Dermatology • Oncology • Pain • Solid Organ Transplantation • Transplantation

Efficacy of a 5-day tirbanibulin topical treatment in actinic keratosis assessed by LC-OCT (EADO-WCM 2025) - "The stability observed in stratum corneum thickness and dermo-epidermal junction undulation suggests that the treatment effectively targets dysplastic keratinocytes without compromising overall skin integrity. These results highlight the potential of 5-day TT for managing AK and underscore the value of combining advanced imaging techniques like LC-OCT with robust analytical approaches to monitor therapeutic outcomes and inform clinical decision-making."

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

Pre-treatment with topical tirbanibulin of surrounding NMSCs cancerization field, to improve surgical outcome. A case-control study (EADO-WCM 2025) - "Regards SCC, margins positivity was equal to 3.7% vs 15.8% of the control group (t>0.05) while for BCC the comparison was equal to 3.3% vs 8.9% ( t<0.05).The average diameters of the SCCs equal to 21mm before the treatment were significantly decreased (p<0.05) up to a value of 17 mm. Also for the BCCs the diameters reduction (23 vs 21mm ) was significative(p<0.05) Conclusions Presurgery topical tirbanibulin treatment improves margin visibility and reduces the size of the lesions to be removed ."

Clinical • Actinic Keratosis • Dermatology • Genetic Disorders • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Exploring New Frontiers: Off-Label Use of Tirbanibulin 1% Ointment for Actinic Keratosis on the Décolleté (EADO-WCM 2025) - "Conclusions This case supports the safety and efficacy of tirbanibulin 1% ointment for treating AKs outside currently approved application sites, including sensitive areas such as the décolleté, and for surface areas exceeding 25 cm². Additionally, its use following DL-PDT on cancerization fields may enhance and prolong the effects."

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

Factors Influencing the Efficacy of Topical Tirbanibulin in Pigmented and Non-Pigmented Actinic Keratosis: Preliminary Results from an Ambispective Cohort Study (EADO-WCM 2025) - "The treatment response appears to be even better in females and in individuals with phototype II, particularly in PAK. Facial locations show a superior response compared to the scalp."

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

Prognostic factors in actinic keratoses (EADO-WCM 2025) - "Various mutations have been identified in this context. LC-OCT has the potential to visualize the proliferation pattern of AK in vivo and could serve as a valuable tool for monitoring treatment outcomes, as demonstrated in cases treated with topical Tirbanibulin."

Biomarker • Actinic Keratosis • Bowens Disease • Dermatology • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • HRAS • PTCH1 • TP53

Mild to moderate local tolerability signs on patients who achieved complete clearance after treatment with tirbanibulin 1% ointment in actinic keratosis (TIRBASKIN study) (EADO-WCM 2025) - "CC at day 57 Conclusions In this post-hoc analysis, CC of patients treated with tirbanibulin is not associated with bothersome LTS. Most of patients who achieved CC experienced absent LTS (24.1%) or mild/moderate LTS reassuring the favorable efficacy/tolerability profile of tirbanibulin treatment for AK patients."

Clinical • Actinic Keratosis • Dermatology

Outcome of treatment with Tirbanibulin 1% ointment in Organ Transplant Recipients (EADO-WCM 2025) - "Conclusions Based on such results, topical Tirbanibulin was showed to be effective in the treatment of AKs in OTRs. Despite the clearance rates were lower than in immunocompetent patients, the overall LSR were mild and did not impact on the conduction of the study."

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

Tirbanibulin data (Businesswire) - "The new data analysis presented at the AAD demonstrates the impact of tirbanibulin on overall AK treatment success and clearance while also assessing patient satisfaction and willingness to continue the treatment. The data show the product´s demonstrated safety and tolerability profile through a combination of clinical trial data and real-world evidence. The analysis from Phase III, phase IV, and real-world studies provide further evidence for tirbanibulin´s tolerability, safety profile and patient satisfaction."

Clinical data • Actinic Keratosis

Exploring Anti-Aging Effects of Topical Treatments for Actinic Keratosis. (PubMed, Medicina (Kaunas)) - "Materials and The literature was analyzed to assess the efficacy, mechanisms, and cosmetic outcomes of commonly used AK treatments, including topical agents (5-fluorouracil (5-FU), imiquimod, diclofenac, and tirbanibulin), and photodynamic therapy (PDT). While PDT remains the gold standard, emerging agents like tirbanibulin ointment exhibit substantial potential. Future research should focus on optimizing treatment protocols and evaluating long-term cosmetic outcomes to enhance patient satisfaction and compliance."

Journal • Review • Actinic Keratosis • Dermatology • Fibrosis • Oncology

Response Rate to the Intervention with Tirbanibulin 1% Ointment for Treating Actinic Keratoses in People Living with HIV Infection. (PubMed, Diagnostics (Basel)) - " The rate of satisfactory responses was in line with a recent multicentric Italian study performed on immunocompetent patients. Our results confirm the efficacy and tolerability of tirbanibulin 1% ointment in treating AKs in PLWH in particular."

Journal • Actinic Keratosis • Dermatology • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor

Almirall 2024 Full-Year Results: Almirall Surpassed Guidance for 2024 - Entering an Era of Sustained Growth and Further Advancing Its Medical Dermatology Pipeline (Businesswire) - "After the approval of Ebglyss (lebrikizumab) by the European Commission (EC)...the product has now launched in 11 countries in Europe...and in 2025: Italy, Switzerland, Austria, Belgium, and Sweden). The rollout in the remaining European countries is expected throughout 2025....Sarecycline’s (Seysara) regulatory review in China is ongoing with an anticipated approval in the second half of 2025. To expand the label for Klisyri to include large field application also in Europe, a current clinical study is aimed at enabling approval for an anticipated launch in 2026....Sun Pharma is running two Phase III studies to assess the efficacy and safety of tildrakizumab in patients suffering from psoriatic arthritis. First results are expected in the second half of 2025....The company is continuing to advance the asset ALM27134...The start of a Phase II study is planned for later this year in patients suffering from Hidradenitis Suppurativa."

China approval • Launch Europe • New P2 trial • P3 data • Dermatology • Hidradenitis Suppurativa • Psoriatic Arthritis

Almirall 2024 Full-Year Results: Almirall Surpassed Guidance for 2024 - Entering an Era of Sustained Growth and Further Advancing Its Medical Dermatology Pipeline (Businesswire) - "Ebglyss achieved 34% growth in Q4 compared to Q3, delivering a total of €33.2 MM sales in 2024, mainly in Germany....Sustained solid growth of the medical dermatology portfolio overall: 17.8% (total of €548.1 MM). Strong performance of Almirall´s broad dermatology portfolio: Wynzora grew 53.3% YoY (total of €25.9 MM), and Klisyri grew 17.8% YoY (total of €24.5 MM). Sustained solid growth of the medical dermatology portfolio overall: 17.8% (total of €548.1 MM)....Ilumetri: Almirall anticipates sustaining the momentum of Ilumetri in the short to mid-term and therefore has recently updated its peak sales guidance to above €300 MM by 2030....resulted in an upgrade of the peak sales forecast to above €800 MM. The positive momentum of the broad dermatology portfolio of products will deliver continued growth in the future - spearheaded by Klisyri and Wynzora in European markets."

Sales • Sales projection • Dermatology • Immunology • Psoriasis

TirbAKare: A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (clinicaltrials.gov) - P3 | N=280 | Active, not recruiting | Sponsor: Almirall, S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Actinic Keratosis • Dermatology

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp (clinicaltrials.gov) - P4 | N=447 | Active, not recruiting | Sponsor: Almirall, S.A. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2027 ➔ Jul 2027 | Trial primary completion date: Mar 2027 ➔ Jul 2027

Enrollment closed • Trial completion date • Trial primary completion date • Actinic Keratosis • Dermatology • Oncology • Squamous Cell Carcinoma

TirbAKare: A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (clinicaltrials.gov) - P3 | N=270 | Recruiting | Sponsor: Almirall, S.A. | Trial completion date: Dec 2024 ➔ Nov 2026 | Trial primary completion date: Dec 2024 ➔ Apr 2026

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