tirbanibulin oral (KX-01 oral) / Athenex - LARVOL DELTA

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

The presence of koilocytes within actinic keratosis identifies those at high risk of developing keratinocyte carcinoma. (EADO-WCM 2025) - "The in vitro and in vivo biological effects of Src inhibition were determined using siRNA and tirbanibulin...Conclusions The presence of koilocytes in AK histology identifies a subset of patients at risk of multiple KC. Inhibiting Src kinase blocks HPV8-associated keratinocyte proliferation and prevents skin tumours."

Actinic Keratosis • Dermatology • Non-melanoma Skin Cancer • Oncology • Skin Cancer

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

Effective Treatment of highly proliferative AK with Tirbanibulin:A Case Report (EADO-WCM 2025) - "Conclusions Tirbanibulin demonstrated strong efficacy in treating high-risk, proliferative AKs, as indicated by the complete remission in LC-OCT imaging. These findings highlight the potential of Tirbanibulin for treating proliferative AKs and emphasize the utility of LC-OCT for non-invasive monitoring of therapeutic outcomes."

Case report • Clinical • Actinic Keratosis • Dermatology • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

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

Safety and tolerability of tirbanibulin for the treatment of actinic keratosis (AK): Results from clinical trials and post-registration (AAD 2025) - P, P3 | "These combined results indicate that tirbanibulin has low risk for serious or severe AEs. Safety data for tirbanibulin applied to 25 or 100 cm2 was comparable."

Clinical • Actinic Keratosis • Dermatology • Pain • Pruritus

Relating patient-reported treatment satisfaction and clinical outcomes in post-registration studies of tirbanibulin for actinic keratosis (AK) (AAD 2025) - P | "Complete or partial clearance was achieved in 74.3% of patients and pooled TSQM-9 scores for Effectiveness, Convenience, and Global Satisfaction at week 24 (score range = 0-100) were 73.5, 83.8, and 74.7, respectively. Adverse events and local skin tolerability were comparable to those in the Phase III studies.2 Results from this combined analysis of results from PROAK and TirbaSkin (N=606 evaluable) indicated that the high AK clearance rate achieved with tirbanibulin was associated with corresponding high scores for all domains of the TSQM-9."

Clinical • Clinical data • Actinic Keratosis • Dermatology

Patient outcomes and satisfaction with tirbanibulin for the treatment of actinic keratosis (AK): Results from post-registration studies (AAD 2025) - P | "Patients were either somewhat (17.1%) or very (65.9%) likely to consider tirbanibulin if they required AK treatment in the future (83%). The combined results for these patient-reported outcomes from two large studies indicated that >80% of patients who used tirbanibulin were satisfied with this treatment for their AK and skin appearance and would consider using it again."

Clinical • Actinic Keratosis • Dermatology

Clearance of actinic keratosis (AK) with tirbanibulin: Comparing results from controlled trials with real-world clinical studies (AAD 2025) - P, P3 | "Reported percent reduction in AK lesions from three phase III trials (N=458) was 79.4% and from two post-registration studies (TirbaSkin and KLIR, N=764) was 76.5%. The results of these analyses 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

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

Tirbanibulin in the Long-Term Management of Recurrent Bowenoid Papulosis: A Retrospective Study. (PubMed, Int J Dermatol) - No abstract available

Journal • Retrospective data • Oncology

Synthesis and evaluation of KX-01 analogs with an exploration of linker attachment points for antibody-drug conjugates. (PubMed, Bioorg Med Chem Lett) - "KX-01 (tirbanibulin, Klisyri®) is a recently FDA-approved drug for treating actinic keratosis, with a distinct dual mechanism of action combining microtubule disruption and non-ATP-competitive Src inhibition. Furthermore, introducing a phenol or aniline functionality as a common linker attachment point preserved substantial cytotoxicity. These results suggest the potential of KX-01 derivatives for future use as ADC payloads."

Journal • Actinic Keratosis • Dermatology • Oncology

From basic to clinical and therapeutic insights: news on actinic keratosis and skin squamous cell carcinoma. (PubMed, Curr Opin Oncol) - "Recent years have seen a diagnostic revolution in dermatology, driven by noninvasive imaging and artificial intelligence; however, the physiopathogenesis of SCC progression remains poorly understood. In treatment, immune checkpoint inhibitors have shown good survival outcomes for advanced SCC. Research continues in the neoadjuvant setting and among transplanted patients, with encouraging preliminary results."

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

Efficacy of tirbanibulin in lentigo maligna: case report and therapeutic considerations (JDP 2024) - No abstract available

Case report • Clinical • Melanoma

Enhancement of sun-damaged skin qualities with tirbanibulin: A prospective Phase 4 study (SunDamage Study). (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • P4 data

Pain and Lesion Count in the Clinical Management of Actinic Keratosis in the Real-World Setting (ISPOR-EU 2024) - "Proportions of patients by pain VAS and lesion count were calculated for topical agents (fluorouracil, diclofenac, imiquimod, and tirbanibulin) and procedures (lesion destruction [laser surgery, electrosurgery, cryosurgery, chemosurgery, or surgical curettement], shaving, excision, chemical peel, and photodynamic therapy). Results provide insights into the roles of pain and lesion count in the management of AK patients in the real-world dermatology setting. Analyses of clinical notes may be beneficial to understand reasons behind different clinical management strategies."

Clinical • Real-world • Real-world evidence • Actinic Keratosis • Aesthetic Medicine • Dermatology • Pain

Tirbanibulin in large field of cancerization: new approach for sequential treatment of contiguous areas. (PubMed, Recenti Prog Med) - "We present the case of an 82-year-old patient, known for previous removals of squamous cell carcinomas at the vertex and currently suffering from a large field of cancerization in the nose and scalp, to whom we proposed a sequential treatment with three cycles of tirbanibulin in contiguous areas. The treatment was well tolerated and allowed complete clearance to be obtained on the nose and > 95% on the scalp, with a reduction of the Actinic Keratosis Area and Severity Index (AKASI) from 9.4 to 1.4."

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

Tirbanibulin in the treatment of actinic keratoses: description of a case with instrumental evaluation and long-term follow-up. (PubMed, Recenti Prog Med) - "Patient was treated with Tirbanibulin 1% ointment once a day for 5 consecutive days and, after 8 days from baseline, mild erythema and desquamation was observed on the treated area, associated with mild pruritus. At 1-year follow-up, no relapse and/or new AK were observed. In conclusion, the reported case is emblematic of the short and long-term efficacy and safety of tirbanibulin in the treatment of AK, as already reported in the literature, as well as of the usefulness of non-invasive imaging technique such as LC-OCT in the therapeutic monitoring."

Journal • Actinic Keratosis • Dermatology • Pruritus

Tir2401: Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses with Downward-directed Proliferation Patterns (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Thomas Dirschka

New trial • Actinic Keratosis • Dermatology

Tirbanibulin 1% ointmet for Actinic Keratosis and surrounding solar-damaged skin (field therapy): Results from a Real-Life Study. (EADV 2024) - "Our real-life experience confirms the effectiveness and safety of tirbanibulin ointment for the treatment of AKs and specially for surrounding solar-damaged skin (field therapy) ."

Clinical • Actinic Keratosis • Aesthetic Medicine • CNS Disorders • Dermatology • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Actinic cheilitis: Diagnosis and monitoring after treatment with Tirbanibulin using optical coherence tomography (EADV 2024) - "Non-surgical treatment options have been reported in small cohort studies, includinglocal treatment with diclofenac, photodynamic therapy and imiquimod...Systemic exposure toTirbanibulin was low in patients treated with topical Tirbanibulin...Optical coherence tomographycould be a useful tool for the diagnosis of actinic cheilitis and for monitoring therapy. However, punch biopsyshould be performed in unclear cases to exclude squamous cell carcinoma."

Actinic Keratosis • Acute Myelogenous Leukemia • Dermatology • Genito-urinary Cancer • Hematological Malignancies • Leukemia • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma

Efficacy of tirbanibulin in sensitive facial areas. Serie of cases. (EADV 2024) - "Tirbanibulin has a mechanism of action different from that of previously commercialized topical treatments. The reported data showed few side adverse effects, mild irritative symptoms, and high efficacy. This new study is consistent with previous studies in terms of the efficacy and safety in sensitive facial areas."

Clinical • Actinic Keratosis • Dermatology

Real-world evidence of tirbanibulin for actinic keratosis in Germany. Insights into patient-reported outcomes, safety and effectiveness (EADV 2024) - "These real-world data confirmed the results of tirbanibulin pivotal trials. No new adverse reactions were observed. The 5-day short-term application showed a high level of acceptance."

Clinical • HEOR • Patient reported outcomes • Real-world • Real-world evidence • Actinic Keratosis • Dermatology