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

Relating patient-reported treatment satisfaction and clinical outcomes in post-registration studies of tirbanibulin for actinic keratosis (EADV 2025) - No abstract available

Clinical • Clinical data • Actinic Keratosis • Dermatology

Clearance of actinic keratosis with tirbanibulin: Comparing results from controlled trials with real-world/low interventional clinical studies (EADV 2025) - No abstract available

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) - No abstract available

Clinical • Actinic Keratosis • Dermatology

Sun exposure monitoring by ultraviolet sensor in patients with actinic keratosis treated with tirbanibulin 10 mg/g ointment or diclofenac sodium 3% gel: a Phase IV randomized study (EADV 2025) - No abstract available

Clinical • P4 data • Actinic Keratosis • Dermatology

Tirbanibulin treatment for Actinic Keratosis: LC-OCT with AI-based algorithm evaluation (EADV 2025) - No abstract available

Actinic Keratosis • Dermatology

Topical treatment of actinic cheilitis with Tirbanibulin: Results of a monocentric phase II study to investigate efficacy and tolerability (EADV 2025) - No abstract available

Clinical • P2 data • Oncology

Efficacy, safety and patients satisfaction of Tirbanibulin in the treatment of actinic keratosis in sensitive facial areas: A prospective observational study (EADV 2025) - No abstract available

Clinical • Observational data • Actinic Keratosis • Dermatology

Eficacia de la tirbanibulina al 1% en el tratamiento de la queratosis actínica pigmentada: un estudio ambispectivo en la vida real (EADV 2025) - No abstract available

Assessing The Holistic Value Of Tirbanibulin For Treating Actinic Keratosis Using Multi-Criteria Decision Analysis (MCDA) In Three European Countries (EADV 2025) - No abstract available

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

Src/FN1 pathway activation drives tumor cell cluster formation and metastasis in lung cancer: A promising therapeutic target. (PubMed, Sci Adv) - "Pharmacological inhibition of Src with the clinical inhibitor KX2-391 disrupted clustering, impaired CTC survival, and reduced metastasis in preclinical models. Our findings identify the Src/FN1 pathway as a key vulnerability in CTC cluster-driven metastasis, suggesting that Src inhibitors are promising therapeutic strategies to disrupt clustering and improve outcomes in patients with metastatic lung cancer."

Journal • Lung Cancer • Oncology • Solid Tumor • CTCs

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 | Recruiting | Sponsor: Thomas Dirschka | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2025 ➔ Oct 2025 | Trial primary completion date: Feb 2025 ➔ Sep 2025

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

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

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