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

Patient- and clinician-reported outcomes, safety and efficacy profile of tirbanibulin 1% for actinic keratosis under conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study). (PubMed, Actas Dermosifiliogr) - " Patients' and clinicians' satisfaction was high, and both groups reported a high likelihood of using tirbanibulin again, if needed."

Journal • Actinic Keratosis • Dermatology

Repurposing flufenamic acid as a putative PmrB-directed adjuvant to restore colistin activity in Klebsiella pneumoniae. (PubMed, Microbiol Spectr) - "High-throughput virtual screening of DrugBank using integrated ligand- and structure-based approaches shortlisted five approved drugs (mebendazole, flurbiprofen, tirbanibulin, flufenamic acid, and netarsudil) for experimental evaluation. Mechanistically, our findings are consistent with modulation of the PmrB/PmrA resistance pathway, supporting bacterial histidine-kinase signaling as a promising direction for antibiotic adjuvant development. Overall, this study highlights a practical and scalable framework for discovering resistance-targeted adjuvants to help protect last-resort antibiotics and improve treatment options for difficult-to-treat infections."

Journal • Infectious Disease • Pneumonia

Efficacy of Tirbanibulin 1% Beyond Complete Clearance (CC): Percent Reduction of Actinic Keratosis (AK) Lesions as a Clinically Meaningful Endpoint (AAD 2026) - P3, P4 | "Tirbanibulin demonstrated good efficacy. Regardless of the number of AK lesions and treatment area, more than ¾ of lesions were cleared both in TFs of 25 and 100 cm2."

Clinical • Actinic Keratosis • Dermatology

Achieving complete clearance (CC) in actinic keratosis (AK) after treatment with tirbanibulin 1% with mild to moderate local skin reactions (LSRs): a pooled post-hoc analysis of three Phase III studies (AAD 2026) - P3 | "Background: Tirbanibulin 1% ointment is effective and safe for the treatment of patients with AK when applied to areas up to 100 cm2 [1,2]. Most patients who achieved CC experienced absent or mild/moderate LSRs, supporting the favorable and balanced efficacy and tolerability profile of tirbanibulin treatment in patients with AK."

P3 data • Retrospective data • Actinic Keratosis • Dermatology

A phase 3 study assessing the efficacy, safety and tolerability of up to two 5-day treatment courses of tirbanibulin 1% ointment in patients with actinic keratosis (AK) over a treatment field up to approximately 100 cm² (AAD 2026) - P3 | "At D57 tirbanibulin showed significant and clinically meaningful efficacy and additional benefit up to 2 courses on fields of up to approximately 100 cm2, and a favorable cosmetic outcome. Safety and tolerability were consistent with previous studies [1,2]."

Clinical • P3 data • Actinic Keratosis • Basal Cell Carcinoma • Dermatology • Non-melanoma Skin Cancer • Squamous Cell Carcinoma

Holistic Value Assessment of Tirbanibulin for Actinic Keratosis: European Multi-Criteria Decision Analysis. (PubMed, Dermatol Ther (Heidelb)) - "Overall, participants recognized tirbanibulin as a valuable treatment for AK, on the basis of robust evidence, favorable safety/tolerability and patient-reported outcomes (PRO) profiles, and alignment with clinical guidelines, with similar efficacy compared with 5FU-4%."

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

Randomized Comparative Study of 5-Fluorouracil 4%, Tirbanibulin, and Photodynamic Therapy for Relapsing Actinic Keratoses. (PubMed, Photodiagnosis Photodyn Ther) - "Short-term efficacy of 5-FU, tirbanibulin, and PDT was comparable, while tolerability differed markedly. Tirbanibulin demonstrated the most favorable inflammatory and cosmetic profile, whereas 5-FU and PDT may be preferred when a more intense field effect is desired. RCM detected subclinical persistence in select cases and may serve as an adjunctive imaging tool for monitoring and guiding retreatment in field cancerization."

Journal • Actinic Keratosis • Dermatology • Oncology

SRC Suppression Attenuates Vascular Aging by Activating FUNDC1-Dependent Mitophagy. (PubMed, Mech Ageing Dev) - "An accelerated vascular aging model was established using a high-fat diet and streptozotocin injection in ApoE-/- mice, while senescence in mouse aortic vascular smooth muscle cells (MOVASs) was induced by doxorubicin. Moreover, FUNDC1 knockdown abolished the anti-senescence effects of KX2-391, confirming that FUNDC1 is essential for SRC-mediated regulation. Together, these findings establish the SRC-FUNDC1 axis as an important regulator of mitophagy and vascular aging, suggesting that SRC inhibition may offer therapeutic benefit against vascular senescence and atherosclerosis."

Journal • Atherosclerosis • Cardiovascular • Metabolic Disorders • APOE

Efficacy of acitretin, cryotherapy, and tirbanibulin combination therapy for recalcitrant plantar and periungual warts: a case series of 30 patients. (PubMed, Ital J Dermatol Venerol) - No abstract available

Journal • Dermatology

Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2) (clinicaltrials.gov) - P1/2 | N=600 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

IO biomarker • New P1/2 trial • Oncology • Solid Tumor

Multidisciplinary Delphi consensus between primary care and dermatology on updated management of actinic keratosis in spain. (PubMed, Actas Dermosifiliogr) - "Regarding treatment, experts recommend the use of treatments adapted to the degree and extent of the injuries, highlighting the use of molecules such as 5-fluorouracil for isolated and field of cancerization injuries, as well as tirbanibulin for grade 1 and 2 isolated and field of cancerization injuries. These consensual recommendations seek to serve as a clinical guide on the routine management of patients with actinic keratosis."

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

Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: TCRx Therapeutics Co.Ltd

New P1 trial • Solid Tumor

Monitoring the effectiveness of noninvasive or minimally invasive therapies for nonmelanocytic lesions using reflectance confocal microscopy: a systematic review. (PubMed, Actas Dermosifiliogr) - "Evaluated therapies included ablative laser, cryosurgery, photodynamic therapy, 5-fluorouracil, imiquimod, and tirbanibulin, among others. RCM allows treatment optimization and early monitoring, even when inflammation hinders clinical assessment. It is recommended that RCM evaluations be performed starting at least 1 month after treatment for squamous conditions and 3 months for BCC."

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

Tirbanibulin 1% real-world use in 679 actinic keratoses patients during warm season (SUMM-AK study). (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Real-world evidence • Actinic Keratosis • Dermatology

Real‐world evidence of tirbanibulin in the treatment of actinic keratosis in Germany – prospective, multicenter, non‐interventional KLIR study. (PubMed, J Dtsch Dermatol Ges) - "Tirbanibulin showed high lesion clearance and a high level of acceptance in real-life conditions."

HEOR • Journal • Real-world evidence • Actinic Keratosis • Dermatology

Modeling the Anticipated Organizational Impact on Health Service Provision of the Introduction of Tirbanibulin for the Topical Treatment of Actinic Keratosis in France: EPIKA Study (ISPOR-EU 2025) - "The modelling study incorporated data on the number of patients treated for AK by dermatologists in France, waiting time for appointments with dermatologists or General Practitioners (GPs), prescribing patterns for other simple-to-use topical treatments for acne, and historical experience with the now withdrawn ingenol mebutate. Introduction of a convenient and safe topical treatment for AK would be expected to transfer care from the specialist to the primary care sector and thus facilitate access to treatment."

Acne Vulgaris • Actinic Keratosis • Dermatology

Src and Abl as Therapeutic Targets in Lung Cancer: Opportunities for Drug Repurposing. (PubMed, Pharmaceuticals (Basel)) - "This review aims to provide a comprehensive overview of five tyrosine kinase inhibitors-saracatinib, imatinib, PP2, nilotinib and, tirbanibulin-that act on Src and/or Abl. Although clinical data for these drugs in lung cancer remain limited, preclinical and clinical studies suggest promising therapeutic potential, particularly in specific molecular subtypes. Overall, this review highlights the therapeutic potential of Src and Abl inhibitors beyond their original contexts and supports their possible role in lung cancer therapy, considering the disease's high heterogeneity and the growing applicability of personalized medicine."

Journal • Review • Lung Cancer • Oncology • Solid Tumor

Berberine: a promising strategy to combat cetuximab-resistance in colorectal cancer. (PubMed, BMC Cancer) - "Adding KX2-391 (Src inhibitor) rather than BML-277 (Chk-2 inhibitor) with cetuximab resulted in more cell death and apoptosis. Conversely, activation of Src with MLR-1023 mitigated the inhibitory effect of berberine alone or in combination with cetuximab. Additionally, the activities of downstream kinases of Src such as mTOR, STAT3 and the production of ROS were inhibited greatly by berberine plus cetuximab. Taken together, we concluded that the synergistic effects of BBR and cetuximab may be mediated by decreasing the activities of Src/mTOR/STAT3 and the production of ROS, thus inducing greater extent of apoptosis in cancer cells."

Journal • Colorectal Cancer • Oncology • Solid Tumor • EGFR • STAT3

Personalized KXV01 TCR Lentinvivo Injection as the Therapy for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: The First Hospital of Jilin University

New P1 trial • Solid Tumor

Personalized KXV01 TCR Lentinvivo Injection as the Therapy for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: TCRx Therapeutics Co.Ltd

New P1 trial • Oncology • Solid Tumor

Tirbanibulin: An effective treatment for recalcitrant plantar warts. (PubMed, Med Clin (Barc)) - No abstract available

Journal • Dermatology

Relating patient-reported treatment satisfaction and clinical outcomes in post-registration studies of tirbanibulin for actinic keratosis (EADV 2025) - P | "Results from this combined analysis of results from PROAK and TirbaSkin 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

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

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) - "UV sensor might be a potential tool to visualize the risks associated with sun overexposure. In spring the UVI average was higher than in summer. Moreover, patients were exposed to UVI higher than recommended but improving habits from one year to another."

Clinical • P4 data • Actinic Keratosis • Dermatology • Squamous Cell Carcinoma