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

Efficacy, tolerability and 1-year long term safety with tirbanibulin 1% ointment in patients with actinic keratosis applied over a field up to 100 cm² and up to 2 treatment courses (EADV 2026) - No abstract available

Clinical • Actinic Keratosis • Dermatology

Efficacy and Safety of Tirbanibulin 1% Ointment for Actinic Keratosis At 1-Year Follow-Up: A Real-Life Extension Study (EADV 2026) - No abstract available

Clinical • Actinic Keratosis • Dermatology

Treating cheilitis actinica with topical tirbanibulin improves quality of life (EADV 2026) - No abstract available

HEOR • Oncology

Subclinical PRO III Actinic Keratoses Detected by LC-OCT Before and After Tirbanibulin 1% Ointment: A Pilot Imaging Assessment (EADV 2026) - No abstract available

Actinic Keratosis • Dermatology

Clinical Clearance of Actinic Keratoses with Tirbanibulin 1% Ointment: Evidence from a Meta-Analysis. (PubMed, Life (Basel)) - "This led to an overall pooled PC rate of 71.96% (95% CI: 64.89-78.09%). In conclusion, tirbanibulin 1% ointment has shown clinical effectiveness and should be considered a promising treatment for AKs."

Journal • Retrospective data • Actinic Keratosis • Dermatology • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Predictors of outcomes and satisfaction with tirbanibulin in actinic keratosis: a multicenter real-world study. (PubMed, Ital J Dermatol Venerol) - "Tirbanibulin 1% achieved high clearance with favorable tolerability and satisfaction, supporting its use in individualized management of field cancerization."

Biomarker • Journal • Real-world evidence • Actinic Keratosis • Dermatology • Oncology

Almirall delivers solid H1 2026 results growing Net Sales by 7.5% and EBITDA by 23.7%, driven by its strong European Dermatology business – reiterating guidance aligned with long-term growth trajectory (Almirall Press Release) - "Continued solid performance of the biologics portfolio, with Ilumetri delivering 10.5% increase to €125.2 MM and Ebglyss growing 88.2% to €84.5 MM in Net Sales; The broader dermatology portfolio delivers positive performance, including Wynzora (19.3%, total of €20.4 MM) and Klisyri (13.9%, total of €15.6 MM); Almirall advances its innovation strategy through progress across its R&D pipeline, including four ongoing PoC/Phase II studies and two additional PoC studies planned to be initiated by end of 2026, targeting five dermatological diseases. The first readouts are expected towards the end of 2026."

Clinical data • Commercial • Actinic Keratosis • Atopic Dermatitis • Hidradenitis Suppurativa • Immunology • Plaque Psoriasis

Potential role of tirbanibulin in the management of superficial basal cell carcinoma. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

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

A single-center prospective observational study evaluating the efficacy and safety of tirbanibulin 1% in actinic keratoses in immunosuppressed patients: the ESTIMATE study. (PubMed, J Dtsch Dermatol Ges) - "This study demonstrates that tirbanibulin is a safe, well-tolerated, and effective option for AK management in OTRs, addressing a critical need in this high-risk population."

Journal • Observational data • Actinic Keratosis • Dermatology • Oncology • Squamous Cell Carcinoma • Transplantation

Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR) (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Avant Health LLC

New trial • Actinic Keratosis • Dermatology

Sequential Keratolytic Pre-Treatment Followed by Tirbanibulin in Hyperkeratotic Actinic Keratoses: A Retrospective Comparative Study. (PubMed, Pharmaceuticals (Basel)) - "Tirbanibulin 1% ointment is an effective short-course field therapy for AK, but its efficacy in hyperkeratotic lesions (Olsen grade II-III) may be limited by reduced drug penetration through a thickened stratum corneum. This retrospective study suggests that keratolytic pretreatment may represent a useful adjunctive strategy in hyperkeratotic AK treated with tirbanibulin. Prospective randomized studies are warranted to confirm these findings and to define standardized treatment protocols."

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

Successful treatment of recurrent condylomas with topical tirbanibulin (EADV-Sp 2026) - "Materials and Methods We present the case of a 63-year-old male with multiple myeloma undergoing intensified treatment with lenalidomide, bortezomib, and dexamethasone in the context of autologous haematopoietic stem cell transplantation. The patient presented with recurrent condylomatous lesions located in the pubic region, with long-standing disease and multiple recurrences despite previous standard treatments, including repeated cryotherapy and topical imiquimod...Conclusions Topical tirbanibulin allowed complete and rapid resolution of multiple condylomas, with good tolerability and mild, transient local adverse effects. Given its antiproliferative effect and its action independent of the immune system, it represents a promising therapeutic option for recalcitrant condylomas, especially in immunocompromised patients, in whom the efficacy of conventional treatments may be limited."

Dermatitis • Hematological Malignancies • Immunology • Multiple Myeloma

Effectiveness of Topical Tirbanibulin for Lentigo Maligna: A Case Series of Eight Patients and Biological Insights. (PubMed, Dermatol Pract Concept) - No abstract available

Journal • Melanoma

TIRBACRYO: Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead (clinicaltrials.gov) - P3 | N=59 | Not yet recruiting | Sponsor: University Hospital, Lille | Trial completion date: Nov 2027 ➔ Nov 2028 | Initiation date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: Nov 2027 ➔ Nov 2028

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

Skin Cancer: Management of Actinic Keratoses and Keratinocyte Carcinomas. (PubMed, FP Essent) - "Cryosurgery is preferred to treat a single or limited number of actinic keratosis lesions, whereas field-directed therapies, such as topical fluorouracil, topical imiquimod, photodynamic therapy, topical tirbanibulin, and off-label topical fluorouracil plus calcipotriene, are preferred treatments for multiple lesions or significant field cancerization. Systemic hedgehog pathway inhibitors are approved for locally advanced or metastatic basal cell carcinoma in patients who are not candidates for surgery or radiation therapy, although adverse effects often limit tolerance. Checkpoint inhibitor immunotherapy can be used in certain advanced cases of basal cell or cutaneous squamous cell carcinoma."

Journal • Review • Actinic Keratosis • Basal Cell Carcinoma • Bowens Disease • Dermatology • Genetic Disorders • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Complete and sustained clearance of recalcitrant facial flat warts with topical tirbanibulin 1. (PubMed, Ital J Dermatol Venerol) - No abstract available

Journal • Dermatology

Tirbanibulin for Pediatric Warts (clinicaltrials.gov) - P4 | N=10 | Recruiting | Sponsor: The Skin Center Dermatology Group | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Nov 2025 ➔ Nov 2026

Trial completion date • Trial primary completion date • Dermatology • Pediatrics

Sequential keratolytic pretreatment enhances tirbanibulin efficacy in field cancerization assessed by line-field confocal optical coherence tomography: a pilot study (EADO 2026) - "Treatment consisted of topical 5% salicylic petrolatum for 2 weeks, followed by tirbanibulin 1% ointment once daily for 5 consecutive days on a maximum treatment area of 25 cm². This combination approach may enhance tirbanibulin effectiveness and potentially extend its applicability to higher-grade AK. Larger, controlled studies are warranted to confirm these findings and to define standardized LC-OCT–based response criteria."

Clinical • Actinic Keratosis • Oncology

Comparative field-directed therapies for relapsing actinic keratoses assessed by clinical and confocal microscopy (EADO 2026) - "Patients were randomized 1:1:1 to receive topical 5-fluorouracil 4% for 28 days, topical tirbanibulin 1% for 5 days, or a single session of photodynamic therapy. Tolerability profiles differ markedly and should guide individualized treatment selection. Reflectance confocal microscopy identifies subclinical persistence and may support personalized monitoring and retreatment strategies."

Clinical • Actinic Keratosis • Dermatology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Efficacy and safety of tirbanibulin 1% ointment in elderly patients with actinic keratosis: a pooled analysis of Phase 3 clinical trials (EADO 2026) - P3 | "LTS at Day 8 were consistent across groups, with mostly mild-to-moderate reactions; severe reactions were infrequent and similar: erythema (≥80 years: 9.3% vs <80 years: 7.4%), flaking/scaling (9.3% vs 7.2%), crusting (2.8% vs 1.7%), swelling (0.9% vs 0.4%), and vesiculation (0% vs 0.2%).Conclusions Tirbanibulin has shown efficacy and favorable safety/tolerability in very elderly patients. These outcomes support 5-day tirbanibulin treatment as a suitable field-directed therapy for AK in these high-risk patients."

P3 data • Retrospective data • Actinic Keratosis • Dermatology

Real-World Experience with Tirbanibulin 1% in Actinic Keratosis: Does Polypharmacy Influence Therapeutic Outcomes? (EADO 2026) - "Tirbanibulin 1% ointment, a tubulin polymerization inhibitor with Src signaling antagonism, demonstrates efficacy through cell cycle arrest and apoptosis induction. These findings support tirbanibulin use in elderly, polypharmacy populations with actinic keratosis, while recommending clinical awareness of potential increased local tolerability events. Regional variation in efficacy between facial and scalp lesions suggests skin thickness and drug penetration differences warrant further investigation."

Clinical • Real-world • Real-world evidence • Actinic Keratosis • Dermatology

Sustained real-world effectiveness of tirbanibulin 1% for actinic keratoses in solid organ transplant recipients (EADO 2026) - "This study aimed to evaluate real-world longitudinal effectiveness and safety of tirbanibulin 1% ointment in SOTR with AKs.Methods We conducted a retrospective observational study including SOTR with AKs treated with tirbanibulin 1% in standard 5-day cycles. Treatment was well tolerated, with no severe local skin reactions reported.Conclusions In SOTR with AKs, tirbanibulin 1% demonstrated sustained real-world effectiveness with a favorable safety profile over extended follow-up. Stability of ORR across time points supports its role as a well-tolerated option for repeated field therapy in this high-risk population requiring long-term management."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Actinic Keratosis • Dermatology • Solid Organ Transplantation • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation

Relationship between efficacy and cosmetic outcome in tirbanibulin-treated patients with actinic keratosis over a field up to 100 cm²: subanalysis from TirbAKare study (EADO 2026) - P3 | "This analysis aimed to evaluate the relationship between lesion clearance and cosmetic outcome in patients treated with tirbanibulin 1% ointment.Methods This post-hoc analysis of the phase III TirbAKare study (NCT06135415) included 280 patients randomized 2:1 to tirbanibulin or vehicle. Similar results were observed at D113 (-0.26; 95%CI: -0.44, -0.08).Conclusions These results suggest a clinical relationship between AK lesion clearance and cosmetic outcome in tirbanibulin-treated patients at both, D57 and D113. Most of tirbanibulin treated patients appeared to achieve both, ≥ 75% reduction in lesion count and good/excellent cosmetic outcome, aligning with treatment expectations of both, patients and investigators."

Clinical • Actinic Keratosis • Dermatology

Efficacy, safety and willingness to be retreated with tirbanibulin 1% ointment in patients with actinic keratosis over a field treatment up to 100 cm² (EADO 2026) - P3 | "No SCC was reported in the tirbanibulin group. Willingness to be retreated (somewhat/very likely) was high in the tirbanibulin arm, both in patients (83.8%) and investigators (85.2%).Conclusions Tirbanibulin showed significantly greater efficacy and favorable safety/tolerability for AK treatment fields up to 100 cm² compared to vehicle, and was associated with high willingness to retreat, among both patients and investigators."

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

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