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Disease

Actinic keratosis

Late-stage therapeutic development
Also known as SK - solar keratosis, actinic (solar) keratosis, actinic keratosis (disease), solar keratosis+3 more

SK - solar keratosis, actinic (solar) keratosis, actinic keratosis (disease), solar keratosis, Senile hyperkeratosis, Senile keratosis, senile keratosis.

18
Clinical trials
12
Associated genes
6
Related proteins
Current focus
Melanocyte-stimulating hormone biologyTherapeutic developmentToll-like 7 biology
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

An Open-Label Clinical Study to Evaluate the Safety and Effect of RLS-1496 Topical Cream for the Treatment of Actinic Keratosis

Clinical trial2026-08-12Status changed to Active, not recruiting · ClinicalTrials.gov

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 3 clinical trials expected to report results, the earliest in Q1 2027.
Upcoming Milestones
Clinical Milestones6View
Results expected 3
Recently completed 3
Activity timeline6

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Tirbanibulinapproved

Approval — Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic acti… (2021)

Imiquimodapproved

Approval — Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic,… (2012)

Clinical trials

18 sponsors · 3 new · 0 completed in the last 12 months (net +3)

The current development programme across all trial phases.

Clinical programme
18
All trials
6
Active
13
Late-stage
6
Completed
Late-stage studies

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves) Ointment in Adult Patients With Actinic Keratosis of the Scalp and the Face

Phase 3 · Recruiting · Aresus Pharma GmbH

Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Face and (Bald) Scalp

Phase 3 · Recruiting · Sun Pharmaceutical Industries, Inc.

Open Phase IV Study to Assess the Impact of Tirbanibulin on the Wellbeing of Patients With Actinic Keratoses (TIRBASKIN)

Phase 4 · Completed · Almirall, S.A.

A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy, Safety and PK Study of KX01 Ointment 1% in Japanese Adult Subjects With Actinic Keratosis on the Face or Scalp

Phase 3 · Completed · PharmaEssentia

Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

Phase 4 · Completed · Medical University of Graz

Prospective, Three-armed, Randomised, Double-blind Study to Evaluate the Efficacy and Safety of the Treatment of Mild and Moderate Actinic Keratosis With a 5% Potassium Hydroxide Solution (Solcera, Medical Device) Versus Placebo and Investigator-blinded Comparison With 3% Diclofenac Gel (Solaraze, Medicinal Product) (Regulated by the Laws for Both Medical Devices and Medicinal Products)

Phase 3 · Completed · Infectopharm Arzneimittel GmbH
Recruiting

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves) Ointment in Adult Patients With Actinic Keratosis of the Scalp and the Face

Phase 3 · Recruiting · Aresus Pharma GmbH

Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Face and (Bald) Scalp

Phase 3 · Recruiting · Sun Pharmaceutical Industries, Inc.

Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans

Phase 2 · Recruiting · VA Office of Research and Development

A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW211026 Ointment After Single or Multiple Doses in Subjects With Actinic Keratosis

Phase 1 · Recruiting · Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Recently completed

Open Phase IV Study to Assess the Impact of Tirbanibulin on the Wellbeing of Patients With Actinic Keratoses (TIRBASKIN)

Phase 4 · Completed · Almirall, S.A.

A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy, Safety and PK Study of KX01 Ointment 1% in Japanese Adult Subjects With Actinic Keratosis on the Face or Scalp

Phase 3 · Completed · PharmaEssentia

Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

Phase 4 · Completed · Medical University of Graz

Prospective, Three-armed, Randomised, Double-blind Study to Evaluate the Efficacy and Safety of the Treatment of Mild and Moderate Actinic Keratosis With a 5% Potassium Hydroxide Solution (Solcera, Medical Device) Versus Placebo and Investigator-blinded Comparison With 3% Diclofenac Gel (Solaraze, Medicinal Product) (Regulated by the Laws for Both Medical Devices and Medicinal Products)

Phase 3 · Completed · Infectopharm Arzneimittel GmbH

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream, With Efudex® (5-FU) Cream, and Both Active Treatments to a Vehicle Control, in the Treatment of Actinic Keratosis

Phase 3 · Completed · Sol-Gel Technologies, Ltd.

A Randomised Double Blind, Placebo Controlled Study of the Efficacy of Topical Menthol for Pain Relief During Topical Photodynamic Therapy

Phase 4 · Completed · University of Dundee

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2021emaApproval — Tirbanibulin· Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults. source ↗
2012emaApproval — Imiquimod· Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

TLR70.58SRC0.57MC1R0.52BNC20.51SLC24A50.48TYRP10.48TPCN20.47KITLG0.47CPVL0.45ADO0.42CPNE70.42SPMIP70.42

Disease biology

6 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Toll-like receptor 7via TLR70.58Proto-oncogene tyrosine-protein kinase Srcvia SRC0.57Melanocyte-stimulating hormone receptorvia MC1R0.52Wee1-like protein kinasevia WEE10.41Metabotropic glutamate receptor 5via GRM50.37Tumor protein p73via TP730.22

Reference

Authoritative identity, definition & identifiers.

Synonyms

SK - solar keratosis, actinic (solar) keratosis, actinic keratosis (disease), solar keratosis, Senile hyperkeratosis, Senile keratosis, senile keratosis

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.