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Disease

Keratosis

Late-stage therapeutic development

Also known as keratoderma.

19
Clinical trials
1
Associated genes
1
Related proteins
Latest activity
beta

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

Approval: Zyclara (EMA)

Regulatory2012-08-23EMA

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 posted 1
Results expected 3
Recently completed 2
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

15 sponsors · 2 new · 1 completed in the last 12 months (net +2)

The current development programme across all trial phases.

Clinical programme
19
All trials
6
Active
15
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

A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients With Actinic Keratosis on the Face or Scalp

Phase 4 · Active, not recruiting · Almirall, S.A.

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.

A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm^2 and up to 100 cm^2 in Adult Patients With Actinic Keratosis

Phase 3 · Completed · Almirall, S.A.

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
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
Recently completed

A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm^2 and up to 100 cm^2 in Adult Patients With Actinic Keratosis

Phase 3 · Completed · Almirall, S.A.

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

A Phase 3, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% Applied to a Field of Approximately 100 cm2 on the Face or Balding Scalp in Adult Patients With Actinic Keratosis

Phase 3 · Completed · Almirall, S.A.

An Open-Label Study Assessing Subject Satisfaction With A-101 Hydrogen Peroxide Topical Solution, 40% (w/w) Treatment for Seborrheic Keratoses of the Face, Neck, and Decolletage

Phase 4 · Completed · Aclaris Therapeutics, Inc.

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

1 match

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

TLR70.54

Disease biology

1 match

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 TLR70.54

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Any horny growth such as a wart or callus.

Synonyms

keratoderma

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.