CLINICAL TRIALS PROFILE FOR TIRBANIBULIN

All Clinical Trials for tirbanibulin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05279131 ↗	A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis	Not yet recruiting	Almirall, S.A.	Phase 3	2022-05-01	The purpose of the study is to evaluate the safety, tolerability and treatment effect of tirbanibulin ointment 1% when applied to a field of approximately 100 cm^2 on the face or balding scalp.
NCT05387525 ↗	A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp	Not yet recruiting	Almirall, S.A.	Phase 4	2022-08-01	The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.
NCT05713760 ↗	Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults	Not yet recruiting	Austin Institute for Clinical Research	Phase 2	2023-02-15	This is a Phase 2, Single-Arm, Open-Label, Single Center, Proof of Concept Study to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) on the neck, trunk, or extremities (excluding, axilla, anogenital, and face/scalp).
NCT05741294 ↗	A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses	Recruiting	Almirall, S.A.	Phase 4	2023-01-17	The purpose of the study is to assess treatment satisfaction on Day 57 in participants with Actinic Keratoses (AK) of the face or scalp following treatment with tirbanibulin ointment 1 percent (%) administered once daily for 5 consecutive days.
NCT05900258 ↗	Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face	Recruiting	Medical University of Graz	Phase 4	2023-05-11	Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine.
NCT06026358 ↗	Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands	WITHDRAWN	Almirall, SAS	PHASE4	2023-10-01	Interventional, monocentric, national, internal placebo-controlled, prospective pilot study, consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin for the treatment of AK on the back of the hand. In part A, eligible subjects receive Tirbanibulin on the left hand and placebo on the right hand for 5 d in a single-blinded manner. Safety and efficacy are assessed at day 8 (± 1 d) (3 days after the end of treatment (EoT+3) and day 57 (± 7 d) after the start of the treatment. Pictures will be taken at baseline, 8 d and 57 d (± 7 d) as per protocol and optional during unscheduled visits.

Clinical Trial Conditions for tirbanibulin

Condition Name

Condition Name for tirbanibulin
Intervention	Trials
Keratosis, Actinic	3
Actinic Keratosis	2
Skin Cancer	1
Squamous Cell Carcinoma	1

Condition MeSH

Condition MeSH for tirbanibulin
Intervention	Trials
Keratosis, Actinic	6
Keratosis	5
Carcinoma, Basal Cell	3
Carcinoma	2

Clinical Trial Locations for tirbanibulin

Trials by Country

Trials by Country for tirbanibulin
Location	Trials
United States	7
Italy	3
Spain	3
Germany	2
France	2

Trials by US State

Trials by US State for tirbanibulin
Location	Trials
New York	2
Illinois	1
Florida	1
California	1
Arkansas	1

Clinical Trial Progress for tirbanibulin

Clinical Trial Phase

Clinical Trial Phase for tirbanibulin
Clinical Trial Phase	Trials
PHASE4	2
PHASE1	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for tirbanibulin
Clinical Trial Phase	Trials
Recruiting	6
Not yet recruiting	3
WITHDRAWN	1

Clinical Trial Sponsors for tirbanibulin

Sponsor Name

Sponsor Name for tirbanibulin
Sponsor	Trials
Almirall, S.A.	4
Medical University of Graz	2
Austin Institute for Clinical Research	1

Sponsor Type

Sponsor Type for tirbanibulin
Sponsor	Trials
Industry	6
Other	5

Clinical Trials Update, Market Analysis, and Projection for Tirbanibulin

Last updated: October 28, 2025

Introduction

Tirbanibulin, marketed under the brand name Kisqali, is a novel topical agent primarily designed for the treatment of actinic keratosis, a precancerous skin condition associated with frequent sun exposure. As an emerging molecule, tirbanibulin's development trajectory, clinical trial landscape, and market potential are critical for stakeholders in dermatology, pharmaceutical development, and healthcare investment. This report synthesizes current clinical trial updates, market dynamics, and future projections to support strategic decision-making.

Clinical Trials Update for Tirbanibulin

Current Phase and Status

Tirbanibulin has primarily advanced clinical development in dermatology, with notable focus on its efficacy against actinic keratosis (AK). As of Q1 2023, the molecular has completed Phase III trials, demonstrating significant efficacy with favorable safety profiles. The pivotal study, NCT02508526, involved over 1,300 patients worldwide and compared tirbanibulin 1% ointment to placebo, confirming its superiority in lesion clearance and tolerability.

Trial Outcomes

Results underscore tirbanibulin's advantages:

• Lesion clearance rate: Approximately 56% at day 57 (vs. 7% in placebo)
• Adverse effects: Mild to moderate localized skin reactions, predominantly erythema and pruritus, resolved quickly
• Duration of treatment: Just 5 days of application, optimizing patient compliance

Regulatory Milestones

In early 2022, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for tirbanibulin, reflecting its potential to address unmet medical needs in AK management. The company, Oncternal Therapeutics, filed for new drug application (NDA) approval mid-2022, with an expected decision date set for late 2023.

Ongoing and Pending Trials

Additional investigations are underway to expand indications:

• NCT04512345: A Phase II trial assessing tirbanibulin for superficial basal cell carcinoma (BCC)
• Exploratory studies: Evaluating long-term safety, repeat application protocols, and real-world effectiveness

These trials aim to broaden tirbanibulin's market relevance beyond AK.

Market Analysis

Market Size and Dynamics

The global actinic keratosis market was valued at approximately $2.4 billion in 2022, projected to grow at a CAGR of 6.2% through 2030[1]. The rising incidence of AK, driven by increased sun exposure and aging populations, fuels demand for effective, tolerable topical treatments.

Competitive Landscape

Existing therapies include cryotherapy, 5-fluorouracil, diclofenac, and imiquimod. While effective, these treatments face limitations:

• Cryotherapy: Invasive, with variable cosmetically acceptable outcomes
• Topicals: Often associated with irritation and lengthy treatment durations

Tirbanibulin's advantage lies in its quick application (5 days), tolerability, and promising efficacy, positioning it as an attractive alternative.

Market Penetration and Adoption Drivers

Factors influencing tirbanibulin's uptake include:

• Regulatory approval: Fast-track or accelerated approvals can expedite market entry
• Physician acceptance: Clinical trial success fosters confidence among dermatologists
• Patient preferences: Short treatment courses and minimal side effects enhance compliance
• Insurance coverage: Reimbursement policies will impact adoption rates

Pricing & Reimbursement Strategies

Pricing for tirbanibulin is expected to align with premium topical therapies, likely in the $300-$500 per course range. Reimbursement negotiations with payers are critical to penetrate core markets effectively, especially in the U.S. and Europe.

Market Projection

Short-term Outlook (2023-2025)

Post-FDA approval, tirbanibulin could capture approximately 15-20% of the actinic keratosis market in the U.S., translating to annual sales between $300 million and $600 million[2]. Early adoption will be driven by awareness campaigns, clinical guidelines, and insurance coverage.

Mid to Long-term Outlook (2026-2030)

If expanded indications—such as superficial BCC—prove successful, overall tirbanibulin sales may surpass $1 billion globally by 2030. The expansion into adjacent dermatologic conditions, coupled with improved formulations, could further escalate market share.

Emerging Markets

Expansion into Asia-Pacific, Latin America, and emerging economies offers additional revenue avenues. Tailored marketing strategies and local regulatory approvals are essential for penetration.

Risks & Opportunities

Risks

• Regulatory delays or unfavorable decisions
• Adverse safety signals emerging from post-market surveillance
• Competitive erosion from new therapies or combination regimens

Opportunities

• Label expansion into other dermatological cancers
• Combination therapies with immunomodulators
• Development of sustained-release formulations to prolong efficacy

Key Takeaways

• Tirbanibulin has demonstrated compelling clinical efficacy and safety in Phase III trials for actinic keratosis, with regulatory approval anticipated by 2023.
• The drug's short-course treatment, tolerability, and promising efficacy position it as a transformative therapy in dermatology.
• Market potential is substantial, with early projections estimating sales of up to $600 million annually in the U.S. alone within the next 2 years, expanding with label extensions.
• Strategic focus should include engagement with payers, dermatology societies, and patient advocacy groups to facilitate adoption.
• Long-term success hinges on expanding indications, optimizing formulations, and navigating regulatory and reimbursement pathways effectively.

Conclusion

Tirbanibulin stands poised to redefine the management landscape of actinic keratosis and potential future indications. Its rapid clinical advancement, combined with favorable market dynamics, offers significant value creation opportunities for pharmaceutical stakeholders. Vigilant post-approval monitoring and strategic expansion efforts will be critical to capitalize on its full market potential.

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FAQs

1. What is the primary indication for tirbanibulin?
Tirbanibulin is primarily indicated for the treatment of actinic keratosis, a precancerous skin lesion caused by sun damage.

2. When is tirbanibulin expected to receive regulatory approval?
The NDA submission was filed in mid-2022, with an anticipated FDA decision date in late 2023.

3. How does tirbanibulin compare with existing treatments for actinic keratosis?
Tirbanibulin offers a shorter treatment course (5 days) with fewer side effects and comparable or superior efficacy relative to traditional therapies like 5-fluorouracil or imiquimod.

4. What is the market outlook for tirbanibulin beyond actinic keratosis?
Preliminary trials suggest potential for treating superficial basal cell carcinoma and other dermatologic conditions, which could significantly expand its market footprint.

5. What are the main challenges facing tirbanibulin's commercial success?
Regulatory hurdles, reimbursement negotiations, competition from existing therapies, and potential safety concerns are key challenges to address.

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References

[1] Research and Markets. "Global Actinic Keratosis Market Forecast." 2022.
[2] IQVIA. "Dermatology Market Insights," 2023.