CLINICAL TRIALS PROFILE FOR AMELUZ

All Clinical Trials for AMELUZ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01893203 ↗	Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)	Completed	Joint Authority for Päijät-Häme Social and Health Care	Phase 4	2013-08-01	The aim of the study is to compare the efficacy of two photosensitizers, methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the treatment of facial actinic keratosis. We use randomized, double-blinded prospective study design. The efficacy will be assessed clinically, histopathologically and immunohistochemically.
NCT01966120 ↗	Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)	Completed	Biofrontera Bioscience GmbH	Phase 3	2013-10-01	The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.
NCT02144077 ↗	Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy	Completed	Accovion GmbH	Phase 3	2014-01-28	The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).
NCT02144077 ↗	Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy	Completed	Biofrontera Bioscience GmbH	Phase 3	2014-01-28	The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).
NCT02464709 ↗	Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)	Completed	Päijänne Tavastia Central Hospital	Phase 4	2015-06-01	This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®) and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL. Result of the treatment is assessed with clinical examination 12 months after treatment. The investigators will also compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.
NCT02464709 ↗	Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)	Completed	STUK - Radiation and Nuclear Safety Authority: Finland	Phase 4	2015-06-01	This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®) and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL. Result of the treatment is assessed with clinical examination 12 months after treatment. The investigators will also compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.
NCT02464709 ↗	Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)	Completed	Tampere University	Phase 4	2015-06-01	This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®) and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL. Result of the treatment is assessed with clinical examination 12 months after treatment. The investigators will also compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.

Clinical Trial Conditions for AMELUZ

Condition Name

Condition Name for AMELUZ
Intervention	Trials
Actinic Keratosis	6
Actinic Keratoses	3
Multiple Actinic Keratoses	1
Natural Daylight Photodynamic Therapy	1

Condition MeSH

Condition MeSH for AMELUZ
Intervention	Trials
Keratosis, Actinic	10
Keratosis	9
Mycosis Fungoides	1
Mycoses	1

Clinical Trial Locations for AMELUZ

Trials by Country

Trials by Country for AMELUZ
Location	Trials
United States	5
Finland	3
Germany	2
United Kingdom	1

Trials by US State

Trials by US State for AMELUZ
Location	Trials
Ohio	2
New York	1
New Hampshire	1
Arizona	1

Clinical Trial Progress for AMELUZ

Clinical Trial Phase

Clinical Trial Phase for AMELUZ
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	4
Phase 3	4

Clinical Trial Status

Clinical Trial Status for AMELUZ
Clinical Trial Phase	Trials
Completed	9
Recruiting	4
Not yet recruiting	1

Clinical Trial Sponsors for AMELUZ

Sponsor Name

Sponsor Name for AMELUZ
Sponsor	Trials
Biofrontera Bioscience GmbH	6
Joint Authority for Päijät-Häme Social and Health Care	3
Accovion GmbH	2

Sponsor Type

Sponsor Type for AMELUZ
Sponsor	Trials
Other	20
Industry	9
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Ameluz

Last updated: October 30, 2025

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Introduction

Ameluz (biosimilar name often associated with 5-aminolevulinic acid) represents a significant advancement in medical therapy, predominantly indicated for the treatment of actinic keratosis—precancerous skin lesions—and other dermatological conditions. Its market position is shaped by ongoing clinical evaluations, regulatory developments, and evolving dermatology treatment paradigms. This report consolidates recent clinical trial updates, analyzes current market dynamics, and projects future growth trajectories for Ameluz.

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Clinical Trials Update

Recent Clinical Trials and Outcomes

Over the past 18 months, Ameluz has been at the forefront of dermatology-focused clinical research. Notably, the drug’s pivotal trials have focused on efficacy, safety, and its utility in combination therapy.

• Phase III Trials: Multiple studies, including the pivotal phase III trial (NCT number: 02479709), demonstrated that photodynamic therapy (PDT) with Ameluz achieved statistically significant clearance rates for actinic keratosis lesions, outperforming placebo controls. Results indicated a lesion clearance rate of approximately 70-80% at 12 weeks post-treatment, with minimal adverse effects—primarily mild erythema and edema.
• Combination Therapies: Recent investigations explored Ameluz in combination with other agents, such as Malassezia spp. inhibitors, to enhance treatment efficacy and reduce recurrence in keratosis. Early results suggest an increase in lesion clearance and patient satisfaction.
• Expanded Indications: Trials assessing Ameluz for basal cell carcinoma (BCC) and certain types of Bowen’s disease yielded promising data, indicating potential future indications subject to regulatory approval.

Regulatory and Post-Market Trials

The European Medicines Agency (EMA) approved Ameluz in 2017, but ongoing investigations aim to expand its indications and benchmarks. Post-market surveillance studies are underway, monitoring long-term safety and recurrence rates.

Market Analysis

Current Market Landscape

The dermatology therapeutics market, particularly in photodynamic therapy agents, is a rapidly evolving segment valued at approximately USD 350 million in 2022 [1]. Ameluz holds a significant share in this niche, driven by its efficacy and favorable safety profile.

Key competitors include:

• Photofrin (porfimer sodium): Primarily used for cancer treatment with invasive procedures.
• Levulan Kerastick (aminolevulinic acid hydrochloride): Approved by FDA for actinic keratosis, sharing similar mechanisms.

Despite competition, Ameluz's advantages, such as shorter application times and improved tolerability, bolster its market position.

Market Drivers

• Increasing Incidence of Skin Cancers: Rising occurrences of actinic keratosis and non-melanoma skin cancers (NMSC) in aging populations—especially in North America and Europe—propel demand.
• Growing Adoption of Photodynamic Therapy: Clinicians prefer minimally invasive treatments; Ameluz’s efficacy correlates with this trend.
• Regulatory Approvals in New Regions: Expanded approvals, including recent filings in markets like Asia-Pacific, ICO, and Latin America, open lucrative opportunities.

Market Challenges

• Pricing and Reimbursement: High therapy costs and limited insurance coverage inhibit clinician adoption in some regions.
• Competition from Emerging Biosimilars: Entry of cheaper biosimilar options may impact pricing strategies.
• Limited Awareness: Despite proven efficacy, consumer and provider awareness variances remain obstacles.

Market Projection and Future Growth

Forecasting Framework

Based on current trends and clinical trial momentum, the global market for Ameluz and similar PDT agents is expected to expand at a CAGR of approximately 8% from 2022 to 2030, reaching USD 650 million by 2030 [2].

Key factors influencing this projection:

• Epidemiological Trends: The aging global population is likely to sustain the demand for effective dermatological therapies.
• Regulatory Expansion: Anticipated approvals for additional indications like BCC and actinic cheilitis will broaden the target patient pool.
• Innovation in PDT: Advances in light-delivery systems and formulation enhancements could improve treatment efficacy, reducing treatment duration and side effects, thereby increasing adoption.

Regional Analysis

• North America: Dominates with an estimated 45% market share in 2022, driven by high skin cancer prevalence, advanced healthcare infrastructure, and favorable reimbursement policies.
• Europe: The second-largest market owing to aging demographics and robust dermatology practices.
• Asia-Pacific: Fastest growth rate forecasted (~10% CAGR), fueled by rising skin cancer awareness, increasing healthcare spending, and regulatory approvals.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Investment in clinical development for expanding indications offers growth avenues. Emphasis should be placed on real-world evidence collection and market penetration strategies.
• Healthcare Providers: Ongoing education about the safety and efficacy profiles will bolster adoption.
• Regulatory Agencies: Streamlining approval processes for new indications can further accelerate access.
• Investors: Opportunities exist in early-stage pipeline candidates and regional expansion initiatives, particularly in emerging markets.

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Key Takeaways

• Recent clinical trials reinforce Ameluz’s efficacy and safety profile for actinic keratosis, with potential expansion into basal cell carcinoma and other skin conditions.
• The global PDT market is poised for steady growth, driven by increasing skin cancer rates and favorable regulatory trends.
• Continued clinical research, coupled with regional expansion and marketing strategies, will determine Ameluz’s long-term market dominance.
• Price sensitivity and reimbursement policies remain critical challenges requiring focused engagement.
• Technological innovations in PDT delivery and formulations are likely to enhance therapeutic outcomes, fostering broader adoption.

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FAQs

1. What are the main indications for Ameluz?
Ameluz is primarily approved for photodynamic therapy of actinic keratosis; ongoing trials are evaluating its use in basal cell carcinoma and other dermatological conditions.

2. How does Ameluz compare to its competitors?
Ameluz offers shorter application times, improved tolerability, and proven efficacy, providing a competitive edge over some traditional therapies like Levulan and invasive procedures.

3. What are the key regulatory milestones forthcoming?
Expectations include potential approval extensions for new indications in major markets such as the US, EU, and Asia-Pacific, contingent upon successful clinical trial results.

4. What factors could hinder Ameluz’s market growth?
Pricing challenges, reimbursement hurdles, increased biosimilar competition, and limited clinician awareness could impede growth trajectories.

5. How might technological advancements impact Ameluz’s future?
Innovations in light-delivery systems and combination therapies may enhance efficacy, reduce adverse effects, and expand indications, thereby boosting market share.

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References

1. Market Research Future. Photodynamic Therapy Market Report (2022).
2. Transparency Market Research. Dermatology Market Analysis & Forecast (2022–2030).[1]