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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR AMELUZ


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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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ameluz

Condition Name

Condition Name for Ameluz
Intervention Trials
Actinic Keratosis 6
Actinic Keratoses 2
Photochemotherapy 1
Photodamaged Skin 1
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Condition MeSH

Condition MeSH for Ameluz
Intervention Trials
Keratosis, Actinic 9
Keratosis 9
Mycoses 1
Lentigo 1
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Clinical Trial Locations for Ameluz

Trials by Country

Trials by Country for Ameluz
Location Trials
United States 4
Finland 3
Germany 2
United Kingdom 1
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Trials by US State

Trials by US State for Ameluz
Location Trials
Ohio 2
New Hampshire 1
Arizona 1
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Clinical Trial Progress for Ameluz

Clinical Trial Phase

Clinical Trial Phase for Ameluz
Clinical Trial Phase Trials
Phase 4 4
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Ameluz
Clinical Trial Phase Trials
Completed 9
Recruiting 3
Not yet recruiting 1
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Clinical Trial Sponsors for Ameluz

Sponsor Name

Sponsor Name for Ameluz
Sponsor Trials
Biofrontera Bioscience GmbH 5
Joint Authority for Päijät-Häme Social and Health Care 3
Accovion GmbH 2
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Sponsor Type

Sponsor Type for Ameluz
Sponsor Trials
Other 19
Industry 7
NIH 1
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Ameluz: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Ameluz

Ameluz, a drug developed by Biofrontera Inc., is a key player in the field of photodynamic therapy (PDT) for the treatment of various skin conditions. This article provides an in-depth look at the current status of Ameluz in clinical trials, its market performance, and future projections.

Clinical Trials Update

Phase 3 Study for Superficial Basal Cell Carcinoma (sBCC)

Biofrontera has been conducting a pivotal Phase 3 clinical trial, ALA-BCC-CT013, to evaluate the safety and efficacy of Ameluz-PDT in treating superficial basal cell carcinoma (sBCC). This study is the first Phase 3 PDT trial for sBCC in the United States and involves 187 patients with at least one clinically and histologically confirmed sBCC lesion[2][4].

Study Design and Outcomes

  • The trial is a double-blind, randomized, placebo-controlled, multicenter study.
  • Patients were randomly assigned to receive either a topical application of Ameluz containing 7.8% 5-aminolevulinic acid (5-ALA) or a placebo.
  • The primary endpoint is the complete clinical and histological clearance of the target BCC lesion.
  • Interim results have shown that Ameluz-PDT achieved complete clinical and histological clearance in 65.5% of patients, which is statistically significant compared to the placebo group[1][4].

Database Lock and FDA Submission

  • The database lock for the treatment phase of the study has been completed, marking the end of data collection. Analysis is currently underway, with interim results expected in November 2024[2].
  • Biofrontera plans to submit a dossier to the FDA in the first quarter of 2025, including 1-year follow-up data, which could lead to potential approval and market entry in late 2025 or 2026[2][4].

Market Analysis

Current Market Position

Ameluz has established itself as a leading drug in the photodynamic therapy (PDT) segment, particularly in the treatment of actinic keratosis (AK) and now potentially for sBCC.

Market Share

  • In Germany, the largest European market for Ameluz, the market share in the PDT drugs segment increased from 64% to 66% in 2023. This growth is attributed to the further establishment of daylight PDT and the introduction of artificial daylight PDT[5].

Revenue and Sales

  • Despite a decrease in sales due to Biofrontera Inc.'s change in stockpiling policy, Ameluz sales increased by nearly 10% in the first half of 2024 in the US. This growth is promising, especially given the expansion of the US sales force and increased marketing efforts[5].

Market Potential

Basal Cell Carcinoma Market

  • Basal cell carcinoma (BCC) is the most common skin cancer in the US, with over 3 million cases annually. If Ameluz-PDT is approved for sBCC, it could significantly expand its market share and revenue potential[2].

Competitive Landscape

  • While cryotherapy remains the dominant form of therapy for actinic keratosis, Ameluz-PDT has been gaining ground due to its advantages, including scar-free healing and the treatment of field cancerization. The PDT segment, though small, is growing, and Ameluz is a strong market leader within this segment[5].

Projections and Future Outlook

Regulatory Approval

  • The anticipated FDA submission in Q1 2025, including 1-year follow-up data, is a critical milestone. Approval could lead to Ameluz-PDT entering the market for sBCC in late 2025 or 2026, significantly expanding its label from premalignant to malignant skin conditions[2][4].

Market Expansion

  • "We are delighted that these highly significant results mirror those found in the European studies," said Hermann Luebbert, PhD, CEO and Chairman of Biofrontera. This optimism suggests that Ameluz-PDT could replicate its European success in the US market[4].

Financial Projections

  • If approved, the expansion of Ameluz's label could lead to a substantial increase in revenue. The growth in the PDT segment, combined with increased market share, positions Ameluz for significant financial gains in the coming years[2][5].

Key Takeaways

  • Ameluz-PDT has shown promising results in the treatment of superficial basal cell carcinoma, with a significant clearance rate in clinical trials.
  • The drug is on track for potential FDA approval in late 2025 or 2026, following the submission of a dossier in Q1 2025.
  • Ameluz has a strong market position in the PDT segment, particularly in Europe, and is expected to expand its market share if approved for sBCC.
  • The market potential for Ameluz is substantial, given the high incidence of BCC and the growing acceptance of PDT as a treatment option.

FAQs

Q: What is Ameluz used for?

A: Ameluz is used for the treatment of actinic keratosis and is currently under clinical trial for the treatment of superficial basal cell carcinoma (sBCC) using photodynamic therapy (PDT).

Q: What are the key findings of the Phase 3 trial for sBCC?

A: The Phase 3 trial (ALA-BCC-CT013) has shown that Ameluz-PDT achieved complete clinical and histological clearance in 65.5% of patients, which is statistically significant compared to the placebo group.

Q: When is the FDA submission expected for Ameluz-PDT for sBCC?

A: Biofrontera plans to submit a dossier to the FDA in the first quarter of 2025, including 1-year follow-up data.

Q: How does Ameluz-PDT compare to other treatments for sBCC?

A: Ameluz-PDT offers advantages such as scar-free healing and the treatment of field cancerization, making it a preferable option over traditional therapies like surgery and cryotherapy.

Q: What is the market potential for Ameluz if it is approved for sBCC?

A: If approved, Ameluz could significantly expand its market share and revenue potential, given the high incidence of BCC and the growing acceptance of PDT.

Sources

  1. Cancer Network: Novel Photodynamic Therapy Yields Clearance in Basal Cell Carcinoma.
  2. Stock Titan: Biofrontera Inc. Announces Database Lock Of Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC).
  3. Biofrontera: Start of Phase 3 Clinical Trial in the US.
  4. OncLive: Ameluz-PDT Leads to Target Lesion Clearance in Superficial Basal Cell Carcinoma.
  5. Biofrontera: 6M half-year report 2024.

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