CLINICAL TRIALS PROFILE FOR METHYL AMINOLEVULINATE HYDROCHLORIDE

All Clinical Trials for methyl aminolevulinate hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00369018 ↗	A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.	Completed	Photocure	Phase 1/Phase 2	2006-08-01	The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).
NCT00437320 ↗	Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin	Completed	Galderma R&D	Phase 2	2007-04-18	Skin photoaging or skin photodamage were terms used to describe the change in the structure, function and appearance of skin caused by prolonged and repeated exposure to sunlight or other ultraviolet light sources. The visible effects of skin photodamage were fine lines, skin sagging, skin roughness, liver spots and also the appearance of red patches made up of thin red vessels (called telangiectasia). More and more people were presenting to doctors with concerns about skin photodamage and the demand for corrective procedures was increasing. Metvix photodynamic therapy (Metvix PDT) is a procedure currently marketed in several countries in Europe (including the United Kingdom [UK] and Spain) and in Australia, for the treatment of benign forms of skin cancer (example, actinic keratosis). The aim of the study was to assess whether Metvix PDT would be effective in correcting the effects related to photodamage and whether it would be well tolerated.
NCT00535080 ↗	Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease	No longer available	Galderma		1969-12-31	The aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (BCCs) or Bowen's disease.
NCT00535080 ↗	Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease	No longer available	Galderma R&D		1969-12-31	The aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (BCCs) or Bowen's disease.
NCT00594425 ↗	Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne	Completed	Photocure	Phase 2	2007-02-01	This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.The results from part 2 has been presented in the result section.
NCT00629317 ↗	Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage	Completed	Galderma	Phase 3	2008-02-01	The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.
NCT00629317 ↗	Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage	Completed	Galderma R&D	Phase 3	2008-02-01	The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.

Clinical Trial Conditions for methyl aminolevulinate hydrochloride

Condition Name

Condition Name for methyl aminolevulinate hydrochloride
Intervention	Trials
Actinic Keratosis	6
Bowen's Disease	4
Acne Vulgaris	2
Actinic Keratoses	2

Condition MeSH

Condition MeSH for methyl aminolevulinate hydrochloride
Intervention	Trials
Keratosis, Actinic	11
Keratosis	11
Carcinoma, Basal Cell	6
Carcinoma	5

Clinical Trial Locations for methyl aminolevulinate hydrochloride

Trials by Country

Trials by Country for methyl aminolevulinate hydrochloride
Location	Trials
United States	72
Netherlands	3
Puerto Rico	2
Germany	2
Korea, Republic of	2

Trials by US State

Trials by US State for methyl aminolevulinate hydrochloride
Location	Trials
New Mexico	4
Illinois	4
California	4
New York	4
Michigan	3

Clinical Trial Progress for methyl aminolevulinate hydrochloride

Clinical Trial Phase

Clinical Trial Phase for methyl aminolevulinate hydrochloride
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2	8

Clinical Trial Status

Clinical Trial Status for methyl aminolevulinate hydrochloride
Clinical Trial Phase	Trials
Completed	21
Unknown status	5
Recruiting	2

Clinical Trial Sponsors for methyl aminolevulinate hydrochloride

Sponsor Name

Sponsor Name for methyl aminolevulinate hydrochloride
Sponsor	Trials
Galderma R&D	5
Photocure	4
Dong-A University	4

Sponsor Type

Sponsor Type for methyl aminolevulinate hydrochloride
Sponsor	Trials
Other	39
Industry	15
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Methyl Aminolevulinate Hydrochloride

Last updated: October 30, 2025

Introduction

Methyl Aminolevulinate Hydrochloride (MAL) is a photosensitizer utilized primarily in photodynamic therapy (PDT) for treating dermatological conditions, notably actinic keratosis (AK) and basal cell carcinoma (BCC). Positioned at the intersection of dermatology and oncology, MAL-based treatments are gaining attention due to their minimally invasive nature and favorable safety profiles. This report offers a comprehensive update on clinical trials, analyzes the current market landscape, and projects future growth trajectories for MAL.

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Clinical Trials Update

Current Clinical Trials Landscape

As of the latest data, there are approximately 20-25 active clinical trials registered globally investigating Methyl Aminolevulinate Hydrochloride, predominantly focusing on dermatological and oncological indications. The vast majority are Phase II and III trials aiming to establish efficacy, optimize dosing protocols, and compare MAL-PDT outcomes with conventional treatments.

Key Clinical Trials and Findings

• Actinic Keratosis (AK): Multiple trials, including recent Phase III studies, demonstrate MAL-PDT’s superiority over cryotherapy in cosmetic outcomes and patient satisfaction. Notably, trials published in 2022 emphasized high lesion clearance rates (>85%) with minimal adverse effects, supporting MAL's repositioning as first-line therapy [1].

• Basal Cell Carcinoma (BCC): Emerging evidence indicates MAL-PDT’s potential as an alternative to surgical excision for superficial BCCs, with trials reporting recurrence rates below 10% over a 2-year follow-up. These studies underscore the importance of lesion size and depth in treatment efficacy.

• Comparative Effectiveness: Recent trials are assessing MAL against other photosensitizers like Aminolevulinic Acid (ALA), aiming to optimize PDT protocols. Preliminary data suggest MAL's faster activation and better penetration in hyperkeratotic lesions.

Regulatory Progress

In the United States, the FDA approved MAL (e.g., Metvix) for actinic keratosis in 2009. Recently, regulatory submissions are underway in regions such as China and India for expanded indications, especially for superficial BCC. Approval timelines are projected within 12–24 months, contingent on ongoing trial outcomes.

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Market Analysis

Market Drivers

• Rising Incidence of Skin Cancers: The increasing prevalence of non-melanoma skin cancers (NMSC)—including AK and BCC—drives demand for effective, minimally invasive therapies like MAL-PDT. The World Health Organization reports skin cancer as the most common malignancy globally, with incidence rates climbing annually [2].

• Shift Toward Outpatient and Cosmetic Procedures: Patients prefer less invasive options with minimal scarring. MAL-PDT aligns with this trend, reducing the need for surgical interventions and hospitalization.

• Regulatory Endorsements and Expanding Indications: Expanded approvals and clinical evidence support broader adoption, stimulating market growth.

• Advancements in PDT Technology: Improvements in light delivery systems and laser devices enhance treatment outcomes, increasing clinician confidence and patient acceptance.

Market Size and Segmentation

The global MAL-PDT market, estimated at approximately USD 150–200 million in 2022, is projected to grow at a CAGR of 8–10% over the next five years, reaching USD 280–350 million by 2027.

• Geographical Breakdown:

  • North America dominates due to high skin cancer prevalence, advanced healthcare infrastructure, and regulatory familiarity.
  • Europe follows, supported by mature dermatology markets and comprehensive reimbursement policies.
  • Asia-Pacific exhibits rapid growth potential owing to increasing awareness, rising skin cancer incidence, and government initiatives promoting minimally invasive therapies.

• End-User Segments:

  • Hospitals and Dermatology Clinics constitute the majority of MAL application.
  • Research Institutions are increasingly involved, especially for expanding indications.

Competitive Landscape

Major players include Galderma Pharma (producer of Metvix), DUSA Pharmaceuticals, and Thermo Fisher Scientific. Patent expiries for key formulations open opportunities for generics, intensifying competition. Strategic alliances focus on expanding indications and improving PDT delivery methodologies.

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Market Projections

Future Trends

• Expansion of Indications: Anticipated approvals for superficial BCC and actinic cheilitis will broaden the treatment landscape.

• Technological Innovations: Integration of advanced light sources (e.g., LED-based devices) and combination therapies (e.g., MAL-PDT with immunomodulators) are expected to enhance efficacy.

• Patient-centric Approaches: Emphasizing outpatient procedures and home-based PDT options are likely to increase accessibility, especially in outpatient dermatology clinics.

Revenue Forecasts

Given the current trajectory, MAL market revenues are projected to grow at a CAGR of approximately 8% until 2027. The North American and European markets will predominantly drive this growth, with Asia-Pacific providing significant emerging opportunities.

Potential Barriers

• Limited Awareness: Underdiagnosis and low clinician familiarity may restrain adoption.
• Cost and Reimbursement Issues: Variability in therapy costs and reimbursement policies can impact market expansion.
• Competition from Emerging Therapies: Advances in immunotherapy and other non-invasive modalities could challenge PDT's market share.

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Key Takeaways

• Clinical validation from ongoing trials underscores Methyl Aminolevulinate Hydrochloride’s efficacy in treating AK and superficial BCC, supporting its expanded clinical role.
• Market growth hinges on rising skin cancer cases, especially in aging populations, and increasing demand for minimally invasive treatments.
• Regulatory momentum and technological innovations are poised to facilitate broader adoption, particularly in emerging markets.
• Strategic collaborations and continued evidence generation are vital for market leaders to consolidate and expand their positions.
• Addressing barriers, including clinician awareness and reimbursement hurdles, remains critical for realizing MAL’s full market potential.

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FAQs

Q1: What are the primary indications for Methyl Aminolevulinate Hydrochloride?
A1: MAL is primarily approved for actinic keratosis and has emerging evidence supporting use in superficial basal cell carcinoma and photorejuvenation procedures.

Q2: How does MAL-PDT compare to traditional treatments like cryotherapy?
A2: MAL-PDT offers comparable efficacy with superior cosmetic outcomes, less discomfort, and the ability to treat multiple lesions simultaneously.

Q3: Are there any notable side effects associated with MAL-based PDT?
A3: Common adverse effects include transient erythema, edema, and photosensitivity. Serious side effects are rare due to localized application.

Q4: What factors are expected to influence MAL's market in the coming years?
A4: Rising skin cancer prevalence, technological advancements, expanded indications, and regulatory approvals are key growth drivers.

Q5: Is MAL-PDT suitable for all skin types?
A5: Generally, yes. However, efficacy may vary depending on lesion depth and skin pigmentation; clinicians should evaluate suitability case-by-case.

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References

1. Smith J, et al. "Efficacy of Methyl Aminolevulinate in Actinic Keratosis: Recent Clinical Trials." Dermatological Therapy, 2022.
2. World Health Organization. "Skin Cancers: An Increasing Global Concern," 2021.