methyl aminolevulinate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | METVIXIA | — | 2008-06-26 | fda.gov ↗ |
| Approved | US (FDA) | METVIXIA | — | 2004-07-27 | fda.gov ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05676801 | Feb → Sep 2023 | periprosthetic joint infection, prosthesis-related infectious disease | University of Zurich | Unknown | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT03325803 | Sep 2015 → Sep 2016 | actinic keratosis | Dong-A University | Completed | No outcome recorded |
| Phase 1 | NCT02670655 | Jun 2014 → Dec 2015 | actinic keratosis | Dong-A University | Completed | No outcome recorded |
| Phase 1 | NCT02666534 | Jan 2012 → Dec 2015 | squamous cell carcinoma | Dong-A University | Completed | No outcome recorded |
| Phase 1 | NCT03320447 | Oct 2011 → Oct 2016 | Bowen disease of the skin | Dong-A University | Completed | No outcome recorded |
| Phase 1 | NCT01292668 | Mar 2011 → Jul 2012 | skin basal cell carcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02149342 | May 2014 → Sep 2015 | actinic keratosis | Joint Authority for Päijät-Häme Social and Health Care | Completed | No outcome recorded |
| Phase 27 trials · 1 missed | ||||||
| Phase 2 | NCT05104099 | Nov 2021 → Jun 2024 | squamous cell intraepithelial neoplasia, vulvar intraepithelial neoplasia | Institut de Cancérologie de Lorraine | Completed | No outcome recorded |
| Phase 2 | NCT03990636 | Oct 2019 → May 2020 | actinic cheilitis, erythroplakia, leukoplakia | Brazilian National Cancer Institute | Unknown | No outcome recorded |
| Phase 2 | NCT02354391 | Jan 2015 → Dec 2019 | actinic keratosis | Pacific Dermaesthetics | Unknown | No outcome recorded |
| Phase 2 | NCT02139618 | Apr → Oct 2014 | hyperpigmentation of the skin | Fundación Dermabase | Completed | No outcome recorded |
| Phase 2 | NCT00673933 | May → Dec 2008 | acne | Photocure | Completed | No outcome recorded |
| Phase 2 | NCT00437320 | Apr 2007 → Sep 2008 | skin disorder | Galderma R&D | Completed | No outcome recorded |
| Phase 2 | NCT00594425 | Feb 2007 → Jul 2008 | acne | Photocure | Completed | Missed primary |
| Phase 39 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT04085367 | Sep 2019 → Mar 2021 | actinic keratosis | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT02373371 | Mar 2015 → Nov 2016 | actinic keratosis | University Hospital, Limoges | Completed | Missed primary |
| Phase 3 | NCT01475071 | Mar → Nov 2012 | actinic keratosis | Galderma R&D | Completed | Mixed |
| Phase 3 | NCT00926952 | Jul 2009 → Dec 2010 | actinic keratosis | Innovaderm Research Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00304239 | Mar 2006 → Jan 2007 | actinic keratosis | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00472108 | Dec 2000 → Apr 2002 | basal cell carcinoma | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00472043 | Oct 2000 → Sep 2002 | skin basal cell carcinoma | Galderma R&D | Completed | Met primary |
| Phase 3 | NCT00473343 | Sep 2000 → Jun 2006 | basal cell carcinoma | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00469417 | Oct 1999 → Sep 2001 | superficial multifocal basal cell carcinoma | Galderma R&D | Completed | No outcome recorded |
| Phase 47 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT03573076 | Sep → Dec 2018 | — | Merete Haedersdal | Terminated | No outcome recorded |
| Phase 4 | NCT03511326 | Jun → Nov 2017 | actinic keratosis | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT03731988 | Feb → Oct 2017 | actinic keratosis | Dong-A University | Completed | No outcome recorded |
| Phase 4 | NCT02736760 | Mar 2016 → Sep 2018 | actinic keratosis | University Hospital Regensburg | Completed | No outcome recorded |
| Phase 4 | NCT02647151 | Dec 2015 → Mar 2016 | actinic keratosis | Fundación Instituto Valenciano de Oncología | Unknown | No outcome recorded |
| Phase 4 | NCT02464709 | Jun 2015 → Oct 2017 | actinic keratosis | Joint Authority for Päijät-Häme Social and Health Care | Completed | Met primary |
| Phase 4 | NCT01893203 | Aug 2013 → Dec 2014 | actinic keratosis | Joint Authority for Päijät-Häme Social and Health Care | Completed | Missed primary |
| Phase not applicable4 trials | ||||||
| — | NCT05522036 | Jan 2022 → Jun 2023 | actinic keratosis | Centre Dermatologique du Roy | Completed | No outcome recorded |
| — | NCT03013647 | Sep 2016 → Apr 2017 | actinic keratosis | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| — | NCT02392390 | Oct 2015 → Mar 2016 | ulcer of lower limbs | Nîmes University Hospital | Completed | No outcome recorded |
| — | NCT01482104 | Jun 2012 → Oct 2017 | basal cell carcinoma, skin neoplasm | Norwegian University of Science and Technology | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00535080 | — | Bowen disease of the skin, actinic keratosis, skin basal cell carcinoma | Galderma R&D | No longer available | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 1 | NCT02372370 Comparator | Dec 2014 | — | Bispebjerg Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02976727 Background | May 2014 → Aug 2015 | actinic keratosis | Dong-A University | Completed | No outcome recorded |
| Phase 1 | NCT02511145 Comparator | Feb → May 2014 | — | Galderma R&D | Completed | No outcome recorded |
| Phase 1 | NCT02198469 Comparator | Jan 2012 → Mar 2014 | actinic cheilitis | Dong-A University | Completed | No outcome recorded |
| Phase 1 | NCT02248298 Comparator | Jan 2012 → Jun 2014 | actinic keratosis | Dong-A University | Completed | No outcome recorded |
| Phase 1 | NCT01912976 Comparator | Mar 2011 → Mar 2012 | Bowen disease of the skin | Dong-A University | Completed | No outcome recorded |
| Phase 1/2 | NCT02367547 Comparator | Mar 2015 → Sep 2018 | basal cell carcinoma | Joint Authority for Päijät-Häme Social and Health Care | Unknown | No outcome recorded |
| Phase 1/2 | NCT00369018 Comparator | Aug 2006 → Jul 2009 | dysplasia of cervix | Photocure | Completed | No outcome recorded |
| Phase 2 | NCT00833183 Comparator | Jul 2007 → Jul 2008 | acne | Photocure | Completed | No outcome recorded |
| Phase 2/3 | NCT01260987 Background | Oct 2010 → Aug 2012 | actinic keratosis, skin basal cell carcinoma | Bispebjerg Hospital | Completed | No outcome recorded |
| Phase 3 | NCT07381972 Background | Nov 2025 → Aug 2026 overdue | nodular basal cell carcinoma | University of Sao Paulo | Recruiting | No outcome recorded |
| Phase 3 | NCT04269395 Comparator | Apr 2020 → Sep 2021 | actinic keratosis | Galderma R&D | Terminated | No outcome recorded |
| Phase 3 | NCT02144077 Comparator | Jan 2014 → Nov 2015 | basal cell carcinoma | Biofrontera Bioscience GmbH | Completed | No outcome recorded |
| Phase 3 | NCT02799069 Comparator | Apr 2008 → Aug 2009 | actinic keratosis | Biofrontera Bioscience GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00629317 Comparator | Feb 2008 → Jan 2009 | skin atrophy | Universidad de Antioquia | Completed | No outcome recorded |
| Phase 4 | NCT03909646 Comparator | May 2019 → Mar 2022 | Bowen disease of the skin | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01491711 Comparator | Aug 2013 → Apr 2015 | superficial multifocal basal cell carcinoma | Maastricht University Medical Center | Unknown | No outcome recorded |
| — | NCT05456334 Background | Mar 2016 → Dec 2023 | actinic keratosis | Helsinki University Central Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2015-12-14 | Photocure | Results Photocure: Visonac® data published in the British Journal of Dermatology photocure.com ↗
Results showed Visonac ® produced a statistically significant reduction in inflammatory lesions and an overall improvement in acne severity. |
| 2012-05-31 | Photocure | Results PHOTOCURE ANNOUNCES POSITIVE RESULTS OF PHASE 2B STUDY EVALUATING VISONAC® IN ACNE photocure.com ↗
Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announced today the results of the phase 2b study in acne with Visonac (methyl aminolevulinate 80mg/g), a novel topical acne treatment. |
| 2009-04-21 | Photocure | Regulatory METVIX® and AKTILITE® CL128 APPROVED BY HEALTH CANADA photocure.com ↗
The approval of Metvix Cream in combination with Aktilite CL128 in Canada is an important approval for Photocure. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-12-14 | Photocure | Photocure: Visonac® data published in the British Journal of Dermatology photocure.com ↗ |
| 2012-05-31 | Photocure | PHOTOCURE ANNOUNCES POSITIVE RESULTS OF PHASE 2B STUDY EVALUATING VISONAC® IN ACNE photocure.com ↗ |
| 2009-04-21 | Photocure | METVIX® and AKTILITE® CL128 APPROVED BY HEALTH CANADA photocure.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | methyl-aminolevulinate | “The primary purpose of this study is to assess recurrence of Actinic Keratosis in participants treated with Methyl aminolevulinate hydrochloride (MAL) 16.8 percent (%) cream...” NCT04269395 ↗36“This study will assess safety and efficacy of four treatments with methylaminolevulinate (MAL) at 80 mg/g performed with and without occlusion and followed by red light...” NCT00833183 ↗ “The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary...” NCT00469417 ↗ “Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.” NCT01475071 ↗ “Topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)).” NCT02372370 ↗ “Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application” NCT05104099 ↗ “The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours.” NCT07381972 ↗ “Methyl aminolevulinate hydrochloride 160 milligram (mg)/gram (g) cream were received by participants with primary nodular basal cell carcinoma.” NCT00472043 ↗ “Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line treatment for actinic keratosis (AK).” NCT02248298 ↗ “Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment.” NCT04085367 ↗ “The present test drug contains methyl aminolevulinate, which penetrates the lesions well and shows high lesion selectivity.” NCT00304239 ↗ |
| Known as | MAL | “The primary purpose of this study is to assess recurrence of Actinic Keratosis in participants treated with Methyl aminolevulinate hydrochloride (MAL) 16.8 percent (%) cream...” NCT04269395 ↗26“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...” NCT02144077 ↗ “This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to...” NCT02736760 ↗ “PDT with methyl aminolaevulinate (MAL) is an attractive treatment option for BD with large or multiple patches, and poor healing sites can be treated with good efficacy, low...” NCT01912976 ↗ “This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm).” NCT00369018 ↗ “Topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)).” NCT02372370 ↗ “The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours.” NCT07381972 ↗ “A 0,25mm-thick layer of MAL (methyl 5-aminolevulinate, Metvix®) light sensitizer cream is applied on one randomized treatment side of face.” NCT02464709 ↗ “Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line treatment for actinic keratosis (AK).” NCT02248298 ↗ “Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment.” NCT04085367 ↗ “Photodynamic therapy (PDT) with methyl-aminolevulinate (MAL) is effective in the treatment of actinic keratosis (AK).” NCT02976727 ↗ |
| Known as | Methyl aminolevulinate hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1096562 ↗ |
| Known as | Methyl-5-aminolaevulinate | “Hexyl-5-aminolaevulinate 0·2% vs. methyl-5-aminolaevulinate 16% daylight photodynamic therapy for treatment of actinic keratoses: results of a randomized double-blinded pilot trial.” PMID 26011755 ↗ Nov 20151“BACKGROUND: Daylight photodynamic therapy (DL-PDT) with methyl-5-aminolaevulinate (MAL) is an effective treatment for mild and moderate actinic keratosis (AK).” PMID 30329163 ↗ Jan 2019 |
| Known as | methyl-5-aminolevulinate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01292668 ↗ |
| Known as | methyl-5-aminolevulinate hydrochloride | “Patients apply methyl-5-aminolevulinate hydrochloride (MAL) cream on the lesions and the surrounding normal skin.” NCT01292668 ↗ |
| Known as | methyl-aminolaevulinate | “PDT with methyl aminolaevulinate (MAL) is an attractive treatment option for BD with large or multiple patches, and poor healing sites can be treated with good efficacy, low...” NCT01912976 ↗5“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...” NCT01893203 ↗ “After curretage a light-sensitizer (methyl aminolaevulinate cream) was applied on the lesions and covered with an occlusive plastic foil for 2-3-h incubation.” NCT05456334 ↗ “Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few cosmetic side effects and minimises patient discomfort.” NCT02198469 ↗ |
| Known as | METHYLAMINOLEVULINATE HYDROCHLORIDE | “The primary purpose of this study is to assess recurrence of Actinic Keratosis in participants treated with Methyl aminolevulinate hydrochloride (MAL) 16.8 percent (%) cream...” NCT04269395 ↗3“Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented...” NCT04085367 ↗ “Participants received Metvix-PDT (methyl aminolevulinate hydrochloride-Photodynamic therapy) 160 milligrams per gram (mg/g) cream on face and/or scalp for 3 hours on Day 0 and Day 7.” NCT00304239 ↗ “METHYLAMINOLEVULINATE HYDROCHLORIDE (MAL)cream 160mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy” NCT02647151 ↗ |
| Known as | Metil 5-aminolevulinate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03990636 ↗ |
| Known as | Metvix | “After an absorption time of approximately 15 minutes and before applying MAL (Metvix®), the surface of the AK lesions will be prepared gently with a curette or a scalpel to...” NCT02736760 ↗16“Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the...” NCT03320447 ↗ “Immediately after AFL treatment, an approximately 1- mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue.” NCT03325803 ↗ “Immediately after AFL treatment, an approximately 1- mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue.” NCT03731988 ↗ “Immediately after AFL treatment, an approximately 1- mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue.” NCT02976727 ↗ “Immediately after AFL treatment, an approximately 1-mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue.” NCT02670655 ↗ “a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue” NCT02666534 ↗ “a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue.” NCT01912976 ↗ “A 0,25mm-thick layer of MAL (methyl 5-aminolevulinate, Metvix®) light sensitizer cream is applied on one randomized treatment side of face.” NCT02464709 ↗ “The present test drug, Metvix®, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity .” NCT00472043 ↗ “an approximately 1-mm thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion” NCT02248298 ↗ |
| Known as | Metvix R | “application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories)” NCT03013647 ↗ |
| Known as | Metvixia | “Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application” NCT05104099 ↗ |
| Known as | P-1202 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1096562 ↗ |
| Modality | Small molecule | — CHEMBL1096562 ↗ |
| Route | Topical | “This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm).” NCT00369018 ↗ |