Overview
Methyl aminolevulinate is a prodrug that is metabolised to Protoporphyrin IX (a photosensitizer) used in photodynamic therapy.
Indication
For topical use, in combination with 570 to 670 nm wavelength red light illumination, in the treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette).
Associated Conditions
- Actinic Keratosis of Face and Scalp
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/02/13 | N/A | Completed | |||
2022/07/13 | Not Applicable | Active, not recruiting | |||
2021/11/02 | Phase 2 | Recruiting | Institut de Cancérologie de Lorraine | ||
2017/01/06 | Not Applicable | UNKNOWN | |||
2015/07/29 | Phase 1 | Completed | |||
2015/06/08 | Phase 4 | Completed | Joint Authority for Päijät-Häme Social and Health Care | ||
2015/03/19 | Not Applicable | Completed | Centre Hospitalier Universitaire de Nīmes | ||
2015/02/27 | Phase 3 | Completed | University Hospital, Limoges | ||
2011/11/21 | Phase 3 | Completed | |||
2008/03/06 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| METVIX methyl aminolevulinate 160mg/g cream tube | 93838 | Medicine | A | 4/4/2003 | |
| LUMEXIA methyl aminolevulinate 160 mg/g cream tube | 231012 | Medicine | A | 6/1/2015 |
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