Methoxsalen
Methoxsalen, Oxsoralen-ultra, Uvadex (methoxsalen) is a small molecule pharmaceutical. Methoxsalen was first approved as 8-mop on 1982-01-01. It is used to treat mycosis fungoides, psoriasis, and vitiligo in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
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Methoxsalen, Oxsoralen-ultra, Uvadex (discontinued: Methoxsalen, Oxsoralen)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Methoxsalen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OXSORALEN-ULTRA | Bausch Health Companies | N-019600 RX | 1986-10-30 | 1 products, RLD, RS |
| UVADEX | Mallinckrodt | N-020969 RX | 1999-02-25 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| methoxsalen | ANDA | 2025-03-11 |
| uvadex | New Drug Application | 2024-12-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| psoriasis | EFO_0000676 | D011565 | L40 |
| vitiligo | EFO_0004208 | D014820 | L80 |
| mycosis fungoides | — | D009182 | C84.0 |
Agency Specific
FDA
EMA
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Clinical
Clinical Trials
67 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mycoses | D009181 | — | B35-B49 | — | 1 | — | 1 | — | 2 |
| T-cell lymphoma | D016399 | — | — | — | 1 | — | 1 | — | 2 |
| Mycosis fungoides | D009182 | — | C84.0 | — | 1 | — | 1 | — | 2 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | — | 1 | — | 1 | — | 2 |
| Lymphoma | D008223 | — | C85.9 | — | — | — | 1 | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | — | D89.81 | 2 | 3 | 1 | — | — | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | 1 | 1 | — | — | — | 2 |
| Sclerosis | D012598 | — | — | — | 1 | — | — | 1 | 2 |
| Sezary syndrome | D012751 | — | C84.1 | — | 1 | — | — | 1 | 2 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | — | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 1 | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft rejection | D006084 | — | — | — | — | — | — | 1 | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 1 | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | — | 1 | 1 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | — | — | — | 1 | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | — | 1 | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | — | — | — | — | 1 | 1 |
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Methoxsalen |
| INN | — |
| Description | Methoxsalen is a member of the class of psoralens that is 7H-furo[3,2-g]chromen-7-one in which the 9 position is substituted by a methoxy group. It is a constituent of the fruits of Ammi majus. Like other psoralens, trioxsalen causes photosensitization of the skin. It is administered topically or orally in conjunction with UV-A for phototherapy treatment of vitiligo and severe psoriasis. It has a role as a dermatologic drug, an antineoplastic agent, a photosensitizing agent, a cross-linking reagent and a plant metabolite. It is a member of psoralens and an aromatic ether. It is functionally related to a psoralen. |
| Classification | Small molecule |
| Drug class | anti-inflammatory agents (salicylic acid derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1c2occc2cc2ccc(=O)oc12 |
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Estimated US medical usage
Methoxsalen
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Methoxsalen, Uvadex
Adverse Events
Top Adverse Reactions
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681 adverse events reported
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