OXSORALEN-ULTRA (methoxsalen)
UVADEX (
How OXSORALEN-ULTRA Works
When exposed to UVA light, the drug forms covalent bonds and crosslinks with DNA, which effectively stops DNA synthesis and prevents cell division. This action helps slow down the turnover of diseased cells and may also stimulate an immune response against malignant T-cells.
Details
- Status
- Prescription
- First Approved
- 1986-10-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE
OXSORALEN-ULTRA Approval History
What OXSORALEN-ULTRA Treats
1 indicationsOXSORALEN-ULTRA is approved for 1 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cutaneous T-Cell Lymphoma
OXSORALEN-ULTRA Boxed Warning
UVADEX ® (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS ® CELLEX ® Photopheresis System. Please consult the CELLEX ® Operator's Manual before using this product....
UVADEX ® (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS ® CELLEX ® Photopheresis System. Please consult the CELLEX ® Operator's Manual before using this product.
OXSORALEN-ULTRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in OXSORALEN-ULTRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OXSORALEN-ULTRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OXSORALEN-ULTRA
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06646016 EPIC | MNK60052002 | Ph 2 | withdrawn | EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis |
| NCT03563040 PROMPT | EORTC-1636-CLTF 2018-001685-42 | Ph 2 | withdrawn | Study of Photopheresis in the Treatment of Erythrodermic MF and SS |
| NCT02524847 results posted | TKS-2014-001 | Ph 3 | terminated | Methoxsalen and Extracorporeal Photopheresis (ECP) for the Treatment of Pediatric Participants With Steroid Refractory Acute Graft Versus Host Disease |
| NCT02322190 results posted | 150039 15-C-0039 | Ph 2 | terminated | Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD |
| NCT00639717 results posted | umcc 2008.003 | Ph 2 | completed | Addition of Etanercept and Extracorporeal Photopheresis (ECP) to Standard Graft-Versus-Host Disease (GVHD) Prophylaxis in Stem Cell Transplant |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OXSORALEN-ULTRA FDA Label Details
Indications & Usage
FDA Label (PDF)OXSORALEN-ULTRA is indicated for the treatment of Cutaneous T-Cell Lymphoma.
UVADEX ® (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS ® CELLEX ® Photopheresis System. Please consult the CELLEX ® Operator's Manua...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.