UVADEX (methoxsalen)
UVADEX (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System for the palliative treatment of skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) in patients who have not responded to other treatments. The medication is used during a photopheresis procedure where a patient’s white blood cells are separated, mixed with UVADEX outside the body, irradiated with UVA light, and then returned to the patient. This approach allows for direct treatment of the buffy coat (white blood cells) to manage disease symptoms.
How UVADEX Works
The exact mechanism of action of methoxsalen in treating CTCL is not fully known. It is a photosensitizing agent that, when activated by UVA light during the photopheresis process, forms covalent bonds and crosslinks with DNA (forming both monofunctional and bifunctional adducts). This inhibits DNA synthesis and cell division in the treated malignant cells. Additionally, the procedure is thought to trigger an immune-mediated response against the cancerous T-cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-02-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
UVADEX Approval History
What UVADEX Treats
1 indicationsUVADEX is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cutaneous T-Cell Lymphoma
UVADEX 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.
UVADEX 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 UVADEX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications UVADEX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to UVADEX
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06646016 EPIC | MNK60052002 | Ph 2 | withdrawn | EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis |
| NCT04291261 | MAGIC-HR-ECP | Ph 2 | active not recruiting | Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease |
| NCT04986605 | ECR-CAN-011068 | Ph 2 | not yet recruiting | Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis |
| 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.
UVADEX FDA Label Details
Indications & Usage
FDA Label (PDF)UVADEX 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment