UNLOXCYT
UNLOXCYT (cosibelimab-ipdl) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adult patients with cutaneous squamous cell carcinoma (CSCC). It is specifically approved for use in patients with metastatic disease or locally advanced disease. This therapy is intended for individuals who are not eligible for curative surgery or curative radiation.
How UNLOXCYT Works
Cosibelimab-ipdl works by binding to PD-L1, a protein that can be expressed on tumor cells to inhibit the body's anti-tumor immune response. By blocking the interaction between PD-L1 and its receptors, PD-1 and B7.1, the drug releases the inhibitory effects on T cells, thereby restoring cytotoxic T-cell activity and proliferation. Additionally, the drug has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
Details
- Status
- Prescription
- First Approved
- 2024-12-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
UNLOXCYT Approval History
What UNLOXCYT Treats
1 indicationsUNLOXCYT is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cutaneous Squamous Cell Carcinoma
UNLOXCYT Competitors
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Competitors share the same molecular target (PD-1). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
UNLOXCYT FDA Label Details
ProIndications & Usage
FDA Label (PDF)UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.