UNLOXCYT (cosibelimab-ipdl) · CHECKPOINT THERAPEUTICS INC
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 Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
UNLOXCYT 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 UNLOXCYT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications UNLOXCYT treats. First-in-class if their pivotal trials read out positive.
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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
Indications & 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.