LOQTORZI (toripalimab-tpzi)
LOQTORZI is indicated for the treatment of Nasopharyngeal Carcinoma.
How LOQTORZI Works
Toripalimab-tpzi is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor on T cells. This binding blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which are often used by tumors to inhibit T cell proliferation and immune surveillance. By preventing this interaction, the drug releases the inhibition of the immune response, thereby enhancing the body's anti-tumor activity.
Details
- Status
- Prescription
- First Approved
- 2023-10-27
- Patent Cliff
- 2030
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LOQTORZI Approval History
What LOQTORZI Treats
1 indicationsLOQTORZI is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nasopharyngeal Carcinoma
LOQTORZI 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.
LOQTORZI 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?
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 LOQTORZI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LOQTORZI treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05479045 | STUDY00005324 | Ph 2 | not yet recruiting | A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients |
| NCT07214987 | 25-494 | Ph 2 | not yet recruiting | PDT For Induction Therapy For Head And Neck Cancer |
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.
LOQTORZI FDA Label Details
Indications & Usage
FDA Label (PDF)LOQTORZI is indicated for the treatment of Nasopharyngeal Carcinoma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.