IMJUDO (tremelimumab-actl) · AstraZeneca
IMJUDO (tremelimumab-actl) is a CTLA-4-directed blocking antibody indicated for the treatment of specific adult cancers. It is used in combination with durvalumab for patients with unresectable hepatocellular carcinoma. Additionally, it is approved for use with durvalumab and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer lacking EGFR or ALK genomic tumor aberrations.
How IMJUDO Works
Tremelimumab-actl is a monoclonal antibody that targets CTLA-4, a protein that acts as a negative regulator of T-cell activity. By binding to CTLA-4, the drug blocks its interaction with the ligands CD80 and CD86. This action releases the CTLA-4-mediated inhibition of T-cell activation, which can lead to decreased tumor growth and increased T-cell proliferation within tumors.
Details
- Status
- Prescription
- First Approved
- 2022-10-21
- Patent Cliff
- 2029
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
IMJUDO Approval History
What IMJUDO Treats
2 indicationsIMJUDO is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
IMJUDO Target & Pathway
ProTarget
An immune checkpoint receptor that downregulates T-cell activation. Unlike PD-1 which works in peripheral tissues, CTLA-4 primarily regulates T-cell activation in lymph nodes. Blocking CTLA-4 enhances T-cell activation and proliferation, boosting anti-tumor immunity.
Pathway Context
CTLA-4 competes with CD28 for binding to CD80/CD86, suppressing T-cell activation
IMJUDO 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.
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 IMJUDO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IMJUDO treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
IMJUDO FDA Label Details
Indications & Usage
FDA Label (PDF)IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. 1.1 Hepatocellular Carcinoma IMJUDO, in combination with durvalumab, is indicated for the treatment o...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.