Drug

Tremelimumab

Approved · EMA

ClassCytotoxic T-lymphocyte protein 4 inhibitorEmerging researchLate-stage developmentCooling momentum

Also known as Imjudo, Ticilimumab.

RxNorm2619313 ChEMBLCHEMBL2108658 ATCL01FX20UNIIQEN1X95CIX

Research papers

Active clinical trials

Cytotoxic T-lymphocyte protein 4

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multicentre Single Arm Phase II Trial Assessing the Efficacy of Immunotherapy, Chemotherapy and Stereotactic Radiotherapy to Metastases Followed by Definitive Surgery or Radiotherapy to the Primary Tumour, in Patients With Synchronous Oligo-metastatic Non-small Cell Lung Cancer

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Phase II Study of Immunotherapy With Durvalumab (MEDI4736) or Durvalumab and Tremelimumab, Both Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082

Clinical trial2026-07-07Results expected Q1 2027 · ClinicalTrials.gov

A Phase 2 Study of MEDI4736 (Durvalumab) and Tremelimumab Alone or in Combination With High or Low-Dose Radiation in Metastatic Colorectal and NSCLC

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

A Phase IIb, Randomized, Multicenter, Open-label Study to Assess the Efficacy of Durvalumab Plus Tremelimumab Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for First-line Treatment in Metastatic Non-small Cell Lung Cancer Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS (TRITON)

Clinical trial2026-07-02Results expected Q4 2026 · ClinicalTrials.gov

Another AstraZeneca Emerald glimmers as Imfinzi, Imjudo delay liver cancer progression

Industry2026-04-02Fierce Pharma

Plasma versus Tissue Tumor Mutational Burden as Biomarkers of Durvalumab plus Tremelimumab Response in Patients with Metastatic Colorectal Cancer in the CO.26 Trial.

Research2024-08-01Clinical cancer research : an official journal of the American Association for Cancer Research

Approval: Imjudo (EMA)

Regulatory2023-02-20EMA

Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study.

Research2022-11-03Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma.

Research2022-06-06NEJM evidence

Effect of Combined Immune Checkpoint Inhibition vs Best Supportive Care Alone in Patients With Advanced Colorectal Cancer: The Canadian Cancer Trials Group CO.26 Study.

Research2020-06-01JAMA oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Tremelimumab

Aliases & brands

ImjudoTicilimumab

RxNorm CUI

2619313

ChEMBL ID

CHEMBL2108658

ATC codes

L01FX20

UNII

QEN1X95CIX

Primary mechanism

Cytotoxic T-lymphocyte protein 4 inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Cytotoxic T-lymphocyte protein 4

CTLA4 · P16410

INHIBITORCytotoxic T-lymphocyte protein 4 inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2023-02-20

Latest approval

2023-02-20

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2023-02-20Approval

Approval: Imjudo (EMA)

Indication: Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Imjudo in… Show full indication

Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

180 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

180

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 180

Early Phase 15Phase 143Phase 1 / 222Phase 291Phase 2 / 31Phase 317Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An International Investigator-led Phase III Multi Arm Multi Stage Multi-centre Randomised Controlled Platform Trial of Adjuvant Therapy in Patients With Resected Primary Renal Cell Carcinoma (RCC) at High or Intermediate Risk of Relapse

RecruitingPH IIIKey trialUniversity College, Londonn=1,7502034

A Phase 2/3, Randomized Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment

RecruitingPH II/IIIAbbVien=6602030

A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

RecruitingPH IIIKey trialAstraZenecan=1,2202030

Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)

RecruitingPH IIINRG Oncologyn=2262029

A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)

Active, not recruitingPH IIIAstraZenecan=7122028

Recent completions

Trials that read out recently, adding to the completed evidence base.

Surgery for Mesothelioma After Radiation Therapy Using Exquisite Systemic Therapy

CompletedPH IIUniversity Health Network, Toronton=302025

Phase I/II Trial Immunotherapy With Durvalumab and Tremelimumab With Continuous or Intermittent MEK Inhibitor Selumetinib in NSCLC

CompletedPH I/IIM.D. Anderson Cancer Centern=402025

A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.

CompletedPH I/IIAstraZenecan=3402025

Randomized Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab Administered in Combination Versus Sequentially in Recurrent Platinum-Resistant Epithelial Ovarian Cancer

CompletedPH IIM.D. Anderson Cancer Centern=1002025

A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer

CompletedPH IICanadian Cancer Trials Groupn=522025

A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma

CompletedPH IICanadian Cancer Trials Groupn=1802025

Research activity

8 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20172024

Most influential

Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma.

NEJM evidence · 2022 · 1,149 cites

Tremelimumab in combination with ablation in patients with advanced hepatocellular carcinoma.

Journal of hepatology · 2017 · 631 cites

Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial.

JAMA oncology · 2020 · 499 cites

Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 340 cites

Effect of Combined Immune Checkpoint Inhibition vs Best Supportive Care Alone in Patients With Advanced Colorectal Cancer: The Canadian Cancer Trials Group CO.26 Study.

JAMA oncology · 2020 · 307 cites

Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study.

Annals of oncology : official journal of the European Society for Medical Oncology · 2020 · 291 cites

Related diseases

4 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications

Carcinoma, Non-Small-Cell Lung2

Active research areas

Colorectal Neoplasms2 Lung Neoplasms2 Neoplasm Metastasis2

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Durvalumab

Studied across 9 of the same disease areas as Tremelimumab in the shared literature.

9 shared diseases6 shared papers

Sorafenib

Studied across 4 of the same disease areas as Tremelimumab in the shared literature.

4 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.