Back to discover
Drug

Ipilimumab

Established medicine

Primarily used for Melanoma & Non-Small-Cell Lung Carcinoma.

ClassCytotoxic T-lymphocyte protein 4 inhibitorResearchActive indication expansion

Also known as Yervoy.

45
Research papers
64
Active clinical trials
Cytotoxic T-lymphocyte protein 4
Primary target
42
Regulatory events
Latest activity
beta

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

Evaluating Immune Checkpoint Blockade in Metastatic Castration-Resistant Prostate Cancers with Deleterious CDK12 Alterations in the Phase 2 IMPACT Trial.

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

Profile

Identifiers & mechanism

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

Canonical name
Ipilimumab
Aliases & brands
Yervoy
RxNorm CUI
1094833
ChEMBL ID
CHEMBL1789844
ATC codes
L01FX04
UNII
6T8C155666
Primary mechanism
Cytotoxic T-lymphocyte protein 4 inhibitor
Regulatory jurisdictions
mhrafdaema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORCytotoxic T-lymphocyte protein 4 inhibitor

Regulatory timeline

42 events

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.

Approval / market entry confirmed across FDA and EMA (2011-03-252011-07-13)
Earliest approval
2011-03-25
Latest approval
2025-05-23
Authorities
FDA · EMA · MHRA
Total events
42
fdaU.S. Food and Drug Administration· 40 events
2026-08-31Label change
Label change: IPILIMUMAB (BLA125377)
Evidence ↗
2026-06-12Label change
Label change: IPILIMUMAB (BLA125377)
Evidence ↗
2025-05-23Indication expansion
Indication expansion: IPILIMUMAB (BLA125377)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2011-07-13ApprovalMulti-authority
Approval: Yervoy (EMA)
Indication: Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years ofShow full indication

Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).  Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non-small cell lung cancer (NSCLC) Yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Malignant pleural mesothelioma (MPM) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Hepatocellular carcinoma (HCC) Yervoy in combination with nivolumab is indicated for the first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2019-01-09Safety communicationSafety
Drug Safety Update: Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

197 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
197
registered trials across all phases
LATEST COMPLETION 2025
64
Active studies
28
Recruiting
21
Late-stage (III+)
89
Completed
44
Discontinued
PHASE DISTRIBUTIONn = 197
Early Phase 13Phase 151Phase 1 / 237Phase 285Phase 2 / 31Phase 317Phase 42Phase N / A1

Late-stage studies

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

Recent completions

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

Research activity

45 papers

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

Publications over time
20102024
Most influential

Improved survival with ipilimumab in patients with metastatic melanoma.

The New England journal of medicine · 2010 · 11,354 cites

Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma.

The New England journal of medicine · 2015 · 5,963 cites

Pembrolizumab versus Ipilimumab in Advanced Melanoma.

The New England journal of medicine · 2015 · 4,468 cites

Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma.

The New England journal of medicine · 2018 · 3,404 cites

Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.

The New England journal of medicine · 2017 · 2,790 cites

Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.

The New England journal of medicine · 2019 · 2,691 cites
Recent papers
Major research themes8
Antineoplastic Combined Chemotherapy Protocols6Melanoma5Ipilimumab4Nivolumab4Carcinoma, Non-Small-Cell Lung3Immune Checkpoint Inhibitors3Immunotherapy3Lung Neoplasms3
Journals, researchers & institutions
Top journals
  • The New England journal of medicine13
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology8
  • Nature communications4
  • JAMA oncology3
  • Journal for immunotherapy of cancer3
  • Journal of immunotherapy (Hagerstown, Md. : 1997)2
Leading researchers
  • Ascierto PA9
  • Wolchok JD9
  • Hodi FS8
  • Carlino MS7
  • Dummer R7
  • Grob JJ7
  • Robert C7
  • Rutkowski P7
Leading institutions
free-text, unnormalised
  • Memorial Sloan Kettering Cancer Center4
  • Netherlands Cancer Institute4
  • Aix-Marseille University3
  • Dana-Farber Cancer Institute3
  • Melanoma Institute Australia3
  • Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College3

Related diseases

12 conditions

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

Related drugs

8 matches

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

Studied across 30 of the same disease areas as Ipilimumab in the shared literature.

27 shared papers30 shared diseases

Studied across 27 of the same disease areas as Ipilimumab in the shared literature.

27 shared diseases4 shared papers

Studied across 10 of the same disease areas as Ipilimumab in the shared literature.

10 shared diseases1 shared paper

Studied across 7 of the same disease areas as Ipilimumab in the shared literature.

7 shared diseases2 shared papers

Studied across 6 of the same disease areas as Ipilimumab in the shared literature.

6 shared diseases1 shared paper

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

4 shared diseases1 shared paper

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

4 shared diseases1 shared paper

Studied across 2 of the same disease areas as Ipilimumab in the shared literature.

2 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.