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Drug

Sorafenib

Approved · EMA
Emerging researchLate-stage developmentCooling momentum
Also known as 4-(4-((((4-Chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-2-pyridinecarboxamide, N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea, NexAVAR, Sorafénib+1 more

4-(4-((((4-Chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-2-pyridinecarboxamide, N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea, NexAVAR, Sorafénib, Sorafenibum.

14
Research papers
16
Active clinical trials
2
Regulatory events
Latest activity
beta

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

Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Clinical trial2026-07-16Results expected Q4 2026 · ClinicalTrials.gov

Paediatric Hepatic International Tumour Trial

Clinical trial2026-05-13Results expected Q4 2026 · ClinicalTrials.gov

Approval: Sorafenib Accord (EMA)

Regulatory2022-11-09EMA

Approval: Nexavar (EMA)

Regulatory2006-07-19EMA

Profile

Identifiers & mechanism

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

Canonical name
Sorafenib
Aliases & brands
4-(4-((((4-Chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-2-pyridinecarboxamideN-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)ureaNexAVARSorafénibSorafenibum
RxNorm CUI
495881
ChEMBL ID
CHEMBL1336
ATC codes
L01EX02
UNII
9ZOQ3TZI87
Regulatory jurisdictions
ema

Regulatory timeline

2 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.

Earliest approval
2006-07-19
Latest approval
2022-11-09
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2022-11-09Approval
Approval: Sorafenib Accord (EMA)
Indication: Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinomaSorafenib Accord is indicated for theShow full indication

Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinomaSorafenib Accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Evidence ↗
2006-07-19Approval
Approval: Nexavar (EMA)
Indication: Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma. Renal cell carcinoma Nexavar is indicated for the treatment of patients with advancedShow full indication

Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma. Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.

Evidence ↗

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

Clinical trials

199 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
199
registered trials across all phases
LATEST COMPLETION 2025
16
Active studies
6
Recruiting
59
Late-stage (III+)
118
Completed
65
Discontinued
PHASE DISTRIBUTIONn = 199
Phase 140Phase 1 / 220Phase 280Phase 2 / 38Phase 338Phase 46Phase N / A7

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

14 papers

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

Publications over time
20082023
Most influential
Recent papers

Hepatocellular carcinoma.

Nature reviews. Disease primers · 2021 · 4,865 cites

Hepatobiliary Cancers, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology.

Journal of the National Comprehensive Cancer Network : JNCCN · 2021 · 778 cites
Major research themes8
Carcinoma, Hepatocellular6Liver Neoplasms6Antibodies, Monoclonal1Antibodies, Monoclonal, Humanized1Drug Delivery Systems1Gastrointestinal Microbiome1Gene Expression Regulation, Neoplastic1Patient Selection1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
  • European urology1
  • Hepatology (Baltimore, Md.)1
  • Investigational new drugs1
  • JAMA oncology1
  • Journal of experimental & clinical cancer research : CR1
Leading researchers
  • Kelley RK3
  • Kudo M3
  • Llovet JM3
  • Qin S3
  • Breder V2
  • Bruix J2
  • Cheng AL2
  • Finn RS2
Leading institutions
free-text, unnormalised
  • Kindai University Faculty of Medicine3
  • Helen Diller Family Comprehensive Cancer Center2
  • Humanitas University2
  • National Taiwan University Hospital2
  • University of Bologna2
  • "Madonna del Soccorso" General Hospital1

Related diseases

3 conditions

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

Related drugs

7 matches

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

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

4 shared diseases3 shared papers

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

4 shared diseases1 shared paper

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

4 shared diseases1 shared paper

Studied across 3 of the same disease areas as Sorafenib in the shared literature.

3 shared diseases1 shared paper

Studied across 3 of the same disease areas as Sorafenib in the shared literature.

3 shared diseases1 shared paper

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

2 shared diseases1 shared paper

Studied across the same disease area as Sorafenib in the shared literature.

1 shared disease1 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.