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Drug

Raltitrexed

Approved medicine
ClassThymidylate synthase inhibitorResearchOngoing clinical research
RxNorm196239ChEMBLCHEMBL225071ATCL01BA03UNIIFCB9EGG971
2
Active clinical trials
Thymidylate synthase
Primary target
Latest activity
beta

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

Fruquintinib Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: a Phase II Study

Clinical trial2025-08-18Primary completion · ClinicalTrials.gov

Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients：An Open-label, Single-arm, Multicenter Phase I/II Study

Clinical trial2025-07-01Primary completion · ClinicalTrials.gov

Phase I Clinical Human Tolerability Test of Raltitrexed in Hyperthermic Intraperitoneal Chemotherapy

Clinical trial2025-06-30Completed · ClinicalTrials.gov

Hypofractionated Radiotherapy Combined With Toripalimab and Chemotherapy +/- Target Therapy for Locally Recurrent Rectal Cancer: a Single-arm, Two-cohort, Phase II Trial (TORCH-R)

Clinical trial2024-12-01Primary completion · ClinicalTrials.gov

Comprehensive Geriatric Assessment (CGA) Guided Ultrafractionated Radiotherapy and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized Colorectal Cancer

Clinical trial2024-10-28Results expected Q4 2027 · ClinicalTrials.gov

A Single-center, Single-arm, Open-label Clinical Study of Fruquintinib Combined With Tislelizumab and HAIC in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Therapy

Clinical trial2024-01-01Primary completion · ClinicalTrials.gov

Raltitrexed Combined With Irinotecan (SALIRI) Based Regimen as First-line Treatment for Advanced Metastatic Colorectal Cancer (mCRC) : an Open-label, Multi-center, and Prospective Study

Clinical trial2023-06-30Primary completion · ClinicalTrials.gov

A Phase II Study of Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer

Clinical trial2022-08-15Primary completion · ClinicalTrials.gov

Raltitrexed Concurrent With Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Phase-II Study

Clinical trial2022-01-30Primary completion · ClinicalTrials.gov

A Multicenter Phase II Clinical Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer

Clinical trial2021-11-28Primary completion · ClinicalTrials.gov

Multicenter, Phase II Study of Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly

Clinical trial2021-08-01Completed · ClinicalTrials.gov

Phase Ⅱ Clinical Study of RALOX or CAPOX Combined With Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer

Clinical trial2021-02-28Primary completion · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Raltitrexed
RxNorm CUI
196239
ChEMBL ID
CHEMBL225071
ATC codes
L01BA03
UNII
FCB9EGG971
Primary mechanism
Thymidylate synthase inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Thymidylate synthase
TYMS · P04818
INHIBITORThymidylate synthase inhibitor

Clinical trials

30 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
30
registered trials across all phases
LATEST COMPLETION 2025
2
Active studies
2
Recruiting
5
Late-stage (III+)
11
Completed
17
Discontinued
PHASE DISTRIBUTIONn = 30
Phase 15Phase 1 / 21Phase 219Phase 33Phase 42

Late-stage studies

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

Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With Head and Neck Squamous Cell Carcinoma: a Prospective Randomized Controlled Trial

Unknown statusPH IVThe First Affiliated Hospital of Dalian Medical Universityn=2022023

Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer

Unknown statusPH IVNanjing Chia-tai Tianqing Pharmaceuticaln=3202017

A Multicenter Phase Ⅲ Trial of Cisplatin Plus Raltitrexed or 5-fluorouracil in Concurrence With Intensity-modulated Radiotherapy (IMRT) for the Treatment of Locoregionally Advanced Head and Neck Squamous Cell Cancer

Unknown statusPH IIIJiangsu Cancer Institute & Hospitaln=1202018

CHEMOTHERAPY CHOICES IN ADVANCED COLORECTAL CANCER: A RANDOMISED TRIAL COMPARING 2 DURATIONS AND 3 SYSTEMIC CHEMOTHERAPY REGIMENS IN THE PALLIATIVE TREATMENT OF ADVANCED COLORECTAL CANCER

Unknown statusPH IIIMedical Research Counciln=9002013

Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma

CompletedPH IIIEuropean Organisation for Research and Treatment of Cancer - EORTCn=2562003

Recent completions

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

Phase I Clinical Human Tolerability Test of Raltitrexed in Hyperthermic Intraperitoneal Chemotherapy

CompletedPH IFudan Universityn=302025

Multicenter, Phase II Study of Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly

CompletedPH IIChinese Academy of Medical Sciencesn=682021

Phase II Trial of Raltitrexed and Paclitaxel as Second-line Chemotherapy for Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

CompletedPH IIChinese Academy of Medical Sciencesn=412018

Phase II Randomized Study Comparing the Association of Intraarterial Perfusion of Raltitrexed and Oxaliplatin Versus Standard Chemotherapy Using Intravenous Perfusion for Colorectal Cancer Patient With Metastases Localized to Liver After Failure of Conventional Treatments.

CompletedPH IICentre Georges Francois Leclercn=312018

Bevacizumab With Pelvic Radiotherapy And Primary Chemotherapy in Patients With Poor-Risk Rectal Cancer: the BRANCH Trial

CompletedPH IINational Cancer Institute, Naplesn=622016

Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma

CompletedPH IIIEuropean Organisation for Research and Treatment of Cancer - EORTCn=2562003
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials