Recent Updates
Recently added Catalysts

Namodenoson

Phase 3

Hepatocellular Carcinoma | Small molecule | Oncology |Can-Fite Biopharma Ltd|Trials Updated: Apr 29, 2025

Namodenoson development status

Highest phase Phase 3
Registered trials 5 across 1 sponsor since Nov 2008

Namodenoson target and mechanism

Molecular targetADORA3
Target classAgonist
ModalitySmall molecule

Also known as CF102

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment491

FDA Designations

ORPHAN_DRUGFAST_TRACK

Namodenoson clinical trials

Namodenoson · 2 trials · 4 indications

Phase 3 1Phase 2 1
NCT05201404Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 CirrhosisHepatocellular Carcinoma
RECRUITING471 Analytics
PHASE3RECRUITING
Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
Hepatocellular CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival (OS)
From the time of randomization until the date of death from any cause, assessed up to 60 months

Median duration of survival

Adverse Events
Every 2 weeks, assessed up to 1 year

Assessments of adverse events (AEs) will include characterization of type, incidence, severity (graded by CTCAE v5.0), seriousness, and relationship to treatment.

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Change from baseline
Every 2 weeks, assessed up to 1 year

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), which is a scale of functioning, from 0 (normal activity) to 5 (death)

Secondary Endpoints

Progression-Free Survival (PFS)
From the time of randomization until the date of disease progression or death from any cause, assessed up to 60 months
Objective Response Rate (ORR)
Through study completion, with a median of 9 months
Incidence and nature of treatment-emergent adverse events
Through study completion, with a median of 9 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Namodenoson (CF102)EXPERIMENTALNamodenoson 25 mg orally BID, until disease progression or unacceptable adverse events
PlaceboPLACEBO_COMPARATORMatching placebo orally BID, until disease progression or unacceptable adverse events
Namodenoson 25 mgEXPERIMENTALnamodenoson capsule, 25 mg, administered orally, twice daily for consecutive 28-day cycles

Interventions

NameTypeDescription
NamodenosonDRUGAdenosine A3 Receptor (A3AR) agonist
PlaceboDRUGControl arm
Namodenoson 25mgDRUGoral capsule
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: 1. Males and females at least 18 years of age. 2. Diagnosis of HCC: * For patients without cirrhosis at the time of diagnosis, histologic confirmation is required (archival tissue is acceptable). * For patients with underlying cirrhosis at the time of diagnosis, diagnosis...

Countries:United StatesBosnia and HerzegovinaBulgariaIsraelMoldovaPolandRomaniaSerbiaSlovakia
Unlock Eligibility Criteria

Frequently asked questions about Namodenoson

What is Namodenoson used for?

Namodenoson is an investigational small molecule being studied for the treatment of pancreatic adenocarcinoma and hepatocellular carcinoma. It is currently in clinical development for these oncology indications.

What does Namodenoson target?

Namodenoson targets the ADORA3 receptor, acting as an agonist. This mechanism is being investigated for its potential role in treating certain cancers.

Who makes Namodenoson?

Namodenoson is being developed by Can-Fite Biopharma Ltd, a biopharmaceutical company traded under the ticker symbol CANF.

What phase is Namodenoson in?

Namodenoson is in Phase 3 clinical development for hepatocellular carcinoma. It is also being studied in a Phase 2 trial for pancreatic cancer. The drug is investigational and not yet approved.

What clinical trials is Namodenoson in?

Namodenoson is being evaluated in two clinical trials. NCT05201404 is a Phase 3 study in advanced hepatocellular carcinoma with Child-Pugh Class B7 cirrhosis, enrolling 471 participants. NCT06387342 is a Phase 2 study in advanced pancreatic cancer, enrolling 20 participants.