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piclidenoson

Phase 3

Plaque Psoriasis | Small molecule | Dermatology |Can-Fite Biopharma Ltd|Last Updated: Feb 18, 2026

Target and mechanism

Molecular targetADORA3
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment705

FDA Designations

No designations recorded

Clinical trial landscape

piclidenoson · 3 trials · 4 indications

Phase 3 1Phase 2 2
NCT06643260A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and EfficacyPlaque Psoriasis
NOT YET_RECRUITING705 Analytics
PHASE3NOT YET_RECRUITING
A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy
Plaque PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75)
16 weeks

Improvement of psoriasis by 75% or more

proportion of subjects who achieve a Static Physician's Global Assessment (sPGA) of 0 or 1 with at least a 2-point improvement from Baseline
16 weeks

Improvement of psoriasis by physicians' judgment

Proportion of subjects who experience adverse events
52 weeks

All adverse events occurring the trial will be recorded

99mTc-DMSA
6 months

The primary end-point is to assess whether treatment for 6 months with piclidenoson improves the functioning of renal proximal tubular cells (PTCs), as assessed by the increase in 99mTc-DMSA uptake as compared to Baseline

Proportion of subjects alive and free of respiratory failure
29 days

Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29

Proportion of subjects discharged home alive
29 days

Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29

Treatment-emergent adverse events (AEs)
29 days

Proportion of patients experiencing AEs

Secondary Endpoints

Efficacy as determined by the proportion of subjects who achieve both PASI 75 and sPGA of 0 or 1 with at least a 2-point improvement from Baseline
16 weeks
Efficacy as determined by the proportion of subjects who achieve improvement of the Psoriasis Symptoms and Signs Diary (PSSD) to a score of 0 or 1
16 weeks
Efficacy as determined by the proportion of subjects who achieve improvement of the Dermatology Life Quality Index (DLQI) to a score of 0 or 1
16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Piclidenoson treatmentEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Piclidenoson (CF101) open-label treated patientsEXPERIMENTALPiclidenoson will be administered orally at a dose of 3 mg twice per day for 6 months
PiclidenosonEXPERIMENTALPiclidenoson 2 mg every 12 hours orally added to standard of care

Interventions

NameTypeDescription
piclidenosonDRUGPiclidenoson is a selective A3AR agonist, supplied as tablets.
PlaceboDRUGInactive control
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Male or female, 18 years and above; 2. Diagnosis of moderate-to-severe chronic plaque-type psoriasis with BSA involvement ≥10%; 3. PASI score ≥12 at the Screening and Baseline visits; 4. Static PGA ≥3 at the Screening and Baseline visits; 5. Candidate for systemic treatment o...

Countries:ItalyBulgariaIsraelRomania
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Frequently asked questions about piclidenoson

What is Piclidenoson used for?

Piclidenoson is an investigational small molecule being studied for the treatment of Lowe Syndrome, plaque psoriasis, and COVID-19. It is being developed by Can-Fite Biopharma Ltd (CANF). The drug is currently in clinical trials, including a Phase 3 study for moderate-to-severe plaque psoriasis and Phase 2 studies for Lowe Syndrome and COVID-19.

What does Piclidenoson target?

Piclidenoson targets the ADORA3 receptor, acting as an agonist. This means it binds to and activates the adenosine A3 receptor. The drug is being investigated for its potential effects in conditions such as plaque psoriasis, Lowe Syndrome, and COVID-19, though its exact mechanism in these diseases is still under study.

Who makes Piclidenoson?

Piclidenoson is being developed by Can-Fite Biopharma Ltd, a biopharmaceutical company traded under the ticker symbol CANF. The company is conducting clinical trials for the drug across multiple indications, including plaque psoriasis, Lowe Syndrome, and COVID-19.

What phase is Piclidenoson in?

Piclidenoson is in Phase 2 and Phase 3 clinical development. It has a completed Phase 2 trial for COVID-19, a Phase 2 trial for Lowe Syndrome that has not yet started recruiting, and a Phase 3 trial for plaque psoriasis that is also not yet recruiting. The drug is investigational and not yet approved.

What clinical trials is Piclidenoson in?

Piclidenoson has three registered clinical trials. NCT04333472 is a completed Phase 2 study for COVID-19 with 6 participants. NCT06643260 is a planned Phase 3 study for moderate-to-severe plaque psoriasis with 705 participants. NCT07410455 is a planned Phase 2 pilot study for Lowe Syndrome with 5 participants.

Is Piclidenoson the same as CF101?

Piclidenoson is also known by the code name CF101. The drug is being developed by Can-Fite Biopharma for multiple indications, including plaque psoriasis, Lowe Syndrome, and COVID-19. It is an adenosine A3 receptor agonist currently in clinical trials.