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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 COVID-19, Lowe Syndrome, and moderate-to-severe plaque psoriasis. It is developed by Can-Fite Biopharma Ltd (CANF). The drug is in Phase 2 clinical development for COVID-19 and Lowe Syndrome, and a Phase 3 study is planned for plaque psoriasis.

What does Piclidenoson target?

Piclidenoson is a small molecule developed by Can-Fite Biopharma Ltd (CANF). Its molecular target has not been disclosed in the available information. The drug is being investigated for COVID-19, Lowe Syndrome, and plaque psoriasis, but its specific mechanism of action is not publicly detailed.

Who makes Piclidenoson?

Piclidenoson is developed by Can-Fite Biopharma Ltd, a biopharmaceutical company traded under the ticker CANF. The company is conducting clinical trials of Piclidenoson for COVID-19, Lowe Syndrome, and plaque psoriasis.

What phase is Piclidenoson in?

Piclidenoson is in Phase 2 clinical development for COVID-19 and Lowe Syndrome. A Phase 3 study for moderate-to-severe plaque psoriasis is planned but has not yet started recruiting. The drug is investigational and not approved by regulatory authorities.

What clinical trials is Piclidenoson in?

Piclidenoson has one completed Phase 2 trial for COVID-19 (NCT04333472) with 6 participants. Two trials are not yet recruiting: a Phase 3 study for plaque psoriasis (NCT06643260) with 705 participants and a Phase 2 pilot study for Lowe Syndrome (NCT07410455) with 5 participants.

Is Piclidenoson the same as other names?

Piclidenoson is not known by alternative names in the available information. It is referred to solely as Piclidenoson in clinical trial records and company communications from Can-Fite Biopharma Ltd.