Drugs / Piclidenoson
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 210 trials · 2 met primary | ||||||
| Phase 2 | NCT07410455 | Jun 2026 → Aug 2027 expected | oculocerebrorenal syndrome | Can-Fite BioPharma | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04333472 | Jan 2021 → Mar 2022 | COVID-19 | Can-Fite BioPharma | Completed | No outcome recorded |
| Phase 2 | NCT01905124 | Jan → Sep 2019 | intermediate uveitis, posterior uveitis | Can-Fite BioPharma | Withdrawn | No outcome recorded |
| Phase 2 | NCT00837291 | Nov → Dec 2018 | osteoarthritis, knee | Can-Fite BioPharma | Withdrawn | No outcome recorded |
| Phase 2 | NCT01033422 | Oct 2010 → Dec 2016 | glaucoma, ocular hypertension | Can-Fite BioPharma | Completed | No outcome recorded |
| Phase 2 | NCT01034306 | Oct 2010 → Dec 2013 | rheumatoid arthritis | Can-Fite BioPharma | Completed | Met primary |
| Phase 2 | NCT00556894 | Feb 2008 → Mar 2009 | rheumatoid arthritis | Can-Fite BioPharma | Completed | No outcome recorded |
| Phase 2 | NCT00428974 | Jun 2007 → Sep 2009 | psoriasis | Can-Fite BioPharma | Completed | Met primary |
| Phase 2 | NCT00349466 | Jan 2007 → May 2009 | dry eye syndrome | Can-Fite BioPharma | Completed | Mixed |
| Phase 2 | NCT00280917 | Jun 2006 → Apr 2007 | rheumatoid arthritis | Can-Fite BioPharma | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT01265667 | Jul 2011 → Mar 2015 | psoriasis | Can-Fite BioPharma | Completed | Missed primary |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT06643260 | Jun 2025 → Dec 2027 expected | psoriasis | Can-Fite BioPharma | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03168256 | Sep 2018 → Jan 2022 | psoriasis | Can-Fite BioPharma | Completed | Met primary |
| Phase 3 | NCT02647762 | Oct 2017 → Nov 2020 | rheumatoid arthritis | Can-Fite BioPharma | Terminated | No outcome recorded |
| Phase 3 | NCT01235234 | Jul 2011 → Nov 2013 | dry eye syndrome | Can-Fite BioPharma | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 48
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Can-Fite BioPharma | Results Scientific Publication of Can-Fite and Vetbiolix Validates Piclidenoson’s Potential in the Multi-Billion Dollar Canine Osteoarthritis Market canfite.com ↗
The study described in the publication demonstrated that oral treatment with Piclidenoson resulted in statistically significant improvement in mobility and pain assessments in dogs suffering from osteoarthritis, while maintaining a favorable safety profile. |
| 2025-08-28 | Can-Fite BioPharma | Results Can-Fite Reports H1 2025 Financial Results and Clinical Update canfite.com ↗
Piclidenoson was found to restore tissue integrity and behavioral function in this vascular dementia model. |
| 2025-07-28 | Can-Fite BioPharma | Results Breakthrough Study from UCLA Demonstrate Can-Fite’s Piclidenoson as a Treatment for Vascular Dementia canfite.com ↗
Piclidenoson was found to restore tissue integrity and behavioral function in this vascular dementia model. |
| 2024-10-18 | Can-Fite BioPharma | Results Significant Positive Results from Osteoarthritis Clinical Study in Dogs Treated with Piclidenoson canfite.com ↗ |
| 2024-06-28 | Can-Fite BioPharma | Results Positive Results from Osteoarthritis Clinical Study in Dogs Reported by Can-Fite’s Partner Vetbiolix canfite.com ↗
The study reached the primary and secondary end points with a dose and time dependent inhibitory effect of piclidenoson on LOAD and VAS and NRS, demonstrating significant improvement in clinical status and decrease in pain in the 500 µg/kg dose. |
| 2024-05-29 | Can-Fite BioPharma | Results Independent Scientists Published a Review Article Demonstrating That Can-Fite Drugs Have Therapeutic Effects on Heart Diseases canfite.com ↗ |
| 2024-01-29 | Can-Fite BioPharma | Results Can-Fite: Top Scientific Journal Published Positive Data from the COMFORT-1 Phase III Psoriasis Study canfite.com ↗
Piclidenoson’s efficacy continued to increase throughout the study period in a linear manner with an excellent safety and tolerability profile. |
| 2023-12-18 | Can-Fite BioPharma | Regulatory Can-Fite Received FDA Positive Response to Psoriasis Pediatric Plan canfite.com ↗
today announced that it received a positive response from the U.S. Food and Drug Administration (FDA) on the Pediatric Study Plan for the treatment of children suffering from psoriasis with Piclidenoson. |
| 2023-08-18 | Can-Fite BioPharma | Regulatory Can-Fite Submitted to FDA a Pediatric Plan to Allow Registration of Piclidenoson for the Treatment of Adolescents with Psoriasis canfite.com ↗
today announced that it submitted a pediatric study plan to the U.S. Food and Drug Administration (FDA) for the treatment of adolescents suffering from psoriasis with Piclidenoson. |
| 2023-04-10 | Can-Fite BioPharma | Regulatory Can-Fite: EMA Gives Green Light for Piclidenoson Pivotal Phase III Clinical Trial for Psoriasis Treatment canfite.com ↗
The pivotal Phase III study and the safety of the 3 mg twice daily dose of Piclidenoson are accepted by the agency. |
| 2023-01-10 | Can-Fite BioPharma | Regulatory Can-Fite Submits Market Registration Plan to European Medicines Agency for Piclidenoson in the Treatment of Psoriasis; FDA Submission to Follow canfite.com ↗ |
| 2022-12-08 | Can-Fite BioPharma | Results Can-Fite’s Partner Vetbiolix is Heading into a European Multicentric Clinical Trial with Piclidenoson for the Treatment of Pets’ Osteoarthritis canfite.com ↗
Vetbiolix completed dose-ranging pharmacokinetic (PK) studies in dogs and determined the optimal efficacy and safety dosage for its upcoming European multicentric clinical study. |
| 2022-11-02 | Can-Fite BioPharma | Results Can-Fite: Positive New Data from it’s Phase III Psoriasis Study will be Presented Today at an Industry Expert Summit in Boston canfite.com ↗
Piclidenoson demonstrated a statistically significant improvement when compared with placebo as measured by the Psoriasis Area and Severity Index (PASI) 75 response and the Physician Global Assessment (PGA) response index calculated based on the Erythema + Infiltration + Desquamation. |
| 2022-09-12 | Can-Fite BioPharma | Results Can-Fite: New Phase III Psoriasis Data Showing Superior Safety & Improved Efficacy Presented by KOL Dr. Papp at the 31st European Academy of Dermatology canfite.com ↗
The COMFORT™ Phase III study met its primary endpoint of superiority vs. placebo at 16 weeks, p=0.037 |
| 2022-08-22 | Can-Fite BioPharma | Results Can-Fite Selected to Present the Positive Psoriasis Phase III Data at the 31st European Academy of Dermatology and Venerology Congress canfite.com ↗
The presentation titled “Treatment of plaque psoriasis with piclidenoson: Efficacy and safety results from a phase 3 clinical trial (COMFORT)” will be delivered on September 10, 2022, during the Late Breaking News session from 8:30 am to 11:45 am in Milan, Italy. |
| 2022-08-17 | Can-Fite BioPharma | Results Can-Fite: Reports Progress in the Development of Piclidenoson for Osteoarthritis in Pets Through its Partner Vetbiolix canfite.com ↗
Piclidenoson was well tolerated, with the pharmacokinetic data proportional to dose. |
| 2022-07-11 | Can-Fite BioPharma | Results Can-Fite to Submit FDA & EMA Registration Plans for Piclidenoson in the Oral Treatment of Moderate to Severe Psoriasis canfite.com ↗
Further analysis of the Phase III COMFORT™ data point towards a better safety profile for Piclidenoson as compared to Otezla, which induced gastro-intestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson. |
| 2022-06-29 | Can-Fite BioPharma | Results Can-Fite Announces Positive Top-Line Results from Piclidenoson Phase III COMFORT™ Study in Moderate to Severe Psoriasis canfite.com ↗
The study data show that patients treated with oral Piclidenoson 2 mg or 3 mg twice daily, had clinically equivalent efficacy responses. |
| 2022-06-09 | Can-Fite BioPharma | Results Can-Fite Announces Publication of Clinical Study Data for Piclidenoson and Namodenoson in Scientific Journal canfite.com ↗
Data suggest Piclidenoson and Namodenoson could potentially be the first A3AR agonists to achieve FDA approval and provide clinicians with new oral and safe drugs in the arsenal for fighting psoriasis, liver cancer, and NASH |
| 2022-04-05 | Can-Fite BioPharma | Results Can-Fite is Developing a Topical Piclidenoson Psoriasis Treatment that Shows Efficacy in a Preclinical Model: Potential Complementary Product to its Phase III Oral Psoriasis Drug canfite.com ↗ |
| 2020-10-06 | Can-Fite BioPharma | Results Can-Fite Announces Positive Phase III Psoriasis Interim Data Analysis canfite.com ↗
Independent Data Monitoring Committee (IDMC) conducted a pre-planned interim analysis of the Company’s Phase III Comfort™ trial of Piclidenoson for the treatment of psoriasis and recommended to continue with this psoriasis study |
| 2020-08-31 | Can-Fite BioPharma | Regulatory FDA Clears Can-Fite to Commence Phase II COVID-19 Study canfite.com ↗ |
| 2020-07-27 | Can-Fite BioPharma | Regulatory Can-Fite Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study canfite.com ↗
Can-Fite BioPharma Ltd . (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that it has submitted an Investigational New Drug (IND) application to U.S. Food and Drug Administration (FDA) for a Phase II study of its lead drug candidate Piclidenoson in the treatment of COVID-19. |
| 2020-05-15 | Can-Fite BioPharma | Regulatory Can-Fite Announces Pre-IND Submission to U.S. FDA for Piclidenoson in the Treatment of COVID-19 Infected Patients with Moderate-to-Severe Symptoms canfite.com ↗
today announced it has filed a pre-Investigational New Drug (IND) meeting request with the U.S. Food and Drug Administration (FDA) for its drug candidate Piclidenoson in the treatment of COVID-19 patients with moderate-to-severe symptoms. |
| 2020-04-13 | Can-Fite BioPharma | Regulatory Can Fite Received Approval for COVID-19 Clinical Trial in Israel, Patient Enrollment and Dosing to Commence Immediately canfite.com ↗
Can-Fite submitted the study protocol, which has been approved by the IRB. |
| 2020-03-03 | Can-Fite BioPharma | Regulatory Can-Fite is Filing Drug Safety Update Report Showing Positive Safety Results from Phase II and Phase III Studies of Namodenoson and Piclidenoson canfite.com ↗
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biopharmaceutical company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it is submitting its annual Drug Safety Update Reports (DSUR) for both Piclidenoson and Namodenoson to the governing health regulatory agencies where its drug candidates are currently treating patients. |
| 2019-01-30 | Can-Fite BioPharma | Results Can-Fite’s Drugs’ Potential Ability to Treat Cytokine Release Syndrome in Cancer Immunotherapy Published in Scientific Journal canfite.com ↗
Can Fite’s drugs robustly inhibit the release of inflammatory mediators that induce Cytokine Release Syndrome (CRS), a potentially fatal side effect of CAR-T and other immune-oncology therapies |
| 2018-04-25 | Can-Fite BioPharma | Results Can-Fite's Piclidenoson Mechanism of Action in Psoriasis Published in 'Journal of Immunology Research' canfite.com ↗
This binding action has shown to induce a robust anti-inflammatory effect by inhibiting IL-17 and IL-23 as demonstrated in the in-vitro studies presented in the paper. |
| 2018-02-22 | Can-Fite BioPharma | Regulatory Can Fite Announces the Submission of Safety Reports for Piclidenoson and Namodenoson to FDA and other Regulatory Authorities Showing Favorable Safety Profile canfite.com ↗
Can-Fite BioPharma Ltd . (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced that it has submitted annual safety summaries for 2017 on both Piclidenoson and Namodenoson to regulatory authorities around the world. |
| 2017-08-07 | Can-Fite BioPharma | Results Can-Fite Successfully Completes Human Cardiodynamic Safety Trial for Piclidenoson canfite.com ↗
Based on the favorable safety data from this cardiodynamic trial, Can-Fite is now cleared to initiate two global Phase III studies for Piclidenoson: the ACRobat trial in rheumatoid arthritis; and the Comfort trial in psoriasis. |
| 2017-05-16 | Can-Fite BioPharma | Regulatory Can-Fite Files Clinical Trial Application in Canada for Piclidenoson Ahead of Upcoming Acrobat Rheumatoid Arthritis Phase III Study canfite.com ↗
announced today it has filed a Clinical Trial Application (CTA) with Health Canada for Piclidenoson. |
| 2016-08-08 | Can-Fite BioPharma | Results Can-Fite's Phase II/III Psoriasis Study Results Published in Journal of Drugs in Dermatology canfite.com ↗
While the Phase II/III study did not meet its primary efficacy endpoint at week 12, Piclidenoson did show a statistically significant improvement on week 32 in the PASI scores (50/75/90/100), a measure of efficacy in the treatment of psoriasis. |
| 2016-07-05 | Can-Fite BioPharma | Results OphthaliX Announces Phase II Glaucoma Data canfite.com ↗
In this trial, no statistically significant differences were found between the CF101 treated group and the placebo group in the primary endpoint of lowering intra ocular pressure (IOP). |
| 2016-06-15 | Can-Fite BioPharma | Results Can-Fite Reports New Data Showing its Psoriasis Drug May Offer Efficacy Similar to Industry Leading Biologics Without Harmful Side Effects canfite.com ↗
today announced new mechanism of action data indicating its lead drug candidate, Piclidenoson (CF101) inhibits two inflammatory cytokines, interleukin 17 (IL-17) and interleukin 23 (IL-23) which are known to play a major role in the inflammatory process of psoriasis. |
| 2016-06-07 | Can-Fite BioPharma | Regulatory Can-Fite Submits Psoriasis Phase III Protocol and Registration Plan to EMA for Piclidenoson (CF101) canfite.com ↗
today announced it has submitted its protocol design to the European Medicines Agency (EMA) for a Phase III trial and Registration Plan for the Company's lead compound Piclidenoson (CF101) in the treatment of psoriasis. |
| 2015-07-29 | Can-Fite BioPharma | Regulatory World Health Organization Accepted "Piclidenoson" as Proposed New Generic Name for Can-Fite's Lead Drug Candidate CF101 canfite.com ↗
We are pleased that the World Health Organization recognized the very unique pharmacological nature of CF101 and has granted it a new generic name, |
| 2015-04-27 | Can-Fite BioPharma | Results Can-Fite Reports Positive Results from Further Analysis of Phase II/III Psoriasis Trial canfite.com ↗ |
| 2015-03-30 | Can-Fite BioPharma | Results Can-Fite Reports Top-Line Results from Phase II/III Trial for CF101 in Treatment of Psoriasis canfite.com ↗
The Study did not achieve its primary efficacy endpoint |
| 2015-02-17 | Can-Fite BioPharma | Regulatory Can-Fite Receives Notice of Allowance in U.S. for Psoriasis Patent canfite.com ↗ |
| 2014-12-15 | Can-Fite BioPharma | Regulatory Second Part of the Glaucoma Phase II study has been Approved in a European Country canfite.com ↗
Can-Fite BioPharma Ltd. (TASE: CFBI), (NYSE MKT: CANF) , a biotechnology company developing a pipeline of small molecule drugs that address inflammatory and cancer diseases, and its subsidiary, OphthaliX Inc. (OTCQB: OPLI) , jointly announced today the receipt of an approval from the regulatory authorities in Bulgaria to initiate the enrollment of patients to the second cohort of the Phase II clinical study in glaucoma. |
| 2014-12-01 | Can-Fite BioPharma | Results US Researchers Published Scientific Findings that are a Potential Breakthrough for Prevention of Neuropathic Pain by CF101 canfite.com ↗
According to the research, the latter binds with high affinity to the A3 adenosine receptor and via specific mechanistic pathways significantly reduces neuropathic pain in animal models. |
| 2014-11-13 | Can-Fite BioPharma | Results Can-Fite CEO Dr. Pnina Fishman to Present Recently Released Positive Data from its Rheumatoid Arthritis Phase IIb Study at the 2014 American College of Rheumatology Annual Meeting canfite.com ↗
In the study, patients treated with CF101 met all primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of RA as compared to the placebo. |
| 2014-08-06 | Can-Fite BioPharma | Results New Data Shows High Efficacy for Can-Fite's CF101 in Rheumatoid Arthritis and Psoriasis Patients canfite.com ↗
The data shows a significant increase in the response to CF101 in patients with a BMI of over 25 in both studies. |
| 2014-06-09 | Can-Fite BioPharma | Results Can-Fite Subsidiary OphthaliX Provides an Update on its Clinical Developments and Strategic Plans canfite.com ↗
Based on lack of correlation between target expression and response of patients to the drug, the development of CF101 for Dry Eye Syndrome will be terminated |
| 2014-01-13 | Can-Fite BioPharma | Results Can-Fite to Present New Clinical Data from Further Analysis of its Clinical Studies of CF101 for the Treatment of Rheumatoid Arthritis and Psoriasis at OneMedForum and Biotech Showcase held in San Francisco, California canfite.com ↗
Based on new data and the excellent safety profile of CF101, and subject to further clinical testing, Can-Fite believes that CF101 may be utilized as a first line therapy in Rheumatoid Arthritis and Psoriasis. |
| 2013-12-30 | Can-Fite BioPharma | Results OphthaliX Announces Top-Line Results of Phase III Study with CF101 for Dry Eye Syndrome canfite.com ↗
In the study, CF101 did not meet the primary efficacy endpoint of complete clearing of corneal staining, nor the secondary efficacy endpoints. |
| 2013-12-23 | Can-Fite BioPharma | Results Can-Fite BioPharma Announces Top-Line Results of Phase IIb Study with CF101 as a Monotherapy for Rheumatoid Arthritis canfite.com ↗
This advantage was also evident in higher response rates in the CF101 group versus placebo in ACR50 (ACR50 response rates: placebo = 9%; CF101 = 19%) and ACR70 (ACR70 response rates: placebo = 3% ; CF101 = 11%). |
| 2012-10-09 | Can-Fite BioPharma | Results Interim Analysis Supports Continuation of Can-Fite's Phase 2/3 Psoriasis Clinical Study with CF101 canfite.com ↗
The positive clinical effects of the CF101-2 mg BID dose relative to placebo were observed in a variety of standard psoriasis assessment parameters, with the responses accumulating steadily over the 24-week treatment period. |
All press releases naming this drug 96 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | piclidenoson | “We investigated the efficacy/safety of piclidenoson (CF101), an orally bioavailable A3AR agonist that inhibits IL-17 and IL-23 production in keratinocytes, in...” PMID 38279575 ↗ Jan 2024 |
| Known as | ALB-7208 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989873 ↗ |
| Known as | CF101 | “We investigated the efficacy/safety of piclidenoson (CF101), an orally bioavailable A3AR agonist that inhibits IL-17 and IL-23 production in keratinocytes, in...” PMID 38279575 ↗ Jan 202413“A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Piclidenoson (CF101) Administered Orally in Subjects With Moderate-to-Severe...” NCT06643260 ↗ “Piclidenoson (CF101) open-label treated patients” NCT07410455 ↗ |
| Known as | IB-MECA | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989873 ↗ |
| Action | Activate | “A(3) adenosine receptor agonist” PMID 20304499 ↗ Mar 20101“Adenosine A3 receptor agonist” CHEMBL3989873 ↗ |
| Modality | Small molecule | — CHEMBL3989873 ↗ |
| Route | Oral | “CF101 0.1 mg, CF101 1 mg, CF101 4 mg, or placebo given orally q12h for 12 weeks” NCT00280917 ↗ |
| Target | ADORA3 | “Adenosine A3 receptor agonist” CHEMBL3989873 ↗ |