Drugs / PALI-2108
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | ulcerative colitis | 2024-09-25 | “The Company has submitted a CTA for its Phase 1 study of PALI-2108” palisadebio.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07428096 | Oct 2025 → Jan 2026 overdue | Crohn disease | Palisade Bio | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06663605 | Nov 2024 → Jul 2025 | ulcerative colitis | Palisade Bio | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-06-29 | Palisade Bio | Regulatory Palisade Bio Receives FDA Clearance of IND for PALI-2108 and Plans to Initiate Global Phase 2 ASCENTRA-UC Study in Ulcerative Colitis palisadebio.com ↗ |
| 2026-05-05 | Palisade Bio | Results Palisade Bio Reports Additional Phase 1a/b Data Demonstrating Colon-Targeted Exposure and Sustained IC90 Coverage Supporting Once-Daily Dosing in Ulcerative Colitis palisadebio.com ↗
Additional analyses describe a differentiated pharmacokinetic profile, including steady-state trough concentrations of PALI-0008 relative to IC90 that are consistent with sustained target engagement over the dosing interval. |
| 2026-03-30 | Palisade Bio | Results Palisade Bio Reports Positive Topline Data from Phase 1b Clinical Study of PALI-2108 in Fibrostenotic Crohn’s Disease palisadebio.com ↗
PALI-2108 demonstrated favorable safety and tolerability with no serious adverse events after two weeks of treatment in a difficult-to-treat population |
| 2026-02-23 | Palisade Bio | Results Palisade Bio Reports Rapid Clinical, Histologic and New Mechanistic Colon Tissue RNA Sequencing Data Supporting Targeted Activity of PALI-2108 at ECCO 2026 palisadebio.com ↗
The poster, titled “Oral Locally Bioactivated PDE4 Inhibitor Prodrug PALI-2108 Demonstrates Rapid Clinical, Histologic, and Biomarker Improvement in Ulcerative Colitis: Phase 1b Translational Findings,” highlights data showing that PALI-2108 produced measurable clinical response within seven days, improved histologic markers of inflammation in colon tissue, and reduced key inflammatory biomarkers. |
| 2025-09-17 | Palisade Bio | Results Palisade Bio Reports Positive PALI-2108 Phase 1b Clinical Data palisadebio.com ↗ |
| 2025-09-05 | Palisade Bio | Regulatory Palisade Bio Receives Health Canada Clearance for Phase 1b Trial of PALI-2108 in Fibrostenotic Crohn’s Disease (FSCD) palisadebio.com ↗ |
| 2025-08-07 | Palisade Bio | Results Palisade Bio Reports 100% Clinical Response in Phase 1b Ulcerative Colitis Cohort with Novel PDE4 Inhibitor, PALI-2108 palisadebio.com ↗
The clinical response rate of 100% was tightly aligned with robust histologic improvements and a marked reduction in tissue lymphocytes-reflecting immunologic resolution. |
| 2025-05-27 | Palisade Bio | Results Palisade Bio Reports Positive Phase 1a Results for PALI-2108, a First-in-Class Terminal Ileum and Colon-Targeted PDE4 B/D Inhibitor for Fibrostenotic Crohn’s Disease and Ulcerative Colitis palisadebio.com ↗ |
| 2025-05-06 | Palisade Bio | Results Palisade Bio Presents Positive Preclinical Data Highlighting Potential of PALI-2108 as a Promising Colon-Specific PDE4 Inhibitor for the Treatment of Ulcerative Colitis and Other Inflammatory Bowel Diseases palisadebio.com ↗
The presented data highlighted the efficacy and safety profile of PALI-2108 in a mouse model of colitis, with a particular focus on its impact on PDE4B expression, cAMP levels, and TNF-α suppression as well as predicting efficacious PALI-0008 levels in patients. |
| 2025-04-09 | Palisade Bio | Results Palisade Bio Completes Dosing in Phase 1a Portion of Ongoing Phase 1a/b Study of PALI-2108 palisadebio.com ↗
Preliminary results show no SAEs and no TEAEs related to laboratory values or EKGs to date. |
| 2025-03-14 | Palisade Bio | Results Palisade Bio Commences Dosing in First Ulcerative Colitis Patient Cohort in Ongoing Phase 1a/b Study of PALI-2108 palisadebio.com ↗
Importantly, there have been no SAEs and no TEAEs related to laboratory values or EKGs. |
| 2025-03-04 | Palisade Bio | Results Palisade Bio Participates in Virtual Investor “What This Means” Segment palisadebio.com ↗
As part of this segment, Dr. Heyer discussed the Company’s positive preclinical data for its lead product candidate, PALI-2108, which was recently presented at the 2025 Crohn’s and Colitis Congress and what this means for Palisade’s UC development program. |
| 2025-02-10 | Palisade Bio | Results Palisade Bio Presents Positive Preclinical Data of PALI-2108 for the Treatment of Ulcerative Colitis palisadebio.com ↗
PALI-2108 demonstrated to effectively reduce colitis symptoms in DSS mouse model without CNS toxicity associated with systemic exposure |
| 2025-01-16 | Palisade Bio | Results Palisade Bio Completes All Five SAD Cohorts and Advances to MAD Cohorts of Phase 1a/b Study of PALI-2108 for Treatment of Ulcerative Colitis palisadebio.com ↗
Preliminary data from the SAD portion of the study, which evaluated doses ranging from 15 mg to 450 mg of PALI-2108, support that the drug was well-tolerated across all dose levels. |
| 2024-12-03 | Palisade Bio | Results Palisade Bio Announces Preliminary Data from Phase 1 Clinical Study of PALI-2108 for the Treatment of Moderate-to-Severe Ulcerative Colitis Appears to be Safe and Well Tolerated in Treated Subjects palisadebio.com ↗ |
| 2024-11-21 | Palisade Bio | Results Palisade Bio to Present Preclinical Results for PALI-2108 Demonstrating Engagement of Key Fibrotic Pathways of Crohn’s Disease and Ulcerative Colitis (UC) palisadebio.com ↗
In recent studies using the Dextran Sulfate Sodium (DSS) colitis mouse model, PALI-2108 demonstrated a dose-dependent effect on key fibrotic pathways, underscoring its potential as an effective treatment for fibrostenotic Crohn’s disease. |
| 2024-10-31 | Palisade Bio | Results Palisade Bio Announces Positive Data from Two Ex Vivo Translational Studies of PALI-2108 for the Treatment of Ulcerative Colitis palisadebio.com ↗ |
| 2024-10-10 | Palisade Bio | Regulatory Palisade Bio Cleared by Health Canada to Commence Phase 1 Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis (UC) palisadebio.com ↗
Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that it has received a No Objection Letter from Health Canada for its Phase 1 human clinical study for PALI-2108 for the treatment of UC. |
| 2024-09-25 | Palisade Bio | Regulatory Palisade Bio Provides Update on Progress Toward Launch of Phase 1 Human Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis palisadebio.com ↗
Submission of the CTA for the Phase 1 clinical study of Normal Healthy Volunteers and ulcerative colitis patients |
| 2024-07-29 | Palisade Bio | Results Palisade Bio Successfully Completes Microbiome Study Confirming Bacterial Enzymes for Local Bioactivation of Lead Product Candidate, PALI-2108 palisadebio.com ↗
The study completed by CosmosID, which uses direct identification of beta-glucuronidase by multiple databases, indicates that the presence of this enzyme is not significantly different among the species or between healthy and disease human cohorts. |
| 2024-05-21 | Palisade Bio | Results Palisade Bio’s Lead Product Candidate, PALI-2108 Demonstrates Local Bioactivation and Dose Dependent Efficacy Response in Preclinical Mouse Models palisadebio.com ↗
PALI-2108 exhibited a dose-dependent efficacy response in two DSS colitis mouse models, achieving efficacy comparable to doses of apremilast considered intolerable for human use in Ulcerative Colitis (UC) patients |
| 2024-05-01 | Palisade Bio | Results Palisade Bio’s Lead Product Candidate, PALI-2108 Demonstrates Potent Anti-Inflammatory Effects in Ex-Vivo Study of Whole Blood Samples Challenged with Pro-Inflammatory Lipopolysaccharide (LPS) palisadebio.com ↗ |
| 2024-04-16 | Palisade Bio | Results Palisade Bio Successfully Demonstrates Bioactivation of PALI-2108 In Ex-Vivo Study of Normal Healthy and Ulcerative Colitis Patients’ Stool palisadebio.com ↗
These findings demonstrated that PALI-2108 exhibited efficient ex-vivo conversion into its active PDE4 inhibitor form in stool samples from both normal healthy volunteers and patients with UC. |
| 2024-01-29 | Palisade Bio | Results Palisade Bio Announces Positive Preclinical Data of Lead Program PALI-2108 at the 2024 Crohn’s & Colitis Congress palisadebio.com ↗
PALI-2108 continues to demonstrate promise as a novel therapy for UC, with colon-selective bioactivation, an expanded therapeutic window, reduced CNS toxicity, potent PDE4 inhibitory activity, and impressive efficacy in preclinical models. |
All press releases naming this drug 44 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PALI-2108 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06663605 ↗ |
| Action | Inhibit | “It works as a phosphodiesterase-4 (PDE4) inhibitor prodrug” NCT06663605 ↗ |
| Modality | Small molecule | “PALI-2108 represents a new chemical entity that has not been previously administered to humans.” NCT06663605 ↗ |
| Route | Oral | “Oral dose” NCT06663605 ↗ |