This section highlights FDA-related milestones and regulatory updates for drugs developed by Palisade Bio (PALI).
Over the past two years, Palisade Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PALI-2108 and PDE4. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
PALI-2108 FDA Regulatory Timeline and Events
PALI-2108 is a drug developed by Palisade Bio for the following indication: For patients affected by UC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PALI-2108
- Announced Date:
- July 31, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that the China National Intellectual Property Administration has issued a Notice of Allowance for a patent covering PALI-2108, the Company's novel, locally-activated, terminal ileum and colon-targeted phosphodiesterase-4 B/D (PDE4 B/D) inhibitor being developed for fibrostenotic Crohn's disease (FSCD) and moderate to severe ulcerative colitis (UC).
AI Summary
Palisade Bio, Inc. announced that the China National Intellectual Property Administration (CNIPA) has issued a Notice of Allowance for a patent covering PALI-2108. This novel, gut-activated PDE4 B/D inhibitor is designed to target the terminal ileum and colon in fibrostenotic Crohn’s disease (FSCD) and moderate to severe ulcerative colitis (UC).
Once issued, the patent titled “Gut Microbiota-Activated PDE4 Inhibitor Prodrug” will cover PALI-2108 in China through 2045, strengthening Palisade’s IP in one of the world’s fastest-growing pharma markets.
Inflammatory bowel disease is a large and growing market in China, with revenues expected to reach $1 billion by 2030. As the first and only PDE4 inhibitor targeting those specific gut regions, PALI-2108 addresses significant unmet medical needs for FSCD and UC patients.
Palisade is currently evaluating PALI-2108 in a Phase 1b/2a clinical trial. The company expects key data readouts in the next 12 to 18 months.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- May 27, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc announced positive topline results from its completed Phase 1 studies of PALI-2108, a novel, locally-activated, terminal ileum and colon-targeted phosphodiesterase-4 B/D (PDE4 B/D) inhibitor being developed for fibrostenotic Crohn's disease (FSCD) and moderate to severe ulcerative colitis (UC).
AI Summary
Palisade Bio, Inc. announced positive topline results from its Phase 1 studies of PALI-2108, a new phosphodiesterase-4 B/D inhibitor designed for fibrostenotic Crohn’s disease and moderate to severe ulcerative colitis. The study successfully met its primary endpoints of safety, tolerability, and pharmacokinetics (PK), with no serious adverse events observed. PALI-2108 is uniquely engineered to target the terminal ileum and colon, ensuring that the medication reaches therapeutic levels in the colon while maintaining low systemic exposure. The targeted prodrug design has shown promising tissue penetration, making it a potential option for addressing critical treatment gaps in these patients. Based on these encouraging results, Palisade Bio plans to move forward with further Phase 1b and Phase 2 studies to evaluate the drug’s efficacy, safety, and optimal dosing strategies in affected patient populations.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- April 9, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced the completion of enrollment and dosing in all five Phase 1a SAD cohorts, all four MAD cohorts, and the food effects crossover in the Phase 1a portion of its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).
AI Summary
Palisade Bio, Inc. announced a major milestone in its study of PALI-2108 for Ulcerative Colitis (UC) by completing enrollment and dosing in all five Phase 1a single ascending dose (SAD) cohorts, all four multiple ascending dose (MAD) cohorts, and the food effects crossover segment. The preliminary results from these groups showed no serious adverse events or treatment-related issues with laboratory values or EKG readings, demonstrating strong safety and tolerability. Most adverse events were mild, even at different dosing levels, which supports the drug’s promise in targeting UC with a favorable safety profile. Screening for the Phase 1b UC patient cohort is still in progress, and the company is on track to report topline data in the first half of 2025, marking an important step forward in developing a new treatment option for patients with UC.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- March 14, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc today provided an update on its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).
AI Summary
Palisade Bio, Inc. provided an update on its ongoing Phase 1a/b study of PALI-2108, a new treatment for Ulcerative Colitis (UC). The final cohort of UC patients has started dosing, following successful safety and tolerability outcomes in earlier study segments. In the Phase 1a portion, five single ascending dose (SAD) cohorts were completed, and in the Phase 1b portion, the first three multiple ascending dose (MAD) cohorts have been finished. No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs have been observed. Most of the TEAEs were mild, with only one participant withdrawing at the highest MAD dose level. The continued favorable results and the smooth transition from healthy volunteers to UC patients promise a positive direction for the trial. Topline data from the study is expected to be reported in the first half of 2025.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- March 12, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that it has been selected to present data from its lead program PALI-2108 for the treatment of ulcerative colitis at Digestive Disease Week® (DDW) 2025 being held May 3–6, in San Diego, California.
AI Summary
Palisade Bio, Inc. recently announced that it has been selected to present key data on its lead program, PALI-2108, for treating ulcerative colitis at Digestive Disease Week® (DDW) 2025 in San Diego, California. The event is scheduled for May 3–6, 2025. Presentations will include details from two poster sessions. One session will focus on a bioinformatic approach that highlights the potential anti-fibrotic benefits of local PDE4 inhibition in cases of intestinal fibrosis. The other session will reveal preclinical findings demonstrating that PALI-2108 is activated in the colon, leading to a dose-dependent reduction in tissue PDE4B, an increase in cAMP, and subsequent suppression of TNF-α in a mouse colitis model. These presentations aim to share valuable insights into an innovative treatment approach for ulcerative colitis and other gastrointestinal diseases.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- February 10, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced the presentation of positive preclinical data from PALI-2108, an orally administered, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug is in development for patients with ulcerative colitis (UC).
AI Summary
Palisade Bio, Inc. recently presented encouraging preclinical data for its novel therapeutic, PALI-2108, at the 2025 Crohn’s and Colitis Congress in San Francisco. PALI-2108 is an orally administered, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug under development for patients with ulcerative colitis (UC).
The preclinical study demonstrated that PALI-2108 significantly reduced UC symptoms in a mouse model without the central nervous system toxicity commonly seen with systemic exposure. When taken orally, the prodrug is activated in the colon, converting into an effective PDE4 inhibitor. These promising results highlight its potential to offer a new, safer oral treatment option for UC patients. Palisade Bio is moving forward with a Phase 1a/b study to further assess the drug’s safety and effectiveness, with topline data expected in the first half of 2025.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- January 16, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc announced the completion of all five planned Single Ascending Dose (SAD) cohorts and the commencement of the Multiple Ascending Dose (MAD) cohorts in its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).
AI Summary
Palisade Bio, Inc. announced a key milestone in its Phase 1a/b study for treating Ulcerative Colitis (UC) with its novel therapeutic, PALI-2108. The company successfully completed all five planned Single Ascending Dose (SAD) cohorts, evaluating doses ranging from 15 mg to 450 mg. Preliminary results show that PALI-2108 is well-tolerated across all dose levels, with no treatment-related dose reductions, serious adverse events, or significant safety concerns. Mild treatment-emergent events were observed only at the highest dose tested. Based on these encouraging findings, Palisade Bio has now advanced to the Multiple Ascending Dose (MAD) cohorts. This next phase will assess the safety and pharmacokinetics of repeat dosing in both healthy volunteers and UC patients. The continued progress of PALI-2108 marks an important step toward developing a new treatment option for UC, with topline data expected in the first half of 2025.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- December 3, 2024
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc, announced preliminary results from its first three single ascending dose (SAD) cohorts in its ongoing Phase 1 human clinical study for PALI-2108 for the treatment of Ulcerative Colitis (UC).
AI Summary
Palisade Bio, Inc. announced promising preliminary results from its Phase 1 study of PALI-2108, a potential treatment for Ulcerative Colitis. In the first three single ascending dose cohorts (15mg, 50mg, and 150mg, with 24 participants overall), the drug was found to be safe and well-tolerated. There were no treatment-related adverse events, serious adverse events, dose reductions, or abnormal lab findings among the subjects. Early pharmacokinetic data indicates that the PDE4 inhibitor in PALI-2108 shows delayed release for colonic bioactivation, suggesting the drug is performing as designed.
Based on these encouraging safety findings, the next steps include a crossover study to examine the effects of food on pharmacokinetics, followed by further multiple ascending dose assessments and studies involving patients with Ulcerative Colitis. These results support ongoing development efforts to target inflammatory bowel diseases with this novel, colon-specific therapy.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- October 10, 2024
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, 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.
AI Summary
Palisade Bio has received a No Objection Letter from Health Canada for its Phase 1 clinical study testing PALI-2108, a new treatment for ulcerative colitis (UC). This significant regulatory milestone enables the company to move forward with its Phase 1 Clinical Trial Application. PALI-2108 is an orally administered PDE4 inhibitor prodrug designed to become active only within the colon, potentially offering a more targeted treatment option for UC patients.
The upcoming study will include both healthy volunteers and UC patients in a carefully controlled setting. It will explore single ascending doses, multiple ascending doses, and the impact of food on the drug’s behavior in the body. Palisade Bio aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PALI-2108, marking an important step toward addressing the significant unmet needs of UC patients.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- September 25, 2024
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, today provided an update on its progress toward the launch of its Phase 1 human clinical study for PALI-2108 for the treatment of ulcerative colitis (UC).
AI Summary
Palisade Bio recently updated on the progress of launching its Phase 1 human clinical study for PALI-2108, a new drug designed to treat moderate to severely active ulcerative colitis (UC). The study is planned to include normal healthy volunteers as well as UC patients, focusing on safety, tolerability, and the drug's behavior in the body. The company has completed essential nonclinical safety and toxicity studies, established dosing levels, and designed the trial to include both single and repeated dosing groups. Additionally, Palisade Bio has submitted a Clinical Trial Application (CTA) following a productive pre-CTA meeting with Health Canada. With plans to enroll approximately 90 participants, the study aims to thoroughly evaluate how PALI-2108 is processed by the body and its potential effectiveness in treating UC. The company is on track for starting clinical sites and dosing its first patient by the end of the year.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- July 29, 2024
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced the successful completion of a microbiome study demonstrating that beta-glucuronidase is present at similar levels among dog, mouse, and human microbiota as well as within healthy humans and those with Crohn's disease (CD) and ulcerative colitis (UC).
AI Summary
Palisade Bio, Inc. recently announced a successful microbiome study that found the enzyme beta-glucuronidase is present at similar levels in dogs, mice, and humans. Researchers compared microbiota from healthy humans as well as patients with Crohn's disease and ulcerative colitis and discovered that the enzyme’s levels remain stable, regardless of species or disease condition. Using direct identification methods via CosmosID’s multiple databases, the study confirmed that beta-glucuronidase is adequately present to allow prodrugs to activate in the gastrointestinal tract.
These promising findings support Palisade’s development of PALI-2108, a prodrug designed to treat ulcerative colitis. Encouraged by the consistent enzyme levels observed across diverse microbiomes, the company is moving toward a Phase 1 clinical study later this year to evaluate the drug’s effectiveness in patients suffering from inflammatory bowel conditions.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- July 11, 2024
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, announced the successful completion of the first Good Manufacturing Practice (GMP) batch of its drug substance PALI-2108, an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC.
AI Summary
Palisade Bio has announced the successful completion of its first Good Manufacturing Practice (GMP) batch of PALI-2108, a colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug designed to treat patients with moderate-to-severe ulcerative colitis (UC). This drug substance is administered orally and is engineered to act locally in the colon. Developed in partnership with Eurofins, the production process was scaled up and refined to meet strict FDA quality standards. The GMP batch has been used in key nonclinical studies involving both murine and non-murine models, confirming its safety profile before its upcoming clinical trials. In addition, enteric-coated tablets have been successfully formulated to ensure that the active ingredient is properly released in the small intestine, highlighting the formulation's strong performance. Palisade Bio is on track to begin Phase 1 human clinical studies before the end of the year.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- May 1, 2024
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, announced today the successful completion of its analysis to determine the effects of bioactivated PALI-2108 on TNF-α production in a whole blood (WB) assay. PALI-2108 is Palisade's orally administered, locally acting, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC.
AI Summary
Palisade Bio announced it successfully completed an analysis that tested how its bioactivated drug candidate, PALI-2108, affects TNF-α production in a whole blood assay. PALI-2108 is an orally administered prodrug designed to work locally in the colon and acts as a phosphodiesterase-4 (PDE4) inhibitor. In this study, whole blood samples from healthy adults were treated with different doses of PALI-2108 before being exposed to lipopolysaccharide (LPS), a molecule that normally triggers TNF-α production and inflammation. The results showed that the treated samples had a significant reduction in TNF-α levels. Notably, the study demonstrated that PALI-2108 achieved a much lower half-maximal inhibitory concentration (IC50) of 0.022 µM compared to 0.41 µM for the currently approved PDE4 inhibitor, apremilast. These findings support the potential of PALI-2108 as a strong, next-generation option to manage Ulcerative Colitis.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- April 10, 2024
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, announced that it presented at IBD Innovate: Product Development for Crohn's & Colitis™ held April 9-10, 2024 in Cambridge, MA.
AI Summary
Palisade Bio recently shared details on its progress in treating inflammatory bowel diseases by presenting at IBD Innovate: Product Development for Crohn's & Colitis™, which took place April 9-10, 2024 in Cambridge, MA. During the presentation, Palisade Bio’s Chief Medical Officer, Dr. Mitch Jones, together with Christophe Mellon from Giiant Pharma, discussed the development and strategic positioning of their PALI-2108 program. This innovative treatment is being developed for moderate-to-severe ulcerative colitis (UC) and aims to move into Phase 1 clinical testing before the end of the year. The presentation, titled “Advancing PALI-2108: Discovery to Strategy Positioning,” highlighted the differentiators of PALI-2108 in a competitive landscape and outlined the clinical pathway towards later-stage development. Additional details of the presentation are available on the company’s website.
Read Announcement
PDE4 FDA Regulatory Events
PDE4 is a drug developed by Palisade Bio for the following indication: For Patient Stratification.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PDE4
- Announced Date:
- September 5, 2024
- Indication:
- For Patient Stratification
Announcement
Palisade Bio, announced the successful completion of refined patient selection strategies based on PDE4-related biomarkers and disease characteristics to optimize clinical outcomes for patients with UC as part of its collaboration with Strand Life Sciences ("Strand").
AI Summary
Palisade Bio announced it has successfully refined its patient selection strategies by using PDE4-related biomarkers and disease characteristics to improve treatment outcomes for those with Ulcerative Colitis (UC). Working with Strand Life Sciences, the company analyzed RNAseq data with a standardized bioinformatics pipeline, finding that PDE4B is substantially elevated in most UC patients. The analysis revealed that 70% of adult patients and 90% of pediatric patients with moderate to severe colitis show levels above a defined threshold. This breakthrough is expected to help healthcare providers better stratify patients and tailor treatments more precisely. Additionally, Palisade is advancing its lead program, PALI-2108—an oral, colon-specific PDE4 inhibitor prodrug—which is poised to begin Phase 1 clinical testing before year-end. These efforts underscore the company’s commitment to personalized medicine in the fight against UC.
Read Announcement
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