Upcoming FDA Events for Palisade Bio
Palisade Bio (PALI) has upcoming FDA regulatory milestones for PALI-2108. The table below outlines estimated target dates and event types for these pending regulatory actions.
Palisade Bio's Drug in the FDA Approval Process
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. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- September 22, 2026
- Target Action Date:
- Q1 2028
- Estimated Target Date Range:
- January 1, 2028 - March 31, 2028
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that primary efficacy readout (Week 12 endoscopic response) targeted for Q1 2028
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- September 22, 2026
- Target Action Date:
- Q1 2027
- Estimated Target Date Range:
- January 1, 2027 - March 31, 2027
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that First patient dosing targeted for Q1 2027
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- September 22, 2026
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for PALI-2108, enabling initiation of the Phase 2 ASCENTRA-CD clinical trial in patients with moderate to severe Crohn’s disease (CD).
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- June 29, 2026
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for PALI-2108, enabling initiation of the global Phase 2 ASCENTRA-UC clinical trial in patients with moderately to severely active ulcerative colitis (UC).
AI Summary
Palisade Bio said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for PALI-2108, allowing the company to move forward with the global Phase 2 ASCENTRA-UC trial in people with moderately to severely active ulcerative colitis. The study is expected to enroll up to 204 patients across North America and Europe.
ASCENTRA-UC is a randomized, double-blind, placebo-controlled trial that will test two once-daily doses of PALI-2108, 15 mg and 30 mg. The main goal is to measure clinical remission at Week 12, while other measures will track response, endoscopic improvement, and tissue healing. Patients who qualify may then enter a 36-week maintenance phase. Palisade expects to begin enrollment in the second half of 2026 and report primary efficacy results in the second half of 2027.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- June 9, 2026
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced Mitchell Jones, MD, PhD, President and Chief Medical Officer, will present at the New York Academy of Sciences ("NYAS") symposium, Molecular Pathways and Cellular Players in the Resolution of Organ Fibrosis, taking place on June 9, 2026, in New York, NY.
AI Summary
Palisade Bio, Inc. said Mitchell Jones, MD, PhD, its President and Chief Medical Officer, will present at the New York Academy of Sciences symposium, Molecular Pathways and Cellular Players in the Resolution of Organ Fibrosis, on June 9, 2026, in New York City. The event will bring together experts from academia, industry, and clinical research to discuss new findings in fibrosis biology and possible treatments for fibrotic diseases.
Dr. Jones’ talk, Locally Bioactivated PDE4 Inhibitor Prodrug for the Treatment of Fibrostenotic Crohn’s Disease (FSCD), will focus on the serious unmet need in FSCD, the biology of intestinal fibrosis, and the potential of locally bioactivated PDE4 inhibition as a treatment approach. He will also explain the scientific basis for Palisade’s lead candidate, PALI-2108, and review preclinical data suggesting it may help control inflammation and fibrosis in the gut.
PALI-2108 is a once-daily oral prodrug designed to activate in the ileum and colon, where disease is present. Palisade said it has already shown positive early clinical results and is moving toward Phase 2 studies in ulcerative colitis and Crohn’s disease.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- May 5, 2026
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced the presentation of additional Phase 1a/b analyses of PALI-2108, including delayed ileocolonic activation, high tissue-to-plasma exposure, and sustained steady-state concentrations of the active metabolite (PALI-0008) above IC90, at Digestive Disease Week 2026, further characterizing the pharmacokinetic and translational profile of the program.
AI Summary
Palisade Bio presented additional Phase 1a/b analyses of PALI-2108 at Digestive Disease Week 2026. The data show the prodrug is selectively bioactivated in the ileum and colon, producing delayed ileocolonic activation and high tissue-to-plasma exposure in colon tissue versus plasma. Tissue studies demonstrated modulation of the PDE4/cAMP signaling pathway, and pharmacokinetic analyses found steady-state trough concentrations of the active metabolite PALI-0008 that remain above the IC90 throughout the dosing interval, consistent with sustained target engagement.
These steady-state pharmacokinetic findings provide mechanistic support for earlier Phase 1b clinical activity and help link PK and tissue pharmacology to reported rapid improvements in clinical, histologic, and biomarker endpoints in ulcerative colitis. Overall, the translational data further characterize PALI-2108’s differentiated, gut-targeted profile and support its potential as a once-daily, gut-directed oral therapy for inflammatory bowel disease. The full poster was presented at Digestive Disease Week 2026.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- April 16, 2026
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that data from its lead program, PALI-2108, has been selected for poster presentation at Digestive Disease Week® (DDW) 2026, taking place May 2–5, 2026 in Chicago.
AI Summary
Palisade Bio announced that data from its lead program, PALI-2108, was selected for a poster presentation at Digestive Disease Week (DDW) 2026, held May 2–5 in Chicago. The poster session is scheduled for Tuesday, May 5 at 12:30 PM CDT.
The company will attend the meeting alongside members of its Clinical Advisory Board, showing active engagement with inflammatory bowel disease experts as it advances PALI-2108 toward the clinic. Management will be available for one-on-one meetings with qualified members of the investor community.
PALI-2108 is a once-daily oral PDE4 inhibitor prodrug designed to initiate localized PDE4 inhibition at disease sites while enabling systemic distribution of the active drug, an approach intended to target inflammation with potentially fewer systemic side effects. For investor inquiries: JTC Team, LLC, Jenene Thomas, 908-824-0775, [email protected].
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- March 30, 2026
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced positive topline data from its Phase 1b clinical study evaluating PALI-2108, a first-in-class, once-daily oral PDE4 inhibitor prodrug designed to be selectively bioactivated in the ileum and colon, in patients with fibrostenotic Crohn's disease (FSCD).
AI Summary
Palisade Bio reported positive topline results from a Phase 1b study of PALI-2108, a once-daily oral PDE4 inhibitor prodrug designed to be activated in the ileum and colon for patients with fibrostenotic Crohn’s disease. In five participants the drug showed favorable safety and tolerability, robust pharmacodynamic target engagement in ileal tissue, and encouraging early signs of clinical activity.
Early endoscopic improvements were seen as soon as Week 2. Although small study size and differences in trial design limit direct comparison, these early changes fall within ranges reported for other Crohn’s therapies in published benchmarks. The findings support that PALI-2108 can target both inflammatory and fibrotic components of disease.
Palisade plans a Phase 2 study in moderate to severe Crohn’s disease to evaluate clinical remission, response, and pharmacodynamic biomarkers over 12 weeks, and to assess potential anti-fibrotic effects earlier in the disease course.Read Announcement
- Drug:
- PALI-2108
- Announced Date:
- February 23, 2026
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced the presentation of new translational data for PALI-2108 at the 21st Congress of the European Crohn's and Colitis Organization (ECCO) in Stockholm, Sweden.
AI Summary
Palisade Bio presented new translational data for PALI-2108 at the 21st Congress of the European Crohn's and Colitis Organization (ECCO) in Stockholm, Sweden. Phase 1b results showed localized ileocolonic target engagement, suppression of inflammatory and fibrotic gene programs, and early clinical response within seven days in patients with moderate-to-severe ulcerative colitis.
Colon biopsy RNA sequencing and translational analyses revealed local downregulation of TNF-α, JAK–STAT, NF-κB, MAPK and TGF-β signaling in colon tissue, with minimal peripheral immune modulation. The safety profile across 89 subjects was encouraging and supports a differentiated, colon-targeted PDE4 approach that appears to limit systemic exposure while engaging disease tissue.
Palisade said the alignment of pharmacokinetics, tissue pharmacodynamics, gene expression changes and early clinical signals helps to de-risk the program. These translational findings support advancing PALI-2108 into later-stage development for ulcerative colitis, with additional studies planned.Read Announcement
- Drug:
- PALI-2108
- Announced Date:
- December 30, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that the Japan Patent Office (JPO) has granted a key patent covering PALI-2108, the Company's lead, gut-microbiota-activated PDE4 B/D inhibitor being advanced for fibrostenotic Crohn's disease (FSCD) and moderate to severe ulcerative colitis (UC).
AI Summary
Palisade Bio announced that the Japan Patent Office has granted a key patent for PALI-2108, titled "Gut Microbiota-Activated PDE4 Inhibitor Prodrug." The patent provides composition-of-matter protection in Japan, extends into 2041, and may be eligible for term extension based on regulatory timelines. This strengthens Palisade’s global intellectual property around locally activated PDE4 prodrugs.
The company said the Japanese patent is an important milestone for its inflammatory bowel disease portfolio. Japan is a significant market for IBD treatments, and the patent supports the long-term commercial opportunity for PALI-2108 as a differentiated, locally acting therapy.
PALI-2108 is an oral prodrug engineered to reach the terminal ileum and colon, where gut bacteria cleave it to release an active PDE4 inhibitor. The design aims for sustained, local exposure with once-daily dosing while limiting systemic absorption and class-related side effects like nausea and headache.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- October 20, 2025
- Target Action Date:
- Q1 2026
- Estimated Target Date Range:
- January 1, 2026 - March 31, 2026
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that Topline data are anticipated in the first quarter of 2026.
AI Summary
Palisade Bio, Inc. has begun dosing patients in a Phase 1b study of PALI-2108, a first-in-class, ileocolonic-targeted PDE4 inhibitor prodrug for fibrostenotic Crohn’s disease (FSCD), a condition with no approved treatments. The drug is designed to activate in the lower intestine, boosting local exposure while minimizing systemic side effects.
The open-label study will enroll 6–12 patients who will receive once-daily oral doses for 14 days. Researchers will assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).
Investigators will also analyze paired ileal biopsies and blood cells using RNA sequencing to study treatment effects on inflammation and fibrosis. Additional measurements include endoscopic, histologic, and ultrasound evaluations of intestinal lesions.
Topline data are anticipated in the first quarter of 2026, and these findings, alongside ulcerative colitis results, will support Phase 2 IND submissions planned for the first half of 2026.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- October 20, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that the first patients have been dosed in its Phase 1b clinical study evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 inhibitor prodrug, for the treatment of fibrostenotic Crohn's disease (FSCD).
AI Summary
Palisade Bio, Inc. announced the first patients have been dosed in a Phase 1b study of PALI-2108, a first-in-class, ileocolonic-targeted PDE4 inhibitor prodrug, for fibrostenotic Crohn’s disease (FSCD). This candidate is designed to deliver anti-inflammatory and anti-fibrotic effects directly to the terminal ileum and colon, an area of high unmet need with no approved therapies. Topline safety, pharmacokinetic (PK), and pharmacodynamic (PD) data are expected in the first quarter of 2026.
The open-label study will enroll 6 to 12 patients receiving once-daily oral doses for 14 days. It will evaluate safety, tolerability, PK/PD, and local effects with paired ileal biopsies and blood tests. Molecular analyses, including RNA sequencing, will track inflammatory and fibrotic changes. Exploratory measures like endoscopy, histology, and intestinal ultrasound will assess FSCD lesions.
These data, together with ongoing ulcerative colitis studies, will support a Phase 2 investigational new drug submission planned for the first half of 2026.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- October 13, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that the Canadian Intellectual Property Office (CIPO) has granted patent number 3,174,137 titled, "Gut Microbiota Bioactivated PDE4 Inhibitor Precursors." The patent covers the composition of PALI-2108, the Company's orally administered, first-in-class, ileocolonic-targeted PDE4 B/D inhibitor in development for the treatment of FSCD and UC.
AI Summary
Palisade Bio, Inc. announced that the Canadian Intellectual Property Office has granted patent number 3,174,137, titled “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.” This patent covers the composition of PALI-2108, the company’s first-in-class, orally administered, ileocolonic-targeted PDE4 B/D inhibitor in development for treating fibrostenotic Crohn’s disease (FSCD) and ulcerative colitis (UC).
The patent provides composition-of-matter protection for PALI-2108 through May 28, 2041. PALI-2108 incorporates a galactose-derived sugar moiety that prevents absorption in the upper gut. Once it reaches the colon, bacterial β-glucuronidase converts the prodrug into its active form. This targeted approach ensures high drug levels in the terminal ileum and colon while minimizing systemic exposure.
This gut-restricted design aims to deliver strong anti-inflammatory and anti-fibrotic effects where they’re needed most, reducing common PDE4 inhibitor side effects such as nausea and headache. Palisade Bio continues to expand its intellectual property around PALI-2108 as it advances the program.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- September 17, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor.
AI Summary
Palisade Bio announced new data from its ongoing clinical studies of PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. Results will be presented at the STAR Consortium Annual Meeting, highlighting the drug’s safety and rapid activity in ulcerative colitis (UC).
In Phase 1a studies, PALI-2108 was well tolerated with no serious adverse events, lab or EKG abnormalities at single doses up to 450 mg and twice-daily doses up to 50 mg. In a 7-day Phase 1b UC cohort, all five patients showed clinical response by FDA-defined endpoints. Two of five achieved remission in just one week, supported by a 62.8% mean drop in modified Mayo scores and notable histologic improvements.
Biomarker analyses revealed normalization of 186 genes linked to fibrosis and Crohn’s strictures, suggesting anti-fibrotic potential. Patient dosing in the Phase 1b study for fibrostenotic Crohn’s disease is expected to begin in the second half of 2025, with further trials planned as part of the program.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- September 5, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc. announced that it received a No Objection Letter ("NOL") from Health Canada for its Clinical Trial Application to evaluate PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor, in a Phase 1b clinical study for the treatment of fibrostenotic Crohn's disease (FSCD).
AI Summary
Palisade Bio announced Health Canada has issued a No Objection Letter for its Phase 1b study of PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor for fibrostenotic Crohn’s disease. PALI-2108 delivers dual anti-inflammatory and anti-fibrotic effects directly to the terminal ileum and colon, a condition with no approved therapies. It is activated by bacterial enzymes in the lower intestine, maximizing local effect while reducing systemic side effects.
The open-label study will enroll 6–12 patients to assess safety and tolerability via adverse event monitoring, lab tests, and EKGs. The study will measure pharmacokinetics in plasma and intestinal tissues, pharmacodynamics through RNA sequencing of ileal biopsies, and exploratory endpoints like histology, intestinal ultrasound, and patient-reported outcomes.
Dosing is expected to start in the second half of 2025, with topline safety, PK, and PD data due in Q1 2026. This NOL brings Palisade closer to its Phase 2 filings and may shift FSCD treatment from symptom relief toward disease modification.
Read Announcement- Drug:
- PALI-2108
- Announced Date:
- August 7, 2025
- Indication:
- For patients affected by UC.
Announcement
Palisade Bio, Inc announced compelling new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 inhibitor, including positive topline results from its Phase 1b open-label cohort in patients with moderate-to-severe UC and colon tissue pharmacokinetic (PK) data from the Phase 1a multiple ascending dose (MAD) cohort.
AI Summary
Palisade Bio shared new clinical data on PALI-2108, an ileocolonic-targeted PDE4 inhibitor for ulcerative colitis (UC). The company reported positive topline results from its Phase 1b open-label cohort in moderate-to-severe UC patients and colon tissue pharmacokinetic data from a Phase 1a multiple ascending dose (MAD) study.
In the 7-day Phase 1b study, five UC patients received 30 mg twice daily. All five achieved a clinical response, with an average 62.8% drop in modified Mayo score and one patient reaching remission. Fecal calprotectin and hsCRP levels fell, and tissue analyses showed increased cAMP, a 51% drop in PDE4B, and reduced inflammatory markers. PALI-2108 was well tolerated, with only mild, transient side effects and no serious adverse events.
In the Phase 1a MAD cohort, colon tissue levels of the active metabolite stayed at or above the IC90 threshold 36 hours after dosing. The extended half-life and local bioactivation support once-daily oral dosing. Palisade Bio plans to submit an IND for a Phase 2 study in the first half of 2026.
Read Announcement- 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.
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Palisade Bio FDA Events - Frequently Asked Questions
As of now, Palisade Bio (PALI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Palisade Bio (PALI) has reported FDA regulatory activity for PALI-2108.
The most recent FDA-related event for Palisade Bio occurred on September 22, 2026, involving PALI-2108. The update was categorized as "primary efficacy readout," with the company reporting: "Palisade Bio, Inc. announced that primary efficacy readout (Week 12 endoscopic response) targeted for Q1 2028"
Currently, Palisade Bio has one therapy (PALI-2108) targeting the following condition: For patients affected by UC..
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:PALI last updated on 9/22/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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