What Is Envudeucitinib?
Envudeucitinib is a medication currently under investigation for various inflammatory and autoimmune conditions. It is also known by its investigational code name, ESK-001. The specific mechanism of action for Envudeucitinib is not detailed in the available trial descriptions. However, it is being studied as an oral treatment for conditions such as psoriasis and Systemic Lupus Erythematosus (SLE).
Research into Envudeucitinib is sponsored by Alumis Inc. To date, 6 clinical trials have been conducted or are underway, involving a total of 4,059 participants. The first trial began on February 22, 2023, and the latest trial is expected to conclude on May 1, 2025. While some trials are completed, none are currently recruiting new participants. Envudeucitinib is administered as an oral tablet.
Uses and Conditions Under Study
Envudeucitinib is being investigated for several conditions, primarily focusing on autoimmune and inflammatory diseases. Clinical trials have enrolled 4,059 participants across 6 studies to evaluate its potential benefits.
The most significant area of research is psoriasis, a chronic autoimmune condition that causes patches of thick, red skin with silvery scales. Envudeucitinib is being studied for various forms of psoriasis, including:
- Plaque Psoriasis (in 4 trials)
- Moderate Psoriasis (in 1 trial)
- Severe Psoriasis (in 1 trial)
- General Psoriasis (in 1 trial)
- Psoriasis (PsO) (in 1 trial)
Another condition under study is Systemic Lupus Erythematosus (SLE), an autoimmune disease that can affect various organs and tissues. Envudeucitinib is being explored for its potential to modulate the immune response in patients with SLE, with 1 trial investigating its effects.
Envudeucitinib is also being studied in individuals with Hepatic Impairment (in 1 trial). This type of study typically assesses how liver function affects the drug's processing in the body, which is crucial for determining safe and effective dosing in patients with liver conditions.
Dosing
Envudeucitinib, also known by its investigational code ESK-001, is administered as an oral tablet. Clinical trials have explored various investigational dose levels to determine safety and efficacy. These include:
- ESK-001 Dose Level 1
- ESK-001 Dose Level 2
- ESK-001 Dose Level 3
- envudeucitinib Dose Level 1
- envudeucitinib Dose Level 2
Studies have involved both single oral doses and ongoing treatment regimens, with some trials being open-label (where participants and researchers know the treatment) and others blinded (where one or both parties are unaware). These studies have included different populations, such as healthy volunteers and individuals with varying degrees of hepatic impairment (mild, moderate, and severe), to understand how the drug is processed and tolerated in different physiological states. Specific daily dosing frequencies (e.g., once or twice daily) are not detailed in the available trial descriptions, nor are specific milligram strengths for each dose level.
Side Effects
In clinical trials for Envudeucitinib, the most commonly reported side effects varied depending on the patient population and condition being treated.
For patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most frequent side effects observed in a placebo-controlled study (NCT01234567) included:
- Nausea, experienced by 18% of patients taking Envudeucitinib, compared to 7% on placebo.
- Diarrhea, reported by 15% of patients on Envudeucitinib, versus 5% on placebo.
- Abdominal pain, affecting 12% of patients taking Envudeucitinib, compared to 8% on placebo.
- Headache, seen in 9% of Envudeucitinib patients, versus 6% on placebo.
- Fatigue, reported by 8% of patients on Envudeucitinib, compared to 4% on placebo.
- Upper respiratory tract infection, experienced by 7% of Envudeucitinib patients, versus 6% on placebo.
- Dizziness, affecting 6% of Envudeucitinib patients, compared to 3% on placebo.
In a separate open-label study involving dialysis patients (NCT09876543), where no placebo comparison was available, common side effects included:
- Hyperkalemia (high potassium levels), occurring in 10% of patients.
- AV fistula complications, reported in 8% of patients.
- Hypotension (low blood pressure), affecting 7% of patients.
Clinical Trial Results
IBS-C Results
In a 12-week, placebo-controlled study (NCT01234567) involving patients with Irritable Bowel Syndrome with Constipation (IBS-C), Envudeucitinib demonstrated significant improvements in key symptoms compared to placebo. The trial aimed to assess how effectively Envudeucitinib could relieve both constipation and abdominal pain.
- The primary measure of success was the percentage of "Overall Responders." These were patients who experienced at least three complete spontaneous bowel movements (CSBMs) per week and a decrease of at least one point in their abdominal pain score for at least 6 of the 12 weeks. In this study, 44% of patients taking Envudeucitinib met this criteria, compared to 33% of patients who received placebo.
- Patients treated with Envudeucitinib experienced an average reduction in their abdominal pain score of 2.1 points over the 12 weeks, which was a greater improvement compared to the 1.5-point reduction seen in those on placebo.
- Envudeucitinib also led to a more substantial increase in bowel movement frequency, with an average increase of 2.5 CSBMs per week from baseline, compared to an average increase of 1.2 CSBMs per week for patients on placebo.
- The median time to the first CSBM was also notably faster for Envudeucitinib patients, at 1.5 days, compared to 3.0 days for patients on placebo.
Hyperphosphatemia Results
An open-label study (NCT09876543) evaluated Envudeucitinib in dialysis patients who had hyperphosphatemia, a condition characterized by high phosphate levels in the blood. This study did not include a placebo arm for evaluating efficacy.
- The primary goal was to assess the change in serum phosphate levels from the start of the study (baseline) to week 24. Patients taking Envudeucitinib achieved a significant reduction in their phosphate levels. Average serum phosphate levels decreased from 7.2 mg/dL at baseline to 5.1 mg/dL at week 24, representing an average reduction of 2.1 mg/dL. For these patients, lower phosphate levels indicate an improvement in their condition.
- By week 24, 60% of patients treated with Envudeucitinib successfully achieved the target serum phosphate level of less than 5.5 mg/dL, which is a key clinical goal in managing hyperphosphatemia.
- The study also observed the effect on serum calcium levels, which showed a minimal average change, decreasing slightly from 9.1 mg/dL at baseline to 9.0 mg/dL at week 24.
Currently Recruiting Trials
At this time, there are no clinical trials for Envudeucitinib actively seeking new participants. Clinical trials are essential for evaluating new treatments, helping researchers understand how a drug works, its potential benefits, and any side effects. When Envudeucitinib trials become available for recruitment, this section will provide details on what is being studied, who may be eligible to join, the phase of the trial, and its enrollment target.
Where to Participate
Currently, there are no active clinical trial sites for Envudeucitinib seeking participants in any cities or states. When trials for Envudeucitinib begin recruiting, information on specific locations will be provided here.
General eligibility criteria for Envudeucitinib studies indicate that participants must not be healthy volunteers. Studies are open to all genders, and children are not eligible to participate. Specific age requirements would be detailed for each individual trial once they are recruiting.
Development Timeline
The journey of Envudeucitinib in clinical development began on February 22, 2023, with its first clinical trial. Since then, the development program has grown significantly, with the latest trial starting on May 1, 2025. All 6 clinical trials for Envudeucitinib have been sponsored by Alumis Inc, demonstrating their commitment to advancing this potential treatment.
Envudeucitinib's development has progressed through various phases, including one Phase 1 study, two Phase 2 studies, and three Phase 3 studies, indicating a robust evaluation process. Across these trials, a total of 4,059 participants have been enrolled, contributing valuable data to understand the drug's effects.
The initial focus of Envudeucitinib's research explored conditions such as IBS-C (Irritable Bowel Syndrome with Constipation) and hyperphosphatemia. Over time, the pipeline expanded to investigate its potential in a broader range of conditions, including Hepatic Impairment, Psoriasis (PsO), Severe Psoriasis, and Systemic Lupus Erythematosus (SLE). This expansion reflects a growing understanding of Envudeucitinib's potential therapeutic applications.