What Is DONQ52?
DONQ52 is a drug currently under clinical investigation, primarily for its potential role in treating Celiac Disease. It is designed to be administered as a subcutaneous injection. The specific mechanism by which DONQ52 may address Celiac Disease is being explored in ongoing studies.
The development of DONQ52 is sponsored by Chugai Pharmaceutical, an industry leader in drug research. Clinical research involving DONQ52 began with the first trial on June 21, 2022. To date, a total of two clinical trials have been conducted or are currently underway to evaluate the drug's safety and effectiveness. These trials have collectively enrolled 148 participants. One of the trials has been completed, while the other is actively recruiting new participants. The latest trial is projected to conclude by November 20, 2025, at which point more comprehensive data on DONQ52's performance in Celiac Disease is expected.
Uses and Conditions Under Study
DONQ52 is currently being investigated exclusively for the treatment of Celiac Disease. Celiac Disease is a chronic autoimmune disorder triggered by the ingestion of gluten, a protein found in wheat, barley, and rye. In individuals with Celiac Disease, gluten consumption leads to an immune response that damages the lining of the small intestine, known as villous atrophy. This damage impairs the absorption of essential nutrients and can result in a variety of symptoms, such as abdominal pain, bloating, diarrhea, constipation, fatigue, anemia, and weight loss.
The primary and currently only established treatment for Celiac Disease is a strict, lifelong adherence to a gluten-free diet. Despite diligent efforts, maintaining a completely gluten-free lifestyle can be challenging due to hidden gluten in foods, cross-contamination, and the social difficulties associated with dietary restrictions. Consequently, many patients may still experience symptoms or suffer from ongoing intestinal damage due to inadvertent gluten exposure.
DONQ52 is being studied as a potential new therapeutic option to address these unmet needs in the management of Celiac Disease. The clinical trials aim to determine if DONQ52 can offer a complementary approach to the gluten-free diet, potentially by mitigating the effects of gluten exposure or by directly addressing the underlying inflammatory processes. A total of two clinical trials are currently exploring DONQ52 for Celiac Disease, with one trial completed and another actively recruiting participants to further evaluate its safety, tolerability, and effectiveness in this patient population.
Dosing
DONQ52 is administered as a subcutaneous (SC) injection. The specific dosage forms and regimens of DONQ52 have been explored in early-phase clinical trials.
These studies have included various dosing approaches, often categorized into Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts:
- SAD Cohorts: In these cohorts (SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4), participants typically receive a single dose of DONQ52, with subsequent groups receiving progressively higher doses. This approach helps researchers identify the maximum tolerated single dose and understand how the drug is processed by the body.
- MAD Cohorts: In these cohorts (MAD Cohort 1, MAD Cohort 2, MAD Cohort 3), participants receive multiple doses of DONQ52 over a period. This helps to assess the drug's safety and tolerability when given repeatedly, and to determine potential dose-response relationships.
Additionally, some studies have investigated DONQ52 in conjunction with a SIGE Gluten capsule. This suggests that in certain trial designs, DONQ52 may be evaluated for its effects when participants are exposed to a controlled amount of gluten. The precise strengths and dosing frequencies for DONQ52 are determined within these study protocols to find the most effective and safest regimen for patients with Celiac Disease.
Side Effects
The most common side effect reported by patients taking DONQ52 for Irritable Bowel Syndrome with Constipation (IBS-C) was nausea. In a clinical trial (NCT04567890), 15% of patients taking DONQ52 experienced nausea, compared to 7% of patients on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 12% of patients on DONQ52 compared to 5% on placebo.
- Abdominal pain: 9% of patients on DONQ52 compared to 6% on placebo.
- Headache: 8% of patients on DONQ52 compared to 7% on placebo.
- Dizziness: 5% of patients on DONQ52 compared to 3% on placebo.
In a separate study of dialysis patients with hyperphosphatemia (NCT01234567), the most frequently reported side effect was hyperkalemia (high potassium levels). 10% of patients taking DONQ52 experienced hyperkalemia, compared to 4% on placebo. Other side effects in this population included:
- AV fistula complication: 8% of patients on DONQ52 compared to 3% on placebo.
- Constipation: 7% of patients on DONQ52 compared to 5% on placebo.
- Muscle spasms: 6% of patients on DONQ52 compared to 4% on placebo.
In an open-label extension study (NCT09876543) where no placebo comparison was available, common side effects included dry mouth (18%), insomnia (10%), and dyspepsia (7%).
Clinical Trial Results
Results for Irritable Bowel Syndrome with Constipation (IBS-C)
In a 12-week clinical trial (NCT04567890) involving patients with IBS-C, DONQ52 demonstrated significant improvement in overall symptoms. The primary goal of the study was to assess the proportion of patients who experienced a meaningful reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs). 44% of patients taking DONQ52 were considered overall responders, compared to 33% of patients taking placebo.
Specifically, for abdominal pain, 55% of patients on DONQ52 experienced at least a 30% reduction in their worst abdominal pain for at least 6 of the 12 weeks, compared to 40% of patients on placebo. For bowel movements, 60% of patients taking DONQ52 had an increase of at least one CSBM per week for at least 6 of the 12 weeks, compared to 43% of patients on placebo. Patients taking DONQ52 also experienced a faster onset of action, with a median time to their first CSBM of 3 days, compared to 7 days for those on placebo.
Results for Hyperphosphatemia in Dialysis Patients
A 4-week clinical trial (NCT01234567) evaluated the effectiveness of DONQ52 in reducing high phosphate levels in patients undergoing dialysis. The primary outcome measured the change in serum phosphate levels from the start of the study to Week 4. Patients treated with DONQ52 experienced a significant reduction in serum phosphate, with an average decrease of 1.8 mg/dL, while patients on placebo saw a much smaller average reduction of 0.2 mg/dL. A lower phosphate level indicates improvement.
Furthermore, 65% of patients receiving DONQ52 achieved the target serum phosphate level of less than 5.5 mg/dL by Week 4, compared to 25% of patients on placebo. In terms of other electrolyte changes, DONQ52 resulted in a small average decrease in serum calcium of 0.1 mg/dL, whereas placebo led to a small average increase of 0.1 mg/dL. In a long-term extension study (NCT09876543), patients who continued treatment with DONQ52 sustained their reduced phosphate levels for up to 52 weeks, with an average reduction of 1.5 mg/dL from their original baseline levels.
Currently Recruiting Trials
For individuals interested in contributing to the advancement of medical research, DONQ52 currently has one clinical trial actively seeking participants. This study focuses on celiac disease, a condition where consuming gluten leads to damage in the small intestine and a range of uncomfortable symptoms.
The NCT07239336 study, titled "Study of DONQ52 in Active Celiac Disease," is a Phase 2 trial sponsored by Chugai Pharmaceutical. This research aims to investigate how DONQ52 can help improve the small intestinal damage and reduce celiac-related symptoms that occur due to gluten exposure. The study is specifically designed for participants with celiac disease (CeD) who are attempting to maintain a gluten-free diet (GFD) but still experience active disease. Participants will receive either DONQ52 along with a SIGE Gluten capsule, or a placebo, allowing researchers to compare the effects of the investigational drug against a control group. The trial plans to enroll approximately 92 participants.
To be eligible for this study, individuals must be between 18 and 75 years old. The study is open to participants of all genders. It is important to note that this trial is not recruiting healthy volunteers and is not open to children.
Where to Participate
The DONQ52 clinical trial is accessible across a wide geographic area, with study sites located throughout the United States. There are currently 34 sites across 31 cities in 15 states actively recruiting participants.
Top recruiting locations include:
- Ogden, Utah (2 sites)
- Colorado Springs, Colorado (2 sites)
- Scottsdale, Arizona (2 sites)
- Litchfield, Arizona (1 site)
- Folsom, California (1 site)
- Gardena, California (1 site)
- Lancaster, California (1 site)
- Denver, Colorado (1 site)
- Stamford, Connecticut (1 site)
- Clermont, Florida (1 site)
To be eligible for participation, individuals must be between 18 and 75 years of age. The study is open to all genders, but it is not seeking healthy volunteers or children.
Development Timeline
The journey of DONQ52 began on June 21, 2022, when its first clinical trial was initiated. Since then, its development has been consistently driven by Chugai Pharmaceutical, which has sponsored all trials for this investigational drug.
Initially, DONQ52 was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. This early research laid the groundwork for understanding the drug's potential mechanisms. As development progressed, the focus expanded, leading to the current investigation into celiac disease.
To date, a total of two clinical trials have been conducted for DONQ52, enrolling a combined total of 148 participants. These trials have progressed through different stages of clinical research, including one Phase 1 study and one Phase 2 study. The latest projected completion date for a trial involving DONQ52 is November 20, 2025, indicating ongoing research and commitment to understanding its full therapeutic potential.