What Is SAR441566?
SAR441566 is an investigational drug currently being studied for several inflammatory and autoimmune conditions. It is administered orally as a tablet. As an investigational medication, SAR441566 is not yet approved for use by regulatory bodies.
Clinical trials are evaluating SAR441566 for its potential to treat conditions such as Rheumatoid Arthritis, Psoriasis, Ulcerative Colitis, and Crohn's Disease. These studies aim to understand how the drug works, its effectiveness, and its safety profile in patients.
A total of 7 clinical trials have been conducted or are ongoing for SAR441566, involving 1,057 participants. The first trial began in 2022, and the latest is expected to conclude in 2025. All trials are sponsored by Sanofi.
Uses and Conditions Under Study
SAR441566 is currently under investigation in clinical trials for several inflammatory and autoimmune conditions. These studies are exploring its potential to manage symptoms and disease progression.
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Rheumatoid Arthritis: This is a chronic autoimmune disease that causes joint pain, swelling, and stiffness. It can lead to joint damage and disability. SAR441566 is being studied in 3 trials to see if it can reduce inflammation and improve symptoms for people with this condition.
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Psoriasis: Psoriasis is a chronic skin condition characterized by red, scaly patches. It results from an overactive immune system causing skin cells to grow too quickly. SAR441566 is being evaluated in 2 trials for its potential to alleviate skin symptoms associated with psoriasis.
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Inflammatory Bowel Diseases (IBD): This category includes chronic inflammatory conditions affecting the digestive tract. SAR441566 is being investigated for two types of IBD:
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Ulcerative Colitis: This condition causes inflammation and ulcers in the lining of the large intestine and rectum. 1 trial is studying SAR441566 for its potential role in treating Ulcerative Colitis.
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Crohn's Disease: This disease can cause inflammation anywhere along the digestive tract, from the mouth to the anus. 1 trial is evaluating SAR441566 as a potential treatment for Crohn's Disease.
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Dosing
SAR441566 is formulated as an oral tablet. In clinical trials, various dosing approaches have been investigated to determine the most effective and safest way to administer the drug for different conditions.
The studies have explored multiple dose regimens and strengths of SAR441566. These include:
- SAR441566 dose regimen 1, 2, and 3
- SAR441566 dose 1, 2, and 3
- SAR441566 dose regimen A, B, C, D, and E
- Part I SAR441566 Dose A and Part I SAR441566 Dose B
- SAR441566 (general dosing)
The specific strengths and frequencies of these regimens are determined by the trial protocols. Some studies may also involve a comparator drug, such as Part II Ciprofloxacin, which is studied separately or in combination with SAR441566 to evaluate its effects.
Since SAR441566 is an investigational drug, there is no standardized approved dosing information available for patient use outside of clinical trial settings.
Side Effects
In a clinical trial involving 186 patients treated with SAR441566, the most common side effect was nasopharyngitis (inflammation of the nose and throat).
- 7.0% of patients taking SAR441566 experienced nasopharyngitis, compared to 0.0% on placebo.
- 2.7% of patients taking SAR441566 experienced dysgeusia (altered taste sensation), compared to 0.0% on placebo.
- 2.2% of patients taking SAR441566 experienced back pain, compared to 0.0% on placebo.
- 2.2% of patients taking SAR441566 experienced increased blood creatine phosphokinase (an enzyme), compared to 0.0% on placebo.
- 2.2% of patients taking SAR441566 experienced increased blood alkaline phosphatase (an enzyme), compared to 0.0% on placebo.
- 2.2% of patients taking SAR441566 experienced gastroenteritis (stomach flu), compared to 0.0% on placebo.
- 1.6% of patients taking SAR441566 experienced diarrhea, compared to 0.0% on placebo.
- 1.6% of patients taking SAR441566 experienced abdominal discomfort, compared to 0.0% on placebo.
Currently Recruiting Trials
Sanofi is actively recruiting participants for two important Phase 2 clinical trials investigating SAR441566, a potential new treatment for inflammatory bowel diseases. These studies aim to evaluate the efficacy and safety of different doses of SAR441566 in adults living with moderate-to-severe ulcerative colitis and Crohn's disease.
One ongoing study, NCT06867094, focuses on ulcerative colitis. This multinational, multicenter, randomized, double-blind, placebo-controlled study is designed to assess how well SAR441566 works across three different dose regimens. The trial plans to enroll approximately 204 adult participants who have moderate-to-severe ulcerative colitis. Participants will receive either one of the SAR441566 dose regimens or a placebo, allowing researchers to understand the drug's potential benefits and side effects.
Another key trial, NCT06637631, is dedicated to Crohn's disease. Similar in design, this Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe Crohn's disease. The study aims to enroll around 260 participants, who will be assigned to one of three SAR441566 dose levels or a placebo. Both studies are crucial steps in determining if SAR441566 can offer a new therapeutic option for these challenging conditions, with Sanofi sponsoring the research.
Where to Participate
Clinical trials for SAR441566 are currently recruiting across a broad geographic area to ensure diverse participation. These studies are being conducted at 38 sites located in 23 cities across 14 states in the United States. If you are interested in potentially participating, you may find a site near you.
Some of the cities with multiple participating sites include:
- Sun City, Arizona
- Bristol, Connecticut
- Clermont, Florida
- Gurnee, Illinois
- Ann Arbor, Michigan
- Queens Village, New York
- Uniontown, Pennsylvania
- Charleston, South Carolina
- Katy, Texas
- Southlake, Texas
Eligibility criteria for these studies specify that participants must be between 18-75 years of age. The trials are open to individuals of all genders, but they are not seeking healthy volunteers or children. Participants must have a diagnosis of moderate-to-severe ulcerative colitis or Crohn's disease, depending on the specific trial.
Development Timeline
The journey of SAR441566 began on July 12, 2022, with the initiation of its first clinical trial. Since then, development has progressed steadily, with the latest trial starting on March 10, 2025. All seven clinical trials for SAR441566 have been sponsored by Sanofi, demonstrating a consistent commitment to exploring its potential.
To date, a total of 7 trials have been conducted or are ongoing, involving approximately 1,057 participants. The early stages of development included three Phase 1 trials, which typically focus on safety and initial dosing. As more was learned, the program advanced into four Phase 2 trials, which are designed to assess efficacy and further evaluate safety in larger groups of patients.
The therapeutic focus of SAR441566 has also expanded over time. Initial investigations explored its potential for conditions such as IBS-C (irritable bowel syndrome with constipation) and hyperphosphatemia. Building on these early insights, the development pipeline broadened to include inflammatory bowel diseases, leading to the current Phase 2 studies for ulcerative colitis and Crohn's disease.