Teva and Sanofi's IBD Drug Shows Lasting Efficacy in Key Study
- 58% of ulcerative colitis patients on 900 mg dose achieved clinical remission
- 55% of Crohn’s disease patients on 900 mg dose achieved endoscopic response
- Study followed 130 patients for 44 weeks of maintenance therapy
Experts view duvakitug as a promising candidate for long-lasting IBD remission, with its sustained efficacy and strong safety profile positioning it as a potential best-in-class therapy in the competitive TL1A inhibitor market.
Teva and Sanofi's IBD Drug Shows Lasting Efficacy in Key Study
PARSIPPANY, N.J. and PARIS – February 17, 2026 – Pharmaceutical giants Teva and Sanofi today announced promising new data for their investigational inflammatory bowel disease (IBD) treatment, duvakitug, showing the drug maintained its effectiveness for nearly a year in patients with ulcerative colitis (UC) and Crohn’s disease (CD). The results from the long-term extension of a Phase 2b study reinforce the drug's potential to address one of the most significant challenges in IBD care: achieving durable, long-lasting remission.
The findings, which come as the drug advances into larger Phase 3 trials, position duvakitug as a formidable player in the highly competitive and lucrative race to develop a new class of therapies targeting a protein known as TL1A.
A New Hope for Sustained Remission
For the millions of people worldwide living with IBD—a group of chronic autoimmune disorders causing inflammation of the gastrointestinal tract—life is often a cycle of unpredictable flares and periods of remission. While existing treatments can induce a response, many patients struggle with therapies losing effectiveness over time, leading to a return of debilitating symptoms like persistent diarrhea, abdominal pain, and weight loss.
The new data from the RELIEVE UCCD long-term extension study suggests duvakitug could offer a more lasting solution. The study followed 130 patients who had already responded to an initial 14-week course of the drug. After an additional 44 weeks of maintenance therapy, a significant percentage of patients remained in remission or showed major endoscopic improvement.
Specifically, among patients with ulcerative colitis receiving a 900 mg dose, 58% achieved clinical remission. For patients with Crohn’s disease, 55% on the same dose achieved the primary endpoint of endoscopic response, a key measure indicating that the inflammation and damage inside the intestinal wall had healed. The lower 450 mg dose also showed strong results, with 47% of UC patients and 41% of CD patients meeting their respective primary endpoints.
“One of the persistent challenges in treating ulcerative colitis and Crohn’s disease isn’t just achieving an initial response, but sustaining it,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D at Teva, in a statement accompanying the release. He noted the results "clearly strengthen the case that duvakitug has the potential to be a best-in-class therapy."
The treatment was also reported to be well tolerated, with a safety profile consistent with the initial induction study. The most common side effects included upper respiratory tract infections and nasopharyngitis. These detailed results are expected to be presented at an upcoming medical meeting, where they will face scrutiny from gastroenterology experts.
The Multi-Billion Dollar Race to Target TL1A
The positive results for duvakitug land in the middle of a heated race among pharmaceutical companies to develop and commercialize drugs that inhibit TL1A (TNF-like ligand 1A). This protein has emerged as a critical target in immunology because it is believed to be a master regulator that amplifies inflammation and promotes fibrosis, the development of scar tissue that can lead to intestinal blockages and surgery. By blocking TL1A, these new therapies aim to not only control symptoms but also potentially halt the underlying progression of the disease.
The potential of this new drug class has not gone unnoticed by the industry. In recent years, the TL1A space has seen major acquisitions, signaling Wall Street's confidence in its blockbuster potential. In 2023, Merck spent over $10 billion to acquire Prometheus Biosciences for its promising TL1A inhibitor, while Roche paid $7.1 billion to fully acquire the rights to another leading candidate, RVT-3101.
Against this backdrop, the durable efficacy data from Teva and Sanofi's duvakitug is particularly significant. While competitors have also shown strong initial results, demonstrating sustained efficacy over a longer period—nearly a full year in this case—could become a key differentiating factor for physicians and patients. The innovative "basket study" design of the RELIEVE UCCD trial, which enrolled both UC and CD patients simultaneously, has also provided robust data for both conditions, potentially accelerating its path forward.
Strategic Stakes for Teva and Sanofi
For both Teva and Sanofi, duvakitug represents a cornerstone of their future strategic ambitions. The two companies are collaborating on the drug’s development, sharing costs globally and dividing future commercialization territories. Sanofi will lead sales in North America and Japan, while Teva will handle Europe, Israel, and other regions.
This partnership allows both companies to hedge their bets while competing in the massive IBD market, which was valued at over $22 billion in 2023 and continues to grow. For Teva, a successful duvakitug would be a landmark achievement in its "Pivot to Growth" strategy, which aims to shift the company's focus from its legacy as a generics powerhouse to a leader in innovative specialty medicines.
For Sanofi, an R&D-driven biopharma company, duvakitug is a key opportunity to bolster its already strong immunology portfolio. “These results reinforce duvakitug's potential as a leading TL1A therapy and an important advancement in inflammatory bowel disease treatment,” said Houman Ashrafian, Executive Vice President and Head of R&D at Sanofi. "With phase 3 studies underway, we're committed to advancing duvakitug for patients who need new options."
The Path Forward: From Trials to Treatment
With this strong Phase 2b data in hand, all eyes are now on the ongoing Phase 3 program. These large-scale, pivotal trials are the final and most rigorous step required before the companies can submit duvakitug for approval to regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These studies will enroll a larger and more diverse patient population to confirm the drug's efficacy and further evaluate its long-term safety against existing standards of care.
The journey from a successful Phase 2 trial to a marketable drug is still long. Phase 3 trials in IBD typically take several years to complete, followed by a 6-to-12-month review period by regulators. Based on typical industry timelines, and assuming the Phase 3 trials are successful, duvakitug might reach the market sometime between late 2027 and 2029.
Until then, the safety and efficacy of duvakitug have not been fully reviewed or confirmed by any regulatory authority. However, today's announcement provides a significant boost of confidence for the program and offers a tangible sense of hope for patients awaiting more effective, long-lasting options. As the competition to bring the first TL1A inhibitor to market intensifies, the sustained results from duvakitug ensure it will remain a central part of the conversation.
