Etrasimod Receives Strong Recommendation in the ACG Clinical Guideline Update: Ulcerative Colitis in Adults for Induction and Maintenance Phase of Moderately to Severely Active UC
Shanghai, Aug. 15, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that etrasimod (VELSIPITY®) has been included in the ACG Clinical Guideline Update: Ulcerative Colitis in Adults (the "Updated Guidelines"). S1P receptor modulators, including etrasimod, are recommended for induction of remission in patients with moderately to severely active UC, and are recommended to be continued for maintenance of remission as compared with no treatment after induction of remission with these agents. Both recommendations are strong, with moderate quality of evidence.
The updated guidelines were developed by the American College of Gastroenterology (ACG) including the latest evidence from the past five years. They provide a comprehensive summary of new approaches and advances in the treatment and prevention of complications in UC, with the goal of offering clinicians standardized and evidence-based recommendations to better manage patients with varying degrees of disease severity.
The updated guidelines note that, etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P) 1,4,5 receptor modulator for the treatment of moderately to severely active UC. The S1P 1 receptor modulation regulates the trafficking of specific lymphocyte subsets out of the lymph nodes, leaving fewer peripheral immune cells available to traffic to sites of inflammation. The updated guidelines also reference the Phase III ELEVATE UC clinical study for etrasimod (ELEVATE UC 52 and ELEVATE UC 12). Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod. Etrasimod has been included in the AGA Living Clinical Practice Guideline on the pharmacological management of moderate-to-severe UC as one of the higher-efficacy medications suggested for first-line use in advanced therapy-naïve patients.
"The updated guidelines further emphasize that achieving endoscopic mucosal healing to enable sustained, steroid-free remission is a core treatment goal for patients. This is not only critical for the long-term and safe management of the disease but is also closely tied to improving patients' quality of life. The strong recommendation of etrasimod for both induction and maintenance therapy in this population reflects the high level of recognition from an internationally authoritative medical authority," said Prof. Wu Kaichun at the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod's Asia clinical trial."As a next-generation selective S1P receptor modulator, once-daily oral etrasimod has a rapid onset of action, significantly increases the proportion of patients with clinical remission，endoscopic normalization and mucosal healing, and helps patients to reach their treatment goals sooner. Notably, in the phase III ELEVATE UC studies, all patients who achieved clinical remission did so without the use of steroids, fully demonstrating etrasimod's potential to help patients overcome steroid dependence and achieve long-term remission."
"The inclusion of etrasimod in the 2025 American College of Gastroenterology (ACG) Clinical Guideline for Adult Ulcerative Colitis, with a strong recommendation, is a clear recognition of its clinical efficacy and favorable safety profile. Mucosal healing is a recognized treatment goal in both domestic and international clinical guidelines for UC. Achieving mucosal healing at an early stage can significantly reduce the risk of disease relapse, hospitalization, colectomy, and the development of colorectal cancer." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "In Asia, the number of UC patients continues to rise, while treatment options remain limited, highlighting an urgent need for innovative therapies that balance efficacy, safety, and convenience. In China alone, the UC patient population was estimated at approximately 800,000 in 2024 and is projected to reach 1 million by 2030, placing an increasing burden on the healthcare system.
As a key innovative asset in Everest Medicines' autoimmune disease portfolio, etrasimod's inclusion in the clinical guidelines underscores its global therapeutic potential as a new treatment option for UC patients across Asia, including in China. We remain committed to accelerating the regulatory approval process for etrasimod in Mainland China, South Korea, and other Asian markets to enhance patient access and help more individuals achieve higher-quality, longer-lasting disease remission."
As a core product of Everest Medicines, etrasimod has been approved in Singapore, Macao SAR, and Hong Kong SAR, and its NDA has been accepted in South Korea. In December 2024, China's National Medical Products Administration (NMPA) officially accepted the NDA for VELSIPITY®. As Everest's third commercialized product, VELSIPITY® has been officially approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC. It is now available at medical institutions designated under the Connect Policy in the Greater Bay Area. Additionally, Everest has launched a factory construction project at its Jiashan site to support local production of VELSIPITY®.
About VELSIPITY® (etrasimod)
VELSIPITY® is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Japan, Australia, Singapore, UK, Switzerland, Israel and the Macau SAR, China for VELSIPITY® in ulcerative colitis, as well as additional countries.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.
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SOURCE Everest Medicines
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