EDG6 agonists(Sphingosine 1-phosphate receptor Edg-6 agonists), S1PR1 agonists(Sphingosine 1-phosphate receptor Edg-1 agonists), S1PR5 agonists(Sphingosine 1-phosphate receptor Edg-8 agonists)

Therapeutic Areas

Digestive System DisordersImmune System DiseasesHemic and Lymphatic Diseases+ [2]

Active Indication

Ulcerative colitis, active moderateUlcerative colitis, active severeColitis, Ulcerative+ [5]

Inactive Indication

EczemaModerate Atopic DermatitisMultiple Sclerosis+ [4]

Originator Organization

Arena Pharmaceuticals, Inc.

Active Organization

Pfizer Inc.Pfizer Europe MA EEIG

Penn Pharmaceutical Services Ltd.

+ [7]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (12 Oct 2023),

Colitis, Ulcerative

Regulation-

Structure/Sequence

Molecular FormulaC32H40F3N5O5

InChIKeyGVPVVOSNDUAUKM-BPGOJFKZSA-N

CAS Registry1206123-97-8

View All Structures (2)

Clinical Trials associated with Etrasimod Arginine

NCT06398626

/ RecruitingNot Applicable

A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod.
All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer.
The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.

Start Date17 Sep 2024

Sponsor / Collaborator

Pfizer Inc.

NCT06521762

/ Not yet recruitingPhase 2IIT

Etrasimod for Immune Checkpoint Inhibitor Diarrhea and Colitis

This is a randomized, double-blind, placebo-controlled, two-arm phase 2 study of etrasimod plus corticosteroids versus placebo plus corticosteroids for the treatment of Immune Checkpoint Inhibitor Diarrhea and Colitis (IMDC) CTCAE v5.0 grade ≥ 2 due to immune checkpoint inhibitors (ICI) therapy alone or combined with another ICI or ICI plus chemotherapy that in the opinion of the treating physician requires treatment with corticosteroid-based immunosuppression and does not require immediate secondary immune suppression.
The purpose of this study is to improve the treatment of IMDC in people taking ICIs and find out if etrasimod combined with corticosteroids is more effective than a placebo combined with corticosteroids at lowering the total number of corticosteroids needed to treat IMDC.
IMDC is one of the most common Immune Related Adverse Events (irAEs) from treatment with ICI. Current guidelines recommend steroid treatment for IMDC CTCAE grade ≥ 2, which requires that ICI therapy be stopped. Corticosteroids may interfere with ICIs and cannot be given at the same time, Strategies are needed to reduce the dose and duration of corticosteroids needed for IMDC treatment and minimize the duration that patients have to be off ICI therapy. (ICIs are a type of immunotherapy.)

Start Date01 Aug 2024

Sponsor / Collaborator

Yale University

[+1]

NCT06294925

/ RecruitingNot Applicable

Effectiveness of Etrasimod on Disease Activity and Patient-reported Outcomes in Ulcerative Colitis - EFFECT-UC

The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.
Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.
All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.
The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.
The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.

Start Date08 May 2024

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Etrasimod Arginine

100 Translational Medicine associated with Etrasimod Arginine

100 Patents (Medical) associated with Etrasimod Arginine

Literatures (Medical) associated with Etrasimod Arginine

01 Jan 2025·FEBS Open Bio

Unique pharmacological properties of etrasimod among S1P receptor modulators

Article

Author: Komori, H. Kiyomi ; Indersmitten, Tim ; Ghetti, Andre ; Crosby, Catherine ; Bruinsma, Karin ; Al‐Shamma, Hussien ; Gatlin, Joel ; Chen, Xiaohua ; Adams, John W. ; Rabbat, Christopher J. ; Anthony, Todd ; Karimi‐Naser, Lisa ; Unett, David ; Dang, Huong ; Abi‐Gerges, Najah ; Ton, Anh‐Tuan ; Stepniak, Dariusz T. ; Gaidarov, Ibragim ; Miller, Paul E.

Etrasimod (ADP334) is an oral, once‐daily, selective sphingosine 1‐phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis and in development for the treatment of immune‐mediated inflammatory diseases. Interaction between S1P and its five receptor subtypes (S1P1–S1P5) plays a role in several physiologic systems, including the cardiovascular and immune systems. Since differences in S1PR binding and downstream intracellular signaling could contribute to distinct profiles of drug efficacy and safety, we directly compared the S1P1–5 selectivity profile of etrasimod to three marketed S1PR modulators: fingolimod, ozanimod, and siponimod. Using both heterologous expression systems and human umbilical vein endothelial cells that spontaneously express S1P1, we profiled key S1P1 downstream signaling pathways and found that etrasimod had similar potency to the other tested S1PR modulators in promoting β‐arrestin recruitment and S1P1 internalization. However, etrasimod was notably less potent than other S1PR modulators in assays measuring S1P1‐mediated G protein activation (GTPγS binding and cAMP inhibition). Relatively lower potency of etrasimod in inducing G protein signaling corresponded to significantly diminished activation of human cardiac G protein‐coupled inwardly rectifying potassium channels when compared to ozanimod. Together with pharmacokinetic properties, this pharmacologic profile of etrasimod may contribute to the positive benefit risk profile of etrasimod observed during the phase III ELEVATE UC 52 and ELEVATE UC 12 trials in patients with moderately to severely active ulcerative colitis.

01 Jan 2025·BMJ Open Gastroenterology

Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis

Article

Author: Dubinsky, Marla C ; Modesto, Irene ; Wu, Joseph ; Regueiro, Miguel ; Rubin, David T ; Green, Jesse ; Peyrin-Biroulet, Laurent ; Lazin, Krisztina ; Dalam, Alexis B ; Vermeire, Séverine ; Goetsch, Martina ; Guo, Xiang ; McDonnell, Aoibhinn ; Gu, Guibao ; Yarur, Andres J ; Irving, Peter M

ObjectiveEtrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). S1P1receptor expression on cardiac cells is involved in cardiac conduction. We report cardiovascular treatment-emergent adverse events (TEAEs) associated with S1P receptor modulators and other cardiovascular events in the etrasimod UC clinical programme.MethodsPatients were analysed in the Placebo-controlled UC cohort and All UC cohort. Incidence rates (IRs, per 100 patient-years) of cardiovascular-related TEAEs associated with S1P receptor modulators, including bradycardia/atrioventricular (AV) block and hypertension, and other cardiovascular events, including coronary artery disease (CAD) and cerebrovascular disease (CVD), were analysed.ResultsIn patients receiving etrasimod, cardiovascular-related TEAEs were infrequent (≤2.6% per AE). In the Placebo-controlled UC cohort, IRs (95% CIs) for cardiovascular-related TEAEs were higher for patients receiving etrasimod (n=577) vs placebo (n=314), respectively, for bradycardia/sinus bradycardia, 3.85 (1.58 to 6.13) vs 0 and AV block, 1.40 (0.03 to 2.76) vs 0; and numerically higher for hypertension, 5.31 (2.62 to 7.99) vs 3.40 (0.07 to 6.72). Most bradycardia/AV block events were reported on day 1. All bradycardia and hypertension TEAEs were non-serious. One serious second-degree AV block type 1 TEAE occurred in the etrasimod group; no events of second-degree AV block type 2 or higher were reported. One event each of CAD and CVD occurred in two patients receiving etrasimod.ConclusionsIn the etrasimod UC clinical programme, IRs of cardiovascular-related TEAEs and other cardiovascular events were low. Most cardiovascular-related TEAEs were non-serious.Trial registration numbersNCT02447302;NCT03945188;NCT03996369;NCT02536404;NCT03950232;NCT04176588.

01 Dec 2024·Gastroenterology

AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis

Review

Author: Agrawal, Manasi ; Ananthakrishnan, Ashwin N ; Singh, Siddharth ; Limketkai, Berkeley N ; Loftus, Edward V. ; Loftus, Edward V ; Ananthakrishnan, Ashwin N. ; Haydek, John P ; Scott, Frank I. ; Scott, Frank I ; Haydek, John P. ; Limketkai, Berkeley N.

BACKGROUND & AIMSThis American Gastroenterological Association (AGA) living guideline is intended to support practitioners in the pharmacological management of moderate-to-severe ulcerative colitis (UC).METHODSA multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to prioritize clinical questions, identify patient-centered outcomes, conduct an evidence synthesis, and develop recommendations on the pharmacological management of moderate-to-severe UC.RESULTSThe AGA guideline panel made 14 recommendations. In adult outpatients with moderate-to-severe UC, the AGA recommends the use of infliximab, golimumab, vedolizumab, tofacitinib, upadacitinib, ustekinumab, ozanimod, etrasimod, risankizumab, and guselkumab, and suggests the use of adalimumab, filgotinib, and mirikizumab over no treatment. In patients who are naïve to advanced therapies, the AGA suggests using a higher-efficacy medication (eg, infliximab, vedolizumab, ozanimod, etrasimod, upadacitinib, risankizumab, and guselkumab) or an intermediate-efficacy medication (eg, golimumab, ustekinumab, tofacitinib, filgotinib, and mirikizumab) rather than a lower-efficacy medication (eg, adalimumab). In patients who have previously been exposed to 1 or more advanced therapies, particularly tumor necrosis factor (TNF)-α antagonists, the AGA suggests using a higher-efficacy medication (eg, tofacitinib, upadacitinib, and ustekinumab) or an intermediate-efficacy medication (eg, filgotinib, mirikizumab, risankizumab, and guselkumab) rather than a lower-efficacy medication (eg, adalimumab, vedolizumab, ozanimod, and etrasimod). In adult outpatients with moderate-to-severe UC, the AGA suggests against using thiopurine monotherapy for induction of remission, but suggests using thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission. The AGA suggests against using methotrexate monotherapy, for induction or maintenance of remission. In adult outpatients with moderate-to-severe UC, the AGA suggests the use of infliximab, adalimumab, and golimumab in combination with an immunomodulator over corresponding monotherapy. However, the AGA makes no recommendation in favor of, or against, the use of non-TNF antagonist biologics in combination with an immunomodulator over non-TNF biologic alone. In patients with UC who are in corticosteroid-free clinical remission for at least 6 months on combination therapy of TNF antagonists and an immunomodulator, the AGA suggests against withdrawal of TNF antagonists, but makes no recommendation in favor of, or against, withdrawing immunomodulators. In adult outpatients with moderate-to-severe UC, who have failed 5-aminosalicylates, and have escalated to therapy with immunomodulators or advanced therapies, the AGA suggests stopping 5-aminosalicylates. Finally, in adult outpatients with moderate-severe UC, the AGA suggests early use of advanced therapies and/or immunomodulator therapy, rather than gradual step-up after failure of 5-aminosalicylates. The panel also proposed key implementation considerations for optimal use of these medications and identified several knowledge gaps and areas for future research.CONCLUSIONSThis guideline provides a comprehensive, patient-centered approach to the pharmacological management of patients with moderate-to-severe UC.

News (Medical) associated with Etrasimod Arginine

18 Dec 2024

·www.everestmedicines.com

Everest Medicines Announces the First Prescription of VELSIPITY® in the Greater Bay Area, Officially Benefiting Mainland China Patients

About Us Company Overview Vision and Mission Leadership Team Board of Directors ESG The United Nations Global Compact Contact Us Product and Science Pipeline and Major Products Discovery Manufacturing Partners Media Press Releases Media Coverage Awards Investors Presentations and Webcasts Announcements and Circulars Financial Reports and Listing Documents Analyst Coverage Corporate Governance Events Calendar IR Contact and Email Alert Career Job Opportunities Shanghai, China – December 18, 2024 – 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 the first prescription for VELSIPITY® has been written at Foshan Fosun Chancheng Hospital in Guangdong, under the "Hong Kong and Macau Medicine and Equipment Connect" policy, which marks the official beginning of this new therapy benefiting patients in mainland China. VELSIPITY® is an innovative advanced therapy that was approved by the Pharmaceutical Administration Bureau of Macau in April 2024. It is an oral treatment taken once daily for the treatment of patients aged 16 and above with moderately to severely active ulcerative colitis (UC). UC is a chronic, relapsing, non-specific inflammatory disease, and as the disease progresses, the risk of disability and colorectal cancer incidence continues to rise. By 2030, the number of patients with UC in China is expected to more than double compared to 2019, reaching approximately 1 million, with a significant unmet need for innovative therapies. Professor Wu Ji, Director of the Gastroenterology Department at Foshan Fosun Chancheng Hospital said, "We are very happy to see that VELSIPITY® has been prescribed in our hospital through the 'Hong Kong and Macau Medicine and Equipment Connect' policy. With a large population of UC patients in the Guangdong province and high clinical demand, this is a significant milestone. As the only drug that has been proven to be effective in isolated proctitis in global Phase III clinical trials, VELSIPITY® is an oral treatment taken once daily with a favorable safety profile, providing an innovative treatment option for patients who have long been troubled by UC. We look forward to Everest Medicines further enhancing the accessibility of VELSIPITY® to benefit more Chinese patients in the future." As a core product of Everest Medicines, VELSIPITY® can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief. In the results of the Asian multi-center Phase 3 clinical trial of VELSIPITY® for the treatment of moderately to severely active UC announced in July this year, VELSIPITY® achieved positive topline data results in both the induction and maintenance treatment periods, providing further solid scientific basis and support for the wide application of the drug in clinical practice. In this October, through the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY® has officially been approved for patients with moderately to severely active UC by the Guangdong Provincial Medical Products Administration and can be used in the medical institutions designated by the Connect Policy in the Greater Bay Area, including First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University and Guangzhou United Family Healthcare. Also, with the recent inclusion in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area, VELSIPITY® is expected to accelerate its availability in all 45 designated medical institutions under the Connect Policy. 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, Australia, Singapore, UK, Switzerland, Israel and Macau for VELSIPITY® in ulcerative colitis. 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. Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

Phase 3Drug ApprovalClinical ResultVaccine

17 Dec 2024

·www.everestmedicines.com

Everest Medicines Announces Acceptance of the New Drug Application for VELSIPITY® by the National Medical Products Administration of China for the Treatment of Moderately to Severely Active Ulcerative Colitis

Shanghai, China - December 17, 2024 - 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 the National Medical Products Administration (NMPA) of China has officially accepted the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of patients with moderately to severely active ulcerative colitis (UC). VELSIPITY® is an effective and convenient, once-daily, oral treatment for patients with moderately to severely active UC. VELSIPITY® was officially approved by the Pharmaceutical Administration Bureau of Macau in April 2024, and was introduced in the Greater Bay Area in October through the "Hong Kong and Macau Medicine and Equipment Connect" policy. VELSIPITY® is now the third commercialized product of Everest Medicines. “We are pleased to see that the NDA for VELSIPITY® has been officially accepted in mainland China., "said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “If approved, China would represent the third approval of VELSIPITY® in Everest’s licensed territories after Macau and Singapore. By 2030, the number of patients with UC in China is expected to more than double compared to 2019, reaching approximately 1 million, with a significant unmet need for innovative therapies. We are committed to expanding access to VELSIPITY®, with the goal of benefiting more patients living with moderately to severely active ulcerative colitis. " "As the only drug that has been proven to be effective in UC patients with moderately to severely active isolated proctitis in global Phase III clinical trials, the official acceptance of the NDA for VELSIPITY® in mainland China brings hope to many patients,” said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod’s Asia clinical trial.” As a next-generation S1P receptor modulator, VELSIPITY® can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief. In addition, the data from the largest-scale Phase III clinical trial of moderately to severely active UC patients in Asia once again confirmed the favorable efficacy and safety profile of VELSIPITY®. We look forward to the early approval of this drug to benefit more patients." As a key product for Everest Medicines, VELSIPITY® was approved in Macau, China and Singapore in the first half of this year. Its first prescription has been issued on December 11th at Kiang Wu Hospital in Macau, which marks the official beginning of this new therapy benefiting patients across Asia. In addition, Everest Medicines has also submitted and had its NDA officially accepted for VELSIPITY® in Hong Kong. With the support of the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY® has also been officially approved to enter the Greater Bay Area and can be used in four designated medical institutions which are the First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University and Guangzhou United Family Hospital. VELSIPITY®has been recently included in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area (“the Catalog”), published by the Guangdong Provincial Medical Products Administration and Health Commission of Guangdong Province. With the inclusion of VELSIPITY® in the Catalog, we expect to accelerate its availability in all 45 designated medical institutions under the Connect Policy. 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, Australia, Singapore, UK, Switzerland, Israel and Macau, China for VELSIPITY® in ulcerative colitis. 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. Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

Phase 3Drug ApprovalNDAClinical Result

16 Dec 2024

·www.everestmedicines.com

Everest Medicines Announces the Inclusion of VELSIPITY® in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area

Shanghai, China – December 16, 2024 - 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 VELSIPITY® (etrasimod) has been included in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area (hereinafter referred to as “the Catalog”), published by the Guangdong Provincial Medical Products Administration and Health Commission of Guangdong Province. Products in the Catalog will be managed in accordance with the “Administrative Regulations on the Pharmaceutical and Medical Devices of Nine Municipalities in Guangdong Province in Guangdong-Hong Kong-Macau Greater Bay Area Imported from Hong Kong and Macau” (hereinafter referred to as “the Regulations”). The Regulations came into effect on December 1, 2024, aiming to legislate the implementation of the "Hong Kong and Macau Medicine and Equipment Connect" policy (hereinafter referred to as “the Connect Policy”), address challenges in the management of Hong Kong and Macau drugs and medical devices, and promote the high-level development of a healthy Bay Area. The list of designated medical institutions for the Connect Policy has recently been expanded to 45, achieving full coverage across the 9 municipalities in the Greater Bay Area. VELSIPITY® is an innovative advanced therapy that was officially approved by the Pharmaceutical Administration Bureau of Macau in April 2024. It is an oral treatment taken once daily for the treatment of patients aged 16 and above with moderately to severely active ulcerative colitis (UC). UC is a chronic, relapsing, non-specific inflammatory disease, and as disease progresses, the risk of disability and colorectal cancer incidence rises. Since October of this year, VELSIPITY® has been available in the First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University and Guangzhou United Family Healthcare, four of the medical institutions designated by the Connect Policy in the Greater Bay Area. With the inclusion of VELSIPITY® in the Catalog, we expect to accelerate its availability in all 45 designated medical institutions under the Connect Policy. “By 2030, the number of patients with UC is projected to more than double compared to 2019, reaching approximately 1 million, highlighting a significant unmet need for innovative therapies," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “The inclusion of VELSIPITY® in the Catalog demonstrates its status as an innovative therapy with proven clinical value, offering both efficacy and safety. This will help address the urgent demand for innovative therapies among UC patients in mainland China. We also plan to submit a New Drug Application for VELSIPITY® in Mainland China soon to enhance its accessibility. " As a core product for Everest Medicines, VELSIPITY® can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief. In the results of the Asian multi-center Phase 3 clinical trial of VELSIPITY® for the treatment of moderately to severely active UC announced in July this year, VELSIPITY® achieved positive topline data results in both the induction and maintenance treatment periods, providing further solid scientific basis and support for the wide application of the drug in clinical practice. VELSIPITY® was approved in Macau and Singapore in the first half of this year. In addition, Everest Medicines has also submitted a new drug application for VELSIPITY® in Hong Kong, China which was officially accepted on December 2, 2024. 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, Australia, Singapore, UK, Switzerland, Israel and Macau, China for VELSIPITY® in ulcerative colitis. 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. Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

Drug ApprovalPhase 3Clinical Result

100 Deals associated with Etrasimod Arginine

External Link

KEGG	Wiki	ATC	Drug Bank
D10930	-	-	DB14766

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Ulcerative colitis, active moderate	EU	Pfizer Europe MA EEIG	16 Feb 2024
Ulcerative colitis, active moderate	IS	Pfizer Europe MA EEIG	16 Feb 2024
Ulcerative colitis, active moderate	NO	Pfizer Europe MA EEIG	16 Feb 2024
Ulcerative colitis, active moderate	LI	Pfizer Europe MA EEIG	16 Feb 2024
Ulcerative colitis, active severe	LI	Pfizer Europe MA EEIG	16 Feb 2024
Ulcerative colitis, active severe	EU	Pfizer Europe MA EEIG	16 Feb 2024
Ulcerative colitis, active severe	IS	Pfizer Europe MA EEIG	16 Feb 2024
Ulcerative colitis, active severe	NO	Pfizer Europe MA EEIG	16 Feb 2024
Colitis, Ulcerative	US	Pfizer Inc.	12 Oct 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	NDA/BLA	CN	Everest Medicines Ltd.	17 Dec 2024
Colitis, Ulcerative	NDA/BLA	CN	Penn Pharmaceutical Services Ltd.	17 Dec 2024
Ulcerative colitis, active moderate	NDA/BLA	HK	Yunding Xinyao Pharmaceutical Technology Co., Ltd.	02 Dec 2024
Ulcerative colitis, active severe	NDA/BLA	HK	Yunding Xinyao Pharmaceutical Technology Co., Ltd.	02 Dec 2024
Crohn Disease	Phase 3	RO	Pfizer Inc.	06 Jan 2020
Crohn Disease	Phase 3	BY	Pfizer Inc.	06 Jan 2020
Crohn Disease	Phase 3	CH	Pfizer Inc.	06 Jan 2020
Crohn Disease	Phase 3	DK	Pfizer Inc.	06 Jan 2020
Crohn Disease	Phase 3	DE	Pfizer Inc.	06 Jan 2020
Crohn Disease	Phase 3	CO	Pfizer Inc.	06 Jan 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04176588 (NEWS) Manual	Phase 3	Colitis, Ulcerative	340	伊曲莫德（VELSIPITY®）	(ezphrhowiw) = rkzuoobvna vhyccoeold (pamomchobl ) View more	Positive	06 Nov 2024
				Placebo	(ezphrhowiw) = hnisnzhqew vhyccoeold (pamomchobl ) View more
NCT05061446 (CTgov)	Phase 2	Colitis, Ulcerative	54	Placebo	fffmfjwben(fqcafgwnwc) = vndqaybkra sryyvonbhz (jgwmuozfju, jdososxkun - yweefkuhuf) View more	-	29 Oct 2024
NCT04176588 (NEWS) Manual	Phase 3	Colitis, Ulcerative	320	伊曲莫德	(ybofjpmuoc) = horaipzgtw fmbzaooywm (alzjgzbowg ) View more	Positive	15 Jul 2024
				安慰剂	(ybofjpmuoc) = jkjcvezlil fmbzaooywm (alzjgzbowg ) View more
NCT04176588 (NEWS) Manual	Phase 3	Colitis, Ulcerative	340	伊曲莫德	(zviefslkhf) = 伊曲莫德组与安慰剂组相比，主要终点和所有关键次要终点均具有显著的临床意义和统计学意义（p<0.0001）的改善 fdgegbqjmx (xpyopojrgz ) View more	Positive	15 Jul 2024
				安慰剂
NCT04556734 (CTgov)	Phase 2	Alopecia Areata	80	Etrasimod (DB Treatment Period: Etrasimod 2 mg)	wrbohwxpwr(czovoacekb) = rriwdxizma wsfoshyvwg (xwxqpegvlv, fdamjbumqh - czuznkbkmz) View more	-	26 Jun 2024
				Etrasimod (DB Treatment Period: Etrasimod 3 mg)	wrbohwxpwr(czovoacekb) = ecgufbghkw wsfoshyvwg (xwxqpegvlv, xqgzkfkgyg - deysfayybn) View more
NCT03996369 \| NCT03945188 (Pubmed \| J Crohns Colitis) Manual	Phase 3	Colitis \| Proctitis	-	Etrasimod 2 mg once daily	(wrejwpqmju) = uhourwsped rleckxigbf (ynfiuzowgn ) View more	Positive	13 Apr 2024
				Placebo	(wrejwpqmju) = vgjdntrnby rleckxigbf (ynfiuzowgn ) View more
NCT02447302 (OASIS, Pubmed) Manual	Phase 2	Colitis, Ulcerative faecal calprotectin \| C-reactive protein	156	etrasimod 1 mg	-	Positive	20 Jan 2024
				Etrasimod 2 mg	(itfxubliiu) = iuwvgafycs pywixvhvir (moxnrbaylt )
NCT04682639 (VOYAGE, CTgov)	Phase 2	Eosinophilic Esophagitis	108	Etrasimod (Experimental: Etrasimod 2 mg)	seiywsfkdj(vmzrbisala) = vtadqpdyfk jiksqvbanw (vaaydnybcb, dtoxojvlac - invuglrtqo) View more	-	26 Oct 2023
				Etrasimod (Experimental: Etrasimod 1 mg)	seiywsfkdj(vmzrbisala) = wyrawlhvkn jiksqvbanw (vaaydnybcb, hgtdqkvkav - ijabldcatd) View more
NCT04706793 (CTgov)	Phase 3	Colitis, Ulcerative	42	placebo+etrasimod (Placebo Comparator: Placebo)	kheqpjtash(yofbvamqjh) = bybvezzhda yoydgebbxc (zewduovmfp, vfsstsxyfu - krnhwzqdgm) View more	-	16 Oct 2023
				Etrasimod (Experimental: Etrasimod 2 mg)	kheqpjtash(yofbvamqjh) = dmttjojixd yoydgebbxc (zewduovmfp, ybiprphzte - idkwfrlvyt) View more
UEGW2023	Not Applicable	-	-	Etrasimod 2 mg	(zkknprhtux) = irgxaogmyu mithindsrl (uawklyeili ) View more	-	15 Oct 2023
				Placebo	(zkknprhtux) = capcykiock mithindsrl (uawklyeili ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis