A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC)

The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.

Start Date29 Sep 2021

Sponsor / Collaborator

Bausch Health Americas, Inc.

EUCTR2020-005232-30-BG

/ Not yet recruitingPhase 2

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC)

Start Date22 Jun 2021

Sponsor / Collaborator

Salix Pharmaceuticals, Inc.

NCT02389790

/ CompletedPhase 2

A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study

The primary objectives of the study are:
-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）

Start Date01 Aug 2015

Sponsor / Collaborator

Mitsubishi Tanabe Pharma Corp.

100 Clinical Results associated with Amiselimod hydrochloride

100 Translational Medicine associated with Amiselimod hydrochloride

100 Patents (Medical) associated with Amiselimod hydrochloride

Literatures (Medical) associated with Amiselimod hydrochloride

10 Jan 2025·ACS Infectious Diseases

High-Throughput Screening of More Than 30,000 Compounds for Anthelmintics against Gastrointestinal Nematode Parasites

Article

Author: Thompson, Paul R. ; Chen, Paulina ; Barasa, Leonard ; Aroian, Raffi V. ; Kim, Youmie ; Elfawal, Mostafa A. ; Goetz, Emily ; Savinov, Sergey N.

Gastrointestinal nematodes (GINs) are among the most common parasites of humans, livestock, and companion animals. GIN parasites infect 1-2 billion people worldwide, significantly impacting hundreds of millions of children, pregnant women, and adult workers, thereby perpetuating poverty. Two benzimidazoles with suboptimal efficacy are currently used to treat GINs in humans as part of mass drug administrations, with many instances of lower-than-expected or poor efficacy and possible resistance. Thus, new anthelmintics are urgently needed. However, screening methods for new anthelmintics using human GINs typically have low throughput. Here, using our novel screening pipeline that starts with human hookworms, we screened 30,238 unique small molecules from a wide range of compound libraries, including ones with generic diversity, repurposed drugs, natural derivatives, known mechanisms of action, as well as multiple target-focused libraries (e.g., targeting kinases, GPCRs, and neuronal proteins). We identified 55 compounds with broad-spectrum activity against adult stages of two evolutionary divergent GINs, hookworms (Ancylostoma ceylanicum) and whipworms (Trichuris muris). Based on known databases, the targets of these 55 compounds were predicted in nematode parasites. One novel scaffold from the diversity set library, F0317-0202, showed good activity (high motility inhibition) against both GINs. To better understand this novel scaffold's structure-activity relationships (SAR), we screened 28 analogs and created SAR models highlighting chemical and functional groups required for broad-spectrum activity. These studies validate our new and efficient screening pipeline at the level of tens of thousands of compounds and provide an important set of new GIN-active compounds for developing novel and broadly active anthelmintics.

06 Sep 2024·MEDICINE

Safety and efficacy of S1P receptor modulators for the induction and maintenance phases in inflammatory bowel disease: A systematic review and meta-analysis of randomized controlled trials

Review

Author: Omer, Areeb ; Akram, Abdullah ; Khan, Ali Tahir ; Farhan, Kanza ; Memon, Saria ; Furqan, Humam ; Anjum, Muhammad Umair ; Kaleem, Shamama ; Aslam, Uzma ; Tahir, Muhammad Abdullah ; Karam, Ayatul ; Ahmed, Misha ; Bhattarai, Pratik

Background::

Inflammatory bowel disease (IBD) is a chronic inflammatory condition that significantly affects quality of life. Conventional treatments have had limited success. this study evaluates the safety and efficacy of Sphingosine 1-phosphate receptor modulators (S1PrMs) as a potential treatment for IBD.

Methods::

We conducted a thorough search of published literature on PubMed, EMBASE, and Google Scholar from 2000 to 2023. The inclusion criteria were randomized controlled trials (RCTs) with a target population comprising of IBD patients receiving either S1PrMs or placebo and a comparison of the 2. The statistical analysis was conducted using RevMan (version 5.4). Forest plots presented the results as risk ratios (RR) with a 95% confidence interval.

Results::

A total of 7 RCTs involving 2471 patients were included. The results were reported for both the induction and maintenance phases of treatment. in the induction phase, the intervention group proved to have a significantly higher incidence of histological remission (RR = 2.67; 95% CI [1.97, 3.60]; P < .00001), endoscopic improvement (RR = 2.06; 95% CI [1.66, 2.56]; P < .00001), clinical remission (RR = 2.23; 95% CI [1.43, 3.46]; P < .0004) and clinical response (RR = 1.37; 95% CI [1.01, 1.84]; P = .04) compared to the placebo group. Outcomes assessed in maintenance phase significantly favored the intervention group over placebo as well, histologic remission (RR = 2.39; 95% CI [1.83, 3.11]; P < .00001), endoscopic improvement (RR = 2.20; 95% CI [1.28, 3.77]; P = .004), clinical remission (RR = 3.03; 95% CI [1.84, 4.99]; P < .0001), and clinical response (RR = 1.74; 95% CI [1.25, 2.42]; P = .001).

Conclusion::

S1PrMs show promising potential for establishing histologic remission, endoscopic improvement, clinical remission, and corticosteroid-free clinical remission. With more studies and clinical trials, these modulators may become a reliable therapeutic choice for UC patients everywhere.

01 Apr 2023·Drugs

Targeted Small Molecules for Systemic Lupus Erythematosus: Drugs in the Pipeline

Article

Author: Mok, Chi Chiu

Despite the uncertainty of the pathogenesis of systemic lupus erythematosus, novel small molecules targeting specific intracellular mechanisms of immune cells are being developed to reverse the pathophysiological processes. These targeted molecules have the advantages of convenient administration, lower production costs, and the lack of immunogenicity. The Janus kinases, Bruton's tyrosine kinases, and spleen tyrosine kinases are important enzymes for activating downstream signals from various receptors on immune cells that include cytokines, growth factor, hormones, Fc, CD40, and B-cell receptors. Suppression of these kinases impairs cellular activation, differentiation, and survival, leading to diminished cytokine actions and autoantibody secretion. Intracellular protein degradation by immunoproteasomes, levered by the cereblon E3 ubiquitin ligase complex, is an essential process for the regulation of cellular functions and survival. Modulation of the immunoproteasomes and cereblon leads to depletion of long-lived plasma cells, reduced plasmablast differentiation, and production of autoantibodies and interferon-α. The sphingosine 1-phosphate/sphingosine 1-phosphate receptor-1 pathway is responsible for lymphocyte trafficking, regulatory T-cell/Th17 cell homeostasis, and vascular permeability. Sphingosine 1-phosphate receptor-1 modulators limit the trafficking of autoreactive lymphocytes across the blood-brain barrier, increase regulatory T-cell function, and decrease production of autoantibodies and type I interferons. This article summarizes the development of these targeted small molecules in the treatment of systemic lupus erythematosus, and the future prospect for precision medicine.

News (Medical) associated with Amiselimod hydrochloride

14 Jun 2024

·www.biospace.com

Bausch Health Reports Promising R&D Trial Updates on Amiselimod and Scientific Data Presented at International Healthcare Conferences

LAVAL, QC / ACCESSWIRE / June 14, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, recently presented at two global healthcare conferences. Bausch Health's gastroenterology (GI) business, Salix Pharmaceuticals presented data from its Amiselimod clinical trials at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on May 19, 2024, in Washington, D.C., and post hoc pooled data analysis of Rifaximin at the International Liver Congress 2024™ (ILC 2024): Annual Meeting of the European Association for the Study of the Liver (EASL) on June 8, 2024 in Milan, Italy. Amiselimod at DDW Bausch Health shared positive late-breaking data from a global Phase 2 study evaluating Amiselimod for the treatment of patients with active, mild to moderate ulcerative colitis (UC) at Digestive Disease Week® (DDW) 2024. The data were presented by Dr. Steven Hanauer and Clifford Joseph Barborka, Professor of Medicine at Northwestern University. The randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of Amiselimod over a 12-week treatment period. The results demonstrated that Amiselimod was well-tolerated and showed promise as a potential treatment for inducing remission in UC patients. Specifically: In the primary endpoint measure - both doses of Amiselimod (0.2mg and 0.4mg daily) led to a significantly greater improvement in Modified Mayo Score (MMS) compared to a placebo group on Day 85. This score reflects disease activity, with a lower score indicating better outcomes. Patients taking Amiselimod experienced an average improvement of -2.3 points, compared to -1.6 points in the placebo group (p-score <0.01) In the secondary measures, endoscopic improvement and clinical remission, after 12 weeks, a significantly higher proportion of patients receiving Amiselimod achieved endoscopic improvement (over 42%) compared to placebo (23%) with statistically significant difference (p-score <0.01). Similarly, over 31% of patients on Amiselimod experienced clinical remission compared to 18% in the placebo group (p-score = 0.03). In the safety evaluation patients were closely monitored for any adverse events throughout the 12 weeks. The findings concluded that Amiselimod treatment was well-tolerated. "Our recent trial results are a testament to the dedication and expertise of our research teams," said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D. "The promising data from this Amiselimod trial brings us closer to offering new, effective treatment to patients suffering from ulcerative colitis (UC). We are excited to advance this therapy to the next stage of development." Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.1 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).1 Rifaximin at EASL At the European Association for the Study of the Liver (EASL) Conference, Bausch Health presented data comparing Rifaximin monotherapy to lactulose monotherapy in preventing overt hepatic encephalopathy (OHE) recurrence in cirrhosis patients with a history of OHE. This analysis, based on pooled data from two randomized trials (one phase 3 double-blind and one phase 4 open-label), focused on adult patients with cirrhosis and a history of OHE episodes showed that: Significantly fewer patients treated with Rifaximin monotherapy experienced an OHE episode compared with lactulose monotherapy (23.2% vs 49.0%, respectively; P<0.0001). Rifaximin monotherapy reduced the risk of a breakthrough OHE event by 60% versus lactulose monotherapy during 6 months of treatment. Rifaximin monotherapy was well tolerated. These data suggest Rifaximin monotherapy has the potential to be a viable treatment option for OHE recurrence risk reduction in appropriate patient populations. About Amiselimod Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5. 2 About XIFAXAN XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. About Salix Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit and connect with us on Twitter and LinkedIn. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit and connect with us on LinkedIn. References 1 IBD Clinic, University of Alberta: 2 BiseraStepanovska, AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019. The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed by Alfasigma S.p.A to Salix Pharmaceuticals or its affiliates. ©2024 Salix Pharmaceuticals or its affiliates. Investor Contact: Garen Sarafian ir@bauschhealth.com (877) 281-6642 (toll-free) Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (908) 541-3785 SOURCE: Bausch Health Companies Inc. View the original press release on accesswire.com

Clinical ResultPhase 2Phase 3

14 Jun 2024

·ir.bauschhealth.com

Bausch Health Reports Promising R&D Trial Updates on Amiselimod and Scientific Data Presented at International Healthcare Conferences

June 14, 2024 LAVAL, Quebec, June 14, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC), a global diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, recently presented at two global healthcare conferences. Bausch Health’s gastroenterology (GI) business, Salix Pharmaceuticals presented data from its Amiselimod clinical trials at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on May 19, 2024, in Washington, D.C., and post hoc pooled data analysis of Rifaximin at the International Liver Congress 2024™ (ILC 2024): Annual Meeting of the European Association for the Study of the Liver (EASL) on June 8, 2024 in Milan, Italy. Amiselimod at DDW Bausch Health shared positive late-breaking data from a global Phase 2 study evaluating Amiselimod for the treatment of patients with active, mild to moderate ulcerative colitis (UC) at Digestive Disease Week® (DDW) 2024. The data were presented by Dr. Steven Hanauer and Clifford Joseph Barborka, Professor of Medicine at Northwestern University. The randomized, double-blind, placebocontrolled trial investigated the efficacy and safety of Amiselimod over a 12-week treatment period. The results demonstrated that Amiselimod was well-tolerated and showed promise as a potential treatment for inducing remission in UC patients. Specifically: In the primary endpoint measure – both doses of Amiselimod (0.2mg and 0.4mg daily) led to a significantly greater improvement in Modified Mayo Score (MMS) compared to a placebo group on Day 85. This score reflects disease activity, with a lower score indicating better outcomes. Patients taking Amiselimod experienced an average improvement of -2.3 points, compared to - 1.6 points in the placebo group (p-score <0.01) In the secondary measures, endoscopic improvement and clinical remission, after 12 weeks, a significantly higher proportion of patients receiving Amiselimod achieved endoscopic improvement (over 42%) compared to placebo (23%) with statistically significant difference (pscore <0.01). Similarly, over 31% of patients on Amiselimod experienced clinical remission compared to 18% in the placebo group (p-score = 0.03). In the safety evaluation patients were closely monitored for any adverse events throughout the 12 weeks. The findings concluded that Amiselimod treatment was well-tolerated. “Our recent trial results are a testament to the dedication and expertise of our research teams,” said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D. “The promising data from this Amiselimod trial brings us closer to offering new, effective treatment to patients suffering from ulcerative colitis (UC). We are excited to advance this therapy to the next stage of development.” Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.1 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).1 Rifaximin at EASL At the European Association for the Study of the Liver (EASL) Conference, Bausch Health presented data comparing Rifaximin monotherapy to lactulose monotherapy in preventing overt hepatic encephalopathy (OHE) recurrence in cirrhosis patients with a history of OHE. This analysis, based on pooled data from two randomized trials (one phase 3 double-blind and one phase 4 open-label), focused on adult patients with cirrhosis and a history of OHE episodes showed that: Significantly fewer patients treated with Rifaximin monotherapy experienced an OHE episode compared with lactulose monotherapy (23.2% vs 49.0%, respectively; P<0.0001). Rifaximin monotherapy reduced the risk of a breakthrough OHE event by 60% versus lactulose monotherapy during 6 months of treatment. Rifaximin monotherapy was well tolerated. These data suggest Rifaximin monotherapy has the potential to be a viable treatment option for OHE recurrence risk reduction in appropriate patient populations. About Amiselimod Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5.2 About XIFAXAN XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. About Salix Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn. References 1 IBD Clinic, University of Alberta: http://www.ibdclinic.ca/what-is-ibd/ulcerative-colitis/ 2 BiseraStepanovska, AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019. The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed by Alfasigma S.p.A to Salix Pharmaceuticals or its affiliates. ©2024 Salix Pharmaceuticals or its affiliates. UNB.0018.USA.24 << Back to News Releases

Clinical ResultPhase 2Phase 3

17 May 2024

·www.biospace.com

Salix to Present Late-Breaking Data from Phase 2 Trial of Amiselimod in Active Ulcerative Colitis at Digestive Disease Week 2024

LAVAL, QC / ACCESSWIRE / May 17, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals, Ltd., today announced that they will be presenting data from its Phase 2 trial evaluating Amiselimod as treatment for active ulcerative colitis (UC). The data will be presented at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on Sunday, May 19, 2024, in Washington, D.C. "We are pleased to present late-breaking data on Amiselimod, our investigational, oral, sphingosine 1-phosphate (S1P) receptor modulator as a potential treatment for the induction of remission in UC," said Tage Ramakrishna, M.D., Chief Medical Officer and President of Research & Development, Bausch Health. "The abstract underscores our steadfast commitment to developing new and innovative therapies for patients with UC." The research to be featured at DDW 2024 and available via the meeting's online platform is as follows: Hanauer, Stephen B. et al. "Amiselimod for the treatment of active ulcerative colitis: a randomized, double-blind, placebo-controlled trial" Abstract #4094796 The Phase 2 clinical trial was a 12-week, double-blind, placebo-controlled, randomized, dose ranging study to evaluate the efficacy and safety of Amiselimod in 320 patients with mildly-to- moderately active UC. Bausch Health announced positive topline results from this study in December 2023. About Amiselimod Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5. 3 About Salix Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit and connect with us on Twitter and LinkedIn. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit and connect with us on Twitter and LinkedIn. About DDW Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at References 1. Kunio Sugahara, Yasuhiro Maeda. Amiselimod, a novel sphingosine 1‐phosphate receptor‐1 modulator, has potent therapeutic efficacy for autoimmune diseases, with low bradycardia risk. British Journal of Pharmacology. January 2017. 2. Peyrin-Biroulet, Ronald Christopher Modulation of sphingosine-1-phosphate in inflammatory bowel disease. Autoimmunity Reviews. February 2017. 3. BiseraStepanovska, AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019. Investor Contact: Media Contact: Garen Sarafian Kevin Wiggins ir@bauschhealth.com corporate.communications@bauschhealth.com (877) 281-6642 (toll-free) (908) 541-3785 SOURCE: Salix Pharmaceuticals View the original press release on accesswire.com

Phase 2Clinical Result

100 Deals associated with Amiselimod hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10905	-	-	-

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 2	United States	Bausch Health Americas, Inc.	29 Sep 2021
Crohn Disease	Phase 2	Japan	Mitsubishi Tanabe Pharma Corp.	01 Mar 2015
Crohn Disease	Phase 2	Czechia	Mitsubishi Tanabe Pharma Corp.	01 Mar 2015
Crohn Disease	Phase 2	France	Mitsubishi Tanabe Pharma Corp.	01 Mar 2015
Crohn Disease	Phase 2	Germany	Mitsubishi Tanabe Pharma Corp.	01 Mar 2015
Crohn Disease	Phase 2	Hungary	Mitsubishi Tanabe Pharma Corp.	01 Mar 2015
Crohn Disease	Phase 2	Israel	Mitsubishi Tanabe Pharma Corp.	01 Mar 2015
Crohn Disease	Phase 2	Italy	Mitsubishi Tanabe Pharma Corp.	01 Mar 2015
Crohn Disease	Phase 2	Netherlands	Mitsubishi Tanabe Pharma Corp.	01 Mar 2015
Crohn Disease	Phase 2	Poland	Mitsubishi Tanabe Pharma Corp.	01 Mar 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Corporate Publications Manual	Phase 2	Colitis, Ulcerative	-	Amiselimod 0.2 mg/d	jfgtyrosic(ijnoaltssr) = mkpnyyxdxg dxflbfbceh (frswqbqlva ) View more	Positive	14 Jun 2024
				Amiselimod 0.4 mg/d	jfgtyrosic(ijnoaltssr) = irpurkqqrh dxflbfbceh (frswqbqlva ) View more
NCT04857112 (Corporate Publications) Manual	Phase 2	Colitis, Ulcerative	320	Amiselimod	yhhdouvrde(dkpqvkkhfn) = vnlgbklggw jvqhqoogrb (jodebpsyhp ) Met View more	Positive	21 Dec 2023
				Placebo	yhhdouvrde(dkpqvkkhfn) = wttlxzzive jvqhqoogrb (jodebpsyhp ) Met View more
NCT01890655 (Pubmed) Manual	Phase 2	Multiple sclerosis relapse	415	amiselimod	sumelfejka(jbfzovkfyw) = agqgflmwbt gtmrzczhmj (sfshzjfcmw ) View more	Positive	01 Oct 2018

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