The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.

Start Date25 Feb 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

NCT06147232

/ Not yet recruitingPhase 2IIT

Prevention of CKD Progression in Type 1 Diabetes With Long Term Use of SGLTi Avoiding Kidney hypOxia(PLUTO)

Background: Sodium-glucose-cotransporter (SGLT) inhibition has been observed to reduce risk of cardiovascular events and kidney failure in persons with type 2 diabetes. People with type 1 diabetes also have increased risk of cardiovascular and kidney disease, and may benefit from SGLT-inhibition. The exact mechanism of how SGLT-inhibition benefits the kidneys are yet unknown. Change in renal hypoxia may be a factor.
Objective: The primary aim of this study is to assess the effects of 12 weeks SGLT-1 and 2 inhibition on renal oxygenation in persons with type 1 diabetes and chronic kidney disease.
Further aims are to study if renal oxygen consumption and response to SGLT-inhibition differs between people of African-Caribbean or Northern European decent.
Additionally effects on left ventricular ejection fraction, kidney function and biomarkers in blood and urine will be explored.
Method: 12 weeks treatment with oral sotagliflozin or matching placebo as intervention. Kidney oxygenation and perfusion parameters and left ventricular ejection fraction will be assessed by functional magnetic resonance imaging. Kidney function and biomarkers will be assessed according to local hospital laboratory guidelines.
Design: Randomized, double-blinded, placebo-controlled, cross over intervention study.
Study population: 69 persons with type 1 diabetes and diabetic kidney disease with albuminuria will be included, 39 at Steno Diabetes Center Copenhagen, 30 at King's College London.
Endpoints: Primary end-point: Change from 0 to 12 weeks in dynamic R2*-weighted signal after treatment with sotagliflozin compared to placebo. Secondary endpoints: Change from 0 to 12 weeks with sotagliflozin compared with placebo on renal perfusion, renal artery flow, renal oxygen consumption, renal parenchymal triglyceride fraction, renal fibrosis, left ventricular ejection fraction, urinary albumin-creatinin ratio, ketone bodies, erythropoietin, pro brain natriuretic peptide, and plasma- and urine inflammation- and fibrosis biomarkers as well as difference after 12 weeks treatment in glomerular filtration rate.
Timeframe: Inclusion of patients from february 2024. Last visit september 2025. Presentation spring 2026, publication fall 2026.

Start Date01 Feb 2025

Sponsor / Collaborator

Steno Diabetes Center A/S

[+4]

NCT06435156

/ RecruitingPhase 2IIT

A Phase 2 Double-blind Randomised Controlled Trial Studying the Effect of Sotagliflozin Versus Placebo in Individuals with Heart Failure and Type 1 Diabetes.

People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population.
In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients' symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that it is not known if these benefits also apply to this population.
This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (UK). This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.

Start Date28 Jan 2025

Sponsor / Collaborator

University Of Dundee

[+2]

100 Clinical Results associated with Sotagliflozin

100 Translational Medicine associated with Sotagliflozin

100 Patents (Medical) associated with Sotagliflozin

332

Literatures (Medical) associated with Sotagliflozin

09 Apr 2025·Journal of the American Chemical Society

Kinetic Steering of Amyloid Formation and Polymorphism by Canagliflozin, a Type-2 Diabetes Drug

Article

Author: Ranson, Neil A. ; Willis, Leon F. ; Xu, Yong ; Zhuravleva, Anastasia ; Brinkworth, Alice ; Radford, Sheena E. ; Foster, Richard ; Chakraborty, Pijush ; Wilkinson, Martin ; Taylor, Alexander I. P.

Amyloid formation is involved in widespread health conditions such as Alzheimer's disease, Parkinson's disease, and type-2 diabetes. Amyloid fibrils have a similar cross-β architecture, but fibrils formed by a single protein sequence can have diverse structures, varying with time, self-assembly conditions, and sequence modifications. Fibril structure has been proposed to be diagnostic of disease, but why different structures result under different conditions, especially in vitro, remains elusive. We previously identified a small molecule, YX-I-1, which inhibits in vitro amyloid formation by islet amyloid polypeptide (IAPP), a peptide hormone whose amyloid formation is involved in type-2 diabetes. Here, using YX-I-1 as a lead, we identified regulator-approved drugs with similar structures by chemical similarity analysis and substructure searches and monitored the effect of 24 of these potential ligands on IAPP amyloid assembly in vitro. We show that one such compound, canagliflozin (Invokana), a type-2 diabetes drug already in clinical use, can strongly delay the kinetics of IAPP amyloid formation, an activity independent of its intended mode of action [sodium-glucose linked transporter 2 (SGLT2) inhibitor] that may have important therapeutic implications. Combining analysis of amyloid self-assembly kinetics, biophysical characterization of monomer and fibril binding, and cryo-EM of the assembly products, we show that YX-I-1 and canagliflozin target IAPP early in aggregation, remodeling the energy landscape of primary nucleation and profoundly altering the resulting fibril structures. Early binding events thus imprint long-lasting effects on the amyloid structures that form.

01 Apr 2025·Physiological Reports

Effects of sotagliflozin on kidney and cardiac outcome in a hypertensive model of subtotal nephrectomy in male mice

Article

Author: Lopez, Natalia ; Zemljic‐Harpf, Alice ; Galdino, Ony Araujo ; Goodluck, Helen ; Vallon, Volker ; Kanoo, Sadhana ; Kim, Young Chul

Abstract:

Dual inhibition of sodium glucose cotransporters 1 and 2 (SGLT1/SGLT2) by sotagliflozin protects the kidney and heart in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). To gain mechanistic insights, the current study aimed to establish a murine model of hypertensive CKD that shows cardio‐renal protection by sotagliflozin. Since protection by SGLT2 inhibitors can be diabetes‐independent, a nondiabetic murine model of subtotal nephrectomy with angiotensin II infusion‐facilitated hypertension was followed for 7 weeks. The model showed 40% lower GFR, doubling in plasma FGF23, 50 mmHg higher systolic blood pressure (SBP), 100‐fold increased albuminuria, and robust signs of kidney injury, inflammation, and fibrosis versus sham controls, associated with a 30% larger left cardiac ventricle and wall thickness and upregulation of markers of cardiac overload and fibrosis. Sotagliflozin, initiated 1 week after the last surgery, showed target‐engagement evidenced by glucosuria, 9 mmHg lower SBP, temporal reduction in body weight and GFR, and 30% higher plasma GLP1. Sotagliflozin, however, did not improve markers of kidney injury, inflammation, fibrosis, albuminuria, and plasma FGF23, or signs of cardiac overload, fibrosis, or impaired function. Limited sotagliflozin responsiveness may relate to short treatment time, limited metabolic benefits in nondiabetic setting and/or the model's dominant angiotensin II‐driven effects/hypertension.

01 Apr 2025·ESC Heart Failure

Effects of sodium–glucose co‐transporter inhibitors on individual clinical endpoints and quality of life

Article

Author: Kiuchi, Márcio G. ; Templin, Christian ; Meyer, Christian ; Chen, Shaojie ; Ebrahimi, Ramin ; Liu, Shaowen ; Liao, Jia ; Schmidt, Boris ; Acou, Willem‐Jan ; Derndorfer, Michael ; Heukäufer, Matthias ; Chun, Julian K. R. ; Martinek, Martin ; Niel, Johannes ; Ebrahimi, Fahim ; Futyma, Piotr ; Empen, Klaus ; Chamling, Bishwas ; Yin, Yuehui ; Janschel, Sarah ; Dörr, Marcus ; Schratter, Alexandra ; Ling, Zhiyu ; Sommer, Philipp ; Pürerfellner, Helmut ; Di Vece, Davide ; Chen, Yang ; Hummel, Astrid

Abstract:

Aims:

Sodium–glucose co‐transporter inhibitors (SGLTis) have cardiovascular protective effects. We aimed to assess the effects of SGLTis on individual hard clinical endpoints and quality of life (QoL) in patients with cardiovascular risk factors.

Methods and Results:

Data was searched in PubMed, Embase, Cochrane Library and clinicaltrials.gov databases up to February 2024. Randomized controlled trials (RCTs) comparing SGLTis with placebo were included. The primary outcomes were individual hard clinical endpoints (Subset A) and QoL (Subset B). For Subset A, 13 RCTs including 90 413 patients were enrolled (age 66 ± 10.1 years, 35.7% female, follow‐up 2.4 ± 0.3 years); as compared with placebo, SGLTis were associated with significantly lower risk of all‐cause mortality [risk ratio (RR): 0.90, 95% confidence interval (CI): 0.86–0.94, P < 0.01], cardiovascular mortality (RR: 0.87, 95% CI: 0.82–0.92, P < 0.01), hospitalization for heart failure (HF) (RR: 0.72, 95% CI: 0.68–0.76, P < 0.01), HF events (RR: 0.72, 95% CI: 0.68–0.75, P < 0.01), hospitalization for any cause (RR: 0.91, 95% CI: 0.88–0.93, P < 0.01) and myocardial infarction (MI) (RR: 0.92, 95% CI: 0.85–0.99, P = 0.03). Notably, the favourable effect of SGLTis on all‐cause mortality was more pronounced in younger (<65 years) patients (RR: 0.86, 95% CI: 0.81–0.92) and in studies with less female (RR: 0.84, 95% CI: 0.79–0.90). The favourable effect of SGLTis on MI was only observed in patients who received sotagliflozin (RR: 0.47, 95% CI: 0.31–0.73). For Subset B, nine RCTs including 2552 HF patients were enrolled (age 67.8 ± 12.4 years, 36.4% female, follow‐up 3.4 ± 1.9 months); SGLTis were associated with significant improvement in QoL as compared with placebo.

Conclusions:

In patients with a broad spectrum of cardiovascular risk factors, SGLTis substantially improve individual hard clinical outcomes and QoL.

168

News (Medical) associated with Sotagliflozin

28 Mar 2025

·www.globenewswire.com

Lexicon Pharmaceuticals Announces Exclusive License Agreement with Novo Nordisk for LX9851

Lexicon eligible to receive up to $1 billion in upfront and development, regulatory and sales milestone payments, including $75 million in upfront and near-term milestone paymentsTHE WOODLANDS, Texas, March 28, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development candidate in obesity and associated metabolic disorders. Under the terms of the agreement, Novo Nordisk obtains an exclusive, worldwide license to develop, manufacture and commercialize LX9851 in all indications. Lexicon will be responsible for completing agreed upon Investigational New Drug (IND) application-enabling activities for LX9851. Novo Nordisk will be responsible for filing the IND, all further development, manufacturing and commercialization of LX9851. Lexicon is eligible to receive upfront and near-term milestone payments of up to $75 million. In total, Lexicon will be eligible to receive $1 billion in upfront and potential development, regulatory and sales milestone payments. Lexicon is also entitled to tiered royalties on net sales of LX9851. LX9851, discovered and developed by Lexicon, is a potent and selective oral small molecule inhibitor of Acyl-CoA Synthetase 5 (ACSL5). ACSL5 plays a key role in the metabolic pathway which regulates fat accumulation and energy balance. Additionally, LX9851 may activate the ileal brake mechanism leading to increased satiety by delaying gastric emptying and suppressing appetite. Preclinical in vivo efficacy data presented at Obesity Week 2024 show that LX9851, when combined with semaglutide, significantly reduced weight, food intake and fat mass compared to semaglutide alone. Separately, LX9851 mitigated weight regain and had positive effects on liver steatosis when introduced after semaglutide discontinuation. "We are thrilled that Novo Nordisk, a global leader in diabetes care and obesity management, has recognized the potential of LX9851," said Mike Exton, Ph.D., chief executive officer and director of Lexicon. "This arrangement decisively strengthens our financial position, providing optionality as we further invest and accelerate our R&D portfolio.” “Novo Nordisk is committed to serving the diverse needs of people living with obesity and other metabolic diseases and to build a pipeline of differentiated drug candidates in this space,” Jacob Sten Petersen, Senior Vice President, Diabetes, Obesity and MASH therapeutic area at Novo Nordisk. “We are pleased to enter this agreement with Lexicon as it will allow us to explore a novel biology and potential treatment paradigm further, and we look forward to building on the great work Lexicon has already done with the development of LX9851.” About LX9851LX9851 is an orally delivered small molecule drug candidate for the treatment of obesity and associated cardiometabolic disorders. Lexicon is investigating the pharmacology of LX9851 as a stand-alone therapy and in combination with GLP-1 agonists such as semaglutide. Lexicon scientists identified the function of ACSL5, the target of LX9851, based on their discovery that knockout mice lacking the target enzyme exhibited favorable phenotypes across multiple measures of metabolic syndrome in preclinical models, including resistance to diet-induced obesity and improved body composition. About Lexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in cardiology, neuropathic pain, metabolism and other indications. For additional information, please visit www.lexpharma.com. About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, conduct preclinical and clinical development and obtain necessary regulatory approvals of pilavapadin (LX9211), LX9851, sotagliflozin and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Investor and Media Inquiries:Lisa DeFrancesco Lexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com

License out/in

03 Mar 2025

·endpts.com

Lexicon plots Phase 3 trial for diabetic pain drug despite mid-stage flop

Lexicon Pharmaceuticals’ non-opioid drug has failed a mid-stage test in a chronic pain indication — but the company says there’s still a path forward and even potential partnership opportunities for the lower dose. The biotech’s AAK1 inhibitor, dubbed pilavapadin, did not meet the primary endpoint of change from baseline in average daily pain score (ADPS) at eight weeks in the Phase 2b PROGRESS trial in moderate to severe diabetic peripheral neuropathic pain (DPNP). The condition develops when high blood sugar levels damage nerves throughout the body, causing pain and numbness. The primary endpoint miss was driven by a “lack of separation” between the 20 mg dose and placebo, according to a Monday release. The 10 mg pilavapadin dose, meanwhile, demonstrated “early and clinically meaningful separation from placebo” in ADPS, which was maintained throughout the trial, Lexicon said. But the trial technically still failed because its primary endpoint was designed to detect a “dose-response signal” that assumed separation from placebo across all treatment cohorts. Detailed results from PROGRESS will be presented at an upcoming medical meeting. Lexicon’s share price $LXRX plummeted around 29% premarket Monday. The Texas biotech still plans to advance the 10 mg dose into Phase 3 based on PROGRESS as well as a previous mid-stage study called RELIEF-DPN-1. The RELIEF-DPN-1 trial tested 10 mg and 20 mg of pilavapadin given after initial loading doses of 100 mg and 200 mg, respectively. By contrast, the PROGRESS trial did not feature a loading dose. In RELIEF-DPN-1, the 10 mg arm met the ADPS primary endpoint at six weeks versus placebo but the 20 mg arm “narrowly missed statistical significance.” In RELIEF-DPN-1, both treatment arms were also negatively impacted by tolerability issues due to the high-loading doses. But in PROGRESS, the 10 mg dose was well tolerated with most side effects being mild or moderate. “The enormous potential of [pilavapadin] has generated significant interest from potential partners, and we intend to accelerate these discussions while we plan for Phase 3 development,” Lexicon CEO Mike Exton said in the Monday release. He added that the neuropathic pain market represents a “multibillion dollar opportunity.” Pilavapadin took center stage for Lexicon in November when the company got rid of its commercial team and switched tack to focus on clinical development. That decision came on the heels of regulatory setbacks for its type 1 diabetes and chronic kidney disease drug sotagliflozin, which faced two rejections from the FDA in the span of five years. In 2022, pilavapadin failed a Phase 2 study in patients with postherpetic neuralgia, a rare side effect of shingles. Editor’s Note: This article was updated to add information about Lexicon’s share price.

Phase 2Phase 3Clinical Result

03 Mar 2025

·www.drugs.com

Sotagliflozin Cuts MACE Rate in Patients With T2DM, CKD, CVD Risk Factors

MONDAY, March 3, 2025 -- For patients with type 2 diabetes , chronic kidney disease, and additional cardiovascular risk factors, the dual sodium-glucose co-transporter (SGLT)-1/2 inhibitor sotagliflozin is associated with a significantly reduced rate of major adverse cardiovascular events (MACE), with independent reductions in myocardial infarction and stroke, according to a study published online Feb. 14 in The Lancet Diabetes & Endocrinology . Rahul Aggarwal, M.D., from Harvard Medical School in Boston, and colleagues conducted a prespecified secondary analysis of the SCORED trial, a double-blind, randomized trial enrolling adult patients with type 2 diabetes, chronic kidney disease, and additional cardiovascular risk factors. A total of 10,584 patients from 750 sites in 44 countries were randomly assigned to receive oral sotagliflozin or placebo (5,292 to each group) between Dec. 8, 2017, and Jan. 20, 2020. The researchers found that the rate of total MACE was significantly lower in the sotagliflozin group versus placebo group (4.8 versus 6.3 events per 100 person-years; hazard ratio [HR], 0.77). Among stratified subgroups, there was a consistent effect for sotagliflozin on total MACE, with no evidence of heterogeneity. Compared with placebo, sotagliflozin also significantly reduced the rate of myocardial infarction (1.8 versus 2.7 events per 100 person-years; HR, 0.68) and stroke (1.2 versus 1.8 events per 100 person-years; HR, 0.66). "This ischemic benefit of sotagliflozin on both stroke and myocardial infarction has not been observed in trials of selective SGLT-2 inhibitors, warranting further investigation of SGLT-1 inhibition as a potential mechanism for these effects," the authors write. Several authors disclosed ties to pharmaceutical companies, including Lexicon Pharmaceuticals, which manufactures sotagliflozin and funded the study.

AHAClinical ResultClinical Study

100 Deals associated with Sotagliflozin

External Link

KEGG	Wiki	ATC	Drug Bank
D10669	Sotagliflozin	A10BK06	DB12713

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Failure	United States	Lexicon Pharmaceuticals, Inc.	26 May 2023
Diabetes Mellitus, Type 1	European Union	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	Iceland	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	Liechtenstein	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	Norway	NCI Healthcare LLC	26 Apr 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	NDA/BLA	United States	Lexicon Pharmaceuticals, Inc.	21 Jun 2024
Diabetic Nephropathies	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Diabetic Nephropathies	Phase 3	Canada	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Kidney Failure, Chronic	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Kidney Failure, Chronic	Phase 3	Canada	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Argentina	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	United Kingdom	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic obstructive cardiomyopathy	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic obstructive cardiomyopathy	Phase 3	Argentina	Lexicon Pharmaceuticals, Inc.	24 Sep 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03315143 (SCORED, Lancet) Manual	Phase 3	Ischemia	10,584	Sotagliflozin	roimhanpyn(cxrdcuskbi) = ldefexuyte kydfzgjjhq (mesyrdftkp ) View more	Positive	14 Feb 2025
				Placebo	roimhanpyn(cxrdcuskbi) = awdlgbwdii kydfzgjjhq (mesyrdftkp ) View more
NCT02531035 \| NCT02384941 \| NCT02421510 (Pubmed) Manual	Not Applicable	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	-	Sotagliflozin 200mg (CKD)	qayceocaic(iqcgakcmug) = jujiqukfjz bkginibmgu (sketdcsezg ) View more	Positive	01 Nov 2024
				Sotagliflozin 400mg (CKD)	qayceocaic(iqcgakcmug) = qlqbhigmcv bkginibmgu (sketdcsezg ) View more
NCT03285594 (SOTA-INS, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Sotagliflozin 400 mg	anbzairiyh(iepammncrb) = ifupsopepc wvxubolbse (qrkqfalhqu )	Positive	10 Sep 2024
				Sotagliflozin 200 mg	anbzairiyh(iepammncrb) = lrutpfjxfl wvxubolbse (qrkqfalhqu )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	Phase 3	Diabetes Mellitus, Type 2 \| Heart Failure	-	Sotagliflozin	gmwbxlwdpi(ttlbeqvnga) = The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups fzlofsxdxj (dwmwrzdgns )	Positive	01 Sep 2024
				Placebo
ESC2024	Not Applicable	Diabetes Mellitus	-	Sotagliflozin	djmpsecegc(mscolmjdqx) = vknwmbdjtv ikdcufuzpv (xogeaphcil ) View more	-	30 Aug 2024
				Placebo	djmpsecegc(mscolmjdqx) = jloeclvgdl ikdcufuzpv (xogeaphcil ) View more
924-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2 Add-on	570	Sotagliflozin 400 mg	jmiurqutjj(yxfmjpznuz) = pbpqremkkw nkeepaqmry (ysufzhkwou )	Positive	14 Jun 2024
				Sotagliflozin 200 mg	jmiurqutjj(yxfmjpznuz) = eqzztezwgm nkeepaqmry (ysufzhkwou )
917-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2	770	Sotagliflozin 400 mg	jkotngshsp(ezsgieoywj) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy slqdqijucc (laeuqiwmmd ) View more	Positive	14 Jun 2024
				Empagliflozin 25 mg
NCT03315143 (SCORED, GlobeNewswire) Manual	Phase 3	Heart Failure	1,932	INPEFA® (sotagliflozin)	zlhcfqqkss(oskbefmoih) = xtjlycxgls lykdzwysyt (xybjpdmjpc )	Positive	14 May 2024
SOLOIST-WHF and SCORED (ESC2024)	Not Applicable	obesity \| type 2 diabetes (T2D)	-	Sotagliflozin	xtcdqbchfb(qxhjzqwixp) = uivfazlums oudsjxebjh (rbegcdmkei )	Positive	14 May 2024
NCT03315143 (SCORED, ACC2024) Manual	Phase 3	Cardiovascular Diseases \| Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	10,584	Sotagliflozin	dajapbpnrv(hdhmnmyvtq) = wsmdxurqfk spahhmodhg (miqysltlrl ) View more	Positive	25 Mar 2024
				Placebo	dajapbpnrv(hdhmnmyvtq) = dvmzsyffjb spahhmodhg (miqysltlrl ) View more

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