Delving into the Latest Updates on Sulodexide with Synapse

Herpes zoster (HZ), especially postherpetic neuralgia, is one of the most typical types of clinical neuralgia. The incidence rate of HZ in China is approximately 7.7%. Among them, 29.8% of HZ patients eventually develop PHN. About 20% of PHN patients suffer from severe neuralgia for more than one year, or even ten years. It is worth noting that patients with neuralgia are prone to comorbidities such as depression, anxiety and sleep disorders, which seriously affect their work efficiency and quality of life. This is a great torment to both the patients and their families, and it also imposes a heavy burden on the medical system.
Professor Xiao Lizu, a collaborator of our team, has discovered in clinical practice that spinal cord electrical stimulation for HZ patients can significantly reduce the risk of developing PHN. Other therapies for reducing the risk of PHN include multiple parvertebral injections of local anesthetics/steroids, which require patients to return for repeated visits. Although these intervention measures have good effects, they may bring additional economic burdens to patients, treatment side effects and prolong their hospital stays. Therefore, they are not suitable for all patients. From this perspective, our development of early screening methods and selective non-pharmacological intervention only for high-risk patients will improve the overall treatment status of HZ, effectively reduce the incidence of PHN, and alleviate the burden on medical insurance and the medical system at the same time.
This project aims to conduct the following research by analyzing the intestinal flora of patients: identifying biomarkers with the ability to predict the risk of PHN in patients, constructing a machine learning classifier for risk prediction, and developing an early screening kit based on this.
Furthermore, traditional studies mostly focus on a single pathological link and lack systematic multi-dimensional analysis. In recent years, the cerebral lymphatic system, as a key pathway for the clearance of metabolic wastes in the brain, has attracted widespread attention. Furthermore, the role of the gut-brain axis in pain regulation has gradually been recognized. Therefore, it is of great scientific significance to integrate and explore the pathological mechanism of PHN from three dimensions: the lymphatic system, neuroinflammation, and intestinal flora.
This project assumes that patients with PHN have a pathological triad of "lymphoid dysfunction - neuroinflammatory activation - intestinal flora imbalance". The specific manifestations are as follows: Impaired lymphoid clearance function (decreased DTI-ALPS index and increased free water), activated systemic inflammatory response (elevated TNF-α and IL-6), and disordered intestinal flora structure (decreased α diversity and increased opportunistic pathogenic bacteria). The three interact with each other and have a synergistic effect, jointly participating in the pathogenesis of PHN.The expected outcome of this project may provide new options for pain management of the large group of neuralgia patients, improve their quality of life, and has great practicality and practical value.

Start Date01 Jul 2025

Sponsor / Collaborator-

NCT06982196

/ Enrolling by invitationPhase 3IIT

Multicenter, Randomized, Double-blinded，Controlled Clinical Study to Evaluate the Efficacy and Safety of Sulodexide in Controlling the Recurrence of Psoriasis

This is a multicenter, randomized, double-blinded，controlled clinical trial. The purpose of the study is to evaluate the efficacy and safety of Sulodexide versus placebo in preventing psoriasis recurrence in patients with plaque psoriasis who have discontinued biologic therapy after achieving clinical cure.

Start Date20 Apr 2025

Sponsor / Collaborator

Xijing Hospital

CTRI/2025/03/082526

/ Not yet recruitingPhase 4IIT

Comparing the outcome of conventional suture ligation technique versus sutureless technique using bipolar diarthermy in thyroidectomy - A randomized controlled trial - NIL

Start Date29 Mar 2025

Sponsor / Collaborator-

100 Clinical Results associated with Sulodexide

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100 Translational Medicine associated with Sulodexide

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100 Patents (Medical) associated with Sulodexide

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370

Literatures (Medical) associated with Sulodexide

01 Sep 2025·Journal of Vascular Surgery-Venous and Lymphatic Disorders

The role of venoactive compounds in the treatment of chronic venous disease

Review

Author: Nicolaides, Andrew ; Gloviczki, Monika Lecomte ; Kakkos, Stavros K ; Chuback, John ; Urbanek, Tomasz

BACKGROUND:

Chronic venous disease (CVD) is a major global health issue, affecting millions of people and contributing to significant morbidity and economic strain. The condition's pathophysiology is complex, involving both mechanical and biochemical processes that lead to venous reflux, obstruction, and chronic inflammation. This review focuses on the role of venoactive compounds (VACs), also known as venoactive drugs in Europe and other parts of the world, in managing CVD. The aim was to review the scientific evidence and to define the role of VACs within the comprehensive treatment algorithm for CVD, alongside established and well adopted interventional therapies and noninterventional therapies such as compression.

METHODS:

The review of the scientific evidence was done on VACs mechanism of action and efficacy in alleviating CVD symptoms, reducing swelling or venous edema, and improving healing of venous leg ulcers. Whenever available, systematic reviews, meta-analyses and randomized controlled trials were used. The quality of evidence assessment followed the GRADE methodology from A (high), B (moderate), to C (low to very low) quality.

RESULTS:

Venoactive drugs or compounds share similar effects, such as sealing the endothelial barrier, enhancing lymphatic drainage, reducing edema, improving venous tone, inhibiting leukocyte adhesion to vein walls/valves and inflammatory mediator release, lowering blood viscosity, and promoting red blood cell flexibility. Scientific evidence on the VACs effectiveness on CVD symptoms (pain, cramps, and heaviness) and swelling or edema have shown some variability. Micronized purified flavonoid fraction (MPFF) and Ruscus extract combined with hesperidin methyl chalcone and ascorbic acid had the highest, mostly level A, quality of evidence. In venous leg ulcers, micronized purified flavonoid fraction, sulodexide, and pentoxifylline were the most effective adjunctive treatments, with evidence level A.

CONCLUSIONS:

The existing scientific evidence provides a strong rationale for incorporating VACs into a comprehensive treatment plan for CVD, alongside established interventional therapies and noninterventional approaches like compression, to optimize patient outcomes and improve quality of life.

01 Jul 2025·Journal of Vascular Surgery-Venous and Lymphatic Disorders

Utility of venoactive compounds in post-thrombotic syndrome: A systematic review

Review

Author: Raffetto, Joseph D ; Gloviczki, Peter ; Puggioni, Alessandra ; Stoughton, Julianne ; Gloviczki, Monika L

BACKGROUND:

Post-thrombotic syndrome (PTS) has been highly prevalent; over 50% of the patients develop PTS after lower extremity acute deep vein thrombosis. Venoactive compounds (VACs) have been recommended for decades for patients with chronic venous insufficiency, including PTS. The objective of our study was to perform a systematic review to determine the quality of evidence on the utility of VACs for both prevention and treatment of PTS.

METHODS:

A systematic review was conducted to search the literature between January 1, 1980, and July 14, 2023, for venoactive drugs or medications, deep vein thrombosis, and PTS using PubMed, MEDLINE, life science journals, and the Cochrane Library. Only randomized controlled trials (RCTs) published in English were included in this review. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the revised Cochrane risk-of-bias tool for RCTs were used.

RESULTS:

Ninety-four references were identified; 11 RCTs fulfilled the inclusion criteria. VACs administered were diosmin, hidrosmin/rutosides, micronized purified flavonoid fraction (MPFF), and sulodexide. The studies included a highly variable proportion of patients with PTS (8.6%-100%). Some older studies omitted details of the methodology. Two studies suggested benefit of diosmin and MPFF as adjunctive treatment to rivaroxaban in the prevention of PTS and showed low or unclear risk of bias. Evaluation of RCTs for the treatment of post-thrombotic chronic venous insufficiency found low or unclear risk of bias in 81.6% to 85.7%. All studies suggested that VACs were beneficial for PTS treatment; they improved venous symptoms, decreased edema, and helped heal venous ulcers.

CONCLUSIONS:

This systematic review found that VACs had at least moderate quality of evidence in improving venous symptoms, decreasing edema, and accelerating venous ulcer healing. Two pilot RCTs of higher quality suggested the usefulness of diosmin and MPFF as adjunctive treatment to rivaroxaban therapy to reduce the incidence of PTS and improve deep vein recanalization. Because most RCTs were published over two decades ago, and several lacked the required precision in reporting, new high-quality, low-bias RCTs are needed to assess the role of specific VACs for both prevention and treatment of PTS.

03 Jun 2025·Zhonghua yi xue za zhi

[A meta-analysis of efficacy and safety of sulodexide in the prevention and treatment of venous thromboembolism].

Article

Author: Zou, F K ; Qu, L F ; Jiang, Q J

Objective: To evaluate the efficacy and safety of sulodexide in preventing venous thromboembolism (VTE) in high-risk populations and reducing recurrence in established VTE patients. Methods: A literature search was conducted in databases including China National Knowledge Infrastructure, Wanfang Data, VIP Chinese Periodical Database, China Biology Medicine disc, PubMed, Embase, the Cochrane Library, and Web of Science to retrieve relevant literature on sulodexide in the treatment of VTE, with the retrieval time frame set from the establishment of the databases to April 2024. According to the inclusion and exclusion criteria, two researchers independently screened the literature and extracted the data. The Cochrane risk of bias tool or the Newcastle-Ottawa Scale was used to evaluate the quality of the included studies. Meta-analysis was performed using Revman5.4.1 software, with the RR value as the effect measure. The trial group comprised high-risk individuals or VTE patients treated with sulodexide, while the control group consisted of patients treated with other traditional anticoagulants or placebos. The outcome measures included the incidence and recurrence rate of VTE, the incidence of post-thrombotic syndrome (PTS), and the risk of bleeding, among others. Results: A total of 11 articles involving 11 studies and 3 364 patients were included according to the inclusion and exclusion criteria. For high-risk populations of VTE, prophylactic use of sulodexide was more effective than the control group in reducing the incidence of VTE in high-risk individuals [2.2% (3/138) vs 10.9% (15/138), RR=0.25, 95%CI: 0.09-0.72, P=0.010]. For VTE patients, sulodexide was more effective than control group in reducing the recurrence rate of VTE [5.6% (56/996) vs 9.7% (198/2 043), RR=0.59, 95%CI: 0.44-0.80, P<0.001]. There was no statistically significant difference in the incidence of PTS between patients treated with sulodexide and those treated with other traditional anticoagulants [14.0% (36/257) vs 16.6% (149/897), RR=0.86, 95%CI: 0.61-1.20, P=0.370]. Moreover, the incidence of bleeding events was lower in patients treated with sulodexide compared to those treated with other traditional anticoagulants [0.8% (2/251) vs 6.1% (40/656), RR=0.11, 95%CI: 0.03-0.37, P<0.001]. Conclusion: Sulodexide exhibits favorable efficacy and safety for VTE prevention in high-risk populations and recurrence reduction in VTE patients.

1

News (Medical) associated with Sulodexide

26 Sep 2023

·www.biopharmadive.com

Intercept, after biotech rollercoaster ride, agrees to buyout by Alfasigma

Liver drug developer Intercept Pharmaceuticals has agreed to be acquired by Italian company Alfasigma for about $800 million, the companies announced Tuesday, ending one of biotechnologys most noteworthy stories of investor exuberance and clinical disappointment in the last decade.Alfasigma will pay Intercept investors $19 per share in cash, an 82% premium from Intercepts closing price on Monday. Alfasigma will fund the transaction with cash on hand and corporate credit facilities, and expects to close the deal by the end of 2023.With the acquisition, Alfasigma will gain Ocaliva, a drug that treats the rare autoimmune disorder primary biliary cholangitis, or PBC, which had sales of $152 million in the first six months of the year. The company recorded losses of $38 million over the same period.Alfasigma executives said the transaction will help it develop its U.S. presence. Intercept represents a compelling fit with Alfasigmas core business areas of gastroenterology and hepatology, and we believe that the transaction represents a transformational opportunity for both companies, said Alfasigma CEO Francesco Balestrieri in a statement.A closely held company controlled by the family of its founder, Alfasigma markets drugs like Zelnorm and rifaximin for irritable bowel syndrome and sulodexide for post-thrombotic syndrome. It also provides contract manufacturing services, as well as nutritional supplements. Its factory in Shreveport, Louisiana,manufactures nutritional supplements for the U.S. market.While Ocalivafirst gained approval for PBC, the drugs potential in the liver disease NASH drove investor enthusiasm in Intercept. NASH, or non-alcoholic steatohepatitis, is a disease connected with obesity, and its believed to be growing widely in prevalence.In 2014, a National Institutes of Health Phase 2 study of Ocaliva in people with NASH was stopped early because it had met its primary goal improvement in disease activity score at an interim analysis. Shares in the company nearly quadrupled in value and took the companys valuation to more than $7 billion, sparking an investor rush to find other companies working on NASH drugs.The path to regulators was not straightforward, however. Intercept reported positive Phase 3 data in 2019, but the FDA asked for longer-term data,rejectingIntercepts first NASH application.The FDA turned back a second application earlier this year, as Ocalivas only modest benefit was balanced against signs of liver damage experienced by some trial participants given the drug. Following that rejection, Intercept canceled all work in NASH, claiming it wasnt economically feasible to collect the data asked for by the FDA, and laid off staff.Meanwhile, competition in Intercepts established market of PBC may be emerging, as CymaBays seladelpar and Genfits elafibranor near key milestones.Raymond James analyst Steven Seedhouse described the transaction as a great return for Intercept investors.Given our bullish view of seladelpar and its ability to take market share in PBC beginning as early as late 2024, it isnt clear to us if [Ocaliva] will even generate that much net profit in the next ~10 years, Seedhouse wrote in a note to clients. '

Clinical ResultAcquisitionPhase 2Drug ApprovalPhase 3

100 Deals associated with Sulodexide

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KEGG	Wiki	ATC	Drug Bank
D08547	Sulodexide	B01AB11	DB06271

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Atherosclerosis	China	Alfa Wassermann SpA	15 Aug 2003
Diabetes Complications	China	Alfa Wassermann SpA	15 Aug 2003
Thrombosis	China	Alfa Wassermann SpA	15 Aug 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Endothelial dysfunction	Phase 3	Mexico	Alfasigma SpA	01 Jun 2023
Post Acute COVID 19 Syndrome	Phase 3	Mexico	Alfasigma SpA	01 Jun 2023
Chronic venous insufficiency	Phase 3	Czechia	Alfasigma SpA	25 Nov 2021
Vein disorder	Phase 3	Czechia	Alfasigma SpA	25 Nov 2021
Coronary Artery Disease	Phase 3	Tunisia	Alfa Wassermann, Inc.	31 Jan 2019
Intermittent Claudication	Phase 3	Tunisia	Alfa Wassermann, Inc.	31 Jan 2019
Peripheral arterial occlusive disease	Phase 3	Tunisia	Alfa Wassermann, Inc.	31 Jan 2019
Venous Insufficiency	Phase 3	Poland	Alfa Wassermann SpA	03 Sep 2016
Chronic Kidney Diseases	Phase 3	Philippines	Alfasigma SpA	01 Nov 2009
Type 2 diabetes mellitus with established diabetic nephropathy	Phase 3	Australia	Keryx Biopharmaceuticals, Inc.	01 Apr 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Code Large Vessel Occlusion Process (ISC2024)	Not Applicable	occlusions RACE score ≥ 5 \| aphasia \| visual field cut ... View more	-	Code Large Vessel Occlusion Process (MER with code LVO activation)	crokswtoyl(qgzvmlwltu) = dnsyoihpiy kbibgzvwen (hilaeysxlb ) View more	Negative	01 Feb 2024
AUA2021	Not Applicable	Complication	-	Bipolar vessel sealing system	yiknfdwbva(zciokhbtwy) = rjagiizzxl tcdllnccdo (ipjklooefp ) View more	-	01 Sep 2021
				BIPOLAR VESSEL SEALING SYSTEM (Silk ligation)	yiknfdwbva(zciokhbtwy) = nimzzodsco tcdllnccdo (ipjklooefp ) View more
ISTH2020	Not Applicable	-	-	Parenteral Sulodexide	eekdywmgmd(lolelgpefv) = duaupxsmvs tszcxuzudl (hveczitaxf )	-	12 Jul 2020
				Saline	eekdywmgmd(lolelgpefv) = ahtmqyuzdl tszcxuzudl (hveczitaxf )
ISTH2020	Not Applicable	-	-	Sulodexide	vuyqbbaozi(dtnfainapp) = odtxzwcyjc qprcrncthf (qwmkyfdrxv )	-	12 Jul 2020
				Porcine Heparin	vuyqbbaozi(dtnfainapp) = ueenvrtcsk qprcrncthf (qwmkyfdrxv )
NCT00130208 (CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Diabetic Nephropathies	1,056	Sulodexide (Sulodexide)	oqshgvqzhk = vaexyjvjej pozohcphoh (sakbdvftrs, yoyhvtkljt - txfcccsgcf) View more	-	23 Mar 2018
				Placebo (Placebo)	oqshgvqzhk = pqedvkmths pozohcphoh (sakbdvftrs, wqzejdcyhg - uenhicedpi) View more
UEGW2016	Not Applicable	Portal Vein Thrombosis	94	Sulodexidum 2 tb/day	lkwwbryseb(ralddylasf) = paebhldgaz qkjzetnrkd (kzqnyycqxh )	Positive	01 Oct 2016
Sun-MACRO (ASN2015)	Not Applicable	Albuminuria urinary albumin-creatinine ratio (UACR)	843	Sulodexide 200 mg/d	qmyznnwwde(evtueaagtt) = nqufjvgyup aejvqlkbtm (difghmdeou, ±0.9)	Positive	03 Nov 2015
				Placebo	qmyznnwwde(evtueaagtt) = cleqedrbah aejvqlkbtm (difghmdeou, ±0.9)
[PP.35.20] (ESH2015)	Not Applicable	Hypotension	-	Sulodexide	xjzjpequdm(rrqjulkfvy) = ibknpmftwl sknirpsdno (tqeoimgmxp, 0.6–2.9) View more	Positive	01 Jun 2015
NCT01295775 (DRESS, Pubmed \| Graefes Arch Clin Exp Ophthalmol)	Phase 2	Nonproliferative diabetic retinopathy	130	Sulodexide	sfjftjonte(jxdmzfnkov) = bewvsnuglc vxsjszdpcv (fcezwaaikn )	Positive	01 Jun 2015
				Placebo	sfjftjonte(jxdmzfnkov) = vrrvlprwkz vxsjszdpcv (fcezwaaikn )
FP585 (ERA2015)	Not Applicable	-	6	Sulodexide	zcuqvgxmmv(qmlgbndoth) = mabyfgwedf zezmvilajp (dlfuvnkksz )	Positive	21 May 2015