Early-onset preeclampsia (PE), defined as preeclampsia presenting before 34 weeks of gestation, is a severe placental disorder associated with significant maternal and perinatal morbidity. There is currently no disease-modifying treatment; management relies on close surveillance and delivery, frequently resulting in extreme prematurity.
Recent laboratory research identified ferroptosis, a form of iron-dependent regulated cell death driven by lipid peroxidation, as a key mechanism of placental injury in early-onset preeclampsia. A high-throughput drug screen identified dipyridamole, an approved oral antiplatelet and vasodilatory agent, as a potent ferroptosis inhibitor in primary human trophoblast cultures (EC50 = 0.146 µM), acting through mechanisms independent of its known phosphodiesterase-inhibitory pharmacology. In preeclamptic placental explants, dipyridamole markedly reduced release of sFlt-1, a central mediator of the maternal syndrome. Dipyridamole carries an established pregnancy safety record supported by randomized trials and a Cochrane meta-analysis of antiplatelet agents in pregnancy.
This is a prospective, single-center, open-label pilot study using a sequential, fixed dose-escalation design. The study will enroll 15 hospitalized pregnant women with early-onset preeclampsia (gestational age 26+0 to 33+6 weeks) and an elevated sFlt-1/PlGF ratio (≥85), for whom expectant management is clinically appropriate. Enrollment proceeds through a staged sentinel design with safety gates reviewed by an independent Safety Monitoring Committee. Participants receive oral dipyridamole added to standard clinical care, using a fixed dose-escalation protocol (75 mg twice daily on Day 1, escalating over 2-3 days to a target dose of 75 mg four times daily, 300 mg/day total). Standard obstetric care continues unchanged, determined entirely on clinical grounds, independent of study participation.
The primary objective is to evaluate the feasibility and clinical implementability of the dipyridamole treatment protocol within routine inpatient obstetric care. Secondary objectives include characterizing the pharmacokinetics of dipyridamole during pregnancy, assessing tolerability, and evaluating longitudinal circulating angiogenic biomarkers (sFlt-1 and PlGF). Exploratory objectives include assessment of placental markers of oxidative stress and ferroptosis-related pathways in tissue obtained at delivery.
Study drug is administered during the antepartum period only and discontinued before delivery. This pilot study is not designed to establish clinical efficacy, but to provide the pharmacokinetic, tolerability, and biological data required to design a subsequent randomized trial.

Start Date01 Sep 2026

Sponsor / Collaborator

Hadassah University Hospital

NCT07199504

/ RecruitingPhase 2/3IIT

A Self-Controlled Study on the Treatment of Restless Legs Syndrome in Uremia With Dipyridamole

The purpose of this clinical trial is to determine whether dipyridamole can treat restless legs syndrome in patients with uremia. In addition, the safety of dipyridamole will also be evaluated. The main questions this study aims to answer include: Can dipyridamole improve the symptoms of restless legs syndrome in participants? Can dipyridamole improve participants' anxiety, depression, sleep quality, and quality of life? What adverse reactions might participants experience while taking dipyridamole? This study is a self-controlled trial in which all participants receive active drug treatment. Participants will take dipyridamole daily (50 mg per dose, three times a day) for 12 weeks. The efficacy of dipyridamole will be evaluated by comparing relevant scale scores and laboratory indicators before and after treatment. In addition, adverse reactions during the treatment follow-up will be monitored to assess the safety of dipyridamole in this patient population.

Start Date20 Sep 2025

Sponsor / Collaborator

Chongqing Medical University /The First Affiliated Hospital/

CTR20253164

/ CompletedNot Applicable

双嘧达莫片在健康受试者中的单剂量、随机、开放、交叉、两周期、空腹和餐后人体生物等效性试验

[Translation] A single-dose, randomized, open-label, crossover, two-period, fasting and fed bioequivalence study of dipyridamole tablets in healthy volunteers

主要目的：以成都归合科技有限公司的双嘧达莫片（规格：25mg）为受试制剂，以株式会社medical Parkland的双嘧达莫片（规格：25mg）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: Using dipyridamole tablets (25 mg) from Chengdu Guihe Technology Co., Ltd. as the test formulation and dipyridamole tablets (25 mg) from Medical Parkland Co., Ltd. as the reference formulation, we investigated the bioequivalence of the two formulations in healthy volunteers according to relevant bioequivalence testing regulations. Secondary objective: To observe the safety of the test and reference formulations in healthy volunteers.

Start Date06 Sep 2025

Sponsor / Collaborator

Chengdu Guihe Technology Co., Ltd.

100 Clinical Results associated with Dipyridamole

100 Translational Medicine associated with Dipyridamole

100 Patents (Medical) associated with Dipyridamole

7,931

Literatures (Medical) associated with Dipyridamole

01 Nov 2026·NEUROLOGICAL SCIENCES

Italian adaptation of international recommendations for the management of restless legs syndrome: A consensus statement by the scientific committee of RLS-Italia

Article

Author: Mogavero, Maria Paola ; Guarnieri, Biancamaria ; Liguori, Claudio ; Romigi, Andrea ; Bruni, Oliviero ; Ferri, Raffaele ; Arnaldi, Dario

BACKGROUND:

Recent international recommendations have substantially changed the management of restless legs syndrome (RLS), emphasizing systematic iron assessment, earlier use of iron therapy and α2δ ligands, and greater caution with chronic dopaminergic treatment because of augmentation. Their implementation requires adaptation to national healthcare organization, regulatory indications, reimbursement, and access to specialist services.

METHODS:

The Scientific Committee of RLS-Italia conducted a structured, non-Delphi consensus process based on the 2025 American Academy of Sleep Medicine clinical practice guideline and systematic review, the 2026 RLS Foundation algorithm, the World Sleep Society partial endorsement, and selected supporting evidence. Successive drafts were circulated, discussed, and approved by all authors.

RESULTS:

The proposed Italian framework prioritizes clinical diagnosis, exclusion of mimics, correction of exacerbating factors, systematic assessment of iron status, and iron treatment when indicated. α2δ ligands are preferred for most adults with chronic persistent RLS, whereas dopamine agonists should be restricted to selected patients and monitored for augmentation. Refractory or augmented disease should be managed by clinicians with specific RLS expertise, with consideration of intravenous iron, opioids, or device-based treatment. Dipyridamole is not included in the standard pathway, and periodic limb movement disorder should not be diagnosed or treated solely on the basis of polysomnographic findings.

CONCLUSIONS:

This consensus statement provides a nationally coherent framework that can support regional implementation through locally appropriate organizational and clinical protocols.

10 Oct 2026·CHEMICAL & PHARMACEUTICAL BULLETIN

Precipitation Profiles of Dipyridamole in Biorelevant pH-Shift Dissolution Test with Clinically Relevant Dose-to-Fluid Volume Ratio Focusing on Liquid–Liquid Phase Separation

Article

Author: Yamamoto, Hibiki ; Sugano, Kiyohiko ; Ito, Ayame

The purpose of this study was to evaluate the precipitation profiles of dipyridamole (DPM) in a biorelevant pH-shift dissolution test under a clinically relevant dose-to-fluid volume (Dose/FV) ratio, focusing on liquid-liquid phase separation (LLPS). In the pH-shift dissolution test, DPM was added to an hydrochloric acid solution (pH 2.0, 450 mL) as the solid drug substance or formulation (Dose/FV = 400 µg/mL, corresponding to a 100 mg dose in 250 mL). In the pH-shift precipitation test, DPM was fully dissolved before the pH shift. After 10 min, the pH was adjusted to 6.5 by adding a 10-fold concentrated bicarbonate buffer (BCB), yielding the conditions of FV = 500 mL and BCB = 10 mM. Under pH 2.0, approximately 90% of the dose dissolved within 10 min. Immediately after the pH shift, turbidity appeared within 1 s and the dissolved DPM concentration dropped to the LLPS concentration (97 µg/mL) (STEP 1), remained there for 3-5 min, and then declined toward the crystalline solubility (6 µg/mL) (STEP 2). In the pH-shift precipitation test examined under polarized light microscopy, noncrystalline droplets appeared instantaneously and persisted for approximately 2 min before crystallization. These results indicate that STEP 1 and STEP 2 corresponded to LLPS and crystallization, respectively. Although DPM is a free-base drug that does not generate LLPS on its own and has been categorized as a rapid crystallizer, this study experimentally demonstrated a two-step precipitation profile under clinically relevant pH-shift and Dose/FV conditions, in which LLPS preceded crystallization.

01 Aug 2026·BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS

Cilostazol inhibits TGF-α-induced migration of hepatocellular carcinoma cells by activating PPARγ

Article

Author: Tokuda, Haruhiko ; Matsushima-Nishiwaki, Rie ; Kozawa, Osamu

Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide and remains a public health problem with high mortality. We have previously reported that activation of cyclic adenosine monophosphate (cAMP)-dependent protein kinase (PKA) suppresses transforming growth factor (TGF)-α-induced migration of HCC cells. In the present study, we investigated whether cilostazol, a phosphodiesterase (PDE) inhibitor, affects the TGF-α-induced migration of HCC cells. Cilostazol significantly inhibited TGF-α-induced migration of human-derived HCC cells, HuH7. Dipyridamole, another PDE inhibitor, also significantly suppressed the cell migration induced by TGF-α. However, neither cilostazol nor dipyridamole increased the intracellular concentrations of cAMP under TGF-α-stimulation. Furthermore, TGF-α-induced HCC cell migration, which was inhibited by cilostazol and dipyridamole, was not affected by a PKA inhibitor. On the other hand, cilostazol and dipyridamole stimulated the activation of peroxisome proliferator-activated receptor γ (PPARγ) in HuH7 cells. We also found that PPARγ activators, ciglitazone and pioglitazone, significantly inhibited the TGF-α-induced migration of HuH7 cells. The inhibitory effects of cilostazol and dipyridamole on the migration of HuH7 cells were blocked by GW9662, an inhibitor of PPARγ. We have shown that AKT is involved in the TGF-α-induced HuH7 cell migration. The PPARγ activators reduced the TGF-α-induced AKT activation without affecting the EGFR activation. Cilostazol and dipyridamole also inhibited the activation of AKT but not EGFR. Taken together, these results strongly suggest that cilostazol and dipyridamole inhibit TGF-α-induced HCC cell migration by suppressing the AKT pathway through PPARγ activation.

News (Medical) associated with Dipyridamole

11 Apr 2024

·www.biospace.com

Baxter Expands Pharmaceuticals Portfolio with New Injectable Products in the U.S.

Five new launches reinforce Baxter’s focus on differentiated products and enhance the company’s Pharmaceuticals portfolio in critical therapeutic areas Products feature ready-to-use formulations to help support patient safety and offer added convenience for healthcare professionals DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International Inc. (NYSE:BAX), a global leader in injectables, anesthesia and drug compounding, announced the continued expansion of its Pharmaceuticals portfolio with five injectable product launches in the U.S. “These launches demonstrate Baxter’s focus on differentiated products that address unmet patient needs in key therapeutic areas, including anti-infective and anti-hypotensive medications,” said Alok Sonig, executive vice president and group president, Pharmaceuticals, at Baxter. “We are proud to offer important new options for our customers and look forward to continuing to bring new innovations to the market.” Product launches within Baxter’s Pharmaceuticals portfolio in the U.S. include the following. For all products, please see full Indications, Important Risk Information and links to full Prescribing Information below. Norepinephrine Bitartrate in 5% Dextrose Injection in a new 16 mg/250 mL strength, which is indicated to raise blood pressure in adult patients with severe, acute hypotension. Baxter offers the first and only FDA-approved ready-to-use Norepinephrine in Dextrose, and now provides Norepinephrine in 4 mg/250 mL, 8 mg/250 mL and 16 mg/250 mL strengths. Vasopressin in 0.9% Sodium Chloride Injection, the first and only FDA-approved ready-to-use Vasopressin in a flexible container. Vasopressin uses Baxter’s proprietary sterile, closed system container, which is collapsible and does not require a vented intravenous set.1 Manufactured closed drug-delivery systems decrease the need for manual admixture and reduce the possibility of contamination.2 Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Baxter offers Vasopressin in 20 units/100 mL and 40 units/100 mL strengths. Vancomycin Injection, USP in 5% Dextrose in new 1.25 g/250 mL and 1.5 g/300 mL strengths. These launches are Baxter’s first frozen ready-to-use offerings in 250 mL and 300 mL volumes. Vancomycin is indicated for serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. Baxter now offers Vancomycin in 500 mg/100 mL, 750 mg/150 mL, 1 g/200 mL, 1.25 g/250 mL and 1.5 g/300 mL strengths. Ropivacaine Hydrochloride Injection, USP in a ready-to-use, single-dose infusion bag. Ropivacaine is indicated in adults to produce local or regional anesthesia for surgery and for acute pain management. Baxter offers Ropivacaine in 200 mg/100 mL and 400 mg/200 mL strengths. Regadenoson Injection pre-filled syringe, a coronary vasodilator that is commonly used in pharmacologic stress testing. Baxter offers Regadenoson in a 0.4 mg/5 mL strength. Ready-to-use formats of standard concentrations of commonly prescribed drugs may offer operational efficiencies for healthcare providers. Compounding a drug for patient use is a multi-step, manual process that requires oversight by pharmacy staff. A ready-to-use product can simplify the preparation process and support patient safety by reducing the chance of contamination2 and avoiding potential errors that may occur when medications are compounded.3 These newly launched products are now available for use in the U.S. About Baxter Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit and follow us on X/Twitter, LinkedIn and Facebook. Norepinephrine Bitartrate in 5% Dextrose Injection Indications Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Important Risk Information Contraindications: None. Tissue Ischemia: Administration of Norepinephrine Bitartrate in Dextrose Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating Norepinephrine Bitartrate in Dextrose Injection. Avoid use in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction. Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients. Extravasation of Norepinephrine Bitartrate in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation. Avoid administration into the veins in the leg in elderly patients. Emergency Treatment of Extravasation: Infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults. Hypotension after Abrupt Discontinuation: Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the infusion rate while expanding blood volume with intravenous fluids. Cardiac Arrhythmias: Norepinephrine Bitartrate in Dextrose Injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias. Elderly Patients: May be at a greater risk of developing adverse reactions. Adverse Reactions: Most common adverse reactions are hypertension and bradycardia. Drug Interactions: Co-administration of Norepinephrine Bitartrate in Dextrose Injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) or with tricyclic antidepressants can cause severe, prolonged hypertension. Anti-diabetics: Norepinephrine Bitartrate in Dextrose Injection can decrease insulin sensitivity and raise blood glucose. Concomitant use of Norepinephrine Bitartrate in Dextrose Injection with halogenated anesthetics may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics. Please see accompanying full Prescribing Information for Norepinephrine Bitartrate in 5% Dextrose Injection. Vasopressin in 0.9% Sodium Chloride Injection Indications Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Important Risk Information Contraindications: Vasopressin in Sodium Chloride Injection is contraindicated in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. Worsening Cardiac Function: A decrease in cardiac index may be observed with the use of vasopressin. Reversible Diabetes Insipidus: Patients may experience reversible diabetes insipidus, manifested by the development of polyuria, a dilute urine, and hypernatremia, after cessation of treatment with vasopressin. Monitor serum electrolytes, fluid status and urine output after vasopressin discontinuation. Some patients may require readministration of vasopressin or administration of desmopressin to correct fluid and electrolyte shifts. Adverse Reactions: The most common adverse reactions include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital). Drug Interactions: Pressor effects of catecholamines and Vasopressin in Sodium Chloride Injection are expected to be additive. Indomethacin may prolong effects of Vasopressin in Sodium Chloride Injection. Co-administration of ganglionic blockers or drugs causing SIADH (syndrome of inappropriate antidiuretic hormone secretion) may increase the pressor response. Co-administration of drugs causing diabetes insipidus may decrease the pressor response. Pregnancy: May induce tonic uterine contractions that could threaten the continuation of pregnancy. Please see accompanying full Prescribing Information for Vasopressin in 0.9% Sodium Chloride Injection. Vancomycin Injection, USP in 5% Dextrose Indications Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is effective in the treatment of: Infective Endocarditis (staphylococcal endocarditis; endocarditis caused by Streptococcus viridans or S. bovis, alone or in combination with an aminoglycoside; endocarditis caused by enterococci (e.g., E. faecalis), only in combination with an aminoglycoside; diphtheroid endocarditis; early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids in combination with either rifampin, an aminoglycoside, or both) Septicemia Skin and Skin Structure Infections Bone Infections Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Important Risk Information Contraindications: Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products. Infusion Reactions: Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest. During or soon after rapid infusion of vancomycin, patients may develop anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“vancomycin infusion reaction”) or pain and muscle spasm of the chest and back. Vancomycin should be administered over a period of not less than 60 minutes. Stopping the infusion usually results in prompt cessation of these reactions. Nephrotoxicity: Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Monitor renal function in all patients; especially with underlying renal impairment, with co-morbidities, and receiving concomitant therapy with a known nephrotoxic drug. Ototoxicity: It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution in patients with renal insufficiency. Severe Dermatologic Reactions: Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue vancomycin Injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. Dosage of vancomycin must be adjusted for patients with renal dysfunction. Clostridioides difficile associated diarrhea (CDAD): May range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. Hemorrhagic Occlusive Retinal Vasculitis: Including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established. Adverse Reactions: Not already mentioned above, patients have been reported to have neutropenia, phlebitis, drug fever, nausea, chills, and vasculitis in association with administration of vancomycin. Drug Interactions: Anesthetic Agents: Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing and anaphylactoid reactions. Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin. Please see accompanying full Prescribing Information for Vancomycin Injection, USP. Ropivacaine Hydrochloride Injection, USP Indications Ropivacaine Hydrochloride Injection is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. Important Risk Information Contraindications: Ropivacaine Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. General Warning: Delay in proper management of dose-related toxicity, underventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies. It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. Unintended Intravenous Injection: In performing Ropivacaine Hydrochloride Injection blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. Ropivacaine hydrochloride injection should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Intra-Articular Infusions and Risk of Chondrolysis: Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine Hydrochloride Injection is not approved for this use. Risk of Methemoglobinemia: Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure. Immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue ropivacaine hydrochloride injection and any other oxidizing agents. Central Nervous System Toxicity: Careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness should be performed after each local anesthetic injection. Hepatic Disease: Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease are at a greater risk of developing toxic plasma concentrations. Adverse Reactions: Most common adverse reactions (incidence ≥ 5%) are hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain. Drug Interactions: Agents structurally related to amide-type local anesthetics: Concurrent use may cause additive effects. Please see accompanying full Prescribing Information for Ropivacaine Hydrochloride Injection, USP. Regadenoson Injection Indications Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Important Risk Information Contraindications: Do not administer regadenoson injection to patients with: Second- or third-degree AV block, or Sinus node dysfunction, unless these patients have a functioning artificial pacemaker. Myocardial Ischemia: Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability, who may be at greater risk. Cardiac resuscitation equipment and trained staff should be available before administration. Sinoatrial (SA) and Atrioventricular (AV) Nodal Block: Adenosine receptor agonists, including regadenoson injection, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia. Atrial Fibrillation/Atrial Flutter: New-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported. Hypersensitivity, Including Anaphylaxis: Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. Have personnel and resuscitative equipment immediately available. Hypotension: Adenosine receptor agonists, including regadenoson injection, induce vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, stenotic valvular heart disease, pericarditis or pericardial effusions, stenotic carotid artery disease with cerebrovascular insufficiency, or hypovolemia. Hypertension: Adenosine receptor agonists, including regadenoson injection, may induce clinically significant increases in blood pressure particularly in patients with a history of hypertension and when the MPI includes low level exercise. Bronchoconstriction: Adenosine receptor agonists, including regadenoson injection, may induce dyspnea, bronchoconstriction and respiratory compromise, especially in patients with chronic obstructive pulmonary disease (COPD) or asthma. Resuscitative measures should be available. Seizure: Regadenoson injection may lower the seizure threshold. New onset or recurrence of convulsive seizures has occurred. Some seizures are prolonged and require urgent anticonvulsive management. Methylxanthine use is not recommended in patients who experience a seizure in association with regadenoson injection. Cerebrovascular Accident (Stroke): Hemorrhagic and ischemic cerebrovascular accidents have occurred. Adverse Reactions: The most common (incidence ≥ 5%) adverse reactions to regadenoson injection are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea. Drug Interactions: Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of regadenoson injection. Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson injection. Dipyridamole may increase the activity of regadenoson injection. When possible, withhold dipyridamole for at least two days prior to regadenoson injection administration. Please see accompanying full Prescribing Information for Regadenoson Injection. This release includes forward-looking statements concerning Norepinephrine Bitartrate in 5% Dextrose Injection, Vasopressin in 0.9% Sodium Chloride Injection, Vancomycin Injection, USP in 5% Dextrose, Ropivacaine Hydrochloride Injection, USP and Regadenoson Injection pre-filled syringe, including potential benefits associated with the use of these products. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements. Baxter is a registered trademark of Baxter International Inc. 1 Baxter data on > 2 Mercaldi CJ, Lanes S, Bradt J. Comparative risk of bloodstream infection in hospitalized patients receiving intravenous medication by open, point-of-care, or closed delivery systems. Am J Health-Syst Pharm. 2013;70:957-965. 3 Billstein-Leber M, Carrillo CJD, Cassano AT, Moline K, Robertson JJ. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Health Syst Pharm. 2018;75(19):1493-1517. US-PH57-240005 (v1.0) 04/2024 View source version on businesswire.com: Contacts Media Contact Andrea Johnson, (224) 948-5353 media@baxter.com Investor Contact Clare Trachtman, (224) 948-3020 Source: Baxter International Inc. View this news release online at:

Drug Approval

05 Nov 2020

·www.biospace.com

Research Roundup: Why Blood Clots in COVID-19 and More

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones. Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones. Cause of COVID-19 Blood Clots Identified Although COVID-19 has a fairly broad range of effects, one of the more peculiar has been blood clots. Researchers at the Michigan Medicine – University of Michigan identified a mechanism of how this happens. They appear to be caused in about half of patients having blood clots by an autoimmune antibody found in the blood that attacks cells and triggers blood clots. In COVID-19, these minuscule clots may also restrict blood flow in the lungs, which impairs oxygen exchange. In patients without COVID-19, these antibodies are typically seen in the autoimmune disease antiphospholipid syndrome. The research was published in the journal Science Translational Medicine . “In patients with COVID-19, we continue to see a relentless, self-amplifying cycle of inflammation and clotting in the body,” said Yogen Kanthi, assistant professor at the Michigan Medicine Frankel Cardiovascular Center and a Lasker Investigator at the National Institutes of Health’s National Heart, Lung and Blood Institute. “Now we’re learning that autoantibodies could be a culprit in this loop of clotting and inflammation that makes people who were already struggling even sicker.” The clinical implications aren’t yet clear, but they want to evaluate whether severely sick COVID-19 patients with high levels of the antibodies would have better outcomes if the antibodies are blocked or removed. One potential therapy, which is aggressive, is plasmapheresis, which is used to treat severe autoimmune diseases. Plasmapheresis involves separating the plasma from the blood and replacing it with saline or albumin, then filtering the plasma and returning it to the body. The researchers are currently running a clinical trial called DICER that is testing dipyridamole, an anti-clotting drug, in COVID-19 patients to determine if it’s more effective than placebo in decreasing excessive blood cloths. “Dipyridamole is an old drug that is safe, inexpensive, and scalable,” Kanthi said. “The FDA approved it 20 years ago to prevent clotting, but we only recently discovered its potential to block this specific type of inflammation that occurs in COVID.” Six Times the Rate of COVID-19 in Bavarian Children than Previously Reported Researchers at Helmholtz Zentrum München, the German Research Center for Environmental Health , analyzed blood samples of almost 12,000 children in Bavaria between the ages of 1 to 18 between January 2020 and July 2020. They tested for SARS-CoV-2 dual-antibody positivity. They identified an average antibody frequency of 0.87% from April to July, which was six times higher than the incidence of virus-positive cases reported by the Bavarian Health and Food Safety Authority in the same period. They found that 47% of the children who tested antibody-positive were asymptomatic. How Allergens Trigger Itching Scientists at Massachusetts General Hospital identified a neuropeptide called Substance P that certain neurons in the skin release when they detect allergens. Substance P is necessary for allergen-induced immune responses. The ways in which the immune system responds to pathogens is well understood, but how it responds to allergens like pollen, dust mites or animal fur is not as clear. They did know that dendritic cells activate T cells that are required for the immune response, but until this discovery, they did not know how the allergen exposure led to itching. The dendritic cells are located next to allergen-responsive neurons in the skin. When exposed to an allergen, the neurons release Substance P, which directly creates migration of the dendritic cells to the lymph nodes, where they activate T cells. The T cells then trigger the immune response against the allergen. COVID-19 Super-Spreading Events More Common and More Dangerous A COVID-19 super-spreading event is defined as where one person with COVID-19 infects more than six other people. Research out of the Massachusetts Institute of Technology (MIT) analyzed 60 super-spreading events and found that they are more common than previously thought and play a larger role in overall disease transmission. The investigators found that for SARS-CoV-2, the “basic reproduction number” is about three, which means that on average, each person infected will pass it on to about three other people, but it can vary from person to person. But so-called “super-spreaders” can infect dozens of people. In the super-spreading events they analyzed, 45 from the current COVID-19 pandemic and 15 from the 2003 SARS-CoV outbreak, they found that between 10 and 55 people were infected, but two of them, both from the 2003 outbreak, involved more than 100 people. They also found that these super-spreaders have a “long tail,” meaning they continue to infect people long after the original exposure event. It supports the idea that groups involving 10 or more people should be advised against to help slow the spread of COVID-19. Gum Disease Linked to Precancerous Cells that Can Lead to Colorectal Cancer Harvard researchers published research that studied the development of two types of irregular cells in the colon, serrated polyps and conventional adenomas, which can lead to colorectal cancers. In their study of 42,486 people, they found that individuals with gum disease had a 17% higher risk of developing serrated polyps and an 11% higher risk of developing conventional adenomas. In people whose gum disease resulted in losing four or more teeth, the risk was 20% higher of developing serrated polyps and a 36% higher risk of developing advanced conventional adenomas; people who had lost one to three teeth had a 28% higher risk of advanced conventional adenomas. The correlation isn’t well understood, and they note that periodontal diseases are related to other factors, including socioeconomics, diabetes and obesity. Testing Different Materials for Face Masks Investigators at the University of Cambridge tested a broad range of materials, from T-shirts and socks to jeans and vacuum bags, to find out what type of material was most effective for use in face masks to trap particles that might contain SARS-CoV-2, the virus that causes COVID-19. The fabrics ranged between 0.02 and 0.1 micrometers, approximately the size of most viruses, at high speeds, similar to that seen with coughing or heavy breathing. They also evaluated N95 and surgical masks. The data demonstrated that most of the materials commonly used for non-clinical masks were effective at filtering ultrafine particles, whereas N95 masks were “highly effective.” A reusable HEPA vacuum bag exceeded the N95 masks in some areas. “We’ve shown that in an emergency situation where N95 masks are not available, such as in the early days of this pandemic, fabric masks are surprisingly effective at filtering particles which may contain viruses, even at high speeds,” said Eugenia O’Kelly, first author of the study published in BMJ Open , and an engineer from Cambridge’s Department of Engineering.

Clinical Result

21 Oct 2010

·www.pharmatimes.com

NICE launches database for referral advice

The National Institute for Health and Clinical Excellence has launched a database pulling together its recommendations on referring patients from primary to secondary care to improve outcomes and cut costs. The database will provide GPs with a one-stop-shop of guidance highlighting when patients could benefit from secondary care or specialist services, which, aside from securing better value for money and clinical outcomes, should help to improve the patient experience and reduce local and regional inequalities in care, the Institute said. Inappropriate referral to secondary care represents a significant and unnecessary cost to the NHS, and the database is one of a number of initiatives designed to help the health service deliver the QIPP (Quality, Improvement, Productivity and Prevention) agenda during a time of financial constraint. Professor Peter Littlejohns, NICE Clinical and Public Health Director said the new ‘referral advice’ recommendations database “is a valuable resource for those providing and commissioning care on when patients should be referred on from primary care”, which should help to ensure that patients receive treatment that is proven to be both clinically and cost effective. Final guidance for clopidogrel/dipyridamol Meanwhile, the cost watchdog has endorsed the wider use of clopidogrel as well as Boehringer Ingelheim’s modified-release dipyridamol for the prevention of occlusive vascular events. The Institute has OK’d funding for the wider use of clopidogrel (using the least costly preparation) in National Health Service patients who have had a stroke or who have peripheral arterial disease, and those who have cardiovascular disease in more than one area, to help prevent a subsequent heart attack or stroke. However, the drug is only recommended for patients who have had a heart attack if they are unable to take aspirin. A combination of modified-release dipyridamole - sold as Persantin Retard and Asasantin Retard by Boehringer - and aspirin is backed as an option for patients who have had a transient ischaemic attack, but should only be used when patients have had an ischaemic stroke where clopidogrel is contraindicated or not tolerated. The drug can also be used alone as an option following ischaemic stroke where aspirin and clopidogrel cannot be taken, the Institute said. Professor Peter Littlejohns, Clinical and Public Health Director at NICE, noted that heart attacks and strokes are some of the biggest killers and causes of disability the country, and that the new guidelines have “the potential to have a significant impact on the treatment of many thousands of patients in England and Wales”.

100 Deals associated with Dipyridamole

External Link

KEGG	Wiki	ATC	Drug Bank
D00302	Dipyridamole	B01AC07	DB00975

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Postoperative Complications	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	06 Dec 1961
Angina Pectoris	Japan	Medical Parkland Co., Ltd.	05 Feb 1960
Angina Pectoris	Japan	Boehringer Ingelheim GmbH	05 Feb 1960
Heart Failure	Japan	Medical Parkland Co., Ltd.	05 Feb 1960
Heart Failure	Japan	Boehringer Ingelheim GmbH	05 Feb 1960
Myocardial Infarction	Japan	Boehringer Ingelheim GmbH	05 Feb 1960
Myocardial Infarction	Japan	Medical Parkland Co., Ltd.	05 Feb 1960
Myocardial Ischemia	Japan	Medical Parkland Co., Ltd.	05 Feb 1960

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Peripheral Arterial Disease	Clinical	United States	Boehringer Ingelheim GmbH	01 Sep 2002
Acute Lung Injury	Preclinical	China	Guangdong Medical University	01 Jul 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04424901 (TOLD, CTgov)	Phase 2	COVID-19	41	Placebo (Standard Care)	claueqohrz(rrekenqknx) = kgcvcknjvl ihocucebui (ilimcwudvq, tcpggmftel - vpetpzfegd) View more	-	21 Apr 2023
				Dipyridamole Tablets (Standard Care With Dipyridamole)	claueqohrz(rrekenqknx) = dncwnovplc ihocucebui (ilimcwudvq, czzbqysqay - wtnsjeuuth) View more
NCT04391179 (DICER, CTgov)	Phase 2	COVID-19	99	Dipyridamole (Dipyridamole 100 Milligram(mg))	exwwcuqtel(wyrxmeisxe) = enxlxdekkz udoexsizld (kkklkgjdky, szctrrkyci - mcektowcwx) View more	-	24 Mar 2022
				Placebo oral tablet (Placebo)	exwwcuqtel(wyrxmeisxe) = ytivrakkvg udoexsizld (kkklkgjdky, xeiapfkbzl - evuexdybvk) View more
NCT02121756 (DAIDS-ES ID 11987, CTgov)	Phase 1/2	Inflammation \| HIV Infections	40	Dipyridamole (ARM A: Dipyridamole for 24 Weeks)	olvudfexxb(caccbdluqp) = boaciuahhy vylnorjubf (iquhybrvjj, xpdkchcdlj - seofqoxkay) View more	-	11 Apr 2019
				Placebo+Dipyridamole (ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks)	olvudfexxb(caccbdluqp) = urcxlqeoav vylnorjubf (iquhybrvjj, aphynigifa - hhhykhzudm) View more
NCT00349973 (CTgov)	Not Applicable	Schizoaffective disorder \| Schizophrenia	29	Dipyridamole (Dipyridamole)	tbjkbkeyon(gzhjlstumn) = gtingprbdq yoasgolyhn (tbjjvxpshd, 1.716) View more	-	10 Dec 2018
				Olanzapine (Olanzapine)	tbjkbkeyon(gzhjlstumn) = qqrgtrmrsq yoasgolyhn (tbjjvxpshd, 0.548) View more
NCT00738894 (REDUCE, CTgov)	Not Applicable	Foramen Ovale, Patent \| Stroke \| Ischemic Attack, Transient	664	Septal Occluder Device+Plavix+Aggrenox+Clopidogrel+Dipyridamole+Aspirin (Device Closure)	fbsrrgnxjs = xxkqgqqwbh hozbcxqqny (nmkcrqnufm, yojuiaispi - vdlvizhcez) View more	-	09 Aug 2018
				Plavix+Aggrenox+Clopidogrel+Dipyridamole+Aspirin (Medical Management)	fbsrrgnxjs = nknznlfklx hozbcxqqny (nmkcrqnufm, ncedmzqdfo - gtvsfkglza) View more
NCT00906035 (CTgov)	Not Applicable	Peripheral Arterial Disease	25	Dipyridamole 200mg and Aspirin 25mg bid: (Dipyridamole 200mg and Aspirin 25mg Bid)	xyhonfckwd(hyicpcjtna) = owersalsps ajqosktesk (xowsvchkrw, evwvnhwngy - qxudcegkru) View more	-	05 Sep 2017
				Dipyridamole 200 mg bid (Dipyridamole 200 mg Bid)	xyhonfckwd(hyicpcjtna) = nzwknnxmsv ajqosktesk (xowsvchkrw, tydaqwcgyj - peydvwxiez) View more
NCT00763009 (CTgov)	Phase 4	Coronary Artery Disease	8	dipyridamole	kkhbajgbub(waqysvilhk) = tacnysuebu mfxiopyzyz (boplixqkfv, dwovkdtuuw - kddxpkhbic) View more	-	24 May 2017

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

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

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.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis