amlodipine besilate / Generic mfg. - LARVOL DELTA

A Green Synchronous Fluorescence Analysis Approach for Simultaneous Determination of the Co-formulated Antihypertensives, Bisoprolol, and Amlodipine. Application to Plasma Samples, Market Formulations, Content Uniformity Test, and Greenness Evaluation. (PubMed, Luminescence) - "In this study, we present a direct, sensitive, and green spectrofluorimetric approach for simultaneous measurement of bisoprolol fumarate (BSL) and amlodipine besylate (AMD) in their tablets and plasma. Besides, BSL is determined in plasma over the range of 0.1-0.5 μg/mL with high percentage recoveries (98.95%-101.60%) and low %RSD values (1.326). The greenness of the developed method was positively assessed using three distinct green metrics, including AGREE, GAPI, and BAGI."

Journal

Prediction of Myasthenia Gravis (MG) Crisis Events by a Machine Learning (ML) Algorithm (ISPOR 2025) - "A regularized logistic regression model was applied to the identified variables using the H2O AutoML package. Patients with MG crises at year 1 (n=332) were significantly (P<0.05) more likely than those without MG crises at year 1 (n=7277) to be older at MG index date (mean±SD: 61.5±14.5 vs 57.1±14.8 years, respectively), have higher rates of comorbidities/symptoms (eg, shortness of breath [21.1% vs 9.3%], dysphagia [20.0% vs 9.0%]), and have certain prescription claims (eg, albuterol sulfate [11.7% vs 4.9%], amlodipine besylate [11.4% vs 5.6%]). This novel analysis using a ML algorithm identified several key patient-relevant characteristics, disease symptoms, and comorbidities that are risk factors for experiencing an MG crisis, and these results may help inform future treatment strategies to reduce the risk of MG crises."

Machine learning • CNS Disorders • Cough • Gastrointestinal Disorder • Myasthenia Gravis • Pulmonary Disease • Respiratory Diseases

Stability and Dissolution Behavior Changes After Drug Compounding for Pediatric Cardiovascular Pharmacotherapy. (PubMed, Pharmaceutics) - " Five cardiovascular drugs (amlodipine besylate, carvedilol, propranolol hydrochloride, hydrochlorothiazide, and tadalafil) were selected as target drugs. There was no change in the dissolution rate of the samples after 120 days of storage under each storage condition. The five cardiovascular drugs commonly compounded for children in Japan maintained their pharmaceutical quality after compounding, even after long-term storage."

Journal • Cardiovascular • Pediatrics

Green vibrational spectroscopic approach for simultaneous quantification of antihypertensive drugs in bulk and tablet formulations. (PubMed, Sci Rep) - "An easy, fast, and environmentally friendly FT-IR spectrophotometric method was developed and validated for the simultaneous measurement of amlodipine besylate (AML) and telmisartan (TEL) in pharmaceutical combination formulations. The MoGAPI, AGREE prep, and RGB model assessment procedure was green and sustainable. The described HPLC technique was not significantly different statistically."

Journal • Acute Myelogenous Leukemia

Solubility and thermodynamic properties of amlodipine besylate in two binary mixtures of n-methyl pyrrolidone + 1-propanol/2-propanol at different temperatures. (PubMed, Ann Pharm Fr) - "In this study, the solubility of amlodipine besylate in N-methyl-pyrrolidone/1-propanol and N-methyl-pyrrolidone/2-propanol binary mixture systems were measured using a common shake-flask method followed by spectroscopy analysis at temperature ranges from 298.2 K to 313.2 K. The generated data were fitted to some models, van't Hoff, Jouyban-Acree, Jouyban-Acree-van't Hoff, mixture response surface, and modified Wilson, to mathematical representation the solubility data. Finally, the apparent thermodynamics properties for the saturated mixtures were computed using van't Hoff and Gibbs equations."

Journal

Antihypertensive drug amlodipine besylate shows potential in alleviating diabetic peripheral neuropathy. (PubMed, Diabetes) - "Additionally, AB suppressed the crosstalk between Schwann cells and endothelial cells /DRG neurons in DPN mice. Collectively, our findings highlight the potential of AB for the treatment of DPN."

Journal • Diabetes • Diabetic Neuropathy • Inflammation • Metabolic Disorders • Pain • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • ARRB1 • NLRP3 • STK11

China Stroke Primary Prevention Trial 2 for Participants with H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT) (clinicaltrials.gov) - P4 | N=32000 | Recruiting | Sponsor: Shenzhen Ausa Pharmed Co.,Ltd | Trial completion date: Jun 2029 ➔ Jun 2030 | Trial primary completion date: Jun 2029 ➔ Jun 2030

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Ischemic stroke • MTHFR

Application of spectrophotometry in novel simultaneous dissolution profiling of a single pill triple therapy of amlodipine, perindopril and indapamide; whiteness evaluation. (PubMed, BMC Chem) - "Simple, diverse univariate spectrophotometric methods were developed and validated for the determination of amlodipine besylate (AM), perindopril arginine (PE), and indapamide (ID). These methods were successfully applied to determine AM, PE, and ID in bulk powder, as well as in Triplixam® tablets, without interference from excipients and in different used dissolution media. The whiteness of the method was evaluated, demonstrating its excellent environmental, analytical and practical efficiency."

Journal

Bioequivalence Study of Single Oral Dose of Allisartan Isoproxil and Amlodipine Besylate Tablets in Healthy Subjects under Fasting Conditions (ChiCTR) - P1 | N=50 | Sponsor: Second Affiliated Hospital of Guangzhou Medical University; Second Affiliated Hospital of Guangzhou Medical University

New P1 trial • Cardiovascular • Hypertension

Novel ecofriendly spectrophotometric methods for the determination of six dihydropyridines calcium channel blockers through derivatization with sulfophtalein dye: application to tablet analysis. (PubMed, BMC Chem) - "Novel, «green» and simple visible spectrophotometric procedures for the determination of six dihydropyridines CCBs (amlodipine besylate (AML), lacidipine (LAC), levamlodipine besylate (LAML), nifedipine (NIF), nimodipine (NIM) and nitrendipine (NIT)) through derivatization with the sulfophthalein dye bromophenol blue (BPB) have been developed. The developed methods are colorimetric and therefore does not require a UV instrument to quantify these drugs. The proposed approach was more efficient in terms of time reliability, sensitivity and «greenness» than other recorded spectrophotometric methods and can be easily implemented for routine pharmaceutical analysis."

Journal • Acute Myelogenous Leukemia

Morning Versus Bedtime Dosing of Antihypertensive Medication (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: Yan Li | Trial completion date: Jan 2023 ➔ Sep 2026 | Trial primary completion date: Jan 2023 ➔ Jun 2026

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension

Modeling craniopharyngioma for drug screening reveals a neuronal mechanism for tumor growth. (PubMed, Sci Transl Med) - "The administration of (S)-amlodipine besylate achieved tumor regression in vivo, potentially by abrogating calcium transients and neuron-to-tumor chemical transmission. Chemogenetic manipulation of neuroendocrine neuronal activity bidirectionally regulated tumor cell growth in our mouse model, suggesting that craniopharyngioma hijacks hypothalamic neurons to promote tumor progression. These findings deepen our understanding of suprasellar tumor biology and offer promising avenues for clinical exploration of effective chemotherapies."

Journal • Preclinical • Brain Cancer • CNS Tumor • Metabolic Disorders • Oncology

Formulation, Development, and Characterization of AMB-Based Subcutaneous Implants using PCL and PLGA via Hot-Melt Extrusion. (PubMed, AAPS PharmSciTech) - "The lead formulation remained stable for 30 days at accelerated stability conditions of 40°C and 75% relative humidity. In conclusion, developing hot-melt extruded implants could be an alternative to the conventional amlodipine besylate (AMB) formulation."

Journal • Cardiovascular • Hypertension

Study of the Acidic, Basic, and Thermal Degradation Kinetics of Three Antihypertensive Drugs-Individually and in Combination. (PubMed, Pharmaceutics) - "Great care must be taken when formulating FDCs with these three drugs, as well as solutions or oral suspensions adjusted for geriatric or pediatric populations, since the stability of all three drugs is greatly affected by pH conditions, as well as light or oxidation factors and their interactions."

Journal • Acute Myelogenous Leukemia • Cardiovascular • Hypertension • Pediatrics

STOP-PA: Statin Combined with Amlodipine Treats Primary Aldosteronism (clinicaltrials.gov) - P4 | N=180 | Recruiting | Sponsor: Third Military Medical University | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Endocrine Disorders • Hypertension

Highly prevalent geriatric medications and their effect on β-amyloid fibril formation. (PubMed, BMC Neurol) - "A higher polypharmacy incidence was observed in an elderly population of 228 ND, 114 MCI, and 124 AD patients. We found that several highly recommended drug components, including vitamin D3, Levothyroxine, Prilosec, Flomax, and Norvasc, efficiently reduce the amount of fibrils formed by monomeric Aβ42 and existing preformed Aβ fibrils in vitro. However, only Levothyroxine was able to prevent Aβ-mediated toxicity to SH-SY5Y cells. Our study suggested that these drugs likely function as polyphenolic inhibitors of Aβ."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Constipation • Dementia • Gastroenterology • Gastrointestinal Disorder • Insomnia • Sleep Disorder • Aβ42

Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial. (PubMed, Chin J Integr Med) - P4 | "Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470)."

Clinical • Journal • Cardiovascular • CNS Disorders • Hypertension • Insomnia • Pain • Psychiatry • Sleep Disorder

Efficacy of atorvastatin calcium on clinical manifestations and serum inflammatory markers in elderly patients with hypertension. (PubMed, Am J Transl Res) - "Adding atorvastatin calcium to amlodipine therapy significantly improves clinical outcomes and reduces serum inflammatory marker levels in elderly patients with hypertension. This combination therapy is considered safe and may be recommended for broader clinical application."

Journal • Cardiovascular • Dyslipidemia • Hypertension • Oncology • CRP • IL6 • TNFA

Poly-Dha Sequences as Pro-polypeptides: An Original Mechanistic Postulate Leads to the Discovery of a Long-Acting Vasodilator KU04212. (PubMed, JACS Au) - "One peptide made in this series, KU04212, a first-in-class polyazole peptide, was found to reduce vascular length density (-17%; p < 0.05) and increase vessel diameter (124%; p < 0.001) in healthy day 6 chick embryos at 24 h post-single dose. It also rescued 75% of the embryos administered a 32-fold lethal dose of ischemia-inducing CoCl2 after 12 h and 12.5% of the embryos after 24 h. In comparison to three mechanistically distinct vasodilators, e.g., isosorbide mononitrate, amlodipine besylate, and prazosin, only KU04212 showed long-acting effects in vivo, making it an enticing lead for the treatment of ischemic disorders."

Journal • Cardiovascular

CSPPT2-TT: China Stroke Primary Prevention Trial 2 for Participants with Hypertension and MTHFR 677 TT Genotype (clinicaltrials.gov) - P4 | N=24000 | Recruiting | Sponsor: Shenzhen Ausa Pharmed Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hypertension • Ischemic stroke • MTHFR

China Stroke Primary Prevention Trial 2 for Participants with H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT) (clinicaltrials.gov) - P4 | N=32000 | Recruiting | Sponsor: Shenzhen Ausa Pharmed Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hypertension • Ischemic stroke • MTHFR

Stability-indicating RP-HPLC method development and validation for the quantification of amlodipine besylate and valsartan tablets in solid oral dosage form. (PubMed, Biomed Chromatogr) - "The method was found to be suitable for the quality control of amlodipine besylate and valsartan in the tablet as well as in stability-indicating studies. The method was applied to the analysis of stability samples."

Journal

Assessment the bioequivalence of test formulation Levamlodiping Besylate 2.5 mg Tablets and reference formulation Norvasc 5 mg Tablets Under Fasting and Fed Condition : A single center, open-label, randomized, single dose, two treatment, two period crossover study in healthy adult subjects (ChiCTR) - P=N/A | N=52 | Completed | Sponsor: Affiliated Hospital to Changchun University of Chinese Medicine; Disha Pharmaceutical Group

New trial • Cardiovascular • Coronary Artery Disease • Heart Failure • Hypertension

A sustainable HPLC method coupled with diode array detection for versatile quantification of telmisartan, chlorthalidone and amlodipine in a fixed-dose antihypertensive formulation and dissolution studies. (PubMed, BMC Chem) - "A new environmentally friendly HPLC-DAD method is introduced in this study for the concurrent analysis of telmisartan (TEL), chlorthalidone (CHT) and amlodipine besylate (AML), in both pure forms and combined pharmaceutical dosage form. These tools had confirmed the eco-friendliness of the proposed method. Additionally, the newly introduced White Analytical Chemistry (WAC), and the Blue Applicability Grade Index (BAGI) have been specifically developed to evaluate the sustainability and the applicability of the method."

Journal • Acute Myelogenous Leukemia • Cardiovascular • Hypertension

MVP-ANOCA: Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries (clinicaltrials.gov) - P2/3 | N=150 | Recruiting | Sponsor: Stanford University | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular