The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.

Start Date10 Sep 2024

Sponsor / Collaborator

Third Military Medical University

NCT04974138

/ RecruitingPhase 4

Comparative Efficacy of Amlodipine Folic Acid Vs. Amlodipine on the Risk of First Ischemic Stroke Among Participants with H-type Hypertension and MTHFR 677 CC/CT Genotype: a Multi-center, Randomized, Double-blind, Double-dummy, Controlled Clinical Trial

This is a multi-center, randomized, double-blind, double-dummy, controlled clinical trial. This trial will include 32,000 Chinese men and women with hypertension (H-type hypertension), MTHFR 677 CC or CT genotype, elevated plasma total homocysteine (tHcy ≥10µmol/L), and insufficient serum folate levels (<12ng/mL).
The participants will be first stratified by their MTHFR 677 genotype (CC vs. CT), then randomized to one of two treatment groups in a 1:1 ratio.
Group A: amlodipine tablet (5mg), taken orally, once daily, serving as active comparator.
Group B: amlodipine folic acid 5.8mg tablet (5mg amlodipine and 0.8mg folic acid), taken orally, once daily.
The treatment period is five years and primary endpoint is first ischemic stroke.

Start Date22 Aug 2024

Sponsor / Collaborator

Shenzhen Ausa Pharmed Co. Ltd.

[+7]

CTIS2024-510835-23-00

/ Not yet recruitingPhase 1

- 204-PKT-202301

Start Date19 Jun 2024

Sponsor / Collaborator

PRO.MED.CS Praha as

100 Clinical Results associated with Amlodipine Besylate

100 Translational Medicine associated with Amlodipine Besylate

100 Patents (Medical) associated with Amlodipine Besylate

833

Literatures (Medical) associated with Amlodipine Besylate

01 Apr 2025·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Spectrophotometric method based on Continuous wavelet transform and ratio substraction methods for the rapid simultaneous quantification of Valsartan, Amlodipine, and hydrochlorothiazide in cardiovascular tablet formulation

Article

Author: Hajilo, Saeedeh ; Sohrabi, Mahmoud Reza

The present study quantified simultaneous determination of the active components included in Valzomix HCT tablets are hydrochlorothiazide (HCT), valsartan (VAL), and amlodipine (AML). Two chemometric methods-continuous wavelet transform (CWT) and ratio subtraction (RS)-along with a rapid and effective spectrophotometric approach-which does not require preparatory separation-were used to do the analysis. The CWT approach applied the zero-crossing method to analyze several wavelet families and selected the Daubechies 2, Symlet 2, and Biorthogonal 1.3 wavelets. At wavelengths of 215, 224, and 233 nm, respectively, each wavelet was selected based on its unique scale characteristics for the purpose of measuring the medicines. The quantification and detection limits for AML and VAL varied between 0.0406 and 0.3906 μg/mL, with recovery rates sometimes above 97 % and root mean square errors below 2. The RS technique identified satisfactory values between 0.1594 and 0.1663 μg/mL. The recovery rates varied from 99.52 % to 102.70 %, with quantification limits of 0.3064 to 0.7669 μg/mL. Both approaches demonstrated relative standard deviations below 1 % and average recovery rates over 94 % in the sample analysis. A one-way ANOVA with a 95 % confidence interval demonstrated no major variances in the methods.

01 Jan 2025·Journal of Chromatography A

Enhancing the practicality along with greenness sustainability of a high throughput HPLC-MS/MS bioanalytical method for the simultaneous determination of amlodipine, perindopril, and its active metabolite perindoprilat in human plasma: Application to a pharmacokinetic study

Article

Author: Elkady, Ehab F ; Sayed, Rawda M ; Moffid, Marwa A ; Mostafa, Eman A

Numerous studies have demonstrated the benefits of amlodipine and perindopril combination therapy in decreasing blood pressure and improving outcomes for high-risk patients. In order to assess the pharmacokinetics of the 2 drugs along with perindoprilat; the active metabolite of perindopril, a simultaneous LC-MS/MS quantification method of amlodipine (AML), perindopril (PER) and perindoprilat (LAT) in human plasma has been developed and validated using amlodipine D4, perindopril D4 and perindoprilat D4 as internal standards (ISs), respectively. A simple and fast protein precipitation method was used to analyze the three analytes from K₃EDTA human plasma. The chromatographic separation included the use of a mixture of methanol and acetonitrile (80:20, v/v) and 0.2 % aqueous formic acid (60:40, v/v) as a mobile phase pumped onto a Zorbax® SB-AQ C18 column. Detection was carried out using a tandem mass spectrometer (MS/MS) in multiple reactions monitoring (MRM) mode. This method exhibited great sensitivity (LLOQ of 0.2 ng/mL for AML and PER and 0.4 ng/mL for LAT), linearity, accuracy (ranging from 97.64 % to 110.28 %), precision (ranging from 2.54 % to 7.60 %), and stability. The method showed good linearity over the range of (0.2-10 ng/mL) for AML, (0.2-160 ng/mL) for PER and (0.4-80 ng/mL) for LAT. The average extraction recoveries of AML, PER and LAT samples were between 81.92 % and 85.07 %. Total elution time was as low as 3 min only. In addition, to ensure the practicality of the developed method, BAGI tool was applied, and the current method has achieved the highest score among the compared methods. Moreover, the sustainability of the proposed method was evaluated using AGREE tool and RGB 12 paradigm showing remarkable sustainability. The developed method is fast, accurate, sensitive, reproducible, ecofriendly, sustainable and suitable for the determination of the concentration of the cited analytes in human plasma. Moreover, it was applied for the bioequivalence study of a generic product to the innovator.

01 Jan 2025·The Journal of Clinical Hypertension

Efficacy of Olmesartan/Amlodipine Single‐Pill Combination on 24‐h Mean Systolic Blood Pressure Measured by Ambulatory Monitoring in Non‐Responders to Valsartan or Candesartan Monotherapy

Article

Author: Choi, Yun‐Seok ; Youn, Ho‐Joong ; Chung, Woo‐Baek ; Ihm, Sang‐Hyun

ABSTRACTThe aim of this study was to evaluate the efficacy of olmesartan/amlodipine (OLM/AML) single‐pill combination (SPC) therapy using ambulatory blood pressure monitoring (ABPM) in non‐responders to valsartan or candesartan monotherapy. Isolated systolic hypertension (ISH) is the most prevalent form of hypertension in middle‐aged and elderly individuals. Patients aged over 55 years who did not achieve the target systolic blood pressure (SBP < 140 mmHg) with valsartan 80 mg or candesartan 8 mg for at least 4 weeks were included. Doses were escalated from 20/5 mg to 40/5 mg and finally to 40/10 mg of OLM/AML SPC until patients reached the target SBP. Efficacy was assessed via ABPM by comparing baseline values with those in the 12th week. Office blood pressure (OBP) and brachial‐ankle pulse wave velocity (baPWV) were assessed at baseline, weeks 4, 8, and 12. Fifty‐four patients (average age 64 ± 6 years; 33 males) participated. The 24‐h mean BPs decreased significantly from an average of 146.2 ± 12.7/93.3 ± 9.2 mmHg to 129.7 ± 14.3/83.4 ± 10.7 mmHg (p < 0.001), and pulse pressures (PPs) from ABPM were reduced (p < 0.001). Additionally, significant reductions in night‐time SBP standard deviations (SDs) (14.7 ± 4.7 vs. 12.5 ± 3.9, p = 0.029) were observed at 12 weeks compared to baseline. OBPs significantly dropped from 151.1 ± 9.7/89.3 ± 8.3 mmHg to 125.5 ± 13.8/77.8 ± 8.8 mmHg after 12 weeks of SPC therapy (p < 0.001). Reductions in PPs of OBP and baPWVs were also observed. OLM/AML SPC therapy effectively reduced the 24‐h mean BP, as measured by ABPM, in hypertensive patients over 55 years old who failed to achieve a target SBP (< 140 mmHg) with angiotensin receptor blocker (ARB) monotherapy using valsartan 80 mg or candesartan 8 mg.Trial Registration: ClinicalTrials.gov identifier: NCT01713920

News (Medical) associated with Amlodipine Besylate

13 Jan 2025

·www.globenewswire.com

George Medicines signs exclusive licensing agreement with Bausch Health to commercialize GMRx2 in Canada, Mexico, Columbia and Central America

George Medicines signs exclusive licensing agreement with Bausch Health to commercialize GMRx2 in Canada, Mexico, Columbia and Central America Bausch Health gains exclusive rights to single-pill triple combination therapy for hypertensionGeorge Medicines receives upfront milestone payment and is eligible for regulatory and commercial milestones, and a stepped royalty rate in licensed territoriesGMRx2 has potential to be the only triple combination approved for the treatment of hypertension including initial treatment London, UK, 13 January 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, has entered into an exclusive licensing and supply agreement with Bausch Health Companies Inc. (NYSE/TSX: BHC) (‘Bausch Health’), a global, diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, granting Bausch Health exclusive rights to seek regulatory approval of, and to commercialize, GMRx2 in Canada, Mexico, Columbia and Central America. GMRx2, George Medicines’ lead pipeline candidate for the treatment of hypertension including initial treatment, is a proprietary single-pill combination of three best-in-class medicines: telmisartan, amlodipine and indapamide. Developed in ultra-low dose, low-dose, and standard-dose options, it has the potential to be the only triple combination approved for the initial treatment of hypertension. The innovative formulation is designed for optimal efficacy, safety and adherence. With a multi-mechanism approach and at lower dosing than today’s therapies, GMRx2 is designed to deliver the synergistic efficacy benefits of a triple therapy while maintaining tolerability. Under the terms of the licensing agreement, George Medicines receives an upfront milestone payment and is eligible for regulatory and commercial milestone payments, as well as a future recurring revenue stream through a stepped royalty rate on sales of GMRx2 in the licensed territories. In return, Bausch Health is granted a license to exclusively commercialize GMRx2, supplied by George Medicines, in Canada, Mexico, Columbia and Central America. Bausch Health is responsible for seeking regulatory approval of GMRx2, with support from George Medicines. Mark Mallon, Chief Executive Officer of George Medicines, said: “This announcement marks a significant milestone for George Medicines, and in Bausch Health we have secured a strong commercial partner who shares our belief in the potential of GMRx2 to enable more patients to achieve better blood pressure control and improve on current hypertension treatment approaches.” Cees Heiman, Senior Vice President, Europe and Canada, Bausch Health, said: “In Canada, seven and a half million people, about 1 in 4 adults, live with hypertension1, and too many do not have their condition under control. The clinically-proven efficacy of GMRx2 compared to dual combinations, coupled with its good tolerability, have the potential to address key challenges in current hypertension treatment approaches. This partnership with George Medicines underscores our commitment to deliver better health outcomes for patients.” Fernando Zarate, Vice President, Latin America, Bausch Health, said: “GMRx2 is a critical innovation that we believe can meaningfully advance cardiovascular care in Mexico, Colombia and Central America. While prevalence of hypertension remains high in the region, its treatment and control is low2. In GMRx2 we have an opportunity to change that.” Globally, many diagnosed hypertension patients are not currently achieving sufficient blood pressure (BP) control because they are on inadequate therapy, are not receiving the right combination of medicines at the right doses or are not taking their treatment as prescribed. With the latest professional guidelines from the European Society of Cardiology3 recommending lower target BP levels and early use of combination therapy, an effective, low-dose, single-pill triple combination with good tolerability provides an opportunity to significantly advance the management of hypertension. GMRx2 is backed by a comprehensive clinical development program, including two pivotal Phase III studies, published in 2024 in the Journal of the American College of Cardiology4 and The Lancet5, demonstrating GMRx2 significantly reduced BP and improved BP control rates, when compared against dual therapy and against placebo. The triple combination was also investigated in the Nigerian VERONICA trial6, which compared GMRx2 with existing, standard of care and reported better BP lowering and control among those receiving GMRx2. In all trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events. A global trial investigating the potential of GMRx2 for the prevention of stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) is ongoing7. GMRx2 has not received regulatory approval for commercial use in any country. A New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking US approval of GMRx2 for the treatment for hypertension, including initiation of treatment, is ongoing with a Prescription Drug User Fee Act (PDUFA) goal date of 5 June 2025. Regulatory submissions in other territories are anticipated in 2025. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm. Ends References: Hypertension Canada Annual Report https://hypertension.ca/wp-content/uploads/2024/10/HC-2024-Annual-Report-Final.pdf)Prevalence, Awareness, Treatment, and Control of Hypertension in the Southern Cone of Latin America; Am J Hypertens; doi: 10.1093/ajh/hpw092 https://academic-oup-com.libproxy1.nus.edu.sg/ajh/article/29/12/1343/27082962024 ESC Guidelines for the management of elevated blood pressure and hypertension; European Heart Journal, Volume 45, Issue 38, 7 October 2024, Pages 3912–4018, https://doi-org.libproxy1.nus.edu.sg/10.1093/eurheartj/ehae178Rodgers A, Salam A, Schutte AE, . . .Whelton P. Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension. Journal of the American College of Cardiology. 2024;0(0). doi:10.1016/j.jacc.2024.08.025Efficacy and safety of a novel low-dose triple single-pill combination, compared with dual combinations for treatment of hypertension; The Lancet; doi: 10.1016/S0140-6736(24)01744-6Ojji DB, Salam A, Sani MU, . . .Rodgers A. Low-dose triple-pill vs standard-care protocols for hypertension treatment in Nigeria: a randomized clinical trial. doi:10.1001/jama.2024.18080. JAMA. 2024.10.1001/jama.2024.18080TRIDENT: Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial https://www.tridentstudy.org/ About George Medicines George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative combinations of best-in-class existing treatments, designed for optimal efficacy and safety. Combining best-in-class molecules from existing medicines in novel low-dose formulations, George Medicines is developing innovative and proprietary treatments to be more efficacious, safer and accessible than currently available treatment options. These multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with cardiometabolic disorders, including hypertension and diabetes, each of which remain the leading causes of premature death and disability worldwide. For more information, please visit www.george-medicines.com. Media contacts ICR Healthcare David Daley, Lindsey Neville, Tom Daniel georgemedicines@icrhealthcare.com; Tel: +44 (0) 203 709 5700

Phase 3License out/inClinical Result

08 Jan 2025

·www.echemi.com

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

Drug ApprovalNDA

02 Sep 2024

·www.pharmaceutical-technology.com

ESC 2024: Single-pill hypertension combo delivers positive results

Caption: At the ESC Congress, the George Institute for Global Health presented positive data from a clinical trial investigating a single pill-combination for mild-to-moderate hypertension. Credit: franckreporter via Getty Images. Kicking off the second day of the European Society of Cardiology (ESC) Congress, researchers presented data suggesting that a single-pill combination of anti-hypertensive drugs could be a viable option as a first-line treatment. As per results presented at the ESC Congress on 30 August, a Phase III placebo-controlled trial (NCT04518306) investigated a single-pill combination therapy for the initial treatment of hypertension. Dubbed GMRx2, the pill combines the active ingredients telmisartan, an angiotensin II antagonist, amlodipine, and indapamide. Amlodipine is a voltage-dependent L Type calcium channel blocker and indapamide is a diuretic drug. Boehringer Ingelheim markets the former drug as Micardis, whilst Viatris sells amplodipine as Norvasc, and Mylan markets the indapamide as Tensaid. London, UK-based George Medicines is developing this triple combination and filed a US Food and Drug Administration new drug application for the pill in August 2024. “Globally, most people treated for high blood pressure (BP) do not achieve adequate control, primarily due to continued use of low-efficacy regimens including monotherapy,” said Dr. Anthony Rogers, the acting director of the cardiovascular division of the George Institute for Global Health, Sydney, Australia. “Single-pill combinations of different low-dose drugs hold promise for improving hypertension management by virtue of additive benefits, rapid action and a low risk of adverse events,” he said while presenting the data. George Medicines is a spinout from George Institute for Global Health. Rogers, the principal investigator of the international study, shared trial results showing that, in a population with mild-to-moderate blood pressure elevation, both dose-versions of the single pill combination were well-tolerated and achieved clinically relevant blood pressure reductions compared with placebo. Furthermore, clinic blood pressure control was achieved in 37% of participants with placebo, compared to 65% and 70% of patients in the GMRx2 quarter- and half-dose cohorts, respectively. See Also: Novavax wins FDA emergency approval for updated Covid-19 vaccine Combating Pharmaceutical Crime with On-Dose Authentication “The availability of a single-pill combination could help to reduce current therapeutic inertia, helping patients achieve BP control quickly in a small number of steps, with potential benefits for improved adherence,” explained Rodgers.

Clinical ResultPhase 3VaccineDrug ApprovalEmergency Use Authorization

100 Deals associated with Amlodipine Besylate

External Link

KEGG	Wiki	ATC	Drug Bank
D00615	Amlodipine Besylate	C08CA01	DBSALT001054

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Deglutition Disorders	CA	Pendopharm, Inc.	11 Jan 2019
Angina Pectoris	GB	Pfizer Inc.	01 Jan 1990
Angina Pectoris, Variant	GB	Pfizer Inc.	01 Jan 1990
Angina, Stable	GB	Pfizer Inc.	01 Jan 1990
Hypertension	GB	Pfizer Inc.	01 Mar 1989
Coronary Artery Disease	CN	-	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Angina Pectoris	NDA/BLA	CN	Sunshine Lake Pharma Co., Ltd.	26 Nov 2024
Angina Pectoris	NDA/BLA	CN	YiChang HEC ChangJiang Pharmaceutical Co., Ltd.	26 Nov 2024
Resistant hypertension	Phase 2	FI	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 2	NL	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 2	CA	Boehringer Ingelheim GmbH	01 Oct 2007
Hypertension	Phase 2	US	Synthon Pharmaceuticals, Inc.	27 Sep 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESH2024	Not Applicable	Hypertension	-	Amlodipine	(chqueqrmge) = jmuueezawc kzpyrciank (bhvrwnpoqo )	Positive	01 May 2024
				Lercanidipine	(chqueqrmge) = hikabugdlo kzpyrciank (bhvrwnpoqo )
NCT02834403 (P4-08-05, CTgov)	Phase 1/2	Metastatic Triple-Negative Breast Carcinoma	37	L-NMMA (Phase Ib - Dose Finding - L-NMMA)	rhcwckzvzt(wtirwmfxlq) = apkupcspbe egdvhlddsb (uhbrrqmryd, ihriikesvl - jxyemwllan) View more	-	15 Dec 2023
				Pegfilgrastim+L-NMMA+Amlodipine+Docetaxel+aspirin (Experimental)	(boalhwttkv) = ajliayclka ewzazwgdyz (imtpnybhsj, tjuctjgnel - vkvcdxiape) View more
ODP190 (ENDO2022)	Not Applicable	Glucose Intolerance	-	Esaxerenone	(jmqinninlw) = czzqnbyqoa tnerhxxvjr (bxilgptxsr, 10) View more	Positive	01 Nov 2022
				Amlodipine	(jmqinninlw) = qixawtwyoq tnerhxxvjr (bxilgptxsr, 14) View more
ECWAMER (ESH2022)	Not Applicable	COVID-19 C-reactive protein - \| ferritin \| fibrinogen ... View more	30	Lisinopril + Amlodipine + Rosuvastatin (ECWAMER)	(apuefhrobm) = xpslyosxob vrcybzlkdr (zgnzwymfji ) View more	Positive	01 Jun 2022
SAT-460 (ENDO2020)	Not Applicable	Myxedema coma	1	Levothyroxine	oouebdekmp(kbaymxhqmo) = xoqtgfqhwe tgelnisqej (joluviqaty ) View more	Positive	08 May 2020
				Dopamine	(irgfxvgdnk) = vyppbdviol fplrhmszdz (rhmfwwqlxv )
NCT02979197 (CTgov)	Phase 3	Hypertension	105	OE 10 mg amlodipine besylate tablet+OE 200 mg celecoxib capsule (Amlodipine+Celecoxib)	zvbcvmshjq(obqgbcvwab) = qpvgazcajk ftxhllsqej (ceiuacvabt, uxzllfrdbo - herpezywov) View more	-	21 Oct 2019
				Matched placebo for OE celecoxib capsule+OE 10 mg amlodipine besylate tablet (Amlodipine+Placebo)	zvbcvmshjq(obqgbcvwab) = cuxjgydqcm ftxhllsqej (ceiuacvabt, ljrwcgybzq - ledziuqdlp) View more
MON-429 (ENDO2019)	Not Applicable	Pulmonary hypertensive crisis	-	St. John's Wort	uthzzxgzmi(ddueddaiwm) = Hypertensive crisis in a young woman with use of St. John's Wort for depression mwziqmokii (elchipefhy ) View more	-	30 Apr 2019
				Amlodipine
NCT02353806 (CTgov)	Phase 4	Hypertension, Pregnancy-Induced	16	Amlodipine besylate	fzjzzlzyqb(pgnalgtmgf) = xdoewvhchq danyyazkgl (bxwfjcdzvy, avbwpqholo - zhdxayefum) View more	-	06 Feb 2019
SMOOTHNESS INDEX OF CENTRAL BLOOD PRESSURE AND PARAMETERS FOR VASCULAR STIFFNESS AFTER 20 WEEK TREATMENT WITH LOSARTAN PLUS AMLODIPINE VS. THIAZIDE RANDOMIZED TRIAL (ESH2018)	Not Applicable	-	143	Losartan plus Amlodipine	fkbviikzgz(srgzvumian) = gbfitkhddp aibjwhiovm (rimjnwsyvf )	Positive	01 Jun 2018
				Hydrochlorothiazide	fkbviikzgz(srgzvumian) = ryhrgatiyb aibjwhiovm (rimjnwsyvf )
NCT02172040 (CTgov)	Phase 3	Hypertension	152	Over-encapsulated 10 mg amlodipine besylate tablet+Over-encapsulated 200 mg celecoxib capsule (Amlodipine+Celecoxib)	dwbdupkten(ayfagkimes) = tdlixvepej bbepdysjoa (coklcfrunm, jpxmmqhgue - gvxmyidydy) View more	-	03 Oct 2017
				Matched placebo capsule for over-encapsulated celecoxib capsule+Over-encapsulated 10 mg amlodipine besylate tablet (Amlodipine+Placebo)	dwbdupkten(ayfagkimes) = havyprivus bbepdysjoa (coklcfrunm, ktajfbjuew - fynznflsxv) View more

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