Delving into the Latest Updates on Zofenopril Calcium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Bifril, Zantipress, Zofenil

+ [12]

Target

ACE

Mechanism

ACE inhibitors(Angiotensin-converting enzyme inhibitors)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

HypertensionMyocardial InfarctionEssential Hypertension

Inactive Indication

Heart Failure

Originator Organization

Menarini International Operations Luxembourg SA

Active Organization

Shanghai Institute of Pharmaceutical IndustryMenarini International Operations Luxembourg SA

Jiangsu Kanion Pharmaceutical Co., Ltd.

Inactive Organization

A. Menarini Industrie Farmaceutiche Riunite SRL

Bristol Myers Squibb Co.

BioSyent, Inc.

Drug Highest PhaseApproved

First Approval Date

NL (05 Jul 2008),

HypertensionMyocardial Infarction

Regulation-

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Structure

Molecular FormulaC44H46CaN2O8S4

InChIKeyHSCMHYHMIZMAQI-LETVYOFWSA-N

CAS Registry81938-43-4

View All Structures (2)

Study to assess the anti-hypertensive efficacy and safety of the extemporaneous combination of Zofenopril 30 mg in combination with Amlodipine 5 mg or AML 10 mg in lowering the sitting diastolic BP after 8 weeks of treatment in patients with uncontrolled BP previously treated with Zofenopril or Amlodipine (5 mg) monotherapies for at least 4 weeks.

Start Date15 Oct 2021

Sponsor / Collaborator

Menarini International Operations Luxembourg SA

NCT05257148 / CompletedPhase 4

Open-label, Multicenter, Multinational, Interventional Clinical Trial to Assess Effectiveness and SAfety of the Extemporaneous Combination of Nebivolol and Zofenopril Calcium in Grade 1 to 2 Hypertensive patIents Versus Each mOnotherapy

Open-label, interventional clinical trial to assess effectiveness and safety of the extemporaneous combination of nebivolol and zofenopril calcium in grade 1 to 2 hypertensive patients versus each monotherapy

Start Date26 May 2021

Sponsor / Collaborator

Menarini International Operations Luxembourg SA

DRKS00020911 / CompletedPhase 1

Bioequivalence of Zofenopril and Nebivolol following their oral co-administration as fixed or extemporaneous combination in healthy volunteers. An open label, randomized, two periods, two sequences, cross-over study - ZOF-NEB-01

Start Date18 Jun 2020

Sponsor / Collaborator

Menarini Ricerche SpA

100 Clinical Results associated with Zofenopril Calcium

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100 Translational Medicine associated with Zofenopril Calcium

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100 Patents (Medical) associated with Zofenopril Calcium

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195

Literatures (Medical) associated with Zofenopril Calcium

02 Dec 2023·Current Medical Research and Opinion

Extemporaneous combination therapy with amlodipine/zofenopril in hypertensive patients: a real-world data analysis in Italy

Article

Author: Pegoraro, Valeria ; Heiman, Franca ; Volpe, Massimo ; Cipelli, Riccardo

OBJECTIVESTo provide clinical characteristics and to quantify the number of patients receiving the extemporaneous combination of the calcium channel blocker amlodipine and the angiotensin converting enzyme inhibitor zofenopril in a real-world setting. This evidence can provide a snapshot of the potential users of the two molecules in a single pill combination (SPC).METHODSRetrospective observational study using data from the IQVIA Italian Longitudinal Patient Database. Adult patients firstly prescribed with amlodipine and zofenopril between 1 July 2011 and 30 June 2020 were identified and demographic and clinical characteristics were extracted. Treatment adherence was evaluated as proportion of days covered (PDC). The potential number of patients eligible for a SPC was calculated.RESULTSA population of 2394 hypertensive patients, mean age of 68.6 years ±12.7, 52.6% male were treated with amlodipine and zofenopril. The majority of patients (54.5%) were low adherent (PDC <40%), 25.9% were intermediate adherent and only 19.6% were high adherent (>80%) to therapy. Around 42,500 adult hypertensive patients were estimated to be prescribed the extemporaneous combination in 2019 in Italy, being potentially eligible for treatment with amlodipine and zofenopril SPC.CONCLUSIONSThe administration of the extemporaneous combination of zofenopril and amlodipine in hypertensive patients is a common practice in Italy. The development of a SPC can be a viable treatment option to simplify therapy and to increase adherence in hypertensive patients who are already on the two monotherapies in combination.

13 Sep 2023·Molecular biotechnology

Effects of Zofenopril on Arterial Stiffness in Hypertension Patients.

Article

Author: Sher, Farooq ; Abdelghani, Heba Taha Mohmmed ; Brizić, Ivica ; Džidić-Krivić, Amina ; Palić, Benjamin ; Sher, Emina Karahmet ; Cvetković, Ivona

Angiotensin-converting enzyme inhibitors (ACEIs) reduce arterial stiffness beyond their antihypertensive effect. Studies showed that sulfhydryl ACEIs have the antioxidative potential to improve endothelial function, which might have a clinical effect on arterial distensibility. However, there are no studies that directly compare the effects of sulfhydryl (zofenopril) and non-sulfhydryl ACEIs (enalapril) on arterial stiffness. Therefore, this prospective study aims to compare the effects of enalapril and zofenopril on arterial stiffness and oxidative stress in both short- and long-term treatment of arterial hypertension (AH). Baseline and post-treatment peripheral and central arterial pressure indices, augmentation index (Aix), aortic pulse wave velocity (ao-PWV), serum levels of oxidized low-density cholesterol lipoprotein, LDL and uric acid (UA) were measured. The results showed that acute treatment with zofenopril, in contrast to enalapril, significantly decreased peripheral and central Aix (p < 0.001). Chronic treatment with zofenopril showed a superior effect over enalapril on the reduction of the peripheral systolic arterial pressure with reduction of ao-PWV (p = 0.004), as well as a reduction in peripheral Aix (p = 0.021) and central Aix (p = 0.021). Therefore, this study indicates that zofenopril has beneficial effects on the reduction of arterial stiffness compared to enalapril. It has potent clinical efficacy in AH treatment and further studies should compare its safety and long-term efficacy to other AH drugs that would aid clinicians in treating AH and other various cardiovascular diseases that have arterial stiffness as a common denominator.

03 Oct 2022·Current Medical Research and Opinion

Extemporaneous combination therapy with nebivolol/zofenopril in hypertensive patients: usage in Italy

Article

Author: Heiman, Franca ; Pegoraro, Valeria ; Meto, Suada ; Peduto, Ilaria ; Volpe, Massimo

OBJECTIVEClinically describing hypertensive patients initiating nebivolol/zofenopril extemporaneous combination (NZ-EXC) and estimating the number of patients currently receiving NZ-EXC and of those potentially eligible for the fixed-dose combination of the two molecules (NZ-FDC) in Italy.METHODSThis retrospective observational study used data from IQVIA Italian Longitudinal Patient Database (LPD). Adult hypertensive patients firstly prescribed NZ-EXC between 1 July 2011 and 30 June 2020 were identified and their demographic and clinical characteristics were extracted. Treatment adherence was evaluated as proportion of days covered (PDC) and classified as low (PDC <40%), intermediate (PDC ≥40% and <80%) or high (PDC ≥80%). Two additional cohorts were identified in 2019 to provide the national-level yearly estimates of patients prescribed NZ-EXC and of patients eligible for NZ-FDC.RESULTSIn total 1745 patients were prescribed NZ-EXC: 60% were women; mean age was 65 years. The most frequent comorbidities were dyslipidemia (19.0%), diabetes (15.5%) and thyroid diseases (13.1%); the most common co-prescribed treatments were antithrombotics (29.1%), lipid-lowering agents (28.8%), nonsteroidal anti-inflammatory drugs (26.1%) and antihyperglycemic agents (13.5%). Mean PDC was 39%, and 57% of the patients had a PDC < 40%. The yearly estimate of patients prescribed NZ-EXC in 2019 was 59,000, while potential users of NZ-FDC were estimated to be 29,000.CONCLUSIONSNZ-EXC in hypertensive patients is a common practice in Italy and the development of a NZ-FDC can be a viable treatment option for hypertensive patients who are already receiving nebivolol and zofenopril through the concomitant assumption of two distinct pills. As supported by scientific literature, FDCs of antihypertensive drugs could simplify treatment, improve adherence and potentially reduce health-care costs as related to a better control of blood pressure.

100 Deals associated with Zofenopril Calcium

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External Link

KEGG	Wiki	ATC	Drug Bank
D03767	Zofenopril Calcium	C09AA15	DB13166

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	NL	Menarini International Operations Luxembourg SA	05 Jul 2008
Myocardial Infarction	NL	Menarini International Operations Luxembourg SA	05 Jul 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 2	CN	Shanghai Institute of Pharmaceutical Industry	30 Aug 2013
Essential Hypertension	Phase 2	CN	Jiangsu Kanion Pharmaceutical Co., Ltd.	30 Aug 2013
Heart Failure	Phase 2	EU	A. Menarini Industrie Farmaceutiche Riunite SRL	-
Hypertension	Phase 2	US	Bristol Myers Squibb Co.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SMILE (EULAR2017)	Not Applicable	Myocardial Infarction hyperuricemic	525	Zofenopril + XOI	(sphlaomyps) = pxpmnsydkn rtottbclgc (xhcjlbbwfq )	Positive	14 Jun 2017
				Zofenopril	(sphlaomyps) = mqpulhbygm rtottbclgc (xhcjlbbwfq )
EUCTR2004-001150-88-IE (SMILE-4, EASD2012)	Phase 3	Left ventricular systolic dysfunction diabetes mellitus	716	Zofenopril + ASA	ulyuwmcwph(kwztrcaihf) = dobdhvxakn qwwasurvpu (hzsymollqe, 0.31 - 1.30)	Positive	04 Oct 2012
				Ramipril + ASA	ulyuwmcwph(kwztrcaihf) = abxozvqwcc qwwasurvpu (hzsymollqe )