主要研究目的：研究空腹/餐后状态下单次口服受试制剂美阿沙坦钾片与参比制剂美阿沙坦钾片（商品名：易达比® ；规格：40mg；Takeda Ireland Ltd.生产）在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂美阿沙坦钾片（规格：40mg）与参比制剂易达比®（规格：40mg）在健康受试者中的安全性。

[Translation]

Primary study objective: To study the pharmacokinetics of the test preparation, Miasartan Potassium Tablets, and the reference preparation, Miasartan Potassium Tablets (trade name: Edabi®; specification: 40 mg; produced by Takeda Ireland Ltd.) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary study objective: To evaluate the safety of the test preparation, Miasartan Potassium Tablets (specification: 40 mg) and the reference preparation, Edabi® (specification: 40 mg) in healthy subjects.

Start Date25 Feb 2025

Sponsor / Collaborator

Tianjin Huajin Pharmaceutical Co. Ltd.

CTR20244532

/ CompletedNot Applicable

美阿沙坦钾片在中国健康人群中餐后状态下单次给药的人体生物等效性临床试验

[Translation] A human bioequivalence clinical trial of Asartan Potassium Tablets after single administration in healthy Chinese people under the fed state

主要目的：以持证商为Takeda Pharma A/S的美阿沙坦钾片（商品名：易达比®（EDARBI®），规格：按美阿沙坦（C30H24N4O8）计80mg）为参比制剂，以杭州端本医药科技有限公司研发的美阿沙坦钾片（规格：按美阿沙坦（C30H24N4O8）计80mg）为受试制剂，评价两种制剂在中国健康受试者中餐后状态下的生物等效性。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the two preparations in the postprandial state in healthy Chinese subjects, using the reference preparation of edartan potassium tablets (trade name: EDARBI®, specification: 80 mg based on edartan (C30H24N4O8)) developed by Hangzhou Duanben Pharmaceutical Technology Co., Ltd. as the test preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date25 Dec 2024

Sponsor / Collaborator

Hangzhou Duanben Pharmaceutical Technology Co., Ltd.

CTR20243804

/ CompletedNot Applicable

美阿沙坦钾片随机、开放、两周期、两序列、双交叉健康受试者餐后单次给药人体生物等效性试验

[Translation] A randomized, open-label, two-period, two-sequence, double-crossover bioequivalence study of Asartan potassium tablets in healthy subjects after a single dose after meal

主要目的：以健康受试者为试验对象，采用随机、开放、两周期、两序列、双交叉试验设计，考察健康受试者餐后单次口服山西德元堂药业有限公司生产的美阿沙坦钾片（受试制剂，规格：80mg）与Takeda Ireland Ltd.生产（Takeda Pharma A/S持证）的美阿沙坦钾片（参比制剂，商品名：易达比®，规格：80mg）后美阿沙坦的体内经时过程，估算其相关药代动力学参数及相对生物利用度，评价其餐后状态下的生物等效性，为受试制剂的生产注册申请提供依据。次要目的：评价美阿沙坦钾片受试制剂和参比制剂（商品名：易达比®）在健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo time course of Asartan Potassium Tablets (test preparation, specification: 80 mg) produced by Shanxi Deyuantang Pharmaceutical Co., Ltd. and Asartan Potassium Tablets (reference preparation, trade name: Edabi®, specification: 80 mg) produced by Takeda Ireland Ltd. (licensed by Takeda Pharma A/S) after a single oral administration of Asartan Potassium Tablets (test preparation, specification: 80 mg) to healthy subjects, estimate their relevant pharmacokinetic parameters and relative bioavailability, evaluate their bioequivalence in the postprandial state, and provide a basis for the production registration application of the test preparation. Secondary objective: To evaluate the safety of the test preparation and reference preparation of Asartan Potassium Tablets (trade name: Edabi®) in healthy subjects.

Start Date05 Nov 2024

Sponsor / Collaborator

Shanxi Deyuantang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Azilsartan Kamedoxomil

100 Translational Medicine associated with Azilsartan Kamedoxomil

100 Patents (Medical) associated with Azilsartan Kamedoxomil

862

Literatures (Medical) associated with Azilsartan Kamedoxomil

01 Mar 2025·Drug Delivery and Translational Research

Multifunctional polymeric nanofibrous scaffolds enriched with azilsartan medoxomil for enhanced wound healing

Article

Author: Singh, Neelu ; Rathore, Kalpana ; Alka ; Ratna, Sheel ; Verma, Vivek ; Verma, Abhishek ; Saraf, Shubhini A ; Mishra, Nidhi ; Singh, Priya ; Nisha, Raquibun

A prolonged and compromised wound healing process poses a significant clinical challenge, necessitating innovative solutions. This research investigates the potential application of nanotechnology-based formulations, specifically nanofiber (NF) scaffolds, in addressing this issue. The study focuses on the development and characterization of multifunctional nanofibrous scaffolds (AZL-CS/PVA-NF) composed of azilsartan medoxomil (AZL) enriched chitosan/polyvinyl alcohol (CS/PVA) through electrospinning. The scaffolds underwent comprehensive characterization both in vitro and in vivo. The mean diameter and tensile strength of AZL-CS/PVA-NF were determined to be 240.42 ± 3.55 nm and 18.05 ± 1.18 MPa, respectively. A notable drug release rate of 93.86 ± 2.04%, was observed from AZL-CS/PVA-NF over 48 h at pH 7.4. Moreover, AZL-CS/PVA-NF exhibited potent antimicrobial efficacy for Staphylococcus aureus and Pseudomonas aeruginosa. The expression levels of Akt and CD31 were significantly elevated, while Stat3 showed a decrease, indicating a heightened tissue regeneration rate with AZL-CS/PVA-NF compared to other treatment groups. In vivo ELISA findings revealed reduced inflammatory markers (IL-6, IL-1β, TNF-α) within treated skin tissue, implying a beneficial effect on injury repair. The comprehensive findings of the present endeavour underscore the superior wound healing activity of the developed AZL-CS/PVA-NF scaffolds in a Wistar rat full-thickness excision wound model. This indicates their potential as novel carriers for drugs and dressings in the field of wound care.

30 Jan 2025·QUINTESSENCE INTERNATIONAL

The effects of photobiomodulation and/or azithromycin treatment on bone resorption biomarkers in gingival crevicular fluid from patients with stage III-IV grade C periodontitis.

Article

Author: Aslan Kehribar, Malike ; Baltacıoğlu, Esra ; Alver, Ahmet ; Dülger, Kıvanç

OBJECTIVES:

This study aimed to investigate the impact of photobiomodulation and/or azithromycin therapy in combination with full-mouth subgingival instrumentation on receptor activator of nuclear factor κB ligand (RANKL) and osteoprotegerin levels and RANKL/osteoprotegerin ratios in gingival crevicular fluid on patients with stage III-IV grade C periodontitis.

METHOD AND MATERIALS:

The study was conducted on 77 stage III-IV grade C periodontitis patients and 20 periodontally healthy controls. Patients with stage III-IV grade C periodontitis were categorized into four treatment groups: 1) only full-mouth subgingival instrumentation (FSI) group; 2) full-mouth subgingival instrumentation + azithromycin (AZM) group; 3) full-mouth subgingival instrumentation + photobiomodulation (PBM) group; and 4) full-mouth subgingival instrumentation + photobiomodulation + azithromycin (AZM+PBM) group. Clinical periodontal parameters and RANKL and osteoprotegerin levels and RANKL/osteoprotegerin ratios in gingival crevicular fluid were measured at baseline and at the third month of therapy.

RESULTS:

Compared with the periodontally healthy controls, all the baseline clinical parameters were higher in the stage III-IV grade C periodontitis groups (P .05); however, there were no statistically significant differences between the stage III-IV grade C periodontitis groups (P > .05). At month 3, the lowest values in all clinical parameters were generally observed in the antibiotics groups, whereas the highest values were observed in the FSI group. Furthermore, the highest RANKL and osteoprotegerin values in antibiotic groups and the highest RANKL/osteoprotegerin ratio in the PBM group were observed in month 3. RANKL/osteoprotegerin ratios did not change in the FSI and antibiotics groups after the treatment, but increased significantly in the PBM group.

CONCLUSION:

While photobiomodulation treatment combined with full-mouth subgingival instrumentation increases the RANKL levels, azithromycin increases osteoprotegerin levels. Also, AZM + PBM treatment shows additional clinical and immunologic beneficial efficacy.

06 Jan 2025·Regenerative Biomaterials

Azithromycin-loaded PLGA microspheres coated with silk fibroin ameliorate inflammation and promote periodontal tissue regeneration

Article

Author: Liu, Chunyi ; Zhang, Li ; Hu, Meilin ; Deng, Zhe ; Wang, Zhengyang ; Sun, Lu ; Liu, Dayong ; Chen, Xiaoyu ; Wang, Ying ChengYao ; Li, Haocong ; Xing, Liangyu ; Zhou, Yangyang ; Ouyang, Zhaoguang ; Lian, Tengye ; Xu, Yue ; Gao, Feng

Abstract:

Periodontitis, a widespread inflammatory disease, is the major cause of tooth loss in adults. While mechanical periodontal therapy benefits the periodontal disease treatment, adjunctive periodontal therapy is also necessary. Topically applied anti-inflammatory agents have gained considerable attention in periodontitis therapy. Although azithromycin (AZM) possesses excellent anti-inflammatory properties, its bioavailability is limited owing to poor water solubility and the absence of sustained release mechanisms. Herein, we synthesized biodegradable microspheres (AZM@PLGA-SF) for sustained AZM release to locally ameliorate periodontal inflammation and facilitate periodontal tissue regeneration. AZM was encapsulated in poly (lactic-co-glycolic acid) (PLGA) microspheres (AZM@PLGA) using single emulsion-solvent evaporation, followed by surface coating with silk fibroin (SF) via electrostatic adsorption, reducing the initial burst release of AZM. In vivo, local treatment with AZM@PLGA-SF microspheres significantly reduced periodontal inflammation and restored periodontal tissue to healthy levels. Mechanically, the formulated microspheres regulated the periodontal inflammatory microenvironment by reducing the levels of pro-inflammatory cytokines (tumor necrosis factor -α, interleukin [IL]-6, interferon-γ, IL-2, and IL-17A) in gingival crevicular fluid and promoted the expression of anti-inflammatory cytokines (IL-4 and IL-10). AZM@PLGA-SF microspheres demonstrated excellent biological safety. Therefore, we introduce an anti-inflammatory therapy for periodontitis with substantial potential for mitigating periodontal inflammation and encouraging the repair and regeneration of periodontal tissues.

News (Medical) associated with Azilsartan Kamedoxomil

04 Nov 2019

·www.stada.com

STADA invests $660 Million USD in Takeda’s OTC portfolio in Russia/CIS to become a major player in these branded markets

Bad Vilbel, Moscow, November 5, 2019 – STADA Arzneimittel AG (together with its subsidiaries ‘STADA’ or ‘the Group’) has agreed to acquire a portfolio of selected products from Takeda Pharmaceutical Company Limited for a total value of $660 Million USD. The portfolio of approximately 20 selected over-the-counter (‘OTC’) and prescription pharmaceutical assets sold inter alia in Russia, Georgia, Azerbaijan, Belarus, Kazakhstan, and Uzbekistan will be divested to STADA Arzneimittel AG. The portfolio includes OTC-vitamins and food supplements, plus selected products within the cardiovascular, diabetes, general medicine, and respiratory therapeutic areas. Included in the transaction is the key product Cardiomagnyl, a well-known name and category leader in Russia, which is used to prevent blood clots, as well as the newer, patent-protected Nesina (for type II diabetes treatment) and Edarbi (angiotensin II receptor blocker for blood pressure control). The acquired portfolio complements STADA’s existing portfolio and capabilities in Russia which include medicines from 16 of 20 therapeutic groups of the best-selling products in retail pharmacies. The transaction will enable the Group to continue expanding its consumer health business in Russia and the CIS. It is expected that the highly capable approximately 500-strong sales and marketing team from Takeda’s business will transfer to STADA on completion of the transaction, which is expected in the first quarter of 2020. In addition, Takeda and STADA will enter into manufacturing and supply agreements in connection with the acquisition under which Takeda will continue to supply the products to STADA. The acquisition is expected to be financed by new debt financing. Peter Goldschmidt, CEO of STADA, commented: “This is STADA’s largest acquisition to date and will position us as a major player in a large and structurally growing market. This transaction also reflects the ambitions of STADA as we continue expanding the business internationally – both organically and through acquisitions – and continue generating significant operating efficiencies worldwide. STADA’s branded products are already well-represented in the most popular pharmacy categories in our key markets. However, we are continuing to expand our portfolio of branded generics, to strengthen our position in strategic niches and to develop new market segments.” Advisers to STADA on this transaction included: Nomura (M&A) and Kirkland & Ellis LLP (legal). About STADA Arzneimittel AG STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a two pillar strategy consisting of generics, including specialty pharmaceuticals and non-prescription consumer health products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2018, STADA achieved adjusted Group sales of EUR 2,330.8 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 503.5 million. As of December 31, 2018, STADA employed 10,416 people worldwide.

AcquisitionBiosimilar

26 Jul 2017

·www.bioportfolio.com

Arbor Pharmaceuticals LLC Pharmaceuticals Healthcare Deals and Alliances Profile. [Report Updated: 20072017] Prices from USD $250

Summary Arbor Pharmaceuticals LLC Arbor is a healthcare products provider that develops prescription products for the hospital, cardiovascular and pediatric segments. The company offers licensing, manufacturing, development and commercialization of latestage prescription products. It also offers generic prescription and development stage products. Arbor's prescription products comprise edarbi, edarbyclor, bidil, nymalize, eryped, and erythromycin group of products. It offers products used in treatment areas including cardiovascular, emergency, pediatrics, psychiatry and endocrinology diseases. The company offers its products through sales professionals to hospitals and physicians across the US. Arbor is headquartered in Atlanta, Georgia, the US. Arbor Pharmaceuticals LLC Pharmaceuticals Healthcare Deals and Alliances Profile. provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.

Acquisition

100 Deals associated with Azilsartan Kamedoxomil

External Link

KEGG	Wiki	ATC	Drug Bank
-	Azilsartan Kamedoxomil	C09CA09	DB08822

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	European Union	Takeda Pharma A/S	07 Dec 2011
Essential Hypertension	Iceland	Takeda Pharma A/S	07 Dec 2011
Essential Hypertension	Liechtenstein	Takeda Pharma A/S	07 Dec 2011
Essential Hypertension	Norway	Takeda Pharma A/S	07 Dec 2011
Hypertension	United States	Azurity Pharmaceuticals, Inc.	25 Feb 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Jan 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESH2021	Not Applicable	Heart failure with normal ejection fraction \| Hypertension	-	Fixed-dose combination AZL-M/CLD	fnuasafitq(ccohztaypm) = lhicbvznjh cxncjevzrg (hhlxjxiuih, 8.7 - 12.3)	Positive	01 Apr 2021
				Non-fixed-dose combinations of iACE/ARB and thiazide/thiazide-like diuretics	fnuasafitq(ccohztaypm) = djjdynwxtm cxncjevzrg (hhlxjxiuih, 9.2 - 12.8)
NCT02541669 (CTgov)	Phase 1	Hypertension	64	TAK-491 (Open Label: TAK-491 40 mg)	vbxezuetjm(ouztwoaktj) = nxrwrbcerb qinnppzzbs (jkzuibgwxp, 25.0) View more	-	05 Feb 2020
				TAK-491 (Open Label: TAK-491 80 mg)	vbxezuetjm(ouztwoaktj) = cbnwsndvgu qinnppzzbs (jkzuibgwxp, 20.5) View more
NCT02517866 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Essential Hypertension	380	Azilsartan Medoxomil	uudzrjcmyn = ahxifwpxxf uofuqopreg (ihsxfcgrtv, xpmdwxfwgj - nqumfutvup) View more	-	01 Mar 2019
NCT02480764 (CTgov)	Phase 3	Essential Hypertension	612	Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 40 mg)	oblmugbcry(yzrvevcwrn) = exgnwcuqzz ygigkxuiol (icdizstugr, 0.5123) View more	-	11 Feb 2019
				Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 80 mg)	oblmugbcry(yzrvevcwrn) = epjlseehcb ygigkxuiol (icdizstugr, 0.5010) View more
NCT00591773 (Pubmed \| J Renin Angiotensin Aldosterone Syst)	Phase 3	Essential Hypertension	551	Azilsartan medoxomil 40 mg plus chlorthalidone	eyqzraituc(vgyoebvedq) = flwyxeqizs aymxzfskdr (vlwxrptjhx )	-	01 Jul 2018
				Azilsartan medoxomil 80 mg plus chlorthalidone	eyqzraituc(vgyoebvedq) = oixxwcmxca aymxzfskdr (vlwxrptjhx )
ESH2018	Not Applicable	Metabolic Syndrome \| Hypertension	32	Azilsartan medoxomil 40 mg	yjwzqoxecx(qjgjogrrbi) = hkzblyscsw lznypevyks (lbsgwwpqlb ) View more	Positive	01 Jun 2018
				Azilsartan medoxomil 80 mg	yjwzqoxecx(qjgjogrrbi) = jfdwqflmrd lznypevyks (lbsgwwpqlb ) View more
[PP.22.13] (ESH2017)	Not Applicable	Essential Hypertension	-	Azilsartan medoxomil 80 mg	qkuoiyebqr(pelzoebgui) = kzutvnywmg tvztfigjkr (xzkyegktey, 1.8) View more	Positive	01 Sep 2017
[PP.12.25] (ESH2017)	Not Applicable	Diabetes Mellitus, Type 2 \| Hypertension	30	Azilsartan medoxomil 40 mg	kmnchafnru(reejngnica) = dmpujeitpl rkvhzbtcco (jhcdpluvdm )	Positive	01 Sep 2017
				Azilsartan medoxomil 80 mg	kmnchafnru(reejngnica) = ngpzjbgteq rkvhzbtcco (jhcdpluvdm )
NCT02203916 (CTgov)	Phase 3	Essential Hypertension	328	Azilsartan medoxomil placebo (Placebo)	dvmxcvxgyy(prasamnmmg) = mcmixtvuze gtdkrtelgh (dcgopcrjdp, 2.0039) View more	-	19 Dec 2016
				Azilsartan medoxomil (Azilsartan Medoxomil 40 mg)	dvmxcvxgyy(prasamnmmg) = mftjkgqujb gtdkrtelgh (dcgopcrjdp, 1.4117) View more
PP.05.13 (ESH2016)	Not Applicable	Diabetes Mellitus \| Hypertension	20	Azilsartan medoxomil 40 mg	fbnbwapmbu(osuyoxqpqm) = snrtsrgwij xdxtdhtvxl (rxywjwjcsv, 5) View more	Positive	01 Sep 2016

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