Delving into the Latest Updates on Fluticasone Propionate/Formoterol Fumarate Hydrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Fluticasone/Formoterol, Flutiform 125, Flutiform 50

+ [6]

Target

GR x β2-adrenergic receptor

Action

agonists

Mechanism

GR agonists(Glucocorticoid receptor agonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Immune System DiseasesRespiratory Diseases

Active Indication

Asthma

Inactive Indication

Moderate asthmaPersistent asthmaPulmonary Disease, Chronic Obstructive+ [1]

Originator Organization

Vectura Group Ltd.

Active Organization

Beijing Mengdi Pharmaceutical Co. Ltd.

KYORIN Pharmaceutical Co., Ltd.Mundipharma Pty Ltd.

+ [1]

Inactive Organization

Abbott LaboratoriesSkyePharma AG

Fisons Ltd.

Drug Highest PhaseApproved

First Approval Date

Australia (14 Jun 2013),

Asthma

Regulation-

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Structure/Sequence

Molecular FormulaC92H118F6N4O24S2

InChIKeyZLQPBKRHFCHUSM-CNJJYQOESA-N

CAS Registry1818371-29-7

Eurofarma Laboratórios S.A. markets a FDC containing formoterol 12 mcg/fluticasone 250 mcg, in a single capsule for inhalation (Lugano®; reference product). The product is indicated for the treatment of asthma in patients aged ≥ 12 years. The company seeks to register a product with lower concentrations of mono-drugs (6 mcg and 125 mcg, respectively) to enable the dosage step up and step down treatment strategies advocated by the Global Initiative for Asthma for the inhaled maintenance treatment of asthma (GINA, 2022 ) with these combinations.
This Phase 3 study will be carried out for demonstrating the non-inferiority of the investigational drug (FDC of formoterol 6 mcg/fluticasone 125 mcg) compared to the FDC of formoterol 6 mcg/budesonide 200 mcg (Alenia® - Aché Laboratórios Farmacêuticos S.A.) in the maintenance treatment of asthma, allowing its registration as a new concentration of the drug already registered by the company.

Start Date30 Jun 2025

Sponsor / Collaborator

Eurofarma Laboratórios SA

CTR20171144

/ CompletedNot Applicable

一项在中国健康受试者中评估FLUTIFORM pMDI 50/5 μg、125/5 μg和250/10 μg,药代动力学特征的开放性、单剂和单剂加多剂给药研究

[Translation] An open-label, single-dose and single-dose plus multiple-dose study to evaluate the pharmacokinetic characteristics of FLUTIFORM pMDI 50/5 μg, 125/5 μg, and 250/10 μg in healthy Chinese subjects

评估在中国健康受试者中经加压定量吸入器（pMDI）吸入单剂（50/5 μg、125/5 μg和250/10 μg）和多剂（250/10 μg）FLUTIFORM 的药代动力学（PK）特征和安全性特征。

[Translation]

To evaluate the pharmacokinetic (PK) and safety profiles of single (50/5 μg, 125/5 μg, and 250/10 μg) and multiple (250/10 μg) doses of FLUTIFORM inhaled by pressurized metered-dose inhaler (pMDI) in healthy Chinese subjects.

Start Date16 Apr 2018

Sponsor / Collaborator

Beijing Mengdi Pharmaceutical Co. Ltd.

[+2]

JPRN-UMIN000029379

/ CompletedNot ApplicableIIT

Rapid effect of Flutiform on pulmonary function compared with Relvar and Symbicort - Rapid effect of Flutiform on pulmonary function compared with Relvar and Symbicort

Start Date02 Oct 2017

Sponsor / Collaborator-

100 Clinical Results associated with Fluticasone Propionate/Formoterol Fumarate Hydrate

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100 Translational Medicine associated with Fluticasone Propionate/Formoterol Fumarate Hydrate

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100 Patents (Medical) associated with Fluticasone Propionate/Formoterol Fumarate Hydrate

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192

Literatures (Medical) associated with Fluticasone Propionate/Formoterol Fumarate Hydrate

01 Dec 2024·Phytomedicine

Semen Cuscutae-Fructus Lycii attenuates tripterygium glycosides-induced spermatogenesis dysfunction by inhibiting oxidative stress-mediated ferroptosis via the Nrf2/HO-1 pathway

Article

Author: Wang, Bin ; Li, Haisong ; Wang, Jingshang ; Xin, Xiyan ; Dong, Lei ; Liu, Qiuning ; Ye, Yang ; Li, Dong ; Guan, Siqi ; Zhang, Jiacheng ; Zhu, Yutian

BACKGROUNDSemen Cuscutae and Fructus Lycii (SC-FL) is known for its potential therapeutic effects on spermatogenesis dysfunction. However, the underlying mechanisms of SC-FL in alleviating spermatogenesis dysfunction is still being elucidated.PURPOSEThis study aimed to explore the effects of SC-FL on spermatogenesis dysfunction and investigate the involved mechanisms, specifically focusing on the modulation of oxidative stress and ferroptosis.METHODSA mouse model of spermatogenesis dysfunction was induced by tripterygium glycosides, followed by treatment with SC-FL. Assessment of testicular spermatogenic function in the mice was performed alongside lipidomics analysis to investigate the metabolic mechanisms of SC-FL. The effects on oxidative stress and ferroptosis-related markers were evaluated, the chemical constituents of SC-FL were identified using liquid chromatography-mass spectrometry, and network pharmacology analysis was carried out. Additionally, an in vitro model of spermatogenesis dysfunction was established using triptolide-induced GC-1 cells, which were treated with Lycium barbarum polysaccharides (LBP) and flavonoids from Semen Cuscutae (FSC) to explore their impact on cell damage, oxidative stress-mediated damage, and ferroptosis.RESULTSSC-FL improved the mouse model of spermatogenesis dysfunction by inhibiting oxidative stress-mediated ferroptosis. In vitro experiments demonstrated that LBP and FSC relieved GC-1 cell damage, with their mechanisms also associated with the inhibition of oxidative stress-mediated ferroptosis.CONCLUSIONSC-FL alleviates spermatogenesis dysfunction in animal and cell models, potentially through the modulation of the Nrf2/HO-1 signaling pathway, which consequently inhibits oxidative stress-mediated ferroptosis in spermatogonial cells.

01 Nov 2024·International Journal of Biological Macromolecules

Flat silk cocoons: A candidate material for fabricating lightweight and impact-resistant composites

Article

Author: Hou, Zhihui ; Liu, Yulong ; Cheng, Lan ; Zhang, Tonghua ; Shao, Jiaxing ; Dai, Fangyin

The utilization of silk cocoons in the production of lightweight and tough composites has been gaining increasing attention. However, the limited applications of normal silk cocoons (NSC) are attributed to their small size and irregular shape. To overcome this deficiency, flat silk cocoons (FSC) with a similar structure and controllable size were prepared. Next, we systematically characterized and compared the microstructures, morphologies, compositions, thermal properties, and mechanical properties of FSC with NSC. Subsequently, FSC was successfully utilized to fabricate a novel silk fibroin fiber reinforced sericin matrix composite (HPFSC) using a hot pressing method, followed by the analysis of its microstructure evolution, mechanical properties, failure modes, and theoretical modeling. This composite has outstanding mechanical properties including hardness, modulus, and strength. HPFSC has a relatively low density of ~1.3 g/cm³, whose absorbed impact energy can reach a maximum value of 11.1 J/mm, exceeding that of most engineering materials, such as aluminum alloy, ceramics, glass, and carbon fiber composites. The exceptional performance of HPFSC can be attributed to the reduced porosity, enhanced bonding between silk fibroin fibers facilitated by sericin, and their structural transformation. This study offers valuable guidance for the fabrication of lightweight and impact-resistant composites using flat silk cocoons.

01 Mar 2024·Tropical Animal Health and Production

Dietary flaxseed cake influences on performance, quality, and sensory attributes of eggs, serum, and egg trace minerals of laying hens

Article

Author: Ebeid, Tarek A ; Alhotan, Rashed A ; Al-Abdullatif, Abdulaziz A ; Shehata, Heba A ; Tufarelli, Vincenzo ; Hussein, El-Sayed O S ; Attia, Youssef A ; Olal, Marai J ; Al-Sagan, Ahmed A ; Alyileili, Salem R

Nowadays, there is a global shortage in feed supply for animal nutrition; however, there are a considerable amount of agro-industrial co- and by-products that may offer a reasonable solution. Flaxseed cake (FSC) is a by-product of flaxseed for oil extraction rich in n-3 α-linolenic acid (ALA). Thus, the dietary inclusion of FSC on laying performance, egg quality, and serum and egg trace elements (Se, Zn, and Fe) was evaluated using Hisex White hens. The hens were distributed to three equal experimental treatments and provided diets including 0%, 5%, or 10% FSC from 48 to 58 weeks of age. Findings clarified that up to 10% FSC in the laying hen diet had no detrimental effect on laying rate, egg mass, and feed utilization. It was found that FSC resulted in a valuable source of protein, energy, macro- (Ca and P), micro- (Se, Zn and Fe) elements, and essential amino acids, with arginine being the highest. Dietary FSC did not negatively influence the egg quality traits, as well as egg sensory attributes. Including 5% or 10% FSC in diet did not significantly affect serum total protein and renal function in terms of creatinine, uric acid, and uric acid-to-creatinine ratio. Different FSC levels did not influence the chemical composition of eggs and trace elements in serum and eggs. It could be concluded that FSC is a valuable feedstuff that can provide a good source of energy, protein, amino acids, and macro- and micro-elements for hens' nutrition. The inclusion of up to 10% of FSC in hens diet did not adversely influence egg laying performance, egg quality of both fresh and stored eggs, sensory attributes, and nutritional composition, as well as Se, Zn, and Fe in serum and eggs due to balanced nutrient profile of FSC.

1

News (Medical) associated with Fluticasone Propionate/Formoterol Fumarate Hydrate

02 Nov 2009

·www.pharmatimes.com

SkyePharma boosted by Flutiform trial success

SkyePharma’s shares were given a hefty boost yesterday after the company announced that a late-stage trial of Flutiform was a success, paving the way for the drug’s filing in Europe during the first quarter of next year. The group’s stock had already jumped more than 22% by mid-morning trading on the London Stock Exchange as investors welcomed news that development and marketing partner Mundipharma has completed the final Phase III clinical trial of the European development programme for its flagship asthma combination drug Flutiform (fluticasone and formoterol), and that the higher dose strength study hit its primary targets. Flutiform HFA-MDI has been designed to bring together the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) and a long-acting beta-agonist (formoterol fumarate) in one product, delivered via "an environmentally-friendly aerosol propellant hydrofluoroalkane" and through a metered dose inhaler, with which the companies will be hoping to gain a significant share of the multi-billion-euro asthma market. In the multi-centre study, 529 patients with severe, persistent and reversible asthma were randomised to receive either Flutiform (fluticasone 500 _g/formoterol 20 _g); a mix of (Flixotide (fluticasone 500 _g) and Foradil (formoterol 24 _g); a lower dose form of Flutiform (fluticasone 100 _g /formoterol 10 _g); or Flixotide alone. The results showed that Flutiform was at least as effective as the Flixotide/Foradil combination in improving pre- and post-dose FEV1 (Forced Expiratory Volume in the first second) over the eight week duration of the study, and also that the drug was well tolerated in patients, enabling a European Marketing Authorisation Application to be filed in Q1 2010, confirmed SkyePharma’s chief executive Dr Ken Cunningham. The news will be particularly welcome given the delays the drug, the success of which is crucial to the company’s future, is facing across the pond. Back in September SkyePharma’s stock was given a knock after it was announced the US regulators have requested more dosing data on the drug, requiring additional clinical work and delaying its potential approval for at least a couple of years.

100 Deals associated with Fluticasone Propionate/Formoterol Fumarate Hydrate

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma	Australia	Mundipharma Pty Ltd.	14 Jun 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Persistent asthma	Discovery	China	Napp Pharmaceuticals Ltd.	19 Apr 2017
Persistent asthma	Discovery	China	Fisons Ltd.	19 Apr 2017
Pulmonary Disease, Chronic Obstructive	Discovery	China	Napp Pharmaceuticals Ltd.	04 Mar 2015
Pulmonary Disease, Chronic Obstructive	Discovery	China	Fisons Ltd.	04 Mar 2015
Pulmonary Disease, Chronic Obstructive	Discovery	China	Beijing Mengdi Pharmaceutical Co. Ltd.	04 Mar 2015
Asthma	Discovery	Germany	SkyePharma AG	01 Mar 2006
Asthma	Discovery	Hungary	SkyePharma AG	01 Mar 2006
Asthma	Discovery	United Kingdom	SkyePharma AG	01 Mar 2006
Asthma	Discovery	Poland	SkyePharma AG	01 Mar 2006
Asthma	Discovery	Romania	SkyePharma AG	01 Mar 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERS2018	Phase 3	-	4,102	Fluticasone propionate/formoterol pMDI	dyaotfkulk(xvowqkzbix) = ntufwhtmak lubrqceokq (xpshdsntlp )	-	15 Sep 2018
ERS2017	Not Applicable	Asthma	6	Flutiform	bikibuinht(landqezewz) = jqpoanjuil qulxztzczl (dkdkpfoesb )	-	01 Sep 2017
EudraCT number: 2015-000744-42 (ERS2017)	Not Applicable	-	36	fluticasone propionate/formoterol	dfqctztqxm(rbkbhcbvte) = lwqgkgkuwc vdazyzgckq (gouzjzuotd )	-	01 Sep 2017
				fluticasone propionate/formoterol	dfqctztqxm(rbkbhcbvte) = duvdhcfzcu vdazyzgckq (gouzjzuotd )
EUPAS4072 (ERS2017)	Not Applicable	Asthma	2,539	Fluticasone propionate/formoterol (FP/FORM)	rpadhzkyue(vqcxblldrf) = yartlvpefz vsshlkctzj (xkxgnypxgn )	Positive	01 Sep 2017
ENCePP/SDPP/3702 (ERS2016)	Not Applicable	Asthma	1,563	Fluticasone propionate/formoterol combination (FP/FORM)	(kgfsgqmgrb) = 160 patients (10.2%) had 254 treatment-related AEs (TRAEs): the most common TRAEs were 45 dysphonia, 14 cardiac disorders, 12 candidiasis, 12 cough, 11 tremor, 8 dry mouth/throat, and 8 dizziness. Other TRAEs included four patients (0.3%) who had 5 asthma exacerbations requiring systemic steroids rtelvdtiyd (duxvjcihcb )	Positive	01 Sep 2016
NCT01978145 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	665	Placebo+Salbutamol+FSC (FSC Capsule-Based Unit Dose DPI)	hzhsnovrca(xxyubtqdqg) = luqvvmcqho hfaeqmbmkb (dbiomsustz, otltrfabdt - eoxeyosdsz) View more	-	18 Jan 2016
				Placebo+Salbutamol+FSC (FSC Multi-Dose DPI)	hzhsnovrca(xxyubtqdqg) = kxuxwmnptp hfaeqmbmkb (dbiomsustz, hoiuefonzu - wucneoqswm) View more
NCT01978119 (CTgov)	Phase 3	Asthma	124	Placebo+Salbutamol+FSC (FSC Capsule-Based Unit Dose DPI)	zxdntljdob(ktuztgiwkp) = zpgunoejvs faydqizyqv (lpecnluuwp, admvtaofhy - bcfubgcjsi) View more	-	08 Oct 2015
				Placebo+Salbutamol+FSC (FSC Multi-Dose DPI)	zxdntljdob(ktuztgiwkp) = kkwwkfwrvk faydqizyqv (lpecnluuwp, tquoraneks - amjuwftgbp) View more
ERS2014	Not Applicable	-	-	Fluticasone propionate/formoterol (FP/FORM)	cecfzrpnmy(kfxbirlmvz) = vwmyovyaxw kftfmnqygi (ojozxpjrxq, 0.07)	-	01 Sep 2014
				Beclometasone/formoterol (BDP/FORM)	cecfzrpnmy(kfxbirlmvz) = mrggslwret kftfmnqygi (ojozxpjrxq, 0.14)
ERS2014	Not Applicable	Asthma	512	Fluticasone propionate/formoterol (FP/FORM) 100/10µg BID	yekvtssrfs(bnpnsczybp) = rndltfgfio nzmdvytyus (tbijwtzwjs )	Positive	01 Sep 2014
				Fluticasone propionate/salmeterol (FP/SAL) 100/50µg BID	yekvtssrfs(bnpnsczybp) = gtwiiavyfq nzmdvytyus (tbijwtzwjs ) View more
ERS2014	Not Applicable	-	-	Fluticasone propionate/formoterol 125/5μg (FP/FORM)	nhvzvpdzff(dgbuoxtmks) = ojytqpkhmx mmuftnfuse (iptlfcjgzp ) View more	-	01 Sep 2014
				Fluticasone propionate/salmeterol 125/25μg (FP/SAL)	nhvzvpdzff(dgbuoxtmks) = yjrhfhvdbd mmuftnfuse (iptlfcjgzp ) View more