GR agonists(Glucocorticoid receptor agonists), mAChRs antagonists(Muscarinic acetylcholine receptor antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Immune System DiseasesRespiratory Diseases

Active Indication

Asthma

Inactive Indication-

Originator Organization

Novartis Pharma AG

Active Organization

Novartis Europharm Ltd.Novartis Pharma AG

Novartis Pharmaceuticals Corp.

+ [2]

Inactive Organization

Beijing Novartis Pharma Co. Ltd.Novartis Pharma Stein AG

Drug Highest PhaseApproved

First Approval Date

JP (29 Jun 2020),

Asthma

Regulation-

Structure

Molecular FormulaC28H32N2O7

InChIKeyIREJFXIHXRZFER-PCBAQXHCSA-N

CAS Registry753498-25-8

View All Structures (3)

Clinical Trials associated with Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate

NCT05776927 / Not yet recruitingPhase 3

A Double-dummy, Double-blind, Randomized, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.

A double-dummy, double-blind, randomized, parallel-group, active controlled study to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.

Start Date23 Dec 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

CTR20242209 / CompletedNot Applicable

茚达格莫吸入粉雾剂（Ⅱ）在中国健康受试者中随机、开放、两制剂、单次给药空腹状态下的生物等效性试验

[Translation] A randomized, open-label, two-dose, single-dose bioequivalence study of indagamox inhalation powder (II) in Chinese healthy subjects under fasting conditions

以北京抗创联生物制药技术研究有限公司研发的茚达格莫吸入粉雾剂（Ⅱ）（规格：150 μg /50 μg/160 μg）为受试制剂，按生物等效性试验的有关规定，以Novartis Pharma AG 持证的茚达格莫吸入粉雾剂（Ⅱ）（规格：150 μg /50 μg/160 μg；商品名：Enerzair®）为参比制剂，对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察受试制剂茚达格莫吸入粉雾剂（Ⅱ）和参比制剂茚达格莫吸入粉雾剂（Ⅱ）（Enerzair®）在健康受试者中的安全性。

[Translation]

Indagamol Inhalation Powder (II) (Specification: 150 μg /50 μg/160 μg) developed by Beijing Kangchuanglian Biopharmaceutical Technology Research Co., Ltd. was used as the test preparation. According to the relevant provisions of the bioequivalence test, Indagamol Inhalation Powder (II) (Specification: 150 μg /50 μg/160 μg; Trade Name: Enerzair®) certified by Novartis Pharma AG was used as the reference preparation. The absorption rate and degree of absorption in healthy humans were compared to investigate the bioequivalence of the two preparations in humans. Secondary objective: To observe the safety of the test preparation Indagamol Inhalation Powder (II) and the reference preparation Indagamol Inhalation Powder (II) (Enerzair®) in healthy subjects.

Start Date09 Jul 2024

Sponsor / Collaborator

Beijing Kangchuanglian Biopharmaceutical Technology Research

NCT05274425 / RecruitingNot Applicable

A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Enerzair (QVM149 150/50/80 μg o.d. and QVM149 150/50/160 μg o.d. Via Breezhaler)

This surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of Enerzair inhalation capsule for up to 24 weeks under routine clinical practice.

Start Date09 May 2022

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate

100 Translational Medicine associated with Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate

100 Patents (Medical) associated with Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate

Literatures (Medical) associated with Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate

01 Jul 2024·Respiratory Investigation

Real-world characteristics of patients with asthma initiating fluticasone furoate/umeclidinium/vilanterol single-inhaler triple therapy in Japan

Article

Author: Yarita, Masao ; Yuanita, Liza ; Oga, Toru ; Ito, Risako ; Requena, Gema ; Noorduyn, Stephen G ; Mita, Chifuku ; Rothnie, Kieran J

BACKGROUND:

Real-world data assessing characteristics of patients with asthma initiating inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist (ICS/LAMA/LABA) triple therapy in Japan are limited.

METHODS:

Descriptive, observational study of patients with asthma aged ≥15 years newly initiating single- or multiple-inhaler triple therapy (SITT: fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI], SITT: indacaterol/glycopyrronium bromide/mometasone furoate [IND/GLY/MF] or MITT) or ICS/LABA using JMDC/Medical Data Vision (MDV) health insurance databases from February 2021-February 2022 (first prescription date: index date). Patients were assigned to three non-mutually exclusive cohorts: A) new FF/UMEC/VI initiators; B) new FF/UMEC/VI, IND/GLY/MF, or MITT initiators; C) new FF/UMEC/VI, IND/GLY/MF, MITT or ICS/LABA initiators as initial maintenance therapy (IMT). Patient characteristics were assessed descriptively for 12-months pre-treatment initiation (baseline period).

RESULTS:

Cohort A: among new FF/UMEC/VI initiators, 12.8% and 0.1% (JMDC) and 21.7% and 0.9% (MDV) of patients had ≥1 moderate and severe exacerbation; 52.0% (JMDC) and 79.2% (MDV) had ICS/LABA use. Cohort B: most patients initiated FF/UMEC/VI and IND/GLY/MF over MITT (JMDC: 91.3% vs 8.7%; MDV: 67.8% vs 32.2%), with fewer exacerbations and lower rescue medication use. Cohort C: a greater proportion of FF/UMEC/VI initiators as IMT experienced a moderate exacerbation at index versus ICS/LABA initiators as IMT (JMDC: 17.8% vs 10.7%; MDV: 8.0% vs 5.1%).

CONCLUSIONS:

Patient characteristics were generally similar between treatment groups; SITT initiators had fewer exacerbations and lower rescue medication use than MITT initiators, represented by the greater proportion of IMT among SITT versus MITT initiators. Physicians may have prescribed triple over dual therapy as IMT in response to an exacerbation.

01 Oct 2023·Respiratory medicine

Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study.

Article

Author: Maspero, Jorge F ; Mezzi, Karen ; Chapman, Kenneth R ; Kostikas, Konstantinos ; Lawrence, David ; van Zyl-Smit, Richard ; Jaumont, Xavier

BACKGROUND:

Baseline characteristics could potentially guide asthma treatments. We evaluated whether baseline eosinophil levels affect the efficacy of mometasone/indacaterol/glycopyrronium (MF/IND/GLY) in patients with inadequately controlled asthma.

METHOD:

In this post hoc analysis of IRIDIUM study, efficacy of high-dose MF/IND/GLY (160/150/50 μg, once-daily [o.d.]) versus high-dose MF/IND (320/150 μg o.d.) and high-dose fluticasone/salmeterol (FLU/SAL [500/50 μg, twice-daily [b.i.d.]); and efficacy of pooled MF/IND/GLY (160/150/50 μg and 80/150/50 μg) versus pooled MF/IND (320/150 μg and 160/150 μg) was evaluated in patient subgroups with baseline blood eosinophil count of <300 cells/μL or ≥300 cells/μL.

RESULTS:

Overall, 3065 patients were included. At Week 26, high-dose MF/IND/GLY showed improved trough FEV₁ versus high-dose MF/IND (Δ78mL [<300 cells/μL]; Δ54mL [≥300 cells/μL]) and FLU/SAL (Δ112mL [<300 cells/μL]; Δ98mL [≥300 cells/μL]). Similarly, pooled MF/IND/GLY also showed improved trough FEV₁ versus pooled MF/IND (Δ75mL [<300 cells/μL]; Δ68mL [≥300 cells/μL]). Over 52 weeks, high-dose MF/IND/GLY reduced the annualized rate of moderate or severe asthma exacerbations by 23% and 10%, severe exacerbations by 31% and 15%, and all exacerbation by 33% and 10% versus high-dose MF/IND for subgroups with <300 cells/μL and ≥300 cells/μL, respectively; and by 33% and 41%, 45% and 42%, 42% and 39% versus FLU/SAL, respectively. Similarly, pooled MF/IND/GLY reduced exacerbations by 22% and 8%, 21% and 7%, 27% and 8%, versus pooled MF/IND, for the respective subgroups.

CONCLUSION:

MF/IND/GLY showed improvement in lung function and reduction in asthma exacerbations over MF/IND and FLU/SAL independent of baseline eosinophil levels, indicating that eosinophil levels did not affect the efficacy of MF/IND/GLY in patients with inadequately controlled asthma.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT02571777 (IRIDIUM).

01 Apr 2023·Chest

Comparison of Clinical Outcomes Among Different Fixed-Dose Combinations of Long-Acting Muscarinic Antagonists and Long-Acting β2-Agonists in Patients With COPD

Article

Author: Wu, Chien-Chih ; Wu, Mei-Hsuan ; Weng, Ching-Fu ; Lin, Fang-Ju

BACKGROUND:

Researchers have yet to obtain conclusive evidence differentiating among fixed-dose combinations (FDCs) of long-acting muscarinic antagonists (LAMAs) and long-acting β₂-agonists (LABAs) for COPD in terms of real-world clinical outcomes.

RESEARCH QUESTION:

What are the differences between available LAMA/LABA FDCs in the risk of acute exacerbation (AE) and cardiovascular events?

STUDY DESIGN AND METHODS:

This retrospective cohort study based on a national insurance claims database included patients with COPD ≥ 40 years of age who were newly prescribed glycopyrronium (GLY)/indacaterol (IND), umeclidinium (UMEC)/vilanterol (VI), or tiotropium (TIO)/olodaterol (OLO) FDC between January 1, 2015, and June 30, 2019. Propensity score matching and Cox regression models were used to compare outcomes of AE and cardiovascular events associated with LAMA/LABA FDC treatment.

RESULTS:

Among the 44,498 patients identified and included, 15,586 received GLY/IND, 20,460 received UMEC/VI, and 8,452 received TIO/OLO. Baseline characteristics were well balanced after 1:1 matching of UMEC/VI and GLY/IND, 2:1 matching of UMEC/VI and TIO/OLO, and 2:1 matching of GLY/IND and TIO/OLO. Risk of severe AE was lower among patients treated with UMEC/VI or GLY/IND than among those who received TIO/OLO (UMEC/VI vs TIO/OLO: 17.85 vs 29.32 per 100 person-years; hazard ratio, 0.76; 95% CI, 0.68-0.84; GLY/IND vs TIO/OLO: 15.54 vs 25.53 per 100 person-years; hazard ratio, 0.77; 95% CI, 0.67-0.88). In addition, GLY/IND users tended to have a lower risk of cardiovascular events than TIO/OLO users, but the difference dissipated when restricting follow up to a shorter duration.

INTERPRETATION:

Our results revealed that the risk of severe AE was lower among patients with COPD receiving UMEC/VI or GLY/IND than among those receiving TIO/OLO, whereas the incidence of cardiovascular events was similar across groups but was slightly lower in GLY/IND users when compared with TIO/OLO users. Further research will be required to confirm these findings.

News (Medical) associated with Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate

03 Sep 2021

·www.biospace.com

Novartis Scuttles Kidney Transplant Drug Study

Harold Cunningham/Getty Images Novartis announced that after conducting an interim analysis from its CIRRUS-1 trial of CFZ533 (iscalimab), it is discontinuing the trial in kidney transplant patients. The drug is dosed with tacrolimus and other immunosuppressive therapies to prevent organ rejection. The company indicated the drug would continue to be developed to treat hidradenitis suppurativa and Sjögen’s syndrome and other autoimmune diseases. It is currently being evaluated in the Phase II CONTRAIL trial in liver transplant patients and other studies in type 1 diabetes and lupus nephritis. The study data apparently indicated that iscalimab was not as effective as tacrolimus at preventing organ rejection in kidney transplant patients when both were added to standard immunosuppressive therapies. Those therapies included drugs such as mycophenolate mofetil and corticosteroids. Earlier studies suggested iscalimab might be more effective than tacrolimus. In those studies, patients had kidney biopsies as healthy as normal kidneys about one year after transplant. Studies show that less than 50% of donated kidneys last 10 years. Any therapy that can extend the life of donated kidneys would have a significant impact on patients and donor organ availability. Worldwide, there are approximately 3.2 million people with end-stage renal disease. The CIRRUS-1 trial evaluated 418 transplant patients and studied three different doses of iscalimab. The drug is a fully human antibody that targets the CD40 antigen. It is engineered to inhibit immune reactions to foreign transplanted tissue. The study was expected to run to at least 2023. Novartis also announced that it is presenting abstracts at the upcoming European Respiratory Society (ERS) International Congress 2021 from September 5 to 8 on its 12 Enerzair Breezhaler and Atectura Breezhaler. The data continues to support the efficacy of Enerzair Breezher, and there will also be an interim analysis of patient engagement and adherence levels of the Enerzair Breezhaler’s optional digital companion. “Our presence at ERS this year reiterates our commitment to patients through the further development of first-in-class therapies like Enerzair Breezhaler, as well as by exploring the potential of digital health companions and the carbon footprint of our solutions,” said Dominic Brittain, Respiratory Global Program Head, Novartis Pharmaceuticals. “As a global leader in respiratory and allergy, we remain committed to reimagining medicine for patients living with chronic respiratory diseases like asthma.” And on September 1, Novartis inked a commercial agreement with the National Health Service (NHS) in England as part of a collaboration to develop a population health management approach for high cholesterol levels in patients with atherosclerotic cardiovascular disease (ASCVD). This deal comes after a positive final recommendation from the National Institute for Health and Care Excellence (NICE) for using inclisiran in primary care for adults for its licensed indication. It is licensed in Europe for adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, in addition to diet modification. “High cholesterol is a major cause of cardiovascular disease—disease of the heart and blood vessels,” said Jules Payne, chief executive at HEART UK, the cholesterol charity. “It is very common and can affect anyone including those who are young, slim, fit and active. HEART UK looks forward to continuing our leading role in helping people effectively manage their cholesterol and we warmly welcome the collaboration between Novartis and the NHS to enable more people to access this innovative medicine.”

CollaborateAntibodyFirst in Class

27 Apr 2021

·www.biospace.com

Valeo Pharma Upsizes And Closes $6.6 Million Non-Brokered Private Placement

Valeo insiders participation of $2.6 million MONTRÉAL, April 27, 2021 /PRNewswire/ - Valeo Pharma Inc. (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) ("Valeo" or the "Company"), a Canadian pharmaceutical company, announced today that it has upsized and closed a $6.645 million non-brokered private placement of unsecured non-convertible debenture units (the "Private Placement"). The Company issued 6,645 unsecured non-convertible debentures units (the "Debenture Units") at a purchase price of $1,000 per Debenture Unit for gross proceeds of $6,645,000. Each Debenture Unit consist of one (1) unsecured non-convertible debenture of the Company in the principal amount of $1,000 (each, a "Debenture") and 200 Class "A" share purchase warrants (each, a "Warrant"). Each Warrant entitles the holder thereof to purchase one Class "A" Share of the Company (each, a "Share") at an exercise price of $1.60 at any time up to 24 months following the closing date of the Offering (the "Closing Date"). The Debentures will mature at the latest 9 months after the closing and bear interest at a rate of 8% per annum from the date of issue, payable in cash, semi-annually in arrears. "The closing of this upsized placement is testament to the confidence and support our insiders and those close to the Company have in management and Valeo's business model", said Steve Saviuk, CEO. "I cannot over emphasize what a pivotal year 2021 is becoming with the recent launch of Redesca® and the imminent launches of Enerzair® Breezhaler® and Atectura® Breezhaler®". The securities issued under the Private Placement are subject to a four-month hold period in accordance with applicable securities legislation. The Company has paid $38,500 as finder's fees to arm's-length parties in connection with the Private Placement and issued a total of 7,700 broker warrants in compliance with applicable securities laws. Insiders, Senior Executives, staff members and 3 Directors of the Company all participated in the Private Placement for an aggregate amount of $2.6 million. The net proceeds of the Offering will be used for working capital and general corporate purposes. Participation of insiders of the Company in the Private Placement constitutes a "related party transaction" as defined under Regulation 61-101 respecting Protection of Minority Security Holders in Special Transactions ("Regulation 61-101"). The Company intends to rely on exemptions from the formal valuation and minority shareholder approval requirements provided under sections 5.5(a) and 5.7(a) of Regulation 61-101 on the basis that participation in the Private Placement by insiders will not exceed 25% of the fair market value of the Company's market capitalization and also because the Company's Common Shares trade only on the Canadian Securities Exchange (CSE). A material change report was not filed in connection with the participation of the insiders in at least 21 days in advance of the closing of the Private Placement, which the Company deemed reasonable in the circumstances, in order to close the transaction as soon as practicable to enable it to use the funds. About Valeo Pharma Valeo Pharma is a Canadian pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on Respiratory Diseases, Neurology, Oncology and Hospital Specialty Products. Headquartered in Kirkland, Quebec Valeo Pharma has all the required capabilities and the full infrastructure to register and properly manage its growing product portfolio through all stages of commercialization. For more information, please visit and follow us on LinkedIn and Twitter. Forward Looking Statements This press release contains forward-looking statements about Valeo's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. Company Codes: OTC-QB:VPHIF, CNSX:VPH, Frankfurt:VP2, OTC-PINK:VPHIF

100 Deals associated with Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	R03AL	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma	JP	Novartis Pharma AG	29 Jun 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Phase 3	Asthma	145	indacaterol acetate+glycopyrronium bromide+mometasone furoate	ehupwvorjg(olmqcbmkwm) = pczdvpfqtf rfucrxqphf (shfwifnlqh ) View more	Positive	30 May 2022
				indacaterol acetate+mometasone furoate	ehupwvorjg(olmqcbmkwm) = gtkltjlalf rfucrxqphf (shfwifnlqh ) View more
ERS2021	Not Applicable	Asthma	135	indacaterol/glycopyrronium/mometasone (IND/GLY/MF) Breezhaler	kgxoryctra(cydfeybqcp) = ejhiaiqicv zkensjbril (dcnossmjkx )	-	05 Sep 2021
AAAAI2021	Phase 1	-	24	IND/GLY/MF medium-dose	zdhvonzkkg(jdpyqxscic) = nxrdcthdml ncvhdhwobd (xribxcqaje ) View more	-	01 Feb 2021
				IND/GLY/MF high-dose	zdhvonzkkg(jdpyqxscic) = ialxdkqytf ncvhdhwobd (xribxcqaje ) View more
NCT03158311 (ARGON, CTgov)	Phase 3	Asthma	1,426	QVM149 (QVM149 150/50/80 μg)	vcearxkjbv(pqqfndxann) = xabobpezjy bqusxdtoqn (vydhuuhjxn, werjchpkjf - rftwlqkwiv) View more	-	14 Oct 2020
				QVM149 (QVM149 150/50/160 μg)	vcearxkjbv(pqqfndxann) = zpwnodzfwm bqusxdtoqn (vydhuuhjxn, pvfxxdantf - yzietilzfl) View more
NCT02571777 (IRIDIUM, CTgov)	Phase 3	Asthma	3,092	QVM149 150/50/160 (QVM149 150/50/160 µg o.d.)	ribvogqkiw(upeishzsxs) = pgukfkcqnl jhmzpopiyh (xjibnfgvhh, ciyurtavdu - kcsjzavkln) View more	-	22 Jul 2020
				QVM149 150/50/80 (QVM149 150/50/80 µg o.d.)	ribvogqkiw(upeishzsxs) = qjnmuplbyo jhmzpopiyh (xjibnfgvhh, gcuvlntfvk - aitqbmgagi) View more
NCT03100825 (CTgov)	Phase 3	Asthma	96	QVM149	nqjxbibzpo(zvfwkqtnlu) = fcnzpbobhy nfbdpeimha (ukdxwebfob, iawfafezvd - jjpxozsguv) View more	-	07 Apr 2020
ERS2019	Not Applicable	-	10	salmeterol/fluticasone	vfqbikyuup(gxuvtrcuja) = umdaoqjtit iezlzfnbmy (gcyzgltcyf )	Positive	28 Sep 2019
				salmeterol/fluticasone	vfqbikyuup(gxuvtrcuja) = zkgkudrwah iezlzfnbmy (gcyzgltcyf )
ERS2012	Not Applicable	Asthma exhaled nitic oxide (FeNO) \| serum C reactive protein (CRP)	13	Salmeterol/fluticasone (Seretide Discus) 50/250 mcg	kcmdviqgal(zsmkdfczzr) = rientcpyme beawmpqkbb (ntjctjrgpg ) View more	-	01 Sep 2012

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