A Randomized, Multicenter, Multiple-dose, Double-blind, Placebo-controlled, Parallel-group Design, Clinical Endpoint Bioequivalence Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (Fluticasone Furoate and Vilanterol Inhalation Powder) 100 mcg/25 mcg (GlaxoSmithKline) in Adult Participants With Asthma

This is a randomized, multi-center, multiple-dose, double-blind, placebo-controlled, Parallel group design, clinical endpoint bioequivalence study in adult participants with asthma.
The study design includes up to a 2-week Screening period, at least a 2-week Run-in period, a 4-week Treatment period, and a safety follow up call one week later.
Visit 1: Screening Visit 2: Run-in period: All eligible participants will enter a 2-week Run-in period in which training will be provided to the participants on the use of inhalers and participant diary.
Visit 3: Day 1: Randomization to one of the 3 treatment groups to receive one inhalation of the study medication quaque die (QD), in the morning, for 28 ± 2 days.
Visit 4: Day 28: EOT
Participants will be contacted one week after their last site visit for Safety follow-up via phone call (end of study). Participants will be instructed to refrain from taking their current inhaled asthma medications from the start of the Run-in period until the end of treatment (EOT) visit. They will be provided with a salbutamol/albuterol inhaler (rescue medication) for use on an as-needed basis during the entire study duration until the EOT visit.

Start Date21 Apr 2026

Sponsor / Collaborator

Sandoz Group AG

CTRI/2024/03/064848

/ Not yet recruitingNot ApplicableIIT

A comparative study of Vilanterol/Fluticasone furoate with Formoterol/Budesonide in the management of stable bronchial asthma - nil

Start Date10 Apr 2024

Sponsor / Collaborator-

CTR20233844

/ TerminatedNot Applicable

糠酸氟替卡松维兰特罗吸入粉雾剂在健康人空腹状态下的生物等效性试验

[Translation] Bioequivalence study of fluticasone furoate and vilanterol inhalation powder in healthy volunteers under fasting condition

主要研究目的：以Glaxo Wellcome Production公司生产的糠酸氟替卡松维兰特罗吸入粉雾剂（RELVAR/ELLIPTA）为参比制剂，评价正大天晴药业集团股份有限公司研制的糠酸氟替卡松维兰特罗吸入粉雾剂在空腹状态下的生物等效性（BE）。次要研究目的：观察受试制剂糠酸氟替卡松维兰特罗吸入粉雾剂和参比制剂RELVAR/ELLIPTA在健康试验参与者中的安全性。

[Translation]

Primary study objective: To evaluate the bioequivalence (BE) of fluticasone furoate vilanterol inhalation powder (RELVAR/ELLIPTA) produced by Glaxo Wellcome Production under fasting conditions. Secondary study objective: To observe the safety of the test preparation fluticasone furoate vilanterol inhalation powder and the reference preparation RELVAR/ELLIPTA in healthy trial participants.

Start Date03 Dec 2023

Sponsor / Collaborator

Lianyungang Runzhong Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Fluticasone Furoate/Vilanterol Trifenatate

100 Translational Medicine associated with Fluticasone Furoate/Vilanterol Trifenatate

100 Patents (Medical) associated with Fluticasone Furoate/Vilanterol Trifenatate

101

Literatures (Medical) associated with Fluticasone Furoate/Vilanterol Trifenatate

01 Mar 2026·VALUE IN HEALTH

Informing the US Medicare Drug Price Negotiation for Trelegy Ellipta and Breo Ellipta: Evaluating the Impact of Real-World Evidence

Article

Author: Carlson, Josh J ; Suh, Kangho ; Wright, Abigail C ; Richardson, Marina ; Rind, David M ; Fahim, Shahariar Mohammed ; Tice, Jeffrey A

OBJECTIVES:

The Institute for Clinical and Economic Review (ICER) conducted a special assessment of Trelegy Ellipta and Breo Ellipta for chronic obstructive pulmonary disease to inform the Centers for Medicare and Medicaid Services (CMS) drug price negotiation process. In this manuscript, we examine the type, quality, and impact of the observational evidence included.

METHODS:

We described the type of observational evidence used in ICER's assessment with a primary focus on adherence and persistence data. Risk of bias was assessed using the ROBINS-I.

RESULTS:

Observational data included in ICER's review primarily informed the assessment of differential adherence and persistence between single and multiple inhaler products. The majority of studies were real-world evidence (RWE), utilizing claims or electronic health record data, and were deemed to be at moderate or severe risk of bias. RWE reported that Trelegy Ellipta and Breo Ellipta were associated with greater adherence and persistence compared with generic multiple-inhaler or multiple-daily-dosing alternatives. Persistence data were critical for differentiating between products in the cost-effectiveness analysis; however, persistence was based on prescription refills which is an imperfect measure of treatment continuation.

CONCLUSIONS:

RWE played a critical role in evaluating the comparative clinical and cost-effectiveness of Trelegy Ellipta and Breo Ellipta to inform Centers for Medicare and Medicaid Services drug price negotiations. Differences in persistence informed differential pricing to generic multiple-inhaler or multiple-daily-dosing alternatives, demonstrating how data collected outside of clinical trials can inform value assessments. However, RWE limitations and the lack of evidence linking adherence or persistence to clinical outcomes highlight the need for future research.

26 Feb 2026·Cureus Journal of Medical Science

An Open-Label, Single-Arm, Multicenter, Prospective, Post-Marketing Study to Evaluate the Effectiveness and Safety of Fluticasone Furoate/Vilanterol (FF/VI) Dry Powder Inhaler (DPI) in the Management of Asthma Patients (PROMISE-OD)

Article

Author: Bhojwani, Divya ; Jhawar, Punit K ; Patil, Saiprasad ; Raparthy, Suresh ; Bhushan, Sumit ; Kumar, Ankit ; Bhagat, Sagar ; Barkate, Hanmant ; Sahoo, Satyajeet ; Gupta, Sandeepkumar ; Raghumanda, Sunil Kumar

BACKGROUND:

A combination of inhaled corticosteroids (ICS) and long-acting β₂-agonists (LABA) is recommended for symptomatic asthma patients. Asthma control with single maintenance and reliever therapy (SMART) in patients remains poor with frequent nighttime awakenings, increased reliever use & severe exacerbations, including non-adherence. Once-daily FF/VI, an ultra LABA/ICS, has proven efficacy and safety in asthma with better adherence than multi-day regimens.

METHODS:

This prospective, multi-center, post-marketing (PROMISE-OD) study evaluated FF/VI DPI (100/25 mcg or 200/25 mcg) over 12 weeks in symptomatic asthma patients (≥12 years) on conventional therapies.

RESULTS:

Among 178 enrolled patients, 177 completed the study (53.9% females & mean age 44.8±15 years). Mean trough FEV1 improved by 180.5±810.7 ml (p=0.003) at week 4 & by 258.8±846.6 ml (p<0.0001) at week 12. The mean ACQ-5 score also reduced by -0.8±0.8 at week 4 and -1.3±0.9 at week 12 (p<0.0001). Adverse events occurred in 15.7% of patients, with no SAEs reported. Rescue medication was low (3.4% at week 4 & 5.1% at week 12). High patient and physician satisfaction was also observed.

CONCLUSION:

FF/VI DPI demonstrated significant improvements in lung function and asthma control with high patient satisfaction and a favorable safety profile, establishing it as a promising maintenance therapy for asthma management in Indian patients.

01 Feb 2026·ADVANCES IN THERAPY

Evaluating Asthma Clinical Remission with Inhaled Therapy: Post Hoc Analyses of CAPTAIN

Article

Author: Weng, Stephen ; Burrows, Emmeline ; Noorduyn, Stephen G ; Slade, David ; Crawford, Jodie ; Oppenheimer, John ; Pavord, Ian D ; Gould, Steven ; Moore, Alison ; Corbridge, Tom ; Lugogo, Njira ; Howarth, Peter ; Hamouda, Mohamed

INTRODUCTION:

Clinical remission (CR) is an emerging treatment goal in asthma. However, evidence showing whether CR is achievable with inhaled therapy is lacking. This post hoc analysis of CAPTAIN evaluated attainability of a composite CR endpoint with inhaled fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or FF/VI.

METHODS:

CAPTAIN (GSK 205715) was a Phase IIIA, randomized, controlled, 24-52-week trial comparing once-daily single-inhaler FF/UMEC/VI versus FF/VI in adults with uncontrolled moderate-to-severe asthma despite ICS/LABA. CR was defined as a composite endpoint comprising no systemic corticosteroids, no severe exacerbations, ACQ-5 total score < 1.50, and either change from baseline in FEV₁ ≥ 0 ml (lung function stabilization) or ≥ 100 ml (lung function optimization), assessed for patients meeting the CR endpoint at Week 24 (W24) and achieving CR at W52 with FF/UMEC/VI (100/62.5/25, 200/62.5/25 μg) versus FF/VI (100/25, 200/25 μg). Additional analyses assessed the CR endpoint at W24/W52 using ACQ-5 ≤ 0.75 and ≤ 1.00 thresholds. Adjusted odds/risk ratios for CR were calculated for W24.

RESULTS:

More patients met the CR endpoint (lung function stabilization/optimization) with FF/UMEC/VI versus FF/VI at W24 (stabilization: 42-47% vs 31-36%; optimization: 31-36% vs 19-26%) and W52 (stabilization: 43-47% vs 33-34%; optimization: 30-38% vs 21-24%). Using more stringent ACQ-5 thresholds, fewer patients met the CR endpoint with ACQ ≤ 0.75 versus < 1.50 across treatment arms and timepoints. The odds and probability of meeting the CR endpoint versus not meeting the CR endpoint at W24 were greater with FF/UMEC/VI versus FF/VI, regardless of FF dose.

CONCLUSION:

The results of this post hoc analysis demonstrate that CR is achievable with inhaled therapy in moderate-to-severe asthma and is more likely with FF/UMEC/VI than FF/VI. CR should be considered an attainable treatment goal for patients with asthma, irrespective of disease severity or treatment history.

TRIAL REGISTRATION:

ClinialTrials.gov identifier, NCT02924688.

News (Medical) associated with Fluticasone Furoate/Vilanterol Trifenatate

16 Jun 2026

·www.biospace.com

Innoviva Specialty Therapeutics Announces Distribution and Licensing Agreement with Dr. Reddy’s for XACDURO® in Select International Markets

Agreement expands access to XACDURO ® for patients with serious Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) infections across South and Central America, the Caribbean, Russia and CIS countries (following applicable regional regulatory approvals) The rate of carbapenem resistant -Acinetobacter in these geographies exceeds 70% 1,2 representing substantial unmet need WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that it has entered into an exclusive distribution and licensing agreement with Dr. Reddy’s Laboratories Ltd., a global pharmaceutical company, for the development and commercialization of XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, in South and Central America, the Caribbean, Russia and Commonwealth of Independent States (CIS) countries. In the United States, XACDURO ® is approved and indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). Acinetobacter is a significant public health concern and is classified as a “critical threat” pathogen in World Health Organization global bacterial priority pathogens list 3 . Under the terms of the agreement, Dr. Reddy’s will be responsible for development, regulatory and commercialization activities in the licensed territory. Innoviva Specialty Therapeutics will retain rights to XACDURO in all unlicensed territories and is eligible to receive an upfront payment, regulatory and commercial milestone payments, and tiered royalties on net sales in the licensed territory. “This agreement reflects our ongoing commitment to addressing antimicrobial resistance by expanding access to important therapeutics for patients and healthcare systems facing serious, difficult-to-treat infections,” said Patricia Drake, Chief Commercial Officer of Innoviva Specialty Therapeutics. “Dr. Reddy’s brings strong regional capabilities and experience in infectious disease treatments, and we believe this partnership provides a practical path to broaden XACDURO’s global reach while maintaining our focus on disciplined execution.” XACDURO is the first and only antibiotic approved in the United States in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex ( Acinetobacter ). Acinetobacter infections remain a significant global health challenge, particularly in hospital settings where resistant pathogens can limit available treatment options. The FDA approved XACDURO in May 2023. About XACDURO ® XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex ( Acinetobacter ). XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter . Current US FDA approved XACDURO ® INDICATION & USAGE Indication XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Limitations of Use XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Contraindications : XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs. Warnings and Precautions: Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO. Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed. Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%). To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or . Before administering, please see the Full Prescribing Information for XACDURO . About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliates, include GIAPREZA ® (angiotensin II), XERAVA ® (eravacycline), XACDURO ® (sulbactam for injection; durlobactam for injection), and NUZOLVENCE ® (zoliflodacin). Innoviva Specialty Therapeutics also markets ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva Specialty Therapeutics, please visit . Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR ® /BREO ® ELLIPTA ® , ANORO ® ELLIPTA ® , GIAPREZA ® , XERAVA ® , XACDURO ® , ZEVTERA ® and NUZOLVENCE ® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the development of the LYNX ® platform; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward looking statements on account of new information, future events or otherwise, except as required by law. ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica International AG, Allschwil. 1 Lavrinenko (2021) Antibiotics 2 Rojas (2026) Antibiotics 3 WHO Bacterial Priority Pathogens List (2024) Contacts Investor and media contact Irwin Tendler Head of Investor Relations Executive Director, Corporate Development investors.relations@inva.com

02 Jun 2026

·www.biospace.com

Innoviva to Participate in Upcoming June 2026 Investor Conferences

BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that management will participate in the following upcoming investor conferences in June: Goldman Sachs 47 th Annual Global Healthcare Conference Format: Fireside chat Date: Monday, June 8, 2026 Time: 1:20 p.m. Eastern Time BTIG Infectious Disease Day Format: 1x1 meetings Date: Tuesday, June 16, 2026 A live webcast of the Goldman Sachs fireside chat can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at . An archived replay of the webcast will be available following the fireside chat date. About Innoviva Innoviva is a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s critical care and infectious disease assets under the IST platform include GIAPREZA ® (angiotensin II) for increasing blood pressure in adults with septic or other distributive shock, XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus , XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults, ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic licensed from Basilea Pharmaceutica International Ltd, Allschwil, and NUZOLVENCE ® (zoliflodacin), approved by the FDA for the oral treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years of age and older weighing at least 35 kg. For more information about Innoviva, go to . For information about Innoviva Specialty Therapeutics, go to . ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica Ltd, Allschwil. Contacts Investor Relations (Internal): Eleanor Barisser Director, Investor Relations & Corporate Communications Eleanor.barisser@inva.com Investors and Media: Argot Partners (212) 600-1902 innoviva@argotpartners.com

01 Jun 2026

·www.businesswire.com

Innoviva to Participate in Upcoming Investor Conferences

BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that management will participate in the following upcoming investor conferences in June: Goldman Sachs 47th Annual Global Healthcare Conference Format: Fireside chat Date: Monday, June 8, 2026 Time: 1:20 p.m. Eastern Time BTIG Infectious Disease Day Format: 1x1 meetings Date: Tuesday, June 16, 2026 A live webcast of the Goldman Sachs fireside chat can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at https://investor.inva.com/presentations-events. An archived replay of the webcast will be available following the fireside chat date. About Innoviva Innoviva is a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s critical care and infectious disease assets under the IST platform include GIAPREZA® (angiotensin II) for increasing blood pressure in adults with septic or other distributive shock, XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus, XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults, ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic licensed from Basilea Pharmaceutica International Ltd, Allschwil, and NUZOLVENCE® (zoliflodacin), approved by the FDA for the oral treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years of age and older weighing at least 35 kg. For more information about Innoviva, go to www.inva.com. For information about Innoviva Specialty Therapeutics, go to www.innovivaspecialtytherapeutics.com. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica Ltd, Allschwil.

Drug ApprovalQualified Infectious Disease Product

100 Deals associated with Fluticasone Furoate/Vilanterol Trifenatate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Fluticasone Furoate/Vilanterol Trifenatate	R03AK10	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bronchitis, Chronic	Japan	GlaxoSmithKline KK	02 Dec 2016
Pulmonary Emphysema	Japan	GlaxoSmithKline KK	02 Dec 2016
Asthma	Japan	GlaxoSmithKline KK	20 Sep 2013
Pulmonary Disease, Chronic Obstructive	United States	Glaxo Group Ltd.	10 May 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ischemic Attack, Transient	Phase 3	United States	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Canada	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Czechia	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Germany	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Poland	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Romania	GSK Plc	01 Apr 2012
Myocardial Infarction	Phase 3	United States	GSK Plc	01 Apr 2012
Myocardial Infarction	Phase 3	Canada	GSK Plc	01 Apr 2012
Myocardial Infarction	Phase 3	Czechia	GSK Plc	01 Apr 2012
Myocardial Infarction	Phase 3	Germany	GSK Plc	01 Apr 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04937387 (CTgov)	Phase 3	Asthma	359	Fluticasone Furoate [FF]+Vilanterol [VI] (Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug)	vntauayfdj(ayefzuhwle) = hepwvjotav ansjclqmkn (rqsjmddglj, 0.0321) View more	-	11 Aug 2025
				Fluticasone Furoate [FF]+Vilanterol [VI]+Umeclidinium [UMEC] (Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug)	vntauayfdj(ayefzuhwle) = quvrjqufhb ansjclqmkn (rqsjmddglj, 0.0316) View more
ATS2025	Not Applicable	Asthma	177	Vilanterol/Fluticasone Furoate (VI/FF) DPI	ingisbmpmj(cdnlyszonj) = xamxvrkmtk xofsalgyxg (nbimsteuts ) View more	Positive	16 May 2025
ATS2023	Not Applicable	Asthma	-	Fluticasone Furoate/Vilanterol	unopkvnuhj(lfxjywgbbs) = Similar proportions of participants experienced ≥1 on-treatment adverse event (AE) in both populations (5-17 year-olds: n=181/454 [40%] receiving FF/VI versus n=163/448 [36%] receiving FF; 5-11 year-olds: n=133/337 [39%] receiving FF/VI versus n=122/336 [36%] receiving FF) uefchyzpdi (trdhrpdxdh )	-	21 May 2023
ATS2022	Not Applicable	Pulmonary Disease, Chronic Obstructive \| Asthma	3,426	Fluticasone furoate/vilanterol 100 µg/25 µg	eqoldrknjx(ograxvavqy) = buiusekxmy qyzxaqogiw (wzqjaqrcsw ) View more	Positive	15 May 2022
				Fluticasone furoate/vilanterol 200 µg/25 µg	eqoldrknjx(ograxvavqy) = edegtuwwxu qyzxaqogiw (wzqjaqrcsw ) View more
NCT01551758 (HZC115151, Pubmed \| Ther Adv Respir Dis)	Phase 3	Pulmonary Disease, Chronic Obstructive	2,802	Fluticasone furoate/vilanterol 100/25 µg	zxyetvhkra(sooxxfxave) = ixwmrcahhl krdpmtlest (ywjgxujpsn ) View more	-	01 Jan 2021
				fluticasone furoate/vilanterol	zxyetvhkra(sooxxfxave) = wovbbfkfhm krdpmtlest (ywjgxujpsn ) View more
NCT03380429 (CTgov)	Phase 4	Asthma	437	Relvar/Breo+salbutamol (Cohort 1: Data on Maintenance Use Supplied to Par and HCP)	jiwjqjaekt(qdghogbgzy) = hnzioghgsd vruperlhlk (majcjdujvs, 3.19) View more	-	05 Feb 2020
				Relvar/Breo+salbutamol (Cohort 5: No Data Supplied to Par or HCP)	jiwjqjaekt(qdghogbgzy) = pdahqkghuz vruperlhlk (majcjdujvs, 3.19) View more
NCT01706198 (Asthma Salford Lung Study, Pubmed \| J Asthma)	Phase 3	Asthma Maintenance	4,233	Fluticasone furoate/vilanterol	vgaigmqwin(pephigrdjp) = gbuyhwvibl nebrmbynru (udvwcvnabl )	Positive	01 Jul 2019
				Fluticasone propionate/salmeterol	vgaigmqwin(pephigrdjp) = dedrnrartv nebrmbynru (udvwcvnabl )
NCT01957150 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	283	VI (Participants Administered VI)	dtjhlrktvm(hrltucssyf) = sbzmvwtgtz jbojbjlldt (yshxibopzl, repqvrqyck - tywucayseh) View more	-	10 Apr 2019
				VI (Participants Administered FF/VI)	dtjhlrktvm(hrltucssyf) = kqzqjsenqg jbojbjlldt (yshxibopzl, llhwlxotzh - qjayruxckz) View more
NCT01313676 (SUMMIT, Pubmed \| ERJ Open Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone furoate (FF)	zlsrmigwej(cmrncygpbm): hazard ratio = 0.65 (95% CI, 0.48 - 0.89)	-	01 Feb 2019
				Placebo
NCT01706198 (Asthma Salford Lung Study \| Salford Lung Study in Asthma \| Asthma Salford Lung \| SLS asthma, CTgov)	Phase 3	Asthma	4,233	fluticasone furoate + vilanterol+inhaled corticosteroid with or without a long acting beta2-agonist	rikbjrphgg = opccektdyv pguzyurjmt (iwgzeyxelw, ipzolzydeg - vdjczclugc) View more	-	24 Jan 2019

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