[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study of indacatetroglycopyrronium bromide inhalation powder in healthy participants under fasting conditions.

主要试验目的：本试验以山东京卫制药有限公司生产的茚达特罗格隆溴铵吸入粉雾剂为受试制剂，原研Siegfried Barbera, S.L.生产（持证商：Novartis Pharma Schweiz AG）的茚达特罗格隆溴铵吸入粉雾剂（商品名：杰润®）为参比制剂，评价受试制剂和参比制剂在空腹条件下给药后的生物等效性。次要试验目的：观察健康试验参与者经口吸入受试制剂茚达特罗格隆溴铵吸入粉雾剂和参比制剂茚达特罗格隆溴铵吸入粉雾剂（商品名：杰润®）的安全性。

[Translation]

Primary Objective: This study evaluated the bioequivalence of the test and reference formulations after administration under fasting conditions, using indacate-luteoside/inosine bromide inhalation powder manufactured by Shandong Jingwei Pharmaceutical Co., Ltd. as the test formulation and indacate-luteoside/inosine bromide inhalation powder manufactured by Siegfried Barbera, S.L. (licensed by Novartis Pharma Schweiz AG, trade name: Jerun®). Secondary Objective: To observe the safety of oral inhalation of the test formulation indacate-luteoside/inosine bromide inhalation powder and the reference formulation indacate-luteoside/inosine bromide inhalation powder (trade name: Jerun®) in healthy participants.

Start Date09 Apr 2026

Sponsor / Collaborator

Jewim Pharmaceutical (Shandong) Co., Ltd

CTR20254479

/ Active, not recruitingNot Applicable

茚达特罗格隆溴铵吸入粉雾剂在健康受试者中单次给药的空腹、单中心、随机、开放、两制剂、两序列、两周期、双交叉、药代动力学生物等效性试验

[Translation] A single-dose, fasting, single-center, randomized, open-label, two-formulation, two-sequence, two-period, two-crossover, pharmacokinetic bioequivalence study of indacatetrosorbone bromide inhalation powder in healthy subjects.

主要目的：以广州呼吸药物工程技术有限公司的茚达特罗格隆溴铵吸入粉雾剂为受试制剂，以诺华公司的茚达特罗格隆溴铵吸入粉雾剂（商品名：杰润®）为参比制剂，评价受试制剂较参比制剂在空腹条件下单次给药的药代动力学生物等效性。次要目的：评价茚达特罗格隆溴铵吸入粉雾剂在健康受试者单次给药的安全性。

[Translation]

Primary objective: To evaluate the pharmacokinetic bioequivalence of indacaterol glycopyrronium bromide inhalation powder from Guangzhou Respiratory Pharmaceutical Engineering Technology Co., Ltd. (test formulation) and Novartis' indacaterol glycopyrronium bromide inhalation powder (trade name: JERUN®) under fasting conditions after a single dose. Secondary objective: To evaluate the safety of indacaterol glycopyrronium bromide inhalation powder after a single dose in healthy subjects.

Start Date21 Nov 2025

Sponsor / Collaborator

Guangzhou Jiankangyuan Respiratory Medicine Engineering

CTR20254546

/ RecruitingNot Applicable

茚达特罗格隆溴铵吸入粉雾剂在COPD受试者中的药效动力学研究

[Translation] Pharmacokinetic study of indidatarbutin glycopyrronium bromide inhalation powder in COPD subjects

主要目的以山东京卫制药有限公司生产的茚达特罗格隆溴铵吸入粉雾剂为受试制剂，以Siegfried Barbera, S.L.生产的茚达特罗格隆溴铵吸入粉雾剂（商品名：杰润®）为参比制剂，比较受试制剂（T）和参比制剂（R）在慢性阻塞性肺疾病（COPD）受试者体内的药效动力学特征，评价两制剂在COPD受试者中的PD-BE等效性，为受试制剂的生产注册申请提供支持。次要目的观察受试制剂和参比制剂在COPD受试者中的安全性。

[Translation]

Primary Objective: To compare the pharmacokinetic characteristics of indacatetroglycopyrronium bromide inhalation powder (T) manufactured by Shandong Jingwei Pharmaceutical Co., Ltd., and indacatetroglycopyrronium bromide inhalation powder (trade name: JERUN®) manufactured by Siegfried Barbera, S.L., in subjects with chronic obstructive pulmonary disease (COPD), evaluate the PD-BE equivalence of the two formulations in COPD subjects, and provide support for the production registration application of the investigational formulation. Secondary Objective: To observe the safety of the investigational and reference formulations in COPD subjects.

Start Date18 Nov 2025

Sponsor / Collaborator

Jewim Pharmaceutical (Shandong) Co., Ltd

100 Clinical Results associated with Glycopyrrolate/Indacaterol Maleate

100 Translational Medicine associated with Glycopyrrolate/Indacaterol Maleate

100 Patents (Medical) associated with Glycopyrrolate/Indacaterol Maleate

Literatures (Medical) associated with Glycopyrrolate/Indacaterol Maleate

01 Jun 2026·THORAX

Disproportionate increase in COPD exacerbation risk for 3 months after discontinuing LAMA or ICS: insights from the FLAME trial

Article

Author: Mathioudakis, Alexander G ; Sivapalan, Pradeesh ; Bakerly, Nawar Diar ; Chatzimavridou-Grigoriadou, Victoria ; Bate, Sebastian ; Vestbo, Jørgen ; Jensen, Jens-Ulrik Stæhr ; Singh, Dave

Background:

In real-world chronic obstructive pulmonary disease (COPD) care, poor adherence often leads to treatment discontinuations. Discontinuing inhaled corticosteroids (ICS) can trigger withdrawal effects transiently increasing exacerbation risk; but evidence for long-acting muscarinic antagonists (LAMA) withdrawal remains limited.

Methods:

We performed a post hoc analysis of the 52-week, double-blind, Effect of Indacaterol Glycopyrronium versus Fluticasone Salmeterol on COPD Exacerbations trial that compared long-acting beta-2 agonist (LABA)+LAMA with LABA+ICS in 3362 patients with moderate-to-severe COPD and exacerbation history. Potential withdrawal effects after discontinuing LAMA or ICS were suggested by monthly exacerbation incidence plots during the first quarter of follow-up. Participants were stratified by their baseline use of these therapies, and outcomes were compared between the first and subsequent quarters among those who continued versus discontinued each treatment. Multivariable mixed-effects models assessed differences in exacerbation rates, with temporal variation in treatment effects interpreted as indicative of withdrawal effects.

Results:

Discontinuing LAMA was associated with a marked, transient increase in moderate-to-severe exacerbations during the first versus subsequent quarters (p=0.001; rate ratio up to 2.2 (95% CI 1.2 to 4.1) in the subgroup least influenced by concomitant ICS use). This observation was not confirmed for severe exacerbations, likely due to low event count. In contrast, discontinuing ICS was associated with a significant early rise in severe exacerbations (p=0.023), though the difference for moderate-to-severe events did not reach statistical significance. Importantly, ICS withdrawal effects appeared consistent regardless of baseline blood eosinophil count.

Conclusion:

Our findings suggest potent LAMA and ICS treatment withdrawal effects on exacerbations, highlighting the importance of treatment adherence and accounting for withdrawal effects in clinical trials.

Trial registration number:

NCT01782326 .

01 Oct 2025·Journal of Thoracic Disease

Efficacy, pharmacokinetics, and safety of nebulized HL231 inhalation solution in patients with chronic obstructive pulmonary disease: a randomized trial

Article

Author: Bian, Tao ; Xiong, Hao ; Li, Fangqiong ; Xie, Lihua ; Yue, Yun ; Li, Yaming ; Xiao, Zuke ; Hu, Qingyuan ; Yang, Guoping ; Zhao, Li ; Chen, Feng ; Wen, Fuqiang ; Luo, Zhu ; He, Qing ; Luo, Lin

Background:

Long-acting beta-agonist (LABA) plus long-acting muscarinic antagonist (LAMA) is superior to monotherapy or corticosteroid/LABA in terms of improving lung function, alleviating symptoms and educe chronic obstructive pulmonary disease (COPD) exacerbations. This study aimed to establish optimal dosage of nebulized HL231 inhalation solution (HL231), comparable to Ultibro^® (110 µg indacaterol maleate/50 µg glycopyrronium bromide), for bronchodilatation, pharmacokinetics, and safety in COPD.

Methods:

This study employed a multicenter, randomized, single-dose, single-blind, crossover design and featured two parts. The randomization schedule was generated by the statistical team using the block randomization procedure in SAS software. Chinese adults aged 40 years or older who were diagnosed with moderate-to-severe COPD using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria were eligible for the study. Blinding was implemented for the personnel conducting pulmonary function tests. In Part A, patients were randomized to receive a single dose of HL231 (132 µg/72 µg, 261 µg/141 µg, or 516 µg/279 µg), Ultibro^®, or placebo in a randomized sequence with a washout period of at least 14 days between two visits. The primary efficacy endpoint was the change in the area under the curve (AUC) of FEV₁ from baseline to 12 h after administration (ΔFEV₁ AUC_0-12h). In Part B, patients were randomized to receive a single dose of HL231 (261 µg/120 µg and 261 µg/141 µg), or Ultibro^® in a randomized sequence. The primary endpoints were pharmacokinetic parameters, including the AUC from time 0 to the last detectable time point (AUC_0-t), AUC from time 0 to infinity (AUC_0-∞), and peak concentration (C_max). Safety was evaluated in both parts.

Results:

The study was initiated and completed between December 2021 and May 2023, with 173 and 29 patients screened in Part A and Part B respectively, resulting in 84 and 18 randomized patients, of whom 83 and 18 completed at least one treatment cycle. In Part A, the least squares (LS) mean differences in ΔFEV₁ AUC_0-12h for HL231 doses (132 µg/72 µg, 261 µg/141 µg, and 516 µg/279 µg) and Ultibro^® versus placebo were 2.30, 2.58, 2.68, and 2.33 L·h (all P<0.001), respectively, while compared to Ultibro^®, differences were -0.04 (P=0.83), 0.24 (P=0.14), and 0.35 L·h (P=0.04), respectively. Moreover, the LS means of ΔFEV₁ AUC0-12h for these doses were 2.30, 2.58, and 2.69 L·h, indicating a dose-response relationship. In Part B, HL231 261 µg/141 µg demonstrated peak concentration (C_max) of indacaterol and glycopyrronium at 86% and 54% of Ultibro^®, with comparable AUC_0-t. Safety was acceptable, with most treatment-emergent adverse events (TEAEs) being grade 1-2.

Conclusions:

HL231 (261 µg/141 µg) is highly comparable to Ultibro^® in bronchodilatation, pharmacokinetics, and safety, making it a potential alternative for COPD patients.

Trial Registration:

This study was registered at Chinese Clinical Trials Registration (ChiCTR2300068316) and clinicaltrials.gov (NCT06619210, retrospectively registered).

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 ; Lawrence, David ; Kostikas, Konstantinos ; 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).

News (Medical) associated with Glycopyrrolate/Indacaterol Maleate

18 May 2026

·www.biospace.com

AeroRx Therapeutics Presents Positive Phase 2a Data for Inhaled AERO-007, the First Potential Nebulized LABA+LAMA Fixed-Dose Combination in Development for COPD

AERO-007 demonstrated rapid, sustained, statistically significant, and clinically meaningful bronchodilation through 24 hours in patients with moderate-to-severe COPD Treatment with AERO-007 was well tolerated at both dose levels, with most adverse events mild and no adverse events leading to treatment discontinuation Data support continued development of AERO-007 as a potential once-daily, first-line maintenance therapy for COPD patients who require or prefer nebulized treatment LA JOLLA, Calif.--(BUSINESS WIRE)-- #Biotech -- AeroRx Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing proprietary nebulized combination therapies for chronic respiratory diseases, today announced the presentation of positive Phase 2a data for inhaled AERO-007, the first potential nebulized LABA+LAMA fixed-dose combination in clinical development for chronic obstructive pulmonary disease (COPD). The data were presented at the American Thoracic Society (ATS) 2026 International Conference. The data support AERO-007’s continued development as a potential first-line maintenance dual bronchodilation therapy for COPD patients who require or prefer nebulized treatment, with both dose levels demonstrating robust and sustained improvements in lung function and a favorable tolerability profile. “Dual bronchodilation is a central part of COPD maintenance therapy, but delivery remains an important barrier for many patients,” said Dave Singh, M.D., Professor of Respiratory Medicine and Clinical Pharmacology at the University of Manchester and principal investigator of the Phase 2a study. “In this Phase 2a study, nebulized AERO-007 demonstrated rapid, clinically meaningful bronchodilation that was sustained over 24 hours, supporting the potential of a once-daily nebulized LABA+LAMA fixed-dose combination approach for patients who may not receive the full benefit of handheld inhaler-based treatment.” The Phase 2a clinical trial was a randomized, double-blind, placebo-controlled, single-dose, three-period crossover, dose-ranging study evaluating the safety, tolerability, pharmacokinetics, and efficacy of AERO-007 in 16 patients with moderate-to-severe COPD. Participants received AERO-007 100/50 μg, AERO-007 200/100 μg, and placebo, separated by a washout period. Treatments were administered using an LC Sprint standard jet nebulizer, and pulmonary function was assessed by serial spirometry over 24 hours after dosing. AERO-007 demonstrated statistically significant and sustained improvements in lung function compared to placebo at both dose levels, including placebo-adjusted standardized FEV₁ AUC 0-24h of 251 mL for AERO-007 100/50 μg and 262 mL for AERO-007 200/100 μg, both p<0.001. Placebo-adjusted peak change from baseline in FEV₁ was 311 mL and 302 mL, respectively, representing a robust, clinically meaningful bronchodilation, and systemic pharmacokinetic exposures to indacaterol and glycopyrrolate were similar to or below exposures reported with reference drug Utibron Neohaler DPI (27.5/15.6 μg twice daily). AERO-007 was well tolerated at both dose levels, with most treatment-emergent adverse events mild and no adverse events leading to treatment discontinuation. “These data strengthen our confidence in AERO-007 as a potential first-line maintenance, once-daily LABA+LAMA bronchodilator therapy for COPD patients who need or prefer nebulized treatment,” said Ahmet Tutuncu, M.D., Ph.D., Co-founder and Chief Executive Officer of AeroRx Therapeutics. “Patients in this segment have not had access to guideline-preferred LABA+LAMA combination therapy in a fixed-dose nebulized formulation. By combining two clinically validated bronchodilators in a proprietary formulation delivered through a standard jet nebulizer, we believe AERO-007 has the potential to address this significant gap in COPD care. I am grateful to the patients, investigators, advisors, and AeroRx team who made this study possible, and we look forward to advancing the program into the next stage of clinical development.” The data were presented on May 17, 2026, by Dr. Tutuncu at ATS 2026 International Conference in a poster titled, “Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of Inhaled AERO-007, a Novel Inhalation Solution of LABA+LAMA Combination (Indacaterol + Glycopyrrolate) for Nebulization Delivery in COPD.” About AERO-007 AERO-007 combines the long-acting, FDA-approved bronchodilators indacaterol (LABA) and glycopyrrolate (LAMA) in a proprietary formulation for delivery via a 510(k)-cleared standard jet nebulizer. More than 16 million people in the United States are diagnosed with COPD, posing a significant economic and social burden, and as many as 50 percent remain symptomatic even while using FDA-approved LABA+LAMA maintenance therapy delivered via handheld inhalers (1). Studies also show that up to 75 percent of patients do not receive the full therapeutic dose from handheld inhaler devices, which demand coordination and forceful inhalation (2). Nebulized delivery offers a passive-breathing alternative that can provide more consistent dosing and better symptom control for patients who find handheld inhalers challenging, particularly older adults and those with advanced COPD, who are at high risk for exacerbations, hospitalization, and disease progression (3,4). References: (1) American Lung Association , accessed July 24, 2025; Boers et al. JAMA Network Open 2023; Molimard et al. Eur Respir J 2017 (2) Kocks et al. BMC Pulm Med 2023 (3) Crater et al. Ther Adv Respir Dis 2022; Barjaktarevic et al. Int J COPD 2020; Melamed et al. Int J COPD 2026. About AeroRx Therapeutics AeroRx Therapeutics is a clinical-stage biopharmaceutical company developing proprietary, combination products for nebulized delivery to improve the treatment of chronic respiratory diseases. The company’s lead product candidate, inhaled AERO-007, is the first nebulized LABA+LAMA fixed-dose combination bronchodilator in clinical development as a first-line maintenance therapy for COPD and has the potential to help millions of patients who remain symptomatic, or poorly served, under existing drugs delivered via handheld inhalers or nebulized LABA or LAMA monotherapy. A second program, AERO-111, is in development as the first nebulized LABA+LAMA+ICS triple therapy, for patients who escalate beyond dual bronchodilators. AeroRx’s leadership team has decades of expertise in aerosol drug delivery, clinical development, and regulatory strategy and guided multiple respiratory therapies from concept to regulatory approval. AeroRx is headquartered in the Avalon BioVentures Accelerator in La Jolla, California. For more visit, . Contacts Company: Bryce Suchomel, info@aerorxtherapeutics.com Media: Jessica Yingling, Ph.D., Little Dog Communications , jessica@litldog.com

Clinical ResultPhase 2

07 Oct 2025

·www.businesswire.com

AeroRx Therapeutics Announces $21 Million Series A Financing to Advance Inhaled AERO-007, the First Nebulized LABA/LAMA for COPD, into Late-Stage Clinical Development

LA JOLLA, Calif.--(BUSINESS WIRE)--AeroRx Therapeutics, Inc., a clinical-stage biopharmaceutical company developing proprietary nebulized combination therapies for chronic respiratory diseases, today announced the closing of a $21 million Series A financing led by Avalon BioVentures, with participation from Correlation Ventures, Alexandria Venture Investments, and others. Proceeds will support late-stage clinical development of AeroRx’s lead candidate, inhaled AERO-007, the first nebulized LABA/LAMA combination in development as a potential first-line maintenance therapy for chronic obstructive pulmonary disease (COPD). “With this Series A financing, we are well positioned to advance AERO-007 into a Phase 2b dose-optimization study and prepare for late-stage, NDA-enabling development,” said Ahmet Tutuncu, M.D., Ph.D., Co-founder and CEO of AeroRx Therapeutics. Data from a completed Phase 2a clinical study of AERO-007 demonstrated that AERO-007 was well tolerated in patients with moderate to severe COPD, and provided rapid-onset, and clinically meaningful, sustained bronchodilation through 24 hours at both low and high doses. “With this Series A financing, we are well positioned to advance AERO-007 into a Phase 2b dose-optimization study and prepare for late-stage, NDA-enabling development,” said Ahmet Tutuncu, M.D., Ph.D., Co-founder and Chief Executive Officer of AeroRx Therapeutics. “Our Phase 2a study data further support AERO-007’s potential as a once-daily nebulized LABA/LAMA combination, designed to address a major unmet need for underserved COPD patients.” “Dual bronchodilation via handheld inhalers is the standard of care, but millions of patients remain poorly controlled due to difficulties with inhaler technique,” said Jay Lichter, Ph.D., Managing Partner at Avalon BioVentures. “AeroRx has the opportunity to deliver meaningful clinical benefit by bringing the preferred guideline therapy to patients in a nebulized form that is designed for full dosing and improved adherence.” The Phase 2a clinical trial was a randomized, double-blind, placebo-controlled, single-dose, three-period crossover that enrolled 16 adults with moderate-to-severe COPD. Both the low- and high-dose treatments of AERO-007 delivered clinically meaningful, statistically significant improvements in forced expiratory volume in one second (FEV1, the standard efficacy parameter based on serial spirometry assessment) compared to placebo. Inhaled AERO-007 was well tolerated with a tolerability and systemic drug exposure profile comparable to the previously approved drugs with the individual active components. About AERO-007 AERO-007 combines the long-acting, FDA-approved bronchodilators indacaterol (LABA) and glycopyrrolate (LAMA) in a proprietary formulation for delivery via a 510(k)-cleared standard jet nebulizer. More than 16 million people in the United States are diagnosed with COPD, posing a significant economic and social burden, and as many as 50 percent remain symptomatic even while using FDA-approved LABA/LAMA maintenance therapy delivered via inhalers (1). Studies also show that up to 75 percent of patients do not receive the full therapeutic dose from handheld inhaler devices, which demand coordination and forceful inhalation (2). Nebulized delivery offers a passive-breathing alternative that can provide more consistent dosing for patients who find inhalers challenging, particularly older adults and those with advanced COPD, who are at high risk for exacerbations, hospitalization, and disease progression (3). References: (1) American Lung Association, accessed July 24, 2025; Boers et al. JAMA Network Open 2023; Molimard et al. Eur Respir J 2017 (2) Kocks et al. BMC Pulm Med 2023 (3) Crater et al. Ther Adv Respir Dis 2022; Barjaktarevic et al. Int J COPD 2020 About AeroRx Therapeutics AeroRx Therapeutics is a clinical-stage biopharmaceutical company developing proprietary, combination products for nebulized delivery to improve the treatment of chronic respiratory diseases. The company’s lead product candidate, inhaled AERO-007, is the first potential nebulized LABA/LAMA fixed-dose combination drug in clinical development as a potential first-line maintenance therapy for COPD and has the potential to help millions of patients who remain symptomatic, or poorly served, under existing drugs delivered via handheld inhalers or nebulized LABA or LAMA monotherapy. A second program, AERO-111, is in development as the first potential nebulized LABA/LAMA/ICS triple therapy, for patients who escalate beyond dual bronchodilators. AeroRx’s leadership team has decades of expertise in aerosol drug delivery, clinical development, and regulatory strategy and guided multiple respiratory therapies from concept to regulatory approval. AeroRx is headquartered in the Avalon BioVentures Accelerator in La Jolla, California. For more visit, www.aerorxtx.com.

Phase 2Clinical Result

07 Oct 2025

·endpoints.news

AeroRx closes $21M Series A in bid to capitalize on COPD momentum

A respiratory biotech that launched Tuesday morning aims to take advantage of excitement in COPD drug development spurred by two recent deals. AeroRx Therapeutics took the wraps off a $21 million Series A that it’s using to get its lead program through Phase 2b testing in chronic obstructive pulmonary disease, or COPD. It’s the same category that spurred Merck’s $10 billion acquisition of Verona Pharma and GSK’s partnership with Hengrui Pharma that could be worth $12 billion if everything pans out. The AeroRx drug, known as AERO-007, is a nebulized reformulation of two approved compounds — indacaterol and glycopyrrolate — that use different mechanisms of action. Indacaterol is a long-acting beta agonist (LABA), while glycopyrrolate is a long-acting muscarinic agonist (LAMA). Combining LABAs and LAMAs is common when treating COPD. AeroRx CEO Ahmet Tutuncu said the FDA has approved five such products. An inhaler combination of indacaterol and glycopyrrolate was approved in 2015 as Utibron, which was developed by Novartis and out-licensed to Sunovion Pharmaceuticals a year later. (Sunovion is now owned by Sumitomo Pharma.) All the approvals are for inhalers with dry powder, which is more difficult for older and sicker patients to use, Tutuncu said. AeroRx believes it can be the first company to offer a nebulized formulation as a first-line maintenance therapy in COPD. “It’s a different delivery technology, or full dose delivery, for those patients who need to be on nebulized medicines,” Tutuncu said. “A significant number of COPD patients who are typically getting older, they are on inhalers, but they are the ones who end up in hospitals with exacerbations for symptom control, and therefore they need to be on nebulized medicine.” So far, AeroRx has run a small Phase 2a study with 16 patients that suggested AERO-007 could be dosed once daily. In the Phase 2b trial, researchers plan to test once-daily and twice-daily doses. Most other details about the trial remain undisclosed until after discussions with the FDA, according to Tutuncu, including how long it’s expected to last. But because both components of AERO-007 are already approved, Tutuncu expects an “abbreviated” late-stage development process comprising the Phase 2b and Phase 3 trials. The trials will also enroll all COPD patients, and if AERO-007 wins approval, AeroRx plans to market it for patients older than 65 years old. The company also has another preclinical program called AERO-111, which is a triple combination nebulized COPD treatment. (There are two approved triple-combo inhalers.) In addition to a LABA and LAMA compound, AERO-111 also includes a corticosteroid. Tutuncu said the company is still figuring out which one to use. AeroRx’s Series A comes about 18 months after it closed a $6 million seed round in the spring of last year. With the new cash in hand, AeroRx is aiming to capitalize on the recent momentum in COPD following the Merck and GSK deals. “Those were two really important validation points for the interest from big pharma for nebulized delivery in the respiratory space, and particularly in the COPD space,” Tutuncu said. “We’re very excited about that potential for collaboration with pharma down the road.”

Phase 2Drug ApprovalAcquisition

100 Deals associated with Glycopyrrolate/Indacaterol Maleate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Glycopyrrolate/Indacaterol Maleate	R03AL04	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Airway Obstruction	United States	Novartis Pharmaceuticals Corp.	29 Oct 2015
Bronchitis, Chronic	United States	Novartis Pharmaceuticals Corp.	29 Oct 2015
Pulmonary Emphysema	United States	Novartis Pharmaceuticals Corp.	29 Oct 2015
Pulmonary Disease, Chronic Obstructive	European Union	Novartis Europharm Ltd.	18 Sep 2013
Pulmonary Disease, Chronic Obstructive	Iceland	Novartis Europharm Ltd.	18 Sep 2013
Pulmonary Disease, Chronic Obstructive	Liechtenstein	Novartis Europharm Ltd.	18 Sep 2013
Pulmonary Disease, Chronic Obstructive	Norway	Novartis Europharm Ltd.	18 Sep 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dyspnea	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	01 Oct 2011
Dyspnea	Phase 3	Canada	Novartis Pharmaceuticals Corp.	01 Oct 2011
Dyspnea	Phase 3	Germany	Novartis Pharmaceuticals Corp.	01 Oct 2011
Dyspnea	Phase 3	Spain	Novartis Pharmaceuticals Corp.	01 Oct 2011
Dyspnea	Phase 3	United Kingdom	Novartis Pharmaceuticals Corp.	01 Oct 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01782326 (FLAME, Pubmed \| Thorax)	Phase 3	Pulmonary Disease, Chronic Obstructive	3,362	Indacaterol Glycopyrronium	bgkgzqnfvb(wrpxhwyeod): RR = 2.2 (95.0% CI, 1.2 - 4.1), P-Value = 0.001 View more	Positive	15 Dec 2025
				Fluticasone Salmeterol
ATS2025	Not Applicable	Pulmonary Disease, Chronic Obstructive	191	Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 µg	bnecwdlbma(xqrijspyei) = qwvglkstrn fpnzckkxhn (ucufmynsqv, 105 - 180)	Positive	16 May 2025
NCT02867761 (RETHINC, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	780	Indacaterol/Glycopyrrolate (Indacaterol/Glycopyrrolate)	uaukqjbmwu = mmjgepcher bmtuabetwo (rzruuaklwg, zbudwcgjpt - xrhyhucics) View more	-	30 Aug 2022
				Placebo (Placebo)	uaukqjbmwu = epteeykzfx bmtuabetwo (rzruuaklwg, paoboengaf - yjqmnnxuud) View more
NCT02566031 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	379	Indacaterol and glycopyrronium (QVA149) (Indacaterol and Glycopyrronium (QVA149))	rphrtgdktl(vrfdehosgw) = jlxkfhlbaw pehkodhdkb (cetykeokqr, 0.18097) View more	-	23 Sep 2019
				Tiotropium (Tiotropium)	rphrtgdktl(vrfdehosgw) = aqdzwlgqdo pehkodhdkb (cetykeokqr, 0.18487) View more
NCT02202616 (POWER, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	401	Sal+Flu+QVA149 (QVA149 110/50 After Flu/Sal)	jaiomxpcxs(pjubinqghg) = eeicyjsfof heifsmsqra (lqtsvmwjms, 0.397) View more	-	24 Jun 2019
				QVA149 (QVA149 110/50 After Tio)	jaiomxpcxs(pjubinqghg) = pleepkqjkj heifsmsqra (lqtsvmwjms, 0.321) View more
NCT02634983 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	31	QVA149 (QVA149 110/50 mcg)	zkttvvfpga(lkjzfbjovp) = mnsmbmujfk vatriaqibl (fgkzcwxolz, nxcatjgvqz - juywpmcyjr) View more	-	03 Jun 2019
				placebo (Matching Placebo)	zkttvvfpga(lkjzfbjovp) = lznxigziju vatriaqibl (fgkzcwxolz, ngpwlssfhh - tezjgkplpv) View more
NCT02442206 (CLAIM, Pubmed \| Am J Respir Crit Care Med)	Phase 4	Pulmonary Disease, Chronic Obstructive	62	Indacaterol/Glycopyrronium	fbjadqjgjk(uysomqfrpy) = xafpfffayh emagrnanan (mmlvxtksdl )	-	01 May 2019
NCT02603393 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	1,053	QVA149 (QVA149)	rfscwezyzq(zsepmvvtwk) = wgasptxjyd pvrkbbfrqt (dilwypaqlq, 0.0119) View more	-	29 Apr 2019
				Tiotropium+Salmeterol/fluticasone (Tiotropium + Salmeterol/Fluticasone)	rfscwezyzq(zsepmvvtwk) = cweqoqflqt pvrkbbfrqt (dilwypaqlq, 0.0115) View more
NCT02516592 (FLASH, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	500	QVA149 110/50 micrograms (QVA149 110/50 Micrograms)	fsbopproqj(opcpymilkw) = bptehswiqz bsdralgafv (vllcnekdnd, 0.0151) View more	-	21 Mar 2019
				Salmeterol/fluticasone 50/500 microgrammes (Salmeterol/Fluticasone 50/500 Micrograms)	fsbopproqj(opcpymilkw) = klltdaeyph bsdralgafv (vllcnekdnd, 0.0152) View more
NCT02233543 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	38	Indacaterol+Glycopyrronium+QVA149 (QVA149 (Indacaterol/Glycopyrronium))	jiwuahwhtq(wzebirihul) = csueotewug byzvrtdxsi (xemzbmdogh, 0.30) View more	-	06 Aug 2018
				QVA149 (Placebo)	jiwuahwhtq(wzebirihul) = piaorhdhvq byzvrtdxsi (xemzbmdogh, 0.28) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis