[Translation] A randomized, open-label, two-formulation, single-dose, two-sequence, two-period, double-crossover bioequivalence study of erdosteine capsules in healthy subjects under fasting and fed conditions

主要研究目的研究空腹/餐后状态下单次口服受试制剂（T）厄多司坦胶囊（规格：0.3g ，浙江东亚药业股份有限公司）与参比制剂（R）厄多司坦胶囊（ERDOTIN®，规格：300mg，Edmond Pharma S.r.l.）在健康成年受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的评价健康受试者在空腹/餐后状态下口服受试制剂（T）厄多司坦胶囊和参比制剂（R）厄多司坦胶囊（ERDOTIN®）后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test formulation (T) Erdosteine Capsules (Specification: 0.3g, Zhejiang Dongya Pharmaceutical Co., Ltd.) and the reference formulation (R) Erdosteine Capsules (ERDOTIN®, Specification: 300mg, Edmond Pharma S.r.l.) in healthy adult subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two formulations in the fasting/fed state. Secondary study objectives To evaluate the safety of the test formulation (T) Erdosteine Capsules and the reference formulation (R) Erdosteine Capsules (ERDOTIN®) in healthy subjects after oral administration in the fasting/fed state.

Start Date07 Apr 2025

Sponsor / Collaborator

Zhejiang East Asia Pharmaceutical Co., Ltd.

ACTRN12624001381572

/ Not yet recruitingNot ApplicableIIT

Evaluating the effect of 2-weeks erdosteine, a novel mucolytic, as add-on treatment during respiratory exacerbations in children with bronchiectasis - a feasibility study

Start Date06 Jan 2025

Sponsor / Collaborator

Queensland University of Technology

CTRI/2024/07/071268

/ Not yet recruitingPhase 3

A Prospective, Randomized, Open-label, Parallel-group, Multi center, Active-controlled, Phase 3 Clinical Trial to Compare the Efficacy and Safety of FDC Erdosteine 300 mg and Acebrophylline 100 mg Tablet (of Macleods Pharmaceuticals Ltd.) versus FDC Acebrophylline 100 mg and Acetylcysteine 600 mg Tablet in Treatment of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease - NIL

Start Date04 Aug 2024

Sponsor / Collaborator-

100 Clinical Results associated with Erdosteine

100 Translational Medicine associated with Erdosteine

100 Patents (Medical) associated with Erdosteine

609

Literatures (Medical) associated with Erdosteine

01 Dec 2025·LUNG

Effect of Treatment with Mucoactive Drugs on COPD Exacerbations During 5 years of Follow-up in the Czech Republic: A Real-World Study

Article

Author: Zatloukal, Jaromír ; Brat, Kristián ; Koblížek, Vladimír ; Svoboda, Michal ; Voláková, Eva ; Kopecký, Michal ; Page, Clive ; Plutinský, Marek

Abstract:

Introduction:

Studies indicate that chronic treatment with mucoactive drugs may reduce COPD exacerbation rates. This real-world, multicenter, prospective, observational study aimed to determine the effect of long-term mucoactive treatment on exacerbations in patients with COPD in the Czech Republic.

Methods:

452 adult patients on the Czech Multicenter Research Database of COPD with post-bronchodilator FEV1 ≤ 60% of predicted value received standard of care and were followed up for 5 years. For the first 24 months, 81 patients received regular thiol-based mucoactive drugs (77 erdosteine, 4 N-acetylcysteine) at the discretion of the treating physician and 371 patients had no mucoactive treatment (control group). Erdosteine was fully reimbursed, and NAC was partially reimbursed for COPD patients. The annual number/rate of COPD exacerbations over 5 years was monitored.

Results:

Patients receiving mucoactive treatment for 24 months had a significantly larger reduction from baseline in all exacerbations compared to the control group (− 0.61 vs − 0.18, p = 0.026; − 0.54 vs − 0.09, p = 0.007; − 0.55 vs 0.04, p = 0.005; − 0.67 vs 0.13, p = 0.002; − 0.53 vs 0.10, p = 0.019 in the first to fifth year, respectively). The reduction in moderate exacerbations was also significantly larger in those receiving mucoactive treatment versus no mucoactive treatment. The exacerbation rate was reduced to a greater extent in the subgroups with cough or with stage 3‒4 COPD who received mucoactive treatment but was independent of the use of inhaled corticosteroids (ICS).

Conclusion:

Mucoactive treatment for two years reduced the number of COPD exacerbations (all, moderate) over five years of follow-up. The reduction in exacerbations was more pronounced in patients with cough or with stage 3‒4 COPD but was independent of the use of ICS.

18 Apr 2025·CURRENT HIV RESEARCH

The RV144 Trial Set Back HIV-1 Vaccine Development but Might Still Yield Useful Information

Article

Author: Moore, John P.

Abstract::

This article discusses how the RV144 Phase 3 HIV-1 vaccine trial conducted over 15 years ago impacted the subsequent direction of research intended to create and evaluate vaccines with potentially greater efficacy. Follow-on Phase 2b and Phase 3 trials directly or indirectly inspired by the modest efficacy reported for the RV144 trial have not shown any significant pro-tection against HIV-1 acquisition. No credibly protective new immunogens have emerged from the Correlates of Protection (CoP) or Risk (CoR) analyses conducted after RV144-inspired stud-ies in either humans or various macaque models. Notably, the RV144 trial did not induce neutral-izing antibodies (NAbs), only non-NAbs. However, only NAbs have been shown to be protective in macaque models. One possible but underappreciated explanation for the outcome of the RV144 trial could be trained innate immune responses against the non-HIV-1 canarypox virus vector antigens, considering the placebo group only received saline. In this article, the author outlines how monkey model research based directly or indirectly on the RV144 trial could still yield useful information on the possible role of trained immunity in short-term vaccine protection. However, non-human primate research, in general, should now focus on testing new immunogens that have a reasonable chance of inducing NAbs in humans, rather than expending more resources on CoP/CoR studies inspired by the RV144 trial and its follow-ups.

01 Apr 2025·TISSUE & CELL

Development of a rat airway organoids model for studying chronic obstructive pulmonary disease

Article

Author: Ren, Zirui ; Xian, Yangling ; Pan, Dequan ; Lin, Yanzhen ; Zhao, Huan ; Yang, Hongwei ; Yu, Kang ; Cheng, Tong ; Yang, Chuanlai ; Zhang, Yali ; Fang, Changjian ; Xia, Ningshao ; Wang, Wei ; Tan, Haoyin ; Huang, Xiumin ; Liu, Nanyi

Chronic obstructive pulmonary disease (COPD) poses global health challenges owing to limited treatment options and high rates of morbidity and mortality. Airway organoids have recently become a valuable resource for the investigation of respiratory diseases. However, limited access to clinical tissue samples hinders the use of airway organoids to study COPD. Therefore, alternative models that can mimic human airway pathology without relying on human tissues are needed. In this study, airway organoids were developed from tracheal epithelial cells obtained from 8-week-old Sprague-Dawley rats and exposed to lipopolysaccharide (LPS) to induce COPD-like characteristics. Exposure to LPS leads to structural changes in organoids, including an increase in goblet cells, a decrease in ciliated cells, increased mucin production, and elevated levels of pro-inflammatory cytokines. The COPD drugs erdosteine and R-HP210 effectively reduced mucin secretion, although none was able to restore the function of ciliated cells. Inflammatory markers responded differently, with ensifentrine and erdosteine significantly reducing cytokine levels. These results demonstrate that rat airway organoids replicate important aspects of human COPD pathology, thus providing an accessible, ethical, and clinically relevant alternative to human tissues and traditional animal models to enhance our understanding of COPD pathogenesis and evaluate potential treatments.

News (Medical) associated with Erdosteine

07 Dec 2023

·firstwordpharma.com

African-led HIV vaccine trial shuts down after disappointing early results

The first trial in Africa of experimental combination vaccines to prevent HIV has been halted after preliminary results suggested it was not working, researchers told the International Conference on AIDS and STIs in Africa (ICASA) this week. Eugene Ruzagira, trial director from the Uganda Virus Research Institute, said vaccinations to participants were stopped after an independent data monitoring committee concluded there was "little or no chance" of demonstrating the jabs would reduce the risk of acquiring the virus.Part of the broader PrEPVacc initiative, the trial conducted in Uganda, Tanzania and South Africa got under way in late 2020 with enrolment of 1512 healthy adults between the ages of 18 and 40 who were considered to be at high risk of infection. Led by African researchers with support from European institutions such as Imperial College London, the study was testing two different combinations of experimental HIV vaccines and was due to complete in 2024.It is also testing a new form of oral pre-exposure prophylaxis (PrEP) to see if it is as effective as existing drugs for HIV. That part of the trial remains ongoing.Previous studies in South Africa to evaluate RV144, the only vaccine that had shown any success in protecting against HIV, was halted in early 2020 after interim results found it was not working."We do clinical trials because we don't know the answer to questions," stated researcher Jonathan Weber, from Imperial College London, adding it was important to find out whether the combination vaccine regimens in PrEPVacc should be ruled out or warrant further development. "While we await the final results and analysis of individual products, I believe that our interim result puts this generation of putative HIV vaccines to bed," he said.

VaccineClinical Study

22 Oct 2020

·alitairpharmaceuticals.com

Erdosteine and COVID-19 in Italy

Our colleagues at Recipharm recently completed an important study in COVID-19 patients in Milan, Italy. This study was the first to look at Health-Related Quality of Life (HRQoL) in COVID-19 patients discharged from the hospital setting. This clinical study involved 20 patients affected by COVID-19 with severe respiratory failure, hospitalized in “L. Sacco” University Hospital in Milan (one of the major COVID-19 centers in Lombardy, the Italian region mostly affected by SARS-CoV-2). The study indicated that patients taking Erdosteine 300 mg twice daily after hospital discharge provided beneficial improvements in health-related quality of life parameters (HRQoL) and dyspnea (shortness of breath). Full results were recently published in Multidisciplinary Respiratory Medicine, the official journal of the Italian Respiratory Society. The paper is titled “Changes in quality of life and dyspnea after hospitalization in COVID-19 patients discharged at home” (Santus P., Tursi F., Croce G., Di Simone C., Frassanito F., Gaboradi P., Airoldi A., Pecis M., Negretto G., Radovanovic D.). This information on Erdosteine in Italy is provided as a courtesy to investors only as an Investor Relations communication. Alitair may or may not pursue COVID-19 development work in the US. Erdosteine is not FDA approved for treating COVID-19 patients , or any patients in the United States and is not available in the US market. Alitair is not making any assertation of the safety or effectiveness of Erdosteine in any patient type and will not do so until FDA approves the product based on our clinical development program and NDA filing. Alitair holds an open IND for Erdosteine and has received Orphan Drug designation for treating bronchiectasis. Once fully funded, Alitair intends to begin Phase II studied in non-CF bronchiectasis patients in the US. Future development in CF-bronchiectasis patients, COVID-19, and other indications will be fully explored; however, these are not focus areas today. FORWARD-LOOKING STATEMENTS The information contained in this letter may contain information about the Company’s future plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical facts and may be "forward looking statements". Forward looking statements may be identified through the use of words such as “may”, "expects/excepted", "will", "anticipates", “allows”, "estimates", "believes", “provides” or by statements indicating certain actions. "may", "could", "should" or "might" occur. Forward looking statements are based on expectations, estimates and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. The information contained in this letter was current as of the date presented and we specifically disclaim any obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise.

Orphan DrugNDAClinical Result

10 Sep 2020

·alitairpharmaceuticals.com

Alitair Pharmaceuticals Investor Relations Communication - 3rd Quarter 2020

Alitair Pharmaceuticals Investor Relations Communication September 10, 2020 Dear Shareholders and Stakeholders: I hope you are faring well as we all continue to navigate life amidst the coronavirus pandemic. The Alitair team is doing fine and we hope you are too. From a business standpoint, we continue to work hard at driving the business forward although the current and recent past business environments have made capital-raising activities even more challenging than normal. Notwithstanding these setbacks, and the unprecedented impacts of the SARS-CoV-2 pandemic, we believe our product portfolio remains attractive, our target markets remain large, and the unmet medical needs remain unfulfilled. We also believe that Alitair still holds fundamental attractiveness from a therapeutic area standpoint and from a valuation standpoint. Raising capital remains our #1 priority – Driving forward benzonatate tablets for prescription cough and erdosteine for bronchiectasis remain the keys to unlocking the value of the Alitair portfolio. Both products would launch into markets of $500 million to $1 billion. Given the differentiated profile of both products, we continue to believe that the commercial revenues would be very attractive. After a lull (during the initial months of the pandemic) in our ability to engage potential financial firms to help us raise the required capital, we now have two initiatives in place. One is a royalty-focused deal approach for benzonatate. The other is a more traditional equity raise targeting broader product development initiatives including erdosteine and some small IP-related work. While we cannot guarantee success with either initiative, we are excited about our strategic plan to gain funding for our pipeline. As a third prong in our strategy, we are targeting some small investment to cover near-term operating costs through a “friends and family” type of capital raise. So, we now have three initiatives in place to help secure the capital required to grow Alitair and unlock value for shareholders. Benzonatate Tablets – This is our lead asset. Benzonatate gel-caps (Pfizer and generics) in its current marketed form has become the leading treatment choice in the large 26 million patient cough market. The molecule has grown to capture over 60% of total prescriptions. However, there are safety risks caused by the dosage form and the dosage frequency is 3-4 times a day. In comparison, Alitair Benzonatate Tablets are designed to deliver the efficacy of the gel-cap, but with a projected safer profile and with the first tablet formulation with a twice-a-day dosing regimen. We believe our Benzonatate Tablets can become the leading brand in the prescription cough market in the US. We hold strong IP in support of our Benzonatate Tablets. Bronchiectasis – We have two assets holding FDA Orphan Drug status for the treatment of bronchiectasis in both CF and non-CF patients. The lead compound here, erdosteine capsules, has an open IND with FDA and is Phase II ready. The other asset is doxofylline capsules. Both compounds have the potential to compete effectively in the 160,000-patient bronchiectasis market. As we have ready access to clinical trial material from an FDA-approved manufacturing site, we are ready to move into Phase II … once funded. Other Pipeline Assets and Special Initiatives – As we continue to evolve as a company, we have deemphasized the narcotic cough portfolio. We have reprioritized Overdose Reduction (ODR) formulation technology as a Business Development initiative available for out-licensing. In terms of special projects, erdosteine and doxofylline are both being studied in Italy for COVID-19 patients (studies being conducted by our licensing partners). We await the full results of these clinical studies. We have not placed any probability of success on these programs as it is too early, there are too many unknowns with the SARS-CoV-2 virus, and the studies are too small to make a definitive judgement on next steps. Enhancing Scientific Support – Gaining input and expertise from leading researchers, clinicians and frontline physicians is critical to our success. To that end, we are updating our team of Scientific Advisors. We are retaining some of our core physicians and adding several new advisors with deep experience in cough, with hands-on patient care expertise in respiratory diseases and emergency medicine, and knowledge of clinical trial design and regulatory requirements. While this initiative will not be completed until mid-4Q20, we have made good progress with leading and well-respected clinicians. While we will not release the new panel details until it is filled in its entirety, our two newest members are stellar. One heads Emergency Medicine in a large metropolitan area and is actively involved in his professional society in a key leadership role. The other is a worldwide Pulmonology expert, the founder of a Cough Center of Excellence, and is involved in the peer-review and publication process at the preeminent medical journal in his specialty area. Stay tuned for more details on our Scientific Advisors in the coming months. Looking ahead – As stated earlier, raising additional capital is the key step for Alitair. Without additional capital, we cannot succeed, and it has been our main challenge over the past several years. However, we have good engagement with our financial partners and a growing engagement with the scientific community. We are still hopeful that we can succeed in our quest. Our focus is on benzonatate, and then, Orphan Drug product development … with narcotic cough and ODR de-emphasized. Three years ago, our Board and Executive team took the reins of the Company and we remain committed and passionate about Alitair Pharmaceuticals. We know what success would mean for patients, stakeholders, and shareholders. That is why, near-term, our #1 priority remains focused on gaining new capital. We will provide a further Investor Relations updates when major news flow develops. James Hoyes - Chairman and CEO FORWARD-LOOKING STATEMENTS The information contained in this letter may contain information about the Company’s future plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical facts and may be "forward looking statements". Forward looking statements may be identified through the use of words such as “may”, "expects/excepted", "will", "anticipates", “allows”, "estimates", "believes", “provides” or by statements indicating certain actions. "may", "could", "should" or "might" occur. Forward looking statements are based on expectations, estimates and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. The information contained in this letter was current as of the date presented and we specifically disclaim any obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise.

Orphan DrugPhase 2Drug Approval

100 Deals associated with Erdosteine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Erdosteine	R05CB15	DB05057

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dyspnea	China	Zhejiang Kangle Pharmaceutical Co., Ltd.	01 Jan 2001
Cough	Italy	-	01 Jan 1993

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bronchitis, Chronic	Phase 2	United States	Adams Respiratory Therapeutics, Inc.	01 Mar 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERS2020	Not Applicable	Pulmonary Disease, Chronic Obstructive	369	Erdosteine + Standard Treatment	fjxomzeewk(linqqdmvxa) = vqulsvngij ejmbdkwiqc (bzcuxwtisn ) View more	Positive	07 Sep 2020
				Standard Treatment	fjxomzeewk(linqqdmvxa) = cpnerezxym ejmbdkwiqc (bzcuxwtisn ) View more
RESTORE study (ERS2018)	Not Applicable	Pulmonary Disease, Chronic Obstructive	528	Erdosteine 300 mg bid	einvbvlbru(kqjpxpdkzb) = hnkcptjwii vjvlkezwhz (eajabbzxqg ) View more	Positive	15 Sep 2018
				Placebo	einvbvlbru(kqjpxpdkzb) = dlhzvlscsf vjvlkezwhz (eajabbzxqg ) View more
AAI2018	Not Applicable	Refractory Cancer acute phase proteins \| granzyme B \| CD8	50	Metformin	fzafvdmaoz(scfuljcvsv) = tfpfucfgbu huxrpifzoo (cqgwnmhnvt ) View more	Positive	01 May 2018
				Pidotimod	fzafvdmaoz(scfuljcvsv) = bgrvlqoxpc huxrpifzoo (cqgwnmhnvt ) View more
NCT01032304 (RESTORE, Pubmed \| Eur Respir J)	Phase 3	Pulmonary Disease, Chronic Obstructive	445	Erdosteine 300mg	orpkftwkas(bsgkthncpn) = csjrxoxfbj rvjjpbxloa (adgfnthupq ) View more	Positive	01 Oct 2017
				Placebo	orpkftwkas(bsgkthncpn) = zucjpaatvj rvjjpbxloa (adgfnthupq ) View more
ERS2017	Not Applicable	Pulmonary Disease, Chronic Obstructive oxidative stress	186	Erdosteine	jkvestabds(ikoznfxous) = urpkvfbdbh uvjjburrct (rpotvaroiz, 12%) View more	Positive	01 Sep 2017
ERS2016	Not Applicable	Disease Progression	-	Erdosteine 900mg daily	wrsrdnggsj(dtniflzpbf) = achxmdeqdh kxysrsntyq (blpfzlebza )	Positive	01 Sep 2016
				Control	wrsrdnggsj(dtniflzpbf) = uuhfvnjabk kxysrsntyq (blpfzlebza )
ERS2014	Not Applicable	Disease Progression serum C-reactive protein (CRP)	-	Erdosteine 900 mg	ssjpnghzgm(jkrpcqhzhk) = improvement of FEV1%pred at 10 (p<0.01) and 30 days ftfvfonioa (zizbatqfll ) View more	Positive	01 Sep 2014

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