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Last update 14 Apr 2025

Mometasone Furoate

Last update 14 Apr 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ASCEND mometasone furoate-coated sinus balloon, Bioabsorbable mometasone-eluting sinus implants - Intersect ENT, Controlled-release-mometasone-furoate

+ [48]

Target

Action

agonists

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [5]

Active Indication

Chronic rhinosinusitis with nasal polypsRhinitis, Allergic, PerennialRhinitis, Allergic, Seasonal+ [17]

Inactive Indication

Acute sinusitisCongestion of nasal mucosaDermatitis, Atopic+ [12]

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

Esocap AGStartupShionogi Pharma Co., Ltd.

Sandoz Pty Ltd.

+ [9]

Inactive Organization

eSolve Capital SA

Novartis Pharmaceuticals Corp.

PH & T SpA

+ [5]

Drug Highest PhaseApproved

First Approval Date

United States (30 Apr 1987),

InflammationPruritus

RegulationOrphan Drug (United States)

Structure/Sequence

Molecular FormulaC27H30Cl2O6

InChIKeyWOFMFGQZHJDGCX-ZULDAHANSA-N

CAS Registry83919-23-7

255

Clinical Trials associated with Mometasone Furoate

NCT06914908

/ Not yet recruitingPhase 2

A Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207).
The study duration will be up to approximately 56 weeks per participant, 52 weeks of treatment period, and 4 weeks of follow-up.

Start Date09 May 2025

Sponsor / Collaborator

Sanofi

NCT06834347

/ RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

EFC18418 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older.
Study details include:
* The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks.
* The treatment duration will be up to 52 weeks.
* The number of visits will be 9 site visits and 20 phone/home visits.

Start Date12 Feb 2025

Sponsor / Collaborator

Sanofi

[+1]

CTR20250190

/ RecruitingNot Applicable

单中心、随机、开放、单次给药的糠酸莫米松乳膏人体生物等效性研究（药代动力学对比研究/初步剂量持续时间-效应研究/关键体内生物等效性研究）

[Translation] A single-center, randomized, open-label, single-dose bioequivalence study of mometasone furoate cream in humans (pharmacokinetic comparison study/preliminary dose-duration-effect study/pivotal in vivo bioequivalence study)

主要目的：1) 通过血药浓度分析，比较糠酸莫米松乳膏受试制剂与参比制剂局部用药后的体内暴露量，评价糠酸莫米松乳膏的系统安全性； 2)通过观测糠酸莫米松使皮肤血管收缩致皮肤变白的作用，探索达到半数最大效应（Emax）的剂量持续时间（ED50）；再在ED50剂量持续时间下评价受试制剂和参比制剂在健康受试者体内的生物等效性。次要目的：观察健康受试者皮肤外用糠酸莫米松乳膏的安全性。

[Translation]

Main objectives: 1) To compare the in vivo exposure of the test and reference furoate creams after topical administration through blood drug concentration analysis, and evaluate the systemic safety of furoate creams; 2) To explore the dose duration (ED50) to achieve the half-maximal effect (Emax) by observing the effect of furoate on skin vasoconstriction and skin whitening; and then evaluate the bioequivalence of the test and reference preparations in healthy subjects at the ED50 dose duration. Secondary objectives: To observe the safety of furoate creams for topical application on the skin of healthy subjects.

Start Date10 Feb 2025

Sponsor / Collaborator

Zhejiang Bio-diamond Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Mometasone Furoate

100 Translational Medicine associated with Mometasone Furoate

100 Patents (Medical) associated with Mometasone Furoate

2,049

Literatures (Medical) associated with Mometasone Furoate

01 Jun 2025·Emerging contaminants

Exposure assessment of 113 exogenous chemicals simultaneously in serum samples from children in north Shandong, China, and their association with sex, age, and body mass index

Author: Wang, Danyang ; Zhi, Mengxue ; Zhang, Fenghong ; Wang, Jianshe

Children are particularly vulnerable to adverse effects from exposure to environmental chems., necessitating comprehensive assessment to mitigate health risks.In this study, we analyzed 477 serum samples from children aged 2-6 years in North Shandong, China, using liquid chromatog.-mass spectrometry (LC-MS) to create an exposure profile of 184 exogenous chems.These chems. encompass pesticides, pharmaceuticals, industrial and consumer chems., and food additives.Of these, 113 exogenous chems. were identified above the limit of detection in the serum of at least one child participant, and 37 were detected in more than 30% of the children.Notably, 17 of the 24 selected perfluoroalkyl and polyfluoroalkyl substances (PFAS) were detected.PFOA, PFBA, and PFHxS exhibited the highest concentrations, with geometric means of 38.11 ng/mL, 17.39 ng/mL, and 7.35 ng/mL, resp.The elevated levels of short-chain PFBA suggests increased production and environmental release in recent years.Anal. of sex-based differences revealed significant differences in the serum levels of 11 chems., with nine compounds displaying higher concentrations in girls than in boys.Notably, long-chain PFAS, including PFUnDA, PFDA, and PFTrDA, were present at higher concentrations in girls, while short-chain PFHpA and PFBS were higher in boys.Addnl., serum levels of di-Ph phosphate and fipronil sulfone declined slightly with age, indicating heightened exposure risk during early childhood.Pos. associations between monoethyl phthalate and fipronil sulfone concentrations with BMI categories were observed, suggesting a potential obesogenic effect of these compoundsThis study provides critical insights into the profiles of exogenous chems. in young children and highlights the need for targeted risk assessment of environmental pollutants impacting pediatric health.

01 May 2025·ANALYTICAL BIOCHEMISTRY

Different manipulations for resolving the overlapped spectra of novel anti-asthmatic combination: Green-blue-white triple evaluation tools

Article

Author: Khalil, Hawa ; Bahgat, Eman A ; Reda, Alaa ; Fawzy, Michael Gamal

This work represents different spectrophotometric techniques for concurrent quantification of Indacaterol (IND) and Mometasone furoate (MOM); co-formulated inhalation capsules to control asthma symptoms. Direct spectrophotometric (D⁰) approach was applied for IND assay. While, absorption factor (AF), ratio difference (RD), mean centering of the ratio spectra (MC), and continuous wavelet transform (CW) techniques were utilized for MOM quantification. The applied methods' validation was accomplished relative to the ICH guidelines. Within the linearity range of (4-20 μg/mL), these approaches provided accurate and precise assessment of IND and MOM in laboratory-synthetic mixtures and pharmaceutical formulation with determination coefficients higher than 0.9997. Moreover, the proposed methods demonstrated good detection and quantification levels. The respective LOD and LOQ for IND were (0.33 μg/mL) and (1.01 μg/mL). While, the LOD and LOQ for MOM were ranging from (0.16-0.30 μg/mL) and (0.47-0.91 μg/mL), respectively. Statistical comparison revealed no significant differences between the findings derived from the proposed methods and the reported one. The applied methods' environmental effect was cheeked using Analytical Greenness Calculator (AGREE), Blue Applicability Grade Index (BAGI), and Red-Green-Blue 12 (RGB12). All the utilized metrics showed reliable scores, approving that the proposed methods were adhered to the sustainability principles.

01 May 2025·INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY

Comparative efficacy of intranasal mometasone furoate monotherapy or combination therapy with montelukast in pediatric adenoid hypertrophy: A systematic review and meta-analysis of randomized clinical trials

Review

Author: Alboqami, Razan Ayed ; Alshammari, Jaber ; Albesher, Meshal Bassam ; Al-Fahd, Abdullah Zaki ; Ateeq, Orjwan Hashem ; Halawani, Mohammed ; Almutairi, Rahaf H ; Fahad Z Alshehri, Rayan

PURPOSE:

Adenoid hypertrophy (AH) is a prevalent pediatric condition associated with nasal obstruction, sleep-disordered breathing, and related comorbidities. This study evaluated comparative efficacies of Mometasone Furoate (MF) monotherapy and MF-Montelukast combination therapy in pediatric AH.

METHODS:

PubMed, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, Web of Science, Google Scholar, and Ovid MEDLINE were searched from their inception to August 22, 2024, and five randomized clinical trials (RCTs) with pediatric patients (age <15 years, n = 416) with clinically diagnosed AH, managed with MF monotherapy or MF-montelukast combination therapy, were identified. Outcomes included changes in x-ray adenoids/nasopharynx ratio, endoscopic adenoid obstruction, total symptom score, and individualized symptoms scores of nasal obstruction, rhinorrhea, mouth breathing, and snoring. Although safety data, including neuropsychiatric adverse effects of montelukast, were of interest, they were not reported in the included studies.

RESULTS:

Compared to MF-monotherapy, MF-montelukast combination therapy significantly improved (mean difference [95 % confidence interval], p-value) adenoids/nasopharynx ratio (-7.01 [-8.96 to -5.07], <0.001), total symptom score (-1.05 [-1.51 to -0.59], <0.001), rhinorrhea (-0.92 [-1.50 to -0.34], 0.002), mouth breathing (-0.67 [-1.27 to -0.08], 0.02), and endoscopic Grade 4 adenoid obstruction (relative risk 0.25 [0.07-0.84], 0.03); no intergroup differences were noted in nasal obstruction (-0.06 [-0.26 to 0.14], 0.56), snoring (-0.56 [-1.19 to 0.08], 0.08), and endoscopic Grade 3 adenoid obstruction (relative risk 0.70 [0.45-1.09], 0.11).

CONCLUSION:

MF-montelukast combination therapy is superior to MF monotherapy in reducing AH symptoms. However, Montelukast has an FDA black box warning due to potential neuropsychiatric side effects, including suicidal thoughts, depression and behavioral changes. None of the included studies systematically assessed these adverse effects highlighting a critical gap in safety evaluation. High-quality RCT-based research is required to evaluate long-term efficacy, safety, dosage, and cost-effectiveness.

News (Medical) associated with Mometasone Furoate

13 Mar 2025

·investors.lyratherapeutics.com

Lyra Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

Company continues to focus on upcoming results from ENLIGHTEN 2 pivotal Phase 3 trial in CRS patients, expected in 2Q 2025 In parallel, the Company continues to analyze data and explore opportunities for LYR-210 in CRS patient cohort with nasal polyps WATERTOWN, Mass., March 13, 2025 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the fourth quarter and full year ended December 31, 2024 and provided a corporate update. “We eagerly await the upcoming readout from the ENLIGHTEN 2 Phase 3 study in Q2 2025 which we expect will provide us with important data and enable us to gain further insight about the potential efficacy of LYR-210 across a broad CRS population, including both patients with and without nasal polyps. The data from this pivotal study will enable us to determine the path for LYR-210 to potentially add value for patients, investors and our business,” said Maria Palasis, Ph.D., President and CEO of Lyra Therapeutics. Dr. Palasis continued, “At the same time, we continue to be encouraged about the positive post-hoc data analyses in the CRS patient cohort with nasal polyps, including the recent results from the 52-week ENLIGHTEN 1 Extension Study in the polyp cohort which are consistent with the previously-reported positive results from the polyp cohort of the ENLIGHTEN 1 main study stage. We are building more evidence in the therapeutic potential of LYR-210 in CRS patients with polyps, and we have also engaged with the FDA to align on details for a registration path in CRS with polyps.” The ENLIGHTEN program consists of two pivotal Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS. Each ENLIGHTEN trial enrolled approximately 180 CRS patients who have failed medical management and have not had prior ethmoid sinus surgery, randomized 2:1 to either LYR-210 (7500µg mometasone furoate) or sham control for 24 weeks. Topline results for patients in the polyp cohort in ENLIGHTEN 1 52-week extension study In early January 2025, in addition to safety data for the entire patient pool, post-hoc results were disclosed for patients in the polyp cohort of the ENLIGHTEN 1 52-week extension study: Polyp patients from the initial sham treatment group who crossed over to receive LYR-210 treatment exhibited a mean improvement in both symptoms and polyp size at 52 weeks. Polyp patients from the initial LYR-210 treatment group who crossed over to receive sham treatment demonstrated a durable response to LYR-210 treatment out to one year. These new data from the polyp cohort in ENLIGHTEN 1 Extension Study are consistent with the previously-reported positive data from the polyp cohort in ENLIGHTEN 1 which showed: Improvement in patient symptoms for LYR-210 treated patients relative to the sham control group was observed. Nasal Congestion Scores improved in polyp patients with at least moderate nasal congestion at baseline. Polyp size was reduced despite inclusion of patients with only small polyps. LYR-210 regulatory highlights In December 2024, Lyra received written responses from the U.S. Food and Drug Administration (FDA) to topics outlined in a briefing document supporting a Type C meeting to discuss the development of LYR-210 for patients who have chronic rhinosinusitis with nasal polyps (CRSwNP). Overall, the responses helped to clarify the potential path forward for LYR-210 for patients with CRSwNP, and signaled, importantly, the safety dataset of the proposed pivotal study should be sufficient, along with data from the ENLIGHTEN program and the LANTERN Phase 2 study, subject to no further safety concerns being observed in current studies with LYR-210. Based on this exchange with FDA, there is alignment on various elements of a potential Phase 3 pivotal study, e.g., choice of co-primary endpoints, sample size, inclusion criteria, and in-study assessments. Milestones for ongoing ENLIGHTEN pivotal program of LYR-210 in CRS Topline results from the ENLIGHTEN 2 pivotal Phase 3 clinical trial of LYR-210 are expected in Q2 2025. We expect an additional ~30 polyp patients in the ENLIGHTEN 2 trial, which combined with the 35 polyp patients in the ENLIGHTEN 1 trial, would result in a total of ~65 polyp patients in the ENLIGHTEN program. Planned Reverse Stock Split Lyra intends to implement a reverse stock split in order to increase the per share trading price of the Company’s common shares for the purpose of complying with the minimum $1.00 bid price requirement for continued listing on The Nasdaq Capital Market. The reverse stock split requires approval by the Company’s board of directors as well as the Company’s stockholders at the annual stockholder meeting to be scheduled in Q2 2025, at which time the Company will be in a position to share the details of the proposed reverse stock split. Fourth Quarter and Full Year 2024 Financial Highlights Cash and cash equivalents as of December 31, 2024 were $40.6 million, compared with cash, cash equivalents and short-term investments of $51.6 million at September 30, 2024. Based on our current business plan, we anticipate that our cash, cash equivalents and any applicable short-term investment balance is sufficient to fund our operating expenses and capital expenditures into the first quarter of 2026. Research and development expenses for the fourth quarter and full year ended December 31, 2024 were $6.4 million and $43.8 million, respectively, compared to $12.2 million and $48.0 million for the same periods in 2023. The decrease in research and development expenses year over year was primarily attributable to a decrease in clinical related costs of $5.5 million as we completed both the BEACON trial for LYR-220 and the ENLIGHTEN 1 trial for LYR-210, a decrease of $3.5 million in employee related costs primarily driven by the reduction in force which occurred in May 2024 and a decrease in product development and manufacturing costs of $1.0 million. This decrease in costs was partially offset by increases in allocated and support costs and depreciation of $4.7 million, an increase in professional and consulting costs of $0.4 million and a $0.6 million gain recorded in 2023 related to our legal settlement with a former contract manufacturer. General and administrative expenses for the fourth quarter and full year ended December 31, 2024 were $3.6 million and $18.5 million, respectively, compared to $4.4 million and $19.1 million for the same periods in 2023. The decrease in general and administrative expenses year over year was primarily driven by a decrease in professional, consulting and public company fees of $0.7 million as we scaled back activities subsequent to announcing in May 2024 that the ENLIGHTEN 1 trial did not meet its primary endpoint, in addition to a decrease in employee related costs of $0.8 million primarily due to the reduction in force which occurred in May 2024 and $0.4 million incurred in 2023 related to our financing efforts. This decrease in costs was partially offset by a net increase in allocation, support, depreciation and financing costs of $1.3 million primarily due to the increased rent and facilities expenses for the Company’s three leased facilities for the full year 2024 compared to the full year 2023. Net loss for the fourth quarter and full year ended December 31, 2024 was $11.0 million and $93.4 million, respectively, compared to $15.1 million and $62.7 million for the same periods in 2023. About LYR-210 LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) in patients who have failed current therapies and require further intervention. LYR-210 is a bioresorbable nasal implant designed to be inserted in a simple, in-office procedure. LYR-210 is intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat CRS. LYR-210 is being evaluated in the ENLIGHTEN pivotal Phase 3 clinical program. About Lyra Therapeutics Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS). Lyra Therapeutics is developing therapies for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210, the company’s lead product, is a bioabsorbable nasal implant designed to be administered in a simple, in-office procedure and is intended to deliver six months of continuous anti-inflammatory drug therapy (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS with a single administration. LYR-210, being evaluated in the ENLIGHTEN Phase 3 clinical program, is intended for patients with and without nasal polyps. The company’s therapies are intended to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratx.com and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the Company’s cash runway into the first quarter of 2026, whether LYR-210 could potentially benefit patients with CRS, the completion of the Company’s ENLIGHTEN 2 Phase 3 clinical trial, the timing of the release of topline data from the ENLIGHTEN 2 Phase 3 clinical trial, whether the ENLIGHTEN results will include important data or enable the Company to gain further insight about the efficacy of LYR-210, and the Company’s intentions concerning the implementation of a reverse stock split to comply with the minimum bid price rule to maintain its listing on the Nasdaq Capital Market. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s failure to meet its primary endpoint in its ENLIGHTEN 1 Phase 3 clinical trial; the fact the Company terminated the employment of approximately 87 employees following the announcement that it failed to attain its primary endpoint; the fact that the Company has incurred significant losses since inception and expects to incur additional losses for the foreseeable future; the Company's need for additional funding, which may not be available; the fact that the Company needs to conduct at least one additional phase 3 clinical trial; the Company’s ability to continue as a going concern; the Company’s limited operating history; the fact that the Company has no approved products; the fact that clinical trial data is subject to change until the completion of the applicable clinical study report; the fact that clinical trials required for the Company’s product candidates are expensive and time-consuming, and their outcome is uncertain; effects of recently enacted and future legislation; the possibility of system failures or security breaches; effects of significant competition; the Company's reliance on third parties to conduct its preclinical studies and clinical trials; failure to obtain and maintain or adequately protect the Company's intellectual property rights; failure to retain key personnel; the fact that the price of the Company's common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company and any securities class action litigation. These and other important factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 13, 2025 and its other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. Contact Information: Jason Cavalier, Chief Financial Officer 917.584.7668 jcavalier@lyratx.com Media Contact: Kathryn Morris, The Yates Network LLC 914.204.6412 kathryn@theyatesnetwork.com

Clinical ResultPhase 3Phase 2Financial Statement

04 Mar 2025

·www.fiercepharma.com

Glenmark issues another recall, this time for nearly 1.5M bottles of generic ADHD drug

Glenmark Pharma is recalling nearly 1.5 million bottles of the attention-deficit/hyperactivity disorder drug atomoxetin. Glenmark Pharma, an India-based drug manufacturer that has been the focal point of a spate of recalls in recent years, has issued another. This time, the product pull covers about 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine.Eli Lilly previously sold the branded version of the drug, Strattera, but discontinued all strengths in 2023 after the arrival of generics.Unlike stimulant-based drugs that make up the bulk of ADHD treatment, including those like Vyvanse and Adderall, atomoxetine is a selective norepinephrine reuptake inhibitor (sNRI).The recall was triggered by the presence of unacceptable levels of N-nitroso atomoxetine, a possible carcinogen, in multiple Glenmark atomoxetine batches, according to the FDA. The voluntary pull, which began Jan. 29, covers bottles of the drug in strengths ranging from 10 mg to 100 mg, the FDA said on its Enforcement Report webpage. The ADHD drugs were manufactured in Glenmark’s facility in Goa, India, and were distributed nationwide. Glenmark has weathered a string of recalls in recent years due to both manufacturing and labelling issues.In June 2024, the company recalled 114 batches of 750 mg potassium chloride extended-release capsules—or roughly 47 million capsules—over concerns that they failed to dissolve properly.In December, the company recalled 90,528 bottles of the high blood pressure drug diltiazem hydrochloride in tablet and extended-release forms due to unacceptable levels of another N-nitroso compound, N-nitroso-Desmethyl-Diltiazem.In separate actions in 2023, Glemark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets used to treat high blood pressure; 37,200 bottles of Indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms; and five lots (no bottle count provided) of Naproxen that is used to reduce fever or relieve mild pain.The previous year it recalled 98,307 packs of mometasone furoate topical solution, a corticosteroid lotion that treats skin conditions such as eczema, psoriasis, allergies and rash.

Clinical Result

17 Dec 2024

·www.globenewswire.com

EsoCap announces publication of comprehensive Phase II results demonstrating ESO-101’s effectiveness in eosinophilic esophagitis

Detailed results of the ACESO Phase II study published in the peer-reviewed medical journal Alimentary Pharmacology & TherapeuticsESO-101 leverages EsoCap’s unique drug delivery technology to achieve localized treatment of the esophageal lining with the anti-inflammatory corticosteroid mometasone furoate BASEL, Switzerland, Dec. 17, 2024 (GLOBE NEWSWIRE) -- EsoCap AG, the Swiss biotech company dedicated to improving the lives of patients with serious diseases of the upper gastrointestinal tract, announced today that the complete results of the ACESO Phase II study evaluating ESO-101 for the treatment of eosinophilic esophagitis have been published in Alimentary Pharmacology & Therapeutics1. The data demonstrate that ESO-101 was safe and well tolerated and improved both histologic and endoscopic outcomes in adults with active eosinophilic esophagitis (EoE). EoE is a chronic, local, immune-mediated esophageal disease characterized clinically by symptoms associated with esophageal dysfunction, including dysphagia (i.e., swallowing difficulties), food impaction, heartburn and vomiting, and histologically by eosinophil-dominated inflammation. The ACESO study was a randomized, placebo-controlled, double-blind Phase II study to evaluate the safety, tolerability, and efficacy of ESO-101 in adult patients with active EoE. ESO-101, EsoCap's lead product candidate, consists of a capsule with a rolled-up, thin mucoadhesive film with the anti-inflammatory corticosteroid mometasone furoate. The study was conducted at 14 medical centers in five European countries and enrolled 43 participants with EoE and a peak eosinophil count of ≥15 eosinophils per high-power field (hpf). Patients were randomized in a 2:1 ratio and treated with ESO-101 or placebo once daily for 28 days. The ACESO trial met its primary endpoint with a statistically significant reduction of the peak eosinophil count from baseline in histology samples. In the ESO-101 group, the mean reduction was 49.1 ± 88.4 eosinophils/hpf (p=0.0318). In addition, while none of the patients from the placebo group achieved histological remission, 48% and 44% of patients achieved <15 and <6 eosinophils/hpf, respectively, when treated with ESO-101 (p=0.0028 and p=0.0035, respectively). Patients treated with ESO-101 had a significant response in the eosinophilic esophagitis endoscopic reference score (EREFS) scores, indicating promising potential for remodeling effects despite the short treatment duration. A significant improvement of dysphagia symptoms was observed after a 4-week period with a high placebo response: a benefit of ESO-101 in relieving EoE dysphagia and odynophagia symptoms is expected to be seen in future clinical trials with a longer treatment period. Importantly, ESO-101 also demonstrated a highly favorable safety and tolerability profile with a notable absence of oral and oropharyngeal as well as esophageal candidiasis, which is commonly observed with topical corticosteroid treatment. Compliance was high, with 100% in the ESO-101 and 93% in the placebo groups. The high level of patient satisfaction with the handling of the study medication underlines the user-friendliness of the ESO-101 drug-delivery system. “The detailed results of the ACESO trial provide robust evidence for the efficacy and safety of ESO-101, a novel drug delivery device for the long-lasting, targeted delivery of the anti-inflammatory corticosteroid mometasone furoate directly to the esophageal mucosa,” said Dr. Alfredo J. Lucendo, Department of Gastroenterology, Hospital General de Tomelloso, Spain, and coordinating principal investigator of the ACESO trial. “The trial’s rigorous design demonstrated significant improvements in inflammatory, histological, and endoscopic parameters compared to placebo, which underscores the potential of this treatment approach. For patients with eosinophilic esophagitis, this approach offers the potential for more effective disease management in a field where treatment options are scarce.” “At EsoCap, we are committed to transforming the lives of patients affected by esophageal diseases. The positive outcome of the ACESO Phase II study with ESO-101 and the publication in a peer-reviewed journal are an important validation of our targeted, topical delivery platform, which has been designed to increase mucosal contact time and drug deposition in the esophagus,” said Isabelle Racamier, CEO of EsoCap. “This marks an important milestone for EsoCap in advancing treatment options for eosinophilic esophagitis.” About eosinophilic esophagitis Eosinophilic esophagitis (EoE) is an increasingly recognized, chronic, local immune-mediated esophageal disease, characterized clinically by symptoms related to esophageal dysfunction and histologically by eosinophil-predominant inflammation. The symptoms of EoE include swallowing disorders, food impaction, vomiting, and heartburn. EoE is the leading cause of dysphagia and food impaction in children and young adults. The only treatment options for the condition are extremely strict diets, off-label treatment with steroids or proton pump inhibitors, an orodispersible budesonide tablet available only in limited territories, or an oral suspension of budesonide approved exclusively in the USA for a short treatment duration. These treatment options remain suboptimal for the vast majority of affected patients. A monoclonal antibody targeting Th2 cell-released cytokines such as interleukin-4 (IL-4) and interleukin-13 (IL-13) was approved to treat EoE globally for steroid resistant patients. Currently, about 500,000 patients worldwide suffer from this disease. The prevalence of EoE is over 6 in 10,000. The current incidence is estimated to exceed 5 cases per 100,000. The incidence of EoE increases with age and peaks at 30-50 years of age. About the ACESO Phase II trial The ACESO trial was a multicenter, randomized, double-blinded, placebo-controlled clinical Phase II trial evaluating the efficacy, tolerability, and safety of ESO-101 in adult patients with active EoE. Patients were treated once daily for 28 days. The trial’s primary objective was to evaluate efficacy based on histological response. Secondary objectives included efficacy based on 1) histological response and clinical symptoms, 2) clinical response assessed by patient-reported outcomes, and 3) endoscopic response; patient-reported treatment satisfaction; as well as evaluation of tolerability and safety. About ESO-101 The EsoCap system is a unique drug delivery system for the upper gastrointestinal tract, consisting of a capsule holder containing a hard gelatin capsule, with a rolled, thin mucoadhesive film, a sinker, and a soluble retainer. The capsule holder is screwed onto the lid of a drinking cup to facilitate swallowing while drinking from the cup. Upon swallowing, the film unrolls and sticks to the esophageal mucosa, where it dissolves, with a contact time of 15 minutes2,3, significantly longer than the mucosal contact time of pharmaceutical dosage forms, such as orodispersible tablets (less than one minute)4. The use of mometasone furoate as a swallowed aerosol formulation has been studied previously in several trials assessing its effect on EoE in adults. In these trials, mometasone furoate was shown to significantly decrease esophageal eosinophilic inflammation and improve clinical symptoms. ESO-101 was designed as a locoregional, esophagus-adjusted drug formulation and novel delivery system to optimize mucosal contact time and maximize esophageal deposition of mometasone furoate. ESO-101 has the potential to provide significant clinical benefits to EoE patients. About EsoCap EsoCap AG is a privately funded company based in Basel, Switzerland. EsoCap’s vision is to improve the lives of patients with serious diseases of the upper gastrointestinal tract through development of a unique and innovative topical drug delivery platform. Effective topical treatment of the esophagus is extremely difficult to achieve with the current standard of care, due to the ultra-short drug contact time of 45 seconds from the mouth to the stomach. Lead candidate ESO-101 has received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for the treatment of EoE and is in clinical development for this indication. EsoCap has developed a unique, proprietary drug delivery platform enabling the efficient topical application of drug substances for the local treatment of diseases of the upper gastrointestinal tract. EsoCap has a strong and broad intellectual property position. For more information, please visit www.esocapbiotech.com and follow EsoCap on LinkedIn. Contacts: Isabelle Racamier, CEO EsoCap AG Malzgasse 9 4052 Basel, Switzerland isabelle.racamier@esocapbiotech.com Media Inquiries:MC Services AGDr. Regina Lutz, Dr. Johanna KoblerPhone: +49 89 210288-0esocap@mc-services.eu ____________________________ 1 Lucendo AJ, el al. Clinical trial: Safety and efficacy of a novel oesophageal delivery system for topical corticosteroids versus placebo in the treatment of eosinophilic oesophagitis. Aliment Pharmacol Ther 2025; https://doi-org.libproxy1.nus.edu.sg/10.1111/apt.18443 2 C Rosenbaum et al, 2021. Functionality and Acceptance of the EsoCap System—A Novel Film-Based Drug Delivery Technology: Results of an In Vivo Study. Pharmaceutics, 13 (6): 828.3 Krause et al., 2020. The EsoCap-system – An innovative platform to drug targeting in the esophagus. Journal of controlled release, 327:1–7.4 Burton et al., 1995. Intragastric Distribution of Ion-exchange Resins: a Drug Delivery System for the Topical Treatment of the Gastric Mucosa. J. of Pharmacy and Pharmacology, 47: 901-906.

Clinical ResultPhase 2Orphan Drug

100 Deals associated with Mometasone Furoate

External Link

KEGG	Wiki	ATC	Drug Bank
D00690	Mometasone Furoate	R01AD09 R03BA07 D07XC03	DB14512

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic rhinosinusitis with nasal polyps	United States	Intersect ENT, Inc.	08 Dec 2017
Asthma	United States	Organon & Co.	30 Mar 2005
Nasal Polyps	United States	Organon & Co.	15 Dec 2004
Rhinitis, Allergic	China	Schering-Plough Corp.	14 Jul 2000
Dermatitis	China	Merck & Co., Inc.	01 Jan 1999
Rhinitis, Allergic, Perennial	United States	Organon & Co.	01 Oct 1997
Rhinitis, Allergic, Seasonal	United States	Organon & Co.	01 Oct 1997
Alopecia Areata	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Drug Eruptions	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Eczema	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Erythema exudativum	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Erythrodermic psoriasis	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Impetigo	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Keloid	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Lupus Erythematosus, Discoid	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Pemphigoid, Bullous	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Pityriasis	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Prurigo	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Psoriasis	Japan	Shionogi Pharma Co., Ltd.	01 Oct 1993
Inflammation	United States	Organon & Co.	30 Apr 1987

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic sinusitis	Phase 3	United States	Lyra Therapeutics, Inc.	24 Jan 2022
Rhinitis perennial	Phase 3	China	Sichuan Otsuka Pharmaceutical Co. Ltd.	10 Apr 2019
Nasal Obstruction	Phase 3	Argentina	PH & T SpA	01 Oct 2012
Sneezing	Phase 3	Argentina	PH & T SpA	01 Oct 2012
Seasonal rhinitis	Phase 3	-	Organon & Co.	01 Aug 2008
Congestion of nasal mucosa	Phase 3	-	Organon & Co.	01 Jul 2008
Intermittent asthma	Phase 3	-	Organon & Co.	01 May 2008
Hypertrophy of adenoids	Phase 3	-	Organon & Co.	01 Aug 2007
Pulmonary Disease, Chronic Obstructive	Phase 3	-	Organon & Co.	01 Oct 2006
Pulmonary Disease, Chronic Obstructive	Phase 3	-	Novartis AG	01 Oct 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04849390 (ACESO, UEGW2024)	Phase 2	Eosinophilic Esophagitis	59	ESO-101 800 µg	pqoyktgdth(gycmkhvqzu) = iekopejbnx segdzmzrcs (xpplxmwcqj, 88.42) View more	Positive	13 Oct 2024
				Placebo	pqoyktgdth(gycmkhvqzu) = kosuowbzop segdzmzrcs (xpplxmwcqj, 65.11) View more
NCT03979209 (CTgov)	Phase 1	Chronic sinusitis	16	Nasal Mometasone Rinse (Mometasone 1mg)	tnkqnjbgza(txrmwduoii) = vfralkclyd fpbrsoyuyz (uznajvushy, rwgfvynamb - iuttlitusf) View more	-	12 Aug 2024
				Nasal Mometasone Rinse (Mometasone 2mg)	tnkqnjbgza(txrmwduoii) = hgcuxupdfi fpbrsoyuyz (uznajvushy, mbvatkfgjb - tmdrvzwuxj) View more
ENDO2024	Not Applicable	Adrenal Insufficiency \| Failure to Thrive	-	Dulera (mometasone furoate and formoterol fumarate)	zwmqlwojkr(eakutwxatr) = oufstookzy gfdukjgjdh (zaaryvzfua )	-	01 Jun 2024
NCT04849390 ( ACESO , Biospace) Manual	Phase 2	Eosinophilic Esophagitis	43	ESO-101	cgcbyntasl(jqxaxsmqzz) = met with a statistically significant reduction of the peak eosinophil count (p=0.0318) compared to placebo. bonxxbuwmx (swxykywbxw )	Positive	05 Dec 2023
				placebo
WSC2023	Not Applicable	Sleep Apnea, Obstructive	56	Acupuncture+Montelukast Sodium+Mometasone Furoate Nasal Spray	ygmkschvsm(rqzrylhmjr) = wuvzycoige fsgnvnnbtx (njfefsctix )	Positive	23 Oct 2023
				Montelukast Sodium+Mometasone Furoate Nasal Spray	ygmkschvsm(rqzrylhmjr) = hirdboreqc fsgnvnnbtx (njfefsctix )
NCT04041609 (CTgov)	Phase 2	Chronic sinusitis	71	LYR-210 (LYR-210 (Low Dose))	cvzpghlevo(wqnzgizkrf) = gpveibnuhp iqadktryvr (nyyqifjisi, 0.637) View more	-	06 Jun 2023
				LYR-210 (LYR-210 (High Dose))	cvzpghlevo(wqnzgizkrf) = zhoofgswvd iqadktryvr (nyyqifjisi, 0.651) View more
AAAAI2021	Not Applicable	-	37	Indacaterol/Mometasone Furoate low-dose	scleudttux(qwgkxmasjt) = kwlyrkonyd vplsrzlbmd (dunxxcuuuc ) View more	-	01 Feb 2021
				Indacaterol/Mometasone Furoate medium-dose	scleudttux(qwgkxmasjt) = nelxqxscig vplsrzlbmd (dunxxcuuuc ) View more
NCT03705793 (CTgov)	Phase 4	Rhinitis, Allergic \| Chronic sinusitis	53	Mometasone Furoate Nasal Irrigation (Mometasone Furoate Nasal Irrigation)	klvypmfuuk(bjhewqrauu) = fxilusnmhd bhwaumfqea (spglibohqy, jlwrrqfnwi - iayhivnwai) View more	-	19 Dec 2020
				Mometasone Nasal Spray (Mometasone Nasal Spray)	klvypmfuuk(bjhewqrauu) = uwsmihhpdc bhwaumfqea (spglibohqy, iqsedlodca - dugzrfyico) View more
NCT01850823 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	880	Mometasone Nasal Spray (NASONEX® Nasal Spray (Schering Corporation))	teddqoqfeo(gbqhigcsbb) = atuexbwzxg fxpynjocsz (pdyjoglvdg, 2.186) View more	-	19 Aug 2020
				Mometasone nasal spray (Mometasone Nasal Spray (Watson Laboratories, Inc))	teddqoqfeo(gbqhigcsbb) = yjqjqvywil fxpynjocsz (pdyjoglvdg, 2.223) View more
Pubmed \| Pulm Pharmacol Ther	Not Applicable	Asthma	739	Mometasone furoate 80 μg (Breezhaler®)	kapzibxygz(iptbelfsdg) = psilpafxqh otgndmjjju (imkwdxtgsz, -34 to 89)	-	01 Jun 2020

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