A 12-Week Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 Mcg of OPN-375 Twice a Day (BID) in Adolescent Subjects with Chronic Rhinosinusitis Without Nasal Polyps

This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with chronic rhinosinusitis without nasal polyps. The total planned number of subjects is approximately 84 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 1:1 ratio (OPN-375 186 µg:placebo). The study includes a PK sub-study, in which up 14 subjects will be enrolled to obtain 10 completers.

Start Date18 Apr 2025

Sponsor / Collaborator

OptiNose, Inc.

ChiCTR2500097445

/ SuspendedNot ApplicableIIT

Preliminary study on single dose, fasting, randomized, open label, three dose, three cycle, crossover bioequivalence of fluticasone propionate nebulized inhalation suspension in healthy subjects

Start Date20 Feb 2025

Sponsor / Collaborator-

CTR20244720

/ RecruitingNot Applicable

丙酸氟替卡松乳膏生物等效性研究与人体药代动力学对比研究

[Translation] Comparative study on bioequivalence of fluticasone propionate cream and pharmacokinetics in humans

(1)通过初步剂量持续时间-效应的探索研究测定以GlaxoSmithKline（Ireland）Limited持证的丙酸氟替卡松乳膏（规格：0.05%(15 g:7.5 mg)）为参比制剂在中国健康受试者中的剂量持续时间-效应关系，确定后续体内生物等效性试验中的剂量持续时间（ED50）和预期满足AUEC值的D2/D1最小比值的受试者比例；（2）结合初步剂量持续时间-效应探索研究结果，以浙江寰领医药科技有限公司提供的丙酸氟替卡松乳膏（规格：0.05%(15 g:7.5 mg)）为受试制剂，以GlaxoSmithKline（Ireland）Limited持证的丙酸氟替卡松乳膏（规格：0.05%(15 g:7.5 mg)）为参比制剂进行人体生物等效性试验，通过比较两制剂的药效学参数，评价两制剂的生物等效性；（3）研究局部给药后受试制剂与参比制剂的体内暴露量比，从而评价受试制剂在中国健康受试者中的安全性。

[Translation]

(1) A preliminary dose-duration-effect exploratory study was conducted to determine the dose-duration-effect relationship of the reference preparation, fluticasone propionate cream (specification: 0.05% (15 g: 7.5 mg)) licensed by GlaxoSmithKline (Ireland) Limited, in healthy Chinese subjects, and to determine the dose-duration (ED50) and the proportion of subjects expected to meet the minimum D2/D1 ratio of the AUEC value in the subsequent in vivo bioequivalence study; (2) Based on the results of the preliminary dose-duration-effect exploratory study, the fluticasone propionate cream (specification: 0.05% (15 g: 7.5 mg)) provided by Zhejiang Huanling Pharmaceutical Technology Co., Ltd. was used as the test preparation, and the fluticasone propionate cream (specification: 0.05% (15 g: 7.5 mg) licensed by GlaxoSmithKline (Ireland) Limited) was used as the reference preparation. (1) The bioequivalence study was conducted on the test preparation using the reference preparation (mg/ml) as the reference preparation, and the bioequivalence of the two preparations was evaluated by comparing the pharmacodynamic parameters of the two preparations; (2) The in vivo exposure ratio of the test preparation to the reference preparation after local administration was studied, so as to evaluate the safety of the test preparation in healthy Chinese subjects.

Start Date09 Jan 2025

Sponsor / Collaborator

Zhejiang Huanling Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Fluticasone Propionate

100 Translational Medicine associated with Fluticasone Propionate

100 Patents (Medical) associated with Fluticasone Propionate

5,652

Literatures (Medical) associated with Fluticasone Propionate

01 Dec 2025·CURRENT ALLERGY AND ASTHMA REPORTS

Olfactory Dysfunction in Chronic Rhinosinusitis with Nasal Polyps: Effect of Treatment with Emphasis on Biological Therapy

Review

Author: Reitsma, Sietze ; Fokkens, Wytske Johanna ; Otten, Josje Janna

PURPOSE OF REVIEW:

Olfactory dysfunction significantly impacts quality of life that affects a majority of the patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The aim of this review is to explore the impact of various treatment regimens on olfactory dysfunction in patients diagnosed with CRSwNP.

RECENT FINDINGS:

Accurate assessment of olfactory dysfunction remains challenging and should incorporate both psychophysical tests and patient-reported outcomes. Patients with CRSwNP appear capable of reliably evaluating their olfactory function. Standard treatment such as intranasal corticosteroids and surgery have limited capability of restoring the sense of smell. Oral corticosteroids have a far greater potency, albeit short-lived and at the cost of adverse events and side effects. Recent studies on registered biological agents- specifically dupilumab, mepolizumab, and omalizumab- indicate their effectiveness in restoring olfactory function in severe CRSwNP. According to meta-analyses and indirect comparisons, dupilumab shows superiority; however, direct comparative studies are necessary.

01 Apr 2025·Journal of Breath Research

Xylometazoline-induced change in aspirated nasal nitric oxide detects obstructed paranasal ostia

Article

Author: Rautiainen, Markus ; Järnstedt, Jorma ; Lehtimäki, Lauri ; Numminen, Jura ; Kivekäs, Ilkka ; Tamminen, Pekka

Abstract:

The concentrations of nasal nitric oxide (nNO) vary in patients with chronic rhinosinusitis (CRS) supposedly depending upon whether the paranasal ostia are open or obstructed. Our aim was to assess whether nNO levels and their response to topical xylometazoline (a local vasoconstrictor used to alleviate nasal congestion) in patients with CRS differ between those with open or obstructed ostia and if the results were altered by the use of nasal corticosteroids. Sixty-six patients with CRS (43% with nasal polyps) or recurrent acute rhinosinusitis and 23 healthy controls were included. Nasal NO was measured (EcoMedics CLD 88p analyser) before and after two xylometazoline sprays during three consecutive visits: with the medication they were using when they were referred, after 4 weeks of medication pause, and after 4 weeks of using intranasal fluticasone propionate. The relative difference between the nNO before and after dosing of xylometazoline was calculated, and ostial obstruction was evaluated with cone-beam computed tomography at every visit. The nNO measurements were lowest in the patients with CRS and obstructed paranasal ostia. The presence or absence of nasal polyps did not affect the results. Xylometazoline did not significantly affect nNO in the subjects with obstructed ostia, but there was a significant reduction of nNO in those with open ostia. The Xylometazoline-induced change in nNO between the groups with open or obstructed ostia was significantly different at each visit: ‘on previous medication’ 10% (−5–25) versus −14% (−19 to −9), p = 0.004, ‘after medication pause’ 6% (−5–17) versus −16% (−23 to −9), p = 0.001 and ‘after regular fluticasone spray’ 6% (−3–15) versus −9% (−16 to −3), p = 0.04. The native nNO and xylometazoline-induced change in nNO can be used to detect the status of ostial obstruction in patients with CRS irrespective of their topical corticosteroid usage.

01 Mar 2025·Pulmonary Therapy

A Retrospective Study Evaluating Asthma Control in Patients on Fluticasone Propionate/Salmeterol Proactive Regular Dosing with a History of Uncontrolled Asthma

Article

Author: Gandhi, Alap ; Lai, Siew Li ; Alaga, Arvindran ; Ismail, Ahmad Izuanuddin ; Ban, Andrea Yu-Lin ; Lem, Li Khen ; Omar, Azza ; Mz Zahrah, Fatimah ; Abu Bakar, Zamzurina ; MZ Zahrah, Fatimah ; Wong, Chee Kuan ; Hyder Ali, Irfhan Ali ; Samsudin, Azlina

INTRODUCTION:

The MERIT study in Malaysia is a real-world retrospective, observational, multicenter study that evaluated asthma control in patients with uncontrolled asthma who were switched from as-needed (pro re nata [PRN]) budesonide/formoterol or inhaled corticosteroid (ICS) whenever a short-acting beta-agonist (SABA) was taken, to proactive regular dosing of fluticasone propionate/salmeterol (FP/SAL PRD).

METHODS:

Data from the medical records of patients who were stepped up to FP/SAL PRD were extracted retrospectively at baseline and follow-up (between 3 and 6 months after stepping up to FP/SAL PRD). The primary endpoint was the percentage of patients with improvement in asthma control assessed via the Asthma Control Test (ACT). Secondary endpoints included safety and the percentage of patients with moderate and severe exacerbations. Additionally, patient-reported use of reliever medication, systemic corticosteroids, emergency department visits, or hospitalization was also analyzed.

RESULTS:

One hundred twenty patients with uncontrolled asthma who were stepped up to FP/SAL PRD were enrolled in the study. Of these, 76 (63.3%) patients were on prior budesonide/formoterol PRN, and 44 (36.7%) were on prior ICS with SABA PRN treatment. After stepping up to FP/SAL PRD with a mean follow-up of 5.8 months, 110 (91.7%) patients achieved asthma control at the follow-up visit (p < 0.001). Similar improvements were observed regardless of prior PRN regimen. A statistically significant improvement was observed in the mean ACT score at the follow-up visit (p < 0.0001). The proportion of patients with moderate and severe exacerbations was also reduced after stepping up to FP/SAL PRD, with no adverse events reported. Over 80% of patients reported a decrease in the use of systemic corticosteroids, visits to the emergency department, or hospitalization.

CONCLUSION:

This study highlights the effectiveness of the FP/SAL PRD treatment approach in patients with uncontrolled asthma on a PRN treatment regimen.

201

News (Medical) associated with Fluticasone Propionate

20 Mar 2025

·www.prnewswire.com

Eupraxia Pharmaceuticals Reports Fourth Quarter 2024 Financial Results

VICTORIA, BC, March 20, 2025 /PRNewswire/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary DiffuSphere™ technology designed to optimize drug delivery for applications with significant unmet need, today announced its financial results for the fourth quarter of 2024. All dollar values are in U.S. dollars unless stated otherwise. "During the fourth quarter of 2024, and again in the current quarter of 2025, we delivered compelling data from our Phase 1b/2a RESOLVE trial for EP-104GI as a potential treatment for eosinophilic esophagitis," said Dr. James Helliwell, Chief Executive Officer of Eupraxia. "The results from the first six cohorts of the trial show that precise, localized delivery of EP-104GI at higher doses is leading to further improvements in tissue health and symptom reduction outcomes. In addition, during the fourth quarter, we raised C$44.5 million, significantly strengthening our balance sheet and ensuring the Company is well-funded into the second half of 2026." Recent Operational and Financial Highlights On October 2, 2024, the Company announced the appointment of Dr. Amanda Malone as the Chief Operating and Scientific Officer of the Company. On October 10, 2024, the Company announced a poster presentation at the United European Gastroenterology Week 2024 featuring data from cohorts one through four of Eupraxia's ongoing RESOLVE trial in EoE. On October 15, 2024, the Company announced that Phase 2b data from its SPRINGBOARD trial evaluating EP-104IAR for the treatment of knee osteoarthritis was published in leading peer reviewed medical journal The Lancet Rheumatology. On October 28, 2024, the Company announced two poster presentations at the American College of Gastroenterology 2024 Annual Scientific Meeting centered on EP-104GI for the treatment of EoE. One poster received a Presidential Award from the conference, which is a distinction for high quality, novel, unique, and interesting research, while the other was designated an "Abstract of Interest". On October 31, 2024, the Company announced the closing of a non-brokered private placement for gross proceeds of C$44.5 million, the appointment of Mr. Joseph Freedman to its Board of Directors, and the termination of its C$12 million convertible debt facility. On November 12, 2024, the Company announced positive 12-week data from the fifth cohort of the ongoing RESOLVE trial in patients with eosinophilic esophagitis ("EoE"), noting increasingly positive data on efficacy and safety outcomes as well as emerging evidence of improved patient responses related to higher dosing levels. On November 14, 2024, the Company announced a poster presentation at the American College of Rheumatology Convergence 2024 Annual Meeting covering data from Eupraxia's Phase 2b SPRINGBOARD trial evaluating EP-104IAR for the treatment of knee osteoarthritis. Subsequent to quarter end, on February 18, 2025, the Company announced the return of seasoned capital markets executive Alex Rothwell to the role of Chief Financial Officer, succeeding the retiring Bruce Cousins. Subsequent to quarter end, on February 25, 2025, the Company announced positive 12-week data from the sixth cohort of the ongoing RESOLVE trial in patients with EoE noting no adverse events and continued positive data on efficacy and safety outcomes as well as further evidence of improved patient responses tied to higher dosing levels. Fourth Quarter 2024 Financial Review The Company incurred a net loss of $7.5 million for the three months ended December 31, 2024, versus a net loss of $10.6 million for the three months ended December 31, 2023. The decrease in net loss was primarily due to lower research and development costs and reduced other expenses incurred during the period. The Company had cash of $33.1 million as of December 31, 2024, up from $19.3 million at the end of the fourth quarter of 2023. These funds are being used to fund clinical trials in EP-104 and the remainder of the proceeds will be used for general and administrative expenses, working capital needs and other general corporate purposes. The Company anticipates that existing cash reserves, and anticipated proceeds from in-the-money warrants, will be sufficient to fund the Company to the third quarter of 2026. As of December 31, 2024, the Company had 35,641,603 common shares issued and 8,905,638 preferred shares outstanding. Potential Impact of Tariffs Management continues to monitor the North American trade situation stemming from the February 2025 announcement by the U.S. government of proposed 25% tariffs on selected imported Canadian goods, and the subsequent Canadian announcement of planned retaliatory tariffs on selected imported U.S. goods. Eupraxia sources its active pharmaceutical ingredient ("API") (fluticasone propionate) from the United States and clinical supplies of EP-104 IAR and EP-104GI are manufactured in the U.S. by a third-party. The Company expects to continue to access both API and manufactured products from the U.S. The Company maintains U.S. dollar balances to pay U.S. dollar expenses and to minimize the impact of short-term fluctuations in exchange rates. Management continues to assess the potential direct and indirect impacts of tariffs, counter-tariffs and other trade protection measures on Eupraxia's business and will take those steps it deems necessary to attempt to mitigate any impact as the situation evolves. Financial Statements and Management Discussion & Analysis Please see the audited consolidated financial statements and related MD&A for more details. The audited consolidated financial statements for the year ended December 31, 2024, and related MD&A, have been reviewed and approved by Eupraxia's Audit Committee and Board of Directors. For a more detailed explanation and analysis, please refer to the MD&A that has been filed under the Company's profile on EDGAR at , and on SEDAR+ at sedarplus.ca and is also available on the Company's website at . About Eupraxia Pharmaceuticals Inc. Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians are wanting to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas. Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: . Notice Regarding Forward-looking Statements and Information This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as "plans", "is expected", "expects", "suggests", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes", "potential" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements in this news release include statements regarding the Company's product candidates, including their expected benefits to patients with respect to safety, tolerability, efficacy and duration; the results gathered from studies and trials of Eupraxia's product candidates; the potential for the Company's technology to impact the drug delivery process; potential market opportunity for the Company's products; potential pipeline indications; expectations regarding the funding of the Company's operations to the third quarter of 2026, and the use of cash reserves and proceeds from the exercise of warrants; and expectations regarding continued access to both API and manufactured products from the U.S., as well as ongoing monitoring and necessary actions to attempt to mitigate any impact of tariffs, counter-tariffs and other trade protection measures on the Company's business. Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company's clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the potential impact of tariffs on the cost of the Company's API and clinical supplies of EP-104IAR and EP-104GI; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company's operations; the Company's restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company's common share price; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise. SOURCE Eupraxia Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultFinancial StatementExecutive Change

20 Mar 2025

·www.fiercepharma.com

Paratek acquires Optinose, rhinosinusitis spray Xhance in deal worth up to $330M

In a move to expand its portfolio, Paratek has bought out Optinose and its chronic rhinosinusitis nasal spray Xhance for up to $330 million. In a move to expand its portfolio beyond antibiotics, Paratek Pharmaceuticals has bought out Optinose and its chronic rhinosinusitis (CRS) nasal spray Xhance for up to $330 million.Triggering the acquisition was a label expansion for Xhance, which was originally approved in 2017 for patients with CRS and nasal polyps. An FDA nod 12 months ago allows it to be used by those who don’t have nasal polyps.The expansion increases the patient population for the drug-device combo product by 10-fold to 10 million, according to Paratek, as Xhance represents the only CRS treatment on the market for those with and without polyps.Optinose—which was founded in Norway in 2000 and now is based in Yardley, Pennsylvania—marketed Xhance to ear, nose, and throat specialists. But the label expansion makes it advantageous to commercialize Xhance through primary care providers, who are already familiar with Paratek’s antibiotic, Nuzyra, according to CEO Evan Loh, M.D. “The majority of the primary care physicians Paratek calls on for Nuzyra and its approved indications are also treating patients with CRS, offering a key overlap in targets for our salesforce,” Loh said in a release. “This transaction creates a stronger platform for future product acquisitions as we leverage our capabilities and further expand our portfolio.”Up front, Boston-based Paratek is paying $9 per share, which is a 50% markup on Optinose’s price at the close of trading on Wednesday. The deal could be worth up to $14 per share, including the payment of contingent value right (CVR) tied to future revenue milestones. “Paratek, with its robust commercial and medical capabilities, has the potential to rapidly extend awareness of Xhance to primary care providers who treat the majority of patients with CRS,” Ramy Mahmoud, M.D., Optinose’s CEO, said in the release. “We are excited about the many ways in which this transaction creates opportunities for Xhance to help more patients achieve better symptom control while creating near- and long-term value for Optinose’s shareholders.”Paratek has been on both ends of M&A deals in the last two years. In 2023, Novo Holdings and healthcare investment firm Gurnet Point acquired Paratek for up to $462 million. That deal also featured CVR tied to a Nuzyra sales threshold for 2026. Gurnet Point was co-founded by current Biogen CEO and former Sanofi chief Christopher Viehbacher.Nuzyra won FDA approval in 2018 and pulled down 2022 sales of $137 million. At the time of Nuzyra’s approval, Leerink analysts pegged the drug's peak sales opportunity at more than $500 million.

AcquisitionDrug Approval

20 Mar 2025

·endpts.com

Paratek boosts commercial portfolio in move to buy Optinose and its nasal spray

Paratek Pharmaceuticals is expanding beyond antibiotics and infectious disease by paying up to $330 million to acquire Optinose and its drug-device combination for chronic rhinosinusitis (CRS). Paratek will obtain Optinose’s Xhance, which features its so-called Exhalation Delivery System that administers a steroid deep into the nasal cavity. Optinose shareholders could get up to $14 per share as part of the deal, including potential payments for certain commercial milestones, according to a release late Wednesday. The upfront consideration of $9 per share represents a 50% premium to Optinose’s share price at Wednesday’s close. Xhance secured its first FDA approval in 2017 for CRS with nasal polyps, with a label expansion following in March last year for CRS without nasal polyps. But the path to label expansion wasn’t all smooth sailing: In 2023, the FDA requested more data from a patient subgroup in one of Optinose’s Phase 3 studies, delaying its regulatory review. Paratek said it plans to broaden access to Xhance from ear, nose and throat specialists to primary care providers, with an eye to maximizing the drug’s prospects in a market of around 10 million patients. In November, Optinose lowered its total 2024 revenue guidance for Xhance from $85 million to $90 million, to between $75 million and $79 million. Optinose’s shares $OPTN were up almost 60% premarket Thursday. The company canceled its fourth-quarter earnings call that had been scheduled for Thursday following the announcement of the deal, which is expected to close by the middle of the year. Xhance will join Paratek’s only marketed medicine, Nuzyra, which is an antibiotic for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection. The drug is also being evaluated for the treatment of anthrax with support from BARDA. In 2023, Paratek was acquired by Novo Holdings and Gurnet Point Capital in a $462 million take-private deal.

Drug ApprovalAcquisitionPhase 3

100 Deals associated with Fluticasone Propionate

External Link

KEGG	Wiki	ATC	Drug Bank
D01708	Fluticasone Propionate	R03BA05 D07AC17 R01AD08	DB00588

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Chronic sinusitis	United States	OptiNose US, Inc.	15 Mar 2024
Nasal Obstruction	United States	Haleon US Capital LLC	23 Jul 2014
Sneezing	United States	Haleon US Capital LLC	23 Jul 2014
Dermatitis, Atopic	United States	Fougera Pharmaceuticals, Inc.	31 Mar 2005
Dermatitis	Japan	GSK Plc	02 Oct 2001
Dermatitis, Contact	Japan	GSK Plc	02 Oct 2001
Dermatitis, Seborrheic	Japan	GSK Plc	02 Oct 2001
Eczema	Japan	GSK Plc	02 Oct 2001
Erythema	Japan	GSK Plc	02 Oct 2001
Lichen Planus	Japan	GSK Plc	02 Oct 2001
Lupus Erythematosus, Discoid	Japan	GSK Plc	02 Oct 2001
Nasal Polyps	Japan	GSK Plc	02 Oct 2001
Neurodermatitis	Japan	GSK Plc	02 Oct 2001
Prurigo	Japan	GSK Plc	02 Oct 2001
Pruritus	Japan	GSK Plc	02 Oct 2001
Psoriasis	Japan	GSK Plc	02 Oct 2001
Asthma	United States	GSK Plc	27 Mar 1996
Anaphylaxis	United States	Haleon US Capital LLC	19 Oct 1994
Rhinitis	United States	Haleon US Capital LLC	19 Oct 1994
Rhinitis, Allergic	Japan	GlaxoSmithKline KK	01 Jul 1994

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic rhinosinusitis without nasal polyps	Phase 3	-	OptiNose, Inc.	18 Apr 2025
Chronic rhinosinusitis with nasal polyps	Phase 3	United States	OptiNose, Inc.	01 Sep 2013
Multiple Hamartoma Syndrome	Phase 3	United States	OptiNose, Inc.	01 Sep 2013
Rhinitis, Allergic, Seasonal	Phase 3	United States	GSK Plc	01 Dec 2012
Severe asthma	Phase 3	China	GlaxoSmithKline Australia Pty Ltd.	27 Sep 2012
Severe asthma	Phase 3	China	GlaxoSmithKline (China) Investment Co., Ltd.	27 Sep 2012
Asthma, Exercise-Induced	Phase 3	-	GSK Plc	01 Jan 2012
Persistent asthma	Phase 3	United States	GSK Plc	01 Feb 2007
Persistent asthma	Phase 3	Australia	GSK Plc	01 Feb 2007
Persistent asthma	Phase 3	Canada	GSK Plc	01 Feb 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05608681 (RESOLVE, Company_Website) Manual	Phase 1/2	Eosinophilic Esophagitis	-	EP-104GI 2.5 mg (Cohort 3 + Number of Injections 8)	zjrzgexlkp(lcerfawcbd) = nuycqcxqlq zqykiiprcr (usjmqueomi ) View more	Positive	25 Feb 2025
				EP-104GI 2.5 mg (Number of Injections 12 + Cohort 4)	zjrzgexlkp(lcerfawcbd) = jvrpnqldsd zqykiiprcr (usjmqueomi ) View more
NCT05608681 (RESOLVE, PRNewswire) Manual	Phase 1/2	Eosinophilic Esophagitis	-	EP-104GI 4 mg (Fifth Cohort)	wtmpwfgxnt(ewzbodleiw) = bzeberxyth vgqwyxhbbc (wnstnakgau ) View more	Positive	12 Nov 2024
				EP-104GI 2.5 mg (Fourth Cohort)	wtmpwfgxnt(ewzbodleiw) = wohxobeeux vgqwyxhbbc (wnstnakgau ) View more
VISUALIZING FLUTICASONE PROPIONATE'S IMPACT ON ALLERGIC RHINITIS FACIAL SYMPTOMS (ACAAI2024)	Not Applicable	Rhinitis, Allergic positive skin-prick tests to dust mite or cat dander allergens	-	Fluticasone propionate	zazbwtjygq(lqoakfliby) = kehrtrfbmy amrgaemuqk (fmnfxveghe )	-	24 Oct 2024
NCT02402465 (CTgov)	Phase 4	Rhinitis, Allergic, Seasonal	22	Placebo (Placebo)	eqqkfgtdpp(kbocqeczcu) = lavaaqphmg jdibjfetrv (shdapzygng, 53.03) View more	-	17 Oct 2024
				Nasal Allergen Challenge+Fluticasone propionate (Fluticasone Propionate)	eqqkfgtdpp(kbocqeczcu) = ljaxvqcjon jdibjfetrv (shdapzygng, 54.22) View more
NCT05608681 (RESOLVE, PRNewswire) Manual	Phase 1/2	Eosinophilic Esophagitis	6	EP-104GI 30mg	innoaevvgi(emcmjoncuk) = rckdwumjwn erlfglptyy (ffqobwvtvy ) View more	Positive	11 Sep 2024
				EP-104GI 20mg	innoaevvgi(emcmjoncuk) = ycklebvvkg erlfglptyy (ffqobwvtvy ) View more
NCT04120402 (SPRINGBOARD \| EP-104IAR-201, CTgov)	Phase 2	Osteoarthritis, Knee	318	EP-104IAR 25 mg (EP-104IAR 25 mg)	hacomwfptu(yifbglwcqa) = eqoygiispv lxquemtorb (eogwelgluq, 0.166) View more	-	25 Jun 2024
				Vehicle (Placebo (Vehicle))	hacomwfptu(yifbglwcqa) = evxorrskeh lxquemtorb (eogwelgluq, 0.171) View more
NCT03960580 (CTgov)	Phase 3	Nasal Polyps \| Chronic sinusitis	223	OPN-375 (Placebo)	vissbaadyo(tbrnifppfd) = rsivwziild mhrgxbrfjp (nsjgqvczho, 0.202) View more	-	21 Dec 2023
				OPN-375 (OPN-375 186 μg BID)	vissbaadyo(tbrnifppfd) = elejvzywer mhrgxbrfjp (nsjgqvczho, 0.204) View more
UEGW2023	Not Applicable	Eosinophilic Esophagitis	-	Fluticasone propionate (FP) SND 800 Âµg/day	jmpwphjdor(vetjctybsl) = Bud resulted overall superior to FP to achieve CHR (82% vs 60%, p<0.001) ahopcyptln (vsycqxroib )	-	15 Oct 2023
				Fluticasone propionate (FP) MDIS 1 mg/day
NCT03781804 (CTgov)	Phase 3	Nasal Polyps \| Chronic sinusitis	332	OPN-375 (OPN-375 186 μg BID)	pptjxrgmze(lwfozypgka) = dtakvxrebg pllzdxwine (rgyannjlxi, 0.161) View more	-	18 Sep 2023
				OPN-375 (OPN-375 372 μg BID)	pptjxrgmze(lwfozypgka) = atqhtznxnd pllzdxwine (rgyannjlxi, 0.163) View more

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