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Last update 30 May 2025

Fluticasone Propionate

Last update 30 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Fluticasone, Fluticasone Propionate Cream, Fluticasone Propionate Inhaled Aerosol

+ [35]

Target

Action

agonists

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [5]

Active Indication

Chronic sinusitisNasal ObstructionSneezing+ [19]

Inactive Indication

Allergic asthmaAnaphylaxisAsthma chronic+ [13]

Originator Organization

GSK Plc

Active Organization

Respirent Pharmaceuticals Co. Ltd.

GSK Plc

Glaxo Group Ltd.

+ [10]

Inactive Organization

Teva Branded Pharmaceutical Products R&D, Inc.

Fougera Pharmaceuticals, Inc.Teva Pharmaceuticals USA, Inc.

+ [4]

License Organization

Paratek Pharmaceuticals, Inc.

OptiNose, Inc.

Beijing Jiu He Pharmaceutical Ltd.

+ [6]

Drug Highest PhaseApproved

First Approval Date

United States (14 Dec 1990),

Skin Diseases

RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)

Structure/Sequence

Molecular FormulaC25H31F3O5S

InChIKeyWMWTYOKRWGGJOA-CENSZEJFSA-N

CAS Registry80474-14-2

420

Clinical Trials associated with Fluticasone Propionate

CTRI/2025/04/084442

/ Not yet recruitingPhase 3IIT

A randomized control trial evaluating dual therapy of oral corticosteroids versus intranasal corticosteroids only to prevent recurrence in chronic rhinosinusitis with nasal polyposis after functional endoscopic sinus surgery - NIL

Start Date19 Apr 2025

Sponsor / Collaborator-

NCT06850805

/ Not yet recruitingPhase 3

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.

CTR20251429

/ RecruitingNot Applicable

单中心、随机、开放、单次给药的丙酸氟替卡松乳膏在中国健康受试者中的生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose bioequivalence study of fluticasone propionate cream in Chinese healthy subjects

主要目的：1）通过血药浓度分析，比较丙酸氟替卡松乳膏受试制剂与参比制剂局部用药后的体内暴露量，评价丙酸氟替卡松乳膏的系统安全性； 2）结合初步剂量持续时间-效应探索研究结果，设计合适的研究条件，以浙江赛默制药有限公司生产的丙酸氟替卡松乳膏（0.05%，持证商：浙江百代医药科技有限公司）为受试制剂，以原研丙酸氟替卡松乳膏（Cutivate®，0.05%，GlaxoSmithKline (Ireland) Limited）为参比制剂进行人体生物等效性试验，通过比较受试制剂与参比制剂的药效学参数，评价两制剂的生物等效性。次要目的：观察健康受试者皮肤外用丙酸氟替卡松乳膏的安全性。

[Translation]

Main objectives: 1) Compare the in vivo exposure of the test preparation and the reference preparation of fluticasone propionate cream after topical administration through blood drug concentration analysis to evaluate the systemic safety of fluticasone propionate cream; 2) Combined with the results of the preliminary dose-duration-effect exploration study, design appropriate research conditions, use fluticasone propionate cream (0.05%, licensee: Zhejiang Baidai Pharmaceutical Technology Co., Ltd.) produced by Zhejiang Thermo Pharmaceutical Co., Ltd. as the test preparation, and use the original fluticasone propionate cream (Cutivate®, 0.05%, GlaxoSmithKline (Ireland) Limited) as the reference preparation to conduct human bioequivalence test, and compare the pharmacodynamic parameters of the test preparation and the reference preparation to evaluate the bioequivalence of the two preparations. Secondary objectives: Observe the safety of topical fluticasone propionate cream on the skin of healthy subjects.

Start Date07 Apr 2025

Sponsor / Collaborator

Zhejiang Bio-diamond 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

5,703

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 Jul 2025·JOURNAL OF PHARMACEUTICAL SCIENCES

Investigation of the suitability of utilizing plasma concentration as a surrogate to understand lung exposure of inhaled drug in rats: Different delivery methods of fluticasone propionate

Article

Author: Nagapudi, Karthik ; Durk, Matthew R ; Chiang, Po-Chang ; Rinderknecht, Cornelia H ; Liu, Jia

Pulmonary diseases, such as asthma and chronic obstructive pulmonary disease (COPD) are complex human airway diseases that affect millions of people worldwide. A topical drug delivery system such as a dry powder inhaler (DPI) is often used to deliver the drug directly to airways to increase the therapeutic index; however, accurately predicting the efficacy and pharmacokinetics of new molecular entities remains challenging, in particular, estimating the effective drug concentration at the site of action. This is of critical importance since many inhaled drugs are designed to have topical-only efficacy to reduce systemic side effects. Preclinically, drug delivery in rodents now focuses on mimicking the clinical dosing regimen, coupled with modeling approaches to better understand the lung PK/PD relationship. One modeling approach is the use of the systemic exposure to predict the drug concentration and release from the lung as the first step to model the lung PK/PD. With a tool compound, fluticasone propionate, the authors used a Loo-Riegelman-based pharmacokinetic analysis and compared several methods of dosing to rats to evaluate the suitability of using the systemic exposure to estimate the amount of drug absorbed by the lung. The Loo-Riegelman approach predicted lung absorption well in humans following DPI dosing. In rats, lung absorption was predicted well for IT dosing, but not DPI dosing, emphasizing caution in using systemic drug concentrations to predict lung concentrations in rats receiving a DPI dose.

03 Jun 2025·DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY

Q1 and Q2 selection, Q3, IVRT, IVPT, pharmacokinetic and pharmacodynamic evaluation of topical generic product

Article

Author: Shelke, Om ; Yulan, Chen ; Jie, Feng ; Yongbo, Liu ; Yijie, Zhu

OBJECTIVE:

To establish a detailed step-by-step example for the topical development of generic products.

SIGNIFICANCE:

Topical semisolids are complex products requiring extensive research for bioequivalence by establishing Q1/Q2/Q3.

METHODS:

The detailed process establishes Q1/Q2 selection and Q3 evaluation of the innovator and proposed formulation. The proposed generic product along with the innovator formulation has been evaluated for physicochemical properties. Once the Q3 structure is matched with innovator formulation, the invitro release and in-vitro permeation study have been conducted to move forward for the bioequivalence study. Pharmacokinetic and pharmacodynamic studies were employed for bioequivalence with an innovator in humans.

RESULTS:

Selection of Q1 and Q2 establish the formulation composition through literature search and reverse engineering. The test and reference products are pharmaceutically equivalent through Q3 characterization, IVRT, and IVPT. In the PK study, test and reference samples were compared for Cmax, T_max, and t_1/2 and found bioequivalent. The PD study was performed in pilot and pivotal study to establish dose duration response relationship and bioequivalence respectively without adverse events. A crucial study has exhibited that reference and test formulations are bioequivalent with a 90% confidence interval and results in 84.67%-101.09%.

CONCLUSION:

The Cutivate^® cream 0.05%, and proposed generic product Fluticasone Propionate cream 0.05% formulations are bioequivalent and have a favorable safety profile.

209

News (Medical) associated with Fluticasone Propionate

21 May 2025

·www.globenewswire.com

Paratek Pharmaceuticals Completes Acquisition of Optinose, Creating an Expanded Portfolio of Specialty Therapies

BOSTON, May 21, 2025 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company focused on the development and commercialization of specialty therapies for specialists and community care providers, that address important medical and public health threats, today announced that the Company has completed its acquisition of Optinose, Inc. (NASDAQ:OPTN). This acquisition broadens Paratek’s commercial portfolio which now includes both its flagship antibiotic, NUZYRA® (omadacycline), and Optinose’s product XHANCE® (fluticasone propionate). “Adding XHANCE to our portfolio is a pivotal first step in achieving our long-term vision to become a multi‑product specialty therapeutics company, focused on addressing significant unmet medical needs,” said Evan Loh, MD, Chief Executive Officer of Paratek. “Our medical and commercial teams are deeply experienced with capabilities focused on bringing innovative treatments to specialists and primary care providers that address the needs of their patients. This transaction establishes a strong platform for us to continue to leverage these capabilities as we move forward to explore opportunities to expand our portfolio through future product acquisitions.” Under the terms of the merger agreement, Paratek acquired all outstanding shares of Optinose for approximately $330 million, including the assumption of debt and assuming full payment of the contingent value rights (CVRs), and Optinose shareholders were paid $9 per share in cash and received CVRs for up to $5 per share in cash payable in the event that certain net revenue milestones are achieved by XHANCE. Paratek will pay $1 per share if XHANCE achieves $150M in net sales in any calendar year prior to December 31, 2028, and $4 per share if XHANCE achieves $225M in net sales in any calendar year prior to December 31, 2029. Optinose shareholders approved the merger proposal at Optinose’s special meeting of shareholders held on May 16, 2025, and following completion of the merger Optinose's common stock will be delisted from the Nasdaq Global Select Market. The transaction was financed with capital from Paratek, B-FLEXION Life Sciences, and Novo Holdings, and debt financing from funds managed by Oaktree Capital Management, L.P. ("Oaktree"). Lazard acted as the exclusive financial advisor to Paratek Pharmaceuticals, and Skadden, Arps, Slate, Meagher & Flom LLP served as its legal advisor. Evercore acted as the exclusive financial advisor to Optinose, and Hogan Lovells US LLP served as its legal advisor. About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a privately held pharmaceutical company providing innovative specialty therapies for specialists and community care providers, addressing important medical and public health threats. Paratek's lead product, NUZYRA (omadacycline), is a once-daily oral and intravenous antibiotic indicated for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek continues to diversify its portfolio to address unmet patient needs. Paratek was acquired in 2023 by B-FLEXION and Novo Holdings. For more information, visit https://www.paratekpharma.com/ or follow us on LinkedIn and X. About B-FLEXION Life SciencesB-FLEXION Life Sciences is part of the B-FLEXION group, a private, entrepreneurial investment firm with offices in Europe and the United States. B-FLEXION seeds, acquires and builds investment partnerships across a number of focused fields and makes principal investments into operating businesses in transformative industries. Through B-FLEXION Life Sciences there is also targeted investment across biopharma, diagnostics and a broad spectrum of innovative healthcare services. It is an active owner, applying the experience and skills of its investment and operationally experienced team to work closely with management to build its portfolio companies. www.bflexion.com About Novo Holdings A/SNovo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk and Novonesis and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Planetary Health Investments and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2024, Novo Holdings had total assets of EUR 142 billion. www.novoholdings.dk About OaktreeOaktree is a leader among global investment managers specializing in alternative investments, with $203 billion in assets under management as of March 31, 2025. The firm emphasizes an opportunistic, value-oriented, and risk-controlled approach to investments in credit, equity, and real estate. The firm has more than 1,200 employees and offices in 25 cities worldwide. For additional information, please visit Oaktree’s website at http://www.oaktreecapital.com/. About NUZYRANUZYRA (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next-generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical, and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs or to any of the excipients. WARNINGS AND PRECAUTIONSMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONSThe most common adverse reactions (incidence 2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONSPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. USE IN SPECIFIC POPULATIONSLactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here. About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also known as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, headache, and nasopharyngitis.Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure. See full prescribing information here. MEDIA CONTACT: Adam Silversteinadam@scientpr.com

AcquisitionDrug ApprovalClinical Result

24 Apr 2025

·eupraxiapharma.com

Eupraxia Pharmaceuticals to Present at Investor and Scientific Conferences in April and May

VICTORIA, British Columbia, April 24, 2025 (GLOBE NEWSWIRE) -- 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 that the Company’s management and scientific teams will present at the following investor and scientific conferences in April and May: Osteoarthritis Research Society International World Congress April 24-27, 2025 Dr. Phil Conaghan, a member of the Company’s OA Clinical Advisory Board, will be presenting a poster on the Company’s behalf at the Osteoarthritis Research Society International (“OARSI”) World Congress 2025, being held April 24-27, 2025 in Incheon (Seoul), South Korea. Poster Details Poster Title: EP-104IAR (extended-release intra-articular injection of fluticasone propionate) shows sustained pain response for subjects with moderate baseline pain and BMI less than 30 in SPRINGBOARD, a Phase 2, randomized, 24-week study of osteoarthritis of the knee. Date: Friday & Saturday, April 25-26, 2025 Presentation Time: 3:30 – 4:15 PM KST Abstract ID: 4203902 Poster Number: 635 Digestive Disease Week Annual Meeting May 3-6, 2025 The Company will be presenting data from the ongoing Phase 1b study of EP-104GI for the treatment of eosinophilic esophagitis (“EoE”) at the upcoming Digestive Disease Week (“DDW”) Annual Meeting 2025. Dr. Evan Dellon, Chair of the Company’s GI Clinical Advisory Board, will be presenting the poster on the Company’s ongoing Phase 1b/2a dose-escalation study of EP-104GI for EoE. Eupraxia's Chief Operating & Scientific Officer, Dr. Amanda Malone, will be presenting the poster on epidemiology of esophageal strictures. The meeting is being held in San Diego, CA, from May 3-6, 2025. Both posters will be presented on May 3, 2025. Poster Details Poster Title #1: Results from dose escalation from RESOLVE, an ongoing Phase 1b/2a dose-escalation study of EP-104GI (long-acting fluticasone propionate injectable suspension) for eosinophilic esophagitis. Date: Saturday, May 3, 2025 Presentation Time: 12:30 – 1:30 PM PDT Abstract ID: 4236223 Poster Number: SA1223 Poster Title #2: Prevalence and Causes of severe esophageal strictures requiring multiple dilations in the United States. Date: Saturday, May 3, 2025 Presentation Time: 12:30 – 1:30 PM PDT Abstract ID: 4233642 Poster Number: SA1109 Bloom Burton & Co. Healthcare Investor Conference May 5-6, 2025 Eupraxia’s CEO, Dr. James Helliwell, will be presenting on May 5th, 2025, at 3:30pm ET at the Bloom Burton & Co. Healthcare Investor Conference being held at the Metro Toronto Convention Centre, and will participate in investor meetings at the conference on May 5th and 6th. Interested parties can access the presentation through the following link: Webcast link here. European Society for Diseases of the Esophagus Annual Congress May 11-13, 2025 Dr. Arjan Bredenoord, a member of the Company’s GI Clinical Advisory Board, will be presenting at the 27th European Society for Diseases of the Esophagus (“ESDE”) Annual Congress on behalf of the Company on May 12th, 2025, at 3:07pm CET at the Pinnacle Hall, Muziekgebouw 't IJ, Amsterdam. Dr. Bredenoord will give a 5-minute presentation, followed by a 2-minute discussion. After the respective conferences, the poster presentations will be available on Eupraxia's website at: https://eupraxiapharma.com/our-science/clinical-trials-and-publications/default.aspx 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: www.eupraxiapharma.com. 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 details of the Company’s presentations at the OARSI World Congress, the DDW Annual Meeting, the Bloom Burton & Co. Healthcare Investor Conference and the ESDE Annual Congress; 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; and potential pipeline indications. 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. For investor and media inquiries, please contact: Danielle Egan, Eupraxia Pharmaceuticals Inc. 778.401.3302 degan@eupraxiapharma.com or Kevin Gardner, on behalf of: Eupraxia Pharmaceuticals Inc. 617.283.2856 kgardner@lifesciadvisors.com SOURCE Eupraxia Pharmaceuticals Inc.

Phase 2Phase 1

26 Mar 2025

·www.globenewswire.com

Optinose Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Highlights

Company reports fourth quarter and full year 2024 XHANCE net revenue of $22.4 million and $78.2 million, increases of 13% and 10% compared to prior year periods Company reports 23% prescription growth from third quarter 2024 to fourth quarter 2024 YARDLEY, Pa., March 26, 2025 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter and year ended December 31, 2024, and provided recent operational highlights. Fourth Quarter 2024 and Recent Highlights New Prescriptions (NRx) and Total Prescriptions (TRx)An inflection in prescription demand first observed in September 2024 NRx continued in fourth quarter 2024 and extended to TRx. NRx increased 12% from approximately 25,600 in third quarter 2024 to approximately 28,700 in fourth quarter 2024. TRx increased 23% from approximately 63,900 in third quarter 2024 to approximately 78,500 in fourth quarter 2024. Fourth Quarter 2024 Financial Results RevenuesThe Company reported $22.4 million in net revenue from sales of XHANCE during the three-month period ended December 31, 2024, an increase of 13% compared to $19.9 million during the three-month period ended December 31, 2023. For the twelve-month period ended December 31, 2024, the Company reported $78.2 million in net revenue from sales of XHANCE, an increase of 10% compared to $71.0 million during the twelve-month period ended December 31, 2023. Costs and expenses and net lossFor the three-month and twelve-month periods ended December 31, 2024, research and development expenses were $0.8 million and $3.9 million, respectively. Selling, general and administrative expenses were $19.3 million and $83.5 million during the three-month and twelve-month periods ended December 31, 2024, respectively. In total, SG&A plus R&D expenses increased by $2.2 million, to $87.3 million for the twelve-month period ended December 31, 2024 when compared to the twelve-month period ended December 31, 2023 total of $85.1 million. Income from operations was for the three-month period ended December 31, 2024, was $0.4 million. This is the first three-month period in which the Company reported income from operations. The net loss for the three-month period ended December 31, 2024 was $0.4 million, or $0.04 per share (basic and diluted). The net loss for the twelve-month period ended December 31, 2024 was $21.5 million, or $2.12 per share (basic and diluted). Balance SheetThe Company had cash and cash equivalents of $84.5 million as of December 31, 2024. OptiNose, Inc.Condensed Consolidated Statement of Operations(in thousands, except share and per share data)(Unaudited) Three Months Ended Year Ended December 31, December 31, 2024 2023 2024 2023 Revenues: Net product revenues $22,418 $19,865 $78,226 $70,987 Total revenues 22,418 19,865 78,226 70,987 Costs and expenses: Cost of product sales $1,954 $2,131 $7,231 $8,633 Research and development 772 1,286 3,855 5,303 Selling, general and administrative 19,338 18,960 83,459 79,799 Total costs and expenses 22,064 22,377 94,545 93,735 Income (loss) from operations 354 (2,512) (16,319) (22,748)Other (income) expense 714 7,455 5,222 12,735 Net (loss) $(360) $(9,967) $(21,541) $(35,483)Net loss per share of common stock, basic and diluted $(0.03) $(1.33) $(2.12) $(4.75)Weighted average common shares outstanding, basic and diluted 11,635,909 7,487,465 10,156,745 7,472,035 OptiNose, Inc.Condensed Consolidated Balance Sheet Data(in thousands) December 31 December 31, 2024 2023 Cash and cash equivalents $84,485 $73,684 Other assets 44,300 34,045 Total assets $128,785 $107,729 Total current liabilities (1) $162,813 $176,524 Other liabilities 6,332 17,811 Total stockholders' deficit (40,360) (86,606)Total liabilities and stockholders' deficit $128,785 $107,729 (1) – All outstanding principal and fees payable upon maturity have been classified as a current liability in accordance with Generally Accepted Accounting Principles ("GAAP") because, as of the date hereof, the Company believes that it is probable that it will not maintain compliance with certain financial covenants contained in its Amended and Restated Note Purchase Agreement for at least the next 12-months. As a result, the Company's audited financial statements for the year ended December 31, 2024 (“2024 Audited Financial Statements”) will state that there is substantial doubt about the Company's ability to continue as a going concern (i.e., a "going concern" paragraph). Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 (including the 2024 Audited Financial Statements) which will be filed after the issuance of this press release for additional information. About OptinoseOptinose is a specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn. About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE. WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, headache, and nasopharyngitis.Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure.Please see full Prescribing Information, including Instructions for Use Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the potential benefits of XHANCE; the potential benefits of the Exhalation Delivery System; the Company's belief that it is probable that it will not maintain compliance with certain financial covenants contained in its Amended and Restated Note Purchase Agreement for at least the next 12-months and the consequences thereof; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives, strategies and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: physician and patient acceptance of XHANCE for its new indication; the Company’s ability to maintain adequate third-party reimbursement for XHANCE (including its new indication); the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than expected; the Company’s ability to efficiently generate XHANCE prescriptions and net revenues; unanticipated costs and expenses; the risk that the positive inflection in new XHANCE prescriptions starting in September does not continue and grow; the Company’s ability to comply with the covenants and other terms of its Amended and Restated Note Purchase Agreement; the Company’s ability to continue as a going concern; risks and uncertainties relating to intellectual property and competitive products; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in the Company’s most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission – which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise. Optinose Investor Contact Jonathan Neely jonathan.neely@optinose.com267.521.0531

Financial StatementDrug Approval

100 Deals associated with Fluticasone Propionate

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

R&D Status

Approved

10 top approved records.

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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.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic rhinosinusitis without nasal polyps	Phase 3	-	OptiNose, Inc.	18 Apr 2025
Asthma chronic	Phase 3	Greece	Respirent Pharmaceuticals Co. Ltd.	09 Dec 2020
Asthma, Nasal Polyps, and Aspirin Intolerance	Phase 3	United States	OptiNose, Inc.	06 Jun 2019
Asthma, Nasal Polyps, and Aspirin Intolerance	Phase 3	Australia	OptiNose, Inc.	06 Jun 2019
Asthma, Nasal Polyps, and Aspirin Intolerance	Phase 3	Bulgaria	OptiNose, Inc.	06 Jun 2019
Asthma, Nasal Polyps, and Aspirin Intolerance	Phase 3	Czechia	OptiNose, Inc.	06 Jun 2019
Asthma, Nasal Polyps, and Aspirin Intolerance	Phase 3	Georgia	OptiNose, Inc.	06 Jun 2019
Asthma, Nasal Polyps, and Aspirin Intolerance	Phase 3	New Zealand	OptiNose, Inc.	06 Jun 2019
Asthma, Nasal Polyps, and Aspirin Intolerance	Phase 3	Poland	OptiNose, Inc.	06 Jun 2019
Asthma, Nasal Polyps, and Aspirin Intolerance	Phase 3	Romania	OptiNose, Inc.	06 Jun 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05608681 (RESOLVE, GlobeNewswire) Manual	Phase 1/2	Eosinophilic Esophagitis	6	EP-104GI 48mg (Cohort 5)	xknikhceta(qajywdrohn) = jwlkxsohsb ywragzjpdy (amrqwnanwg ) View more	Positive	05 May 2025
				EP-104GI 64mg (Cohort 6)	xknikhceta(qajywdrohn) = lcrvrmtkhw ywragzjpdy (amrqwnanwg )
NCT05608681 (RESOLVE, Company_Website) Manual	Phase 1/2	Eosinophilic Esophagitis	-	EP-104GI 2.5 mg (Cohort 3 + Number of Injections 8)	adhiamwvfe(thapqlbjah) = yhkvgvhikw lovkegkirq (divpaodvre ) View more	Positive	25 Feb 2025
				EP-104GI 2.5 mg (Number of Injections 12 + Cohort 4)	adhiamwvfe(thapqlbjah) = kqzzewntzy lovkegkirq (divpaodvre ) View more
NCT05608681 (RESOLVE, PRNewswire) Manual	Phase 1/2	Eosinophilic Esophagitis	-	EP-104GI 4 mg (Fifth Cohort)	llokolezyf(bkorzdbxvk) = klhaabfvjh nxfggymmyy (rmnqqligup ) View more	Positive	12 Nov 2024
				EP-104GI 2.5 mg (Fourth Cohort)	llokolezyf(bkorzdbxvk) = yznpedjxdh nxfggymmyy (rmnqqligup ) 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	orqgwupvml(xzzqxhqurh) = fqsvidnpfc uldrhwfdba (vqfaapeyek )	-	24 Oct 2024
NCT02402465 (CTgov)	Phase 4	Rhinitis, Allergic, Seasonal	22	Placebo (Placebo)	tmtalchlkq(hiqetkyphj) = labmgsmvbi kjythtezjs (cqyfcgtqhp, 53.03) View more	-	17 Oct 2024
				Nasal Allergen Challenge+Fluticasone propionate (Fluticasone Propionate)	tmtalchlkq(hiqetkyphj) = qickrvtltu kjythtezjs (cqyfcgtqhp, 54.22) View more
UEGW2024	Not Applicable	Eosinophilic Esophagitis	-	EP-104GI 4 mg total dose	yypodssljn(sapzfcgjlu) = mild-moderate AEs; the majority not related to EP-104GI. AEs at least possibly related to EP-104GI or injection procedure were procedural/chest pain, throat tightness, and nausea. Glucose levels post-dose have remained stable. Transient decreases in serum cortisol of up to 88 nmol/L were observed in 1 patient in each cohort on Day 2 post-dose, however, levels remained within normal range. There have been no symptoms of adrenal insufficiency. ccfpgeybjr (paxxnhqgku )	-	13 Oct 2024
				EP-104GI 8 mg total dose
NCT05608681 (RESOLVE, PRNewswire) Manual	Phase 1/2	Eosinophilic Esophagitis	6	EP-104GI 30mg	uxwmveqtzh(hzrsvtggxu) = lmtemncgaa bmvqlccseg (mmrcbnjmbs ) View more	Positive	11 Sep 2024
				EP-104GI 20mg	uxwmveqtzh(hzrsvtggxu) = rzqdjslcsr bmvqlccseg (mmrcbnjmbs ) View more
NCT04120402 (SPRINGBOARD \| EP-104IAR-201, CTgov)	Phase 2	Osteoarthritis, Knee \| Primary osteoarthritis of knee NOS	318	EP-104IAR 25 mg (EP-104IAR 25 mg)	ytwdkebkyv(crbzvducvk) = kznrlvbuts jkpegtmsfo (xixnwpmvun, 0.166) View more	-	25 Jun 2024
				Vehicle (Placebo (Vehicle))	ytwdkebkyv(crbzvducvk) = ctlltscvzy jkpegtmsfo (xixnwpmvun, 0.171) View more
NCT03960580 (CTgov)	Phase 3	Asthma, Nasal Polyps, and Aspirin Intolerance \| Nasal Polyps \| Chronic sinusitis	223	OPN-375 (Placebo)	ryqsmhxukr(lzvuqdgvjq) = urjpvxhumv lmhbnuptyo (batdikaopl, 0.202) View more	-	21 Dec 2023
				OPN-375 (OPN-375 186 μg BID)	ryqsmhxukr(lzvuqdgvjq) = rwmopoxbfo lmhbnuptyo (batdikaopl, 0.204) View more

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