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Last update 13 Nov 2025

Celecoxib

Last update 13 Nov 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryCELEBREX (celecoxib) is a nonsteroidal anti-inflammatory drug. Celecoxib has analgesic, anti-inflammatory, and antipyretic properties.The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro. Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.CELEBREX

Drug Type

Small molecule drug

Synonyms

Celecoxib (JAN/USP/INN), p-(5-p-Tolyl-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide, AD-2111

+ [24]

Target

COX-2

Action

inhibitors

Mechanism

COX-2 inhibitors(Cyclooxygenase-2 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [7]

Active Indication

Migraine DisordersPainToothache+ [19]

Inactive Indication

Actinic KeratosisAdenocarcinoma of EsophagusAdenocarcinoma of prostate+ [49]

Originator Organization

Pfizer Inc.

Active Organization

University of Hafr Al-Batin

Beijing Deli Furui Pharmaceutical Technology Co. Ltd.Upjohn EESV

+ [9]

Inactive Organization

Pfizer Inc.

Viatris, Inc.

Pharmacia Corp.

+ [12]

License Organization

Ethypharm SAS

Dr. Reddy's Laboratories Ltd.

Scilex Pharmaceuticals, Inc.

+ [6]

Drug Highest PhaseApproved

First Approval Date

United States (31 Dec 1998),

OsteoarthritisRheumatoid Arthritis

RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC17H14F3N3O2S

InChIKeyRZEKVGVHFLEQIL-UHFFFAOYSA-N

CAS Registry169590-42-5

806

Clinical Trials associated with Celecoxib

IRCT20200306046708N1

/ SuspendedPhase 2/3IIT

Celecoxib added to mood stabilizer for treating acute mania: A randomized, double-blind, placebo-controlled trial

Start Date15 Dec 2633

Sponsor / Collaborator

Mashhad University of Medical Sciences

NCT03590821

/ Not yet recruitingEarly Phase 1IIT

Modulating Celecoxib Induced Blood Pressure Changes by Timed Administration of Aspirin and the Human Chronobiome

To determine whether timed administration of aspirin ameliorates the effects of celecoxib on blood pressure.

Start Date01 Dec 2026

Sponsor / Collaborator

University of Pennsylvania

NCT07139405

/ Not yet recruitingPhase 2

A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, PHASE II TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND SUPERIORITY OF TRIGLYTZA® OVER METFORMIN IN PATIENTS WITH INADEQUATE GLYCEMIC CONTROL OVER 24 WEEKS OF TREATMENT

Type 2 diabetes (T2DM) is still very difficult to treat because current medicines mostly help with symptoms but don't stop the damage happening inside the pancreas. Many people who start on common treatments like Metformin, and even newer drugs like Ozempic, eventually stop responding to them. This is because these drugs don't address the real problem: the gradual loss of the pancreas' ability to make insulin and the body's increasing resistance to it.
Myopharm is developing a new treatment called TriGlytza®, which combines existing medicines (Celecoxib and Valsartan) with Metformin. This new approach is designed to target the inflammation and biological pathways that cause ongoing damage in Type 2 diabetes, aiming to protect the pancreas and reduce insulin resistance. Early animal studies and past clinical trials with the individual drugs show promising results.
The number of people with Type 2 diabetes is expected to double by 2045, and the disease brings huge health and financial costs. It also raises the risk of heart disease, stroke, kidney damage, nerve problems, vision loss, certain cancers, and even conditions like Alzheimer's. Because of this, a treatment that addresses the root causes rather than just symptoms could make a major difference.
TriGlytza® aims to provide a safe, affordable, and more effective long-term treatment than current options, helping people manage their diabetes better and avoid related health problems.

Start Date01 Feb 2026

Sponsor / Collaborator

Myopharm Ltd.

100 Clinical Results associated with Celecoxib

100 Translational Medicine associated with Celecoxib

100 Patents (Medical) associated with Celecoxib

9,702

Literatures (Medical) associated with Celecoxib

01 Jan 2026·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

A near-infrared AIE probe targeting COX-2 for imaging of Cancer cells

Article

Author: Liu, Jianxi ; Xue, Ying ; Liu, Wanhui ; Zhu, Yanping ; Shen, Li ; Zhang, Yonglin ; Wang, Aiping ; Chen, Shulin ; Xu, Lixiao ; Hu, Jiale

High expression of cyclooxygenase-2 (COX-2) in the inflammatory tumor microenvironment is a critical target for early cancer diagnosis. We designed and synthesized a series of near-infrared (NIR) fluorescent probes based on the aggregation-induced emission (AIE) mechanism for targeted COX-2 imaging. Leveraging a D-π-A quinoline-malononitrile core, we developed probes YL-180 (non-targeted control), YL-181 (celecoxib conjugate), and YL-186 (indomethacin conjugate). Notably, this work represents the first report combining this specific AIE core with established COX-2 targeting ligands, celecoxib and indomethacin, for this application. These probes exhibit characteristic AIE properties, with YL-181 showing fluorescence enhancement up to approximately 9.7-fold from pure THF in aggregated state, effectively overcoming the aggregation-caused quenching (ACQ) issue. They also possess favorable optical features including NIR emission (>650 nm) and large Stokes shifts (>200 nm). Their aggregation behavior and nanoparticle formation were characterized by DLS and TEM. In vitro cellular imaging revealed that YL-181 achieved superior tumor cell selectivity, demonstrating approximately 22-fold higher fluorescence intensity in MCF-7 cancer cells over normal HUVEC cells (around 4-fold for YL-186 over normal HUVEC cells). A competitive assay confirmed YL-181's specific COX-2 binding. Furthermore, YL-181 sensitively reflected intracellular COX-2 levels, with fluorescence decreasing by approximately 97 % from untreated upon COX-2 inhibition and increasing by around 135 % from untreated upon induction. Molecular docking and dynamics simulations provided insights into the specific binding mode and dynamic stability of YL-181 with COX-2 from an atomic perspective. In vivo imaging validated YL-181's excellent tumor targeting ability and high contrast performance in mouse models, showing a tumor-to-background ratio (TBR) of around 1.83 from normal tissue background, consistent with ex vivo organ analysis. Our highly sensitive and selective COX-2 targeted AIE probe, YL-181, holds significant potential for precise early tumor imaging.

01 Jan 2026·BIOORGANIC & MEDICINAL CHEMISTRY

Design, synthesis, and evaluation of antipyrine and nicotinic acid derivatives as anti-inflammatory agents: in vitro and in vivo studies

Article

Author: Mikhail, Demiana S ; Emam, Soha H ; Hassanin, Soha O ; Hassan, Rasha A ; Abdou, Amr M ; Khalil, Mona G ; Osman, Eman O

A series of new antipyrine and nicotinic acid-based scaffolds were synthesized and evaluated for their inhibitory activity against cyclooxygenase-1 and cyclooxygenase-2, using indomethacin and celecoxib as reference drugs. Among the synthesized compounds, 4d and 6b demonstrated the most potent COX-2 inhibition, exhibiting IC₅₀ values of 0.940 ± 0.05 μM and 0.614 ± 0.03 μM, respectively, in comparison to celecoxib (IC₅₀ = 0.844 ± 0.04 μM). Compound 4d displayed the highest COX-2 selectivity index (SI = 13.57), surpassing that of celecoxib (SI = 7.92), thereby indicating superior COX-2 selectivity. Consequently, the in vivo anti-inflammatory activity of compound 4d was comparable to that of indomethacin. Compound 4d significantly reduced paw edema, achieving edema inhibition percentages of 14.75 %, 30.77 %, and 45.33 % at the first, second, and third hours, respectively. In contrast, celecoxib exhibited the most pronounced anti-inflammatory effect, achieving edema inhibition percentages of 59.02 %, 69.23 %, and 78.67 % at the corresponding time points. Histopathological examination confirmed the absence of gastric ulceration following oral administration of compound 4d. Furthermore, it effectively lowered serum levels of prostaglandin E2 and interleukin-1β. To elucidate its selectivity and binding affinity, molecular docking of compound 4d into the COX-2 active site was conducted, revealing favorable interactions consistent with its biological activity. Collectively, these findings identify compound 4d, an antipyrine-urea hybrid with para-Cl and meta-CF₃ substitutions, as a useful lead scaffold for effective, safe, and selective COX-2 inhibitors.

01 Jan 2026·JOURNAL OF ETHNOPHARMACOLOGY

Anti-inflammatory activity of 7-methoxycoumarin isolated from Ayapana triplinervis Vahl (Compositae) via inhibition of inflammatory mediators – In-vivo, in-vitro and in-silico studies

Article

Author: Cheriyan, Binoy Varghese ; Shanmugasundaram, Jaikumar ; Nadipelly, Jagan ; Luke, Lally Hanna ; Sayeli, Vijaykumar ; Anandakumar, Shanmugam

ETHNOPHARMACOLOGICAL RELEVANCE:

Ayapana triplinervis is a medicinal plant traditionally used in South India for treating wounds and insect bites. Fresh bruised leaves are applied on affected parts. Its widespread use in wound healing inspired this study, which investigates the anti-inflammatory potential of its major bioactive compound, 7-methoxycoumarin. Since inflammation is a key component of the wound healing process, it is hypothesized that the compound's anti-inflammatory effect may underlie its traditional therapeutic efficacy.

AIM OF THE STUDY:

To evaluate the anti-inflammatory activity of 7-methoxycoumarin isolated from the leaves of Ayapana triplinervis and to elucidate its underlying mechanisms using in vivo, in vitro and in silico approaches.

MATERIAL AND METHODS:

The in vivo anti-inflammatory effect of 7-methoxycoumarin (3.5 and 7 mg/kg) was assessed in rats using the carrageenan-induced paw edema model, with indomethacin as the reference drug. In vitro assays were conducted to determine inhibition of COX-2, IL-1β and TNF-α. Molecular docking studies were carried out using Patch Dock to validate the inhibitory effect on the above inflammatory mediators.

RESULTS:

7-Methoxycoumarin significantly reduced paw edema in a dose- and time-dependent manner (p < 0.001), showing 49.78 % inhibition compared to 57.93 % by indomethacin. It inhibited COX-2 with an IC₅₀ of 17.26 μM (vs. 4.89 μM for celecoxib) and IL-1β and TNF-α with IC₅₀ values of 110.96 μM and 34.32 μM, respectively (vs. 96.10 μM and 29.20 μM for dexamethasone). Docking studies revealed good binding affinities at COX-2 (-184.30 kcal/mol), IL-1β (-158.45 kcal/mol) and TNF-α (-193.83 kcal/mol) receptors.

CONCLUSION:

The present study demonstrated the anti-inflammatory potential of 7-methoxycoumarin and provide pharmacological support for the traditional use of Ayapana triplinervis in wound healing.

355

News (Medical) associated with Celecoxib

04 Nov 2025

·www.globenewswire.com

Scilex Holding Company Announces Worldwide Exclusive License for Tokenization and Monetization of Real-World Asset (RWA) in Genomic, DNA Data, Diagnosis, Therapeutics Products, Genetic and Drug information from Datavault AI

PALO ALTO, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, today announced that it has in-licensed a worldwide exclusive license, with right to sublicense, to Datavault AI’s proprietary AI-driven technology for the use within the biotech and biopharma industry, specifically enabling the creation and operation of a Biotech Exchange platform. This license allows Scilex to leverage Datavault AI’s advanced data platforms for secure tokenization, trading, and monetization of biotech assets, including genomic, DNA data, diagnostic, therapeutic products, genetic and drug information, marking a significant step forward in the commercialization of biotech innovations. Scilex also believes that this advanced data platform will have the potential to expand into the creation of a Pharmaceutical Exchange platform which will potentially revolutionize the entire pharmaceutical industry. Scilex believes that there is an opportunity to tokenize approximately $2.0 trillion dollars pharmaceutical drug sales and diagnostic sales.1 Scilex also believes the potential of using tokenization on the exchange platform might provide an alternative vehicle for companies to raise non-dilutive funding to develop and commercialize diagnostic and therapeutic products. The license centers on Datavault AI’s robust portfolio of intellectual property, including the key pending patent for “Platform and Method for Tokenizing DNA Data” (U.S. Patent Application No. 17/941,623), which provides a framework for securely tokenizing and exchanging sensitive genetic information. This technology is supported by a suite of issued and pending patents that collectively enable the Biotech Exchange, such as: Issued: “Platform for Management of User Data” (U.S. Patent Nos. 11,593,515; 11,960,622; 12,100,025) and continuations, which facilitate secure user data handling and monetization.Issued: “Portfolio Driven Targeted Advertising Network, System, and Method” (U.S. Patent No. 11,315,150), enabling data-driven targeting in exchange ecosystems.Pending: “System and Method for Tokenized Minting, Authentication, and Utilization of Assets" (U.S. Patent Application No. 17/842,139), supporting asset tokenization for biotech applications.Pending: “Platform and Method for Tokenization of Corporate Data” (U.S. Patent Application No. 17/941,550), adaptable for biotech corporate datasets.Pending: “System and Method for Tokenized Licensing of Content” (U.S. Patent Application No. 17/842,328), for licensing biotech intellectual property.Pending: “System and Method for Tokenized Affiliate Marketing” (U.S. Patent Application No. 17/842,265), to drive partnerships in biotech data exchanges.Pending: “System and Method for Funding a Virtual Location” (U.S. Patent Application No. 17/842,220), applicable to virtual biotech marketplaces.Pending: “System and Method for Tokenized Event Management” (U.S. Patent Application No. 19/248,284), for managing biotech events and collaborations.Pending: “System and Method for Registering Claims of Ownership Rights” (U.S. Patent Application No. 18/412,128), ensuring ownership verification in data trades. These technologies collectively provide the infrastructure for a secure, efficient Biotech Exchange, allowing for the tokenization, valuation, and seamless trading of biotech data assets while maintaining compliance and privacy standards. According to the licensing agreement, Scilex shall pay a non-refundable upfront license fee in four equal installments of $2.5 million each on or before December 31, 2025, March 31, 2026, June 30, 2026, and September 30, 2026. Datavault will earn sales milestone payments of up to an aggregate of $2.55 billion upon the achievement of certain applicable sales milestones. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com For more information on ZTlido®, including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), which is owned by Semnur (a majority owned subsidiary of Scilex) and is a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. Scilex is headquartered in Palo Alto, California. About Datavault AI Inc. Datavault AI™ (Nasdaq: DVLT) is leading the way in AI driven data experiences, valuation and monetization of assets. The company’s cloud-based platform provides comprehensive solutions with a collaborative focus in its Acoustic Science and Data Science Divisions. Datavault AI’s Acoustic Science Division features WiSA®, ADIO® and Sumerian® patented technologies and industry-first foundational spatial and multichannel wireless HD sound transmission technologies with IP covering audio timing, synchronization and multi-channel interference cancellation. The Data Science Division leverages the power of high-performance computing to provide solutions for experiential data perception, valuation and secure monetization. Datavault AI’s cloud-based platform provides comprehensive solutions serving multiple industries, including HPC software licensing for sports & entertainment, events & venues, biotech, education, fintech, real estate, healthcare, energy and more. The Information Data Exchange® (IDE) enables Digital Twins, licensing of name, image and likeness (NIL) by securely attaching physical real-world objects to immutable metadata objects, fostering responsible AI with integrity. Datavault AI’s technology suite is completely customizable and offers AI and Machine Learning (ML) automation, third-party integration, detailed analytics and data, marketing automation and advertising monitoring. The company is headquartered in Philadelphia, PA. Learn more about Datavault AI at www.dvlt.ai Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts and may be accompanied by words that convey projected future events or outcomes, such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” or variations of such words or by expressions of similar meaning. These forward-looking statements include, but are not limited to, statements regarding future events, Scilex’s ability to leverage Datavault’s platforms for secure tokenization, trading, and monetization of biotech assets, Scilex’s ability to create a [Pharmaceutical Exchange platform], Scilex’s expectations as to the opportunity to tokenize pharmaceutical drug sales and diagnostic sales, including the size of such opportunity, future opportunities for Scilex and its subsidiaries, the future business strategies, long-term objectives and commercialization plans of Scilex and its subsidiaries, the current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity of Scilex and its subsidiaries, statements regarding SP-102, if approved by the FDA, Scilex’s potential to attract new capital and avoid the effects of negative debt leverage and other statements that are not historical facts. These statements are based on management’s current expectations of and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Scilex. These statements are subject to a number of risks and uncertainties regarding Scilex’s business, and actual results may differ materially. These risks and uncertainties include, but are not limited to, general economic, political and business conditions; the ability of Scilex and its subsidiaries to achieve the benefits of the transactions contemplated with Datavault, including future financial and operating results; risks related to the outcome of any legal proceedings that may be instituted against the parties regarding the transactions contemplated with Datavault, including the license agreement and Scilex’s intended use for the licensed material; the risk that the transactions contemplated with Datavault disrupts current plans and operations; the ability of Scilex and its subsidiaries to develop and successfully market products; the ability of Scilex and its subsidiaries to grow and manage growth profitably and retain its key employees; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the prior results of the clinical trials may not be replicated; regulatory and intellectual property risks; the risk of failure to realize the anticipated benefits of the transactions contemplated with Datavault; the risk that Scilex will not be able to develop, commercialize or benefit from a [Pharmaceutical Exchange platform] and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the SEC. There may be additional risks that Scilex presently does not know or that Scilex currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Scilex’s expectations, plans or forecasts of future events and views as of the date of the communication. Scilex anticipates that subsequent events and developments will cause such assessments to change. However, while Scilex may elect to update these forward-looking statements at some point in the future, Scilex specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Scilex’s assessments as of any date subsequent to the date of this communication. Accordingly, investors are cautioned not to place undue reliance on these forward-looking statements. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com 1 References Sources for Pharmaceutical Drug Sales Data The data for global pharmaceutical drug sales was primarily drawn from IQVIA Institute reports on global medicine spending, excluding COVID-19 vaccines and therapeutics for consistency. Here is the list of key sources referenced: The Global Use of Medicines Outlook Through 2029 by IQVIA Institute (Published June 26, 2025). This report provides historical spending from 2020-2024 and forecasts through 2029, including the 5-8% CAGR projection. URL: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-global-use-of-medicines-outlook-through-2029 The Global Use of Medicines 2025: Outlook to 2029 (PDF Presentation) by IQVIA (Published August 27, 2025). This includes details on the 38% growth over the past five years and forward projections. URL: https://www.iqvia.com/-/media/iqvia/pdfs/events/presentation_global-meds-webinar_public.pdf Global Medicine Spending and Usage Trends by IQVIA. This outlines projections to exceed $1.1 trillion in 2024 with 2-5% annual growth. URL: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-medicine-spending-and-usage-trends Sources for Diagnostic Sales Data The data for global in vitro diagnostics (IVD) market sales was compiled from market research reports, with forecasts based on observed CAGRs (around 6.9% from 2020-2024). IQVIA provides qualitative insights, but quantitative figures were cross-referenced from other industry analyses for accuracy. Here is the list of key sources referenced: Unlock Insights with Global In Vitro Diagnostic (IVD) Market Data by IQVIA MedTech (Published October 24, 2025). This fact sheet discusses market size, revenue trends, and competitive performance. URL: https://www.iqvia.com/library/fact-sheets/unlock-insights-with-global-in-vitro-diagnostic-market-data In Vitro Diagnostic (IVD) Market Data (PDF Brochure) by IQVIA. Provides analysis of the worldwide IVD molecular diagnostics market with revenue estimates. URL: https://www.iqvia.com/-/media/iqvia/pdfs/library/fact-sheets/2025/iqvia-medtech---ivd-solution-brochure.pdf Navigating the Future of In Vitro Diagnostics by IQVIA (Published September 27, 2024). Covers IVD market evolution in 2024, driven by tech and regulations. URL: https://www.iqvia.com/blogs/2024/09/navigating-the-future-of-in-vitro-diagnostics In Vitro Diagnostics Market Size, Share | Industry Report, 2030 by Grand View Research. Estimates 2024 at USD 108.30 billion with projections to 2030. URL: https://www.grandviewresearch.com/industry-analysis/in-vitro-diagnostics-ivd-market In-vitro Diagnostics Market Size, Growth Outlook 2025–2034 by Global Market Insights. 2024 estimate at USD 105.7 billion, with growth to 2025 and beyond. URL: https://www.gminsights.com/industry-analysis/in-vitro-diagnostics-market In Vitro Diagnostics Market Growth, Drivers, and Opportunities by MarketsandMarkets. 2024 at $101.06 billion, 2025 at $109.07 billion, with 7.6% CAGR. URL: https://www.marketsandmarkets.com/Market-Reports/ivd-in-vitro-diagnostics-market-703.html In-vitro Diagnostics [IVD] Market Size, Trends | Growth, 2032 by Fortune Business Insights. Projections from 2025 at $77.73 billion to 2032. URL: https://www.fortunebusinessinsights.com/industry-reports/in-vitro-diagnostics-ivd-market-101443 In Vitro Diagnostics - Worldwide | Statista Market Forecast. Forecasted revenue of US$92.03 billion by 2025. URL: https://www-statista-com.libproxy1.nus.edu.sg/outlook/hmo/medical-technology/in-vitro-diagnostics/worldwide In Vitro Diagnostics Market Size & Outlook, 2026-2034 by Straits Research. 2024 at USD 82.98 billion, 2025 at USD 86.51 billion. URL: https://straitsresearch.com/report/in-vitro-diagnostics-market SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a majority-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. Scilex Bio™ is a trademark owned by Scilex Holding Company, Inc. All other trademarks are the property of their respective owners. © 2025 Scilex Holding Company All Rights Reserved.

Phase 3Fast TrackPhase 2License out/inDrug Approval

08 Oct 2025

·www.businesswire.com

Kiel Laboratories Reaches New Milestone With Its 16th New Drug Application Approval

FLOWERY BRANCH, Ga.--(BUSINESS WIRE)--Kiel Laboratories, a leading strategic consulting and pharmaceutical services provider, announced the successful approval of its 16th New Drug Application (NDA) through the U.S. Food and Drug Administration (FDA), solidifying its reputation as a trusted partner in drug development and regulatory strategy. “This latest NDA approval highlights Kiel Laboratories' ability to pair strategic regulatory guidance with execution,” said Greg Thomas, Ph.D., vice president of research and development. The approval of Vyscoxa™ marks a significant achievement in both formulation science and regulatory strategy. To address the challenges of developing an oral suspension, the team incorporated a novel excipient, a key component of the system. In combination with other functional ingredients, the formulation delivered improved dose uniformity, long-term stability, controlled dissolution, and better palatability. Because the excipient was critical to the product’s performance, obtaining FDA approval was essential. This process required rigorous regulatory work, including thorough DMF reviews and toxicology evaluations. Bringing this novel excipient from concept to an FDA-approved product showcases Kiel’s expertise in both drug development and regulatory execution. “The decision confirms the strength of our scientific rigor and its relevance for people living with rheumatic diseases,” said Roy Bryant, senior director of technical services. “This milestone reflects our unwavering commitment to delivering high-quality, patient-centric pharmaceutical solutions.” “This latest approval highlights Kiel Laboratories’ ability to pair strategic regulatory guidance with execution,” said Greg Thomas, Ph.D., vice president of research and development. “We remain at the forefront, delivering regulatory excellence and accelerating time to market for life-changing therapies.” Founded in 1991 by Dr. Jeff Kiel, Kiel Laboratories has built a legacy of excellence in pharmaceutical R&D, specializing in 505(b)(2) and orphan drug submissions. As the pharmaceutical industry continues to evolve, Kiel Laboratories remains at the forefront delivering tailored, end-to-end support across strategy, consulting, and execution and accelerating time to market for life-changing therapies. About Kiel Laboratories Kiel Laboratories is a pharmaceutical R&D company offering cGMP consulting and non-GMP technical services throughout an entire product lifecycle. With over 30 years of experience and 16 NDA approvals, we provide formulation, analytical, quality, and regulatory support backed by insider expertise from the development of innovative, generic, and OTC products. Acting as an extension of your team, Kiel delivers flexible, end-to-end solutions that anticipate challenges and accelerate your path to market. To explore our services, visit kiellaboratoriesinc.com.

Orphan DrugNDA

06 Oct 2025

·www.prnewswire.com

NeuroSense: PrimeC Produces Statistically Significant Reductions in Alzheimer's Disease Biomarkers

CAMBRIDGE, Mass., Oct. 6, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced new positive findings based on plasma samples from its Phase-2b PARADIGM study. These results indicate that PrimeC produced robust, statistically significant reductions in multiple microRNAs that are consistently implicated in Alzheimer's disease pathology - changes that reflect reduction of neuroinflammatory and neurodegenerative activity. Key Highlights - PrimeC treatment significantly reduced several AD-associated microRNAs, including miR-146a-5p (p=0.007), miR-21-5p (p=0.003), miR-let-7a-5p (p=0.028) and miR-let-7e-5p (p=0.006), measured as change from baseline, while no significant change was observed in the placebo group over time. MicroRNAs are master regulators of gene expression. The miRNAs described above are associated with neuroinflammation, amyloid and tau pathology, synaptic dysfunction which relate to a cognitive decline. By lowering these biomarkers, PrimeC demonstrated the ability to directly target biological pathways central to AD progression, supporting its potential as a disease-modifying therapy. Alon Ben-Noon, Chief Executive Officer of NeuroSense, said: "These biomarker data provide a clearer view of how our novel combination modulates biological pathways implicated in Alzheimer's disease. The magnitude and consistency of the observed miRNA changes are highly encouraging and, together with our Phase 2 clinical findings, will inform a design of follow-on AD study, all while we continue to advance PrimeC's Phase 3 readiness program in ALS." About Alzheimer's Disease Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families. About PrimeC PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS and AD. About PARADIGM PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation. Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug. About NeuroSense NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases. For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels. Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law. Logo: SOURCE NeuroSense WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical Result

100 Deals associated with Celecoxib

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KEGG	Wiki	ATC	Drug Bank
D00567	Celecoxib	L01XX33 M01AH01	DB00482

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	United States	Scilex Pharmaceuticals, Inc.	05 May 2020
Pain	Japan	Astellas Pharma, Inc.	22 Dec 2011
Toothache	Japan	Viatris Pharmaceutical GK	22 Dec 2011
Bursitis	Japan	Viatris Pharmaceutical GK	17 Jun 2009
Cervicobrachial syndrome	Japan	Astellas Pharma, Inc.	17 Jun 2009
Cervicobrachial syndrome	Japan	Viatris Pharmaceutical GK	17 Jun 2009
Low Back Pain	Japan	Viatris Pharmaceutical GK	17 Jun 2009
Low Back Pain	Japan	Astellas Pharma, Inc.	17 Jun 2009
Periarthritis	Japan	Astellas Pharma, Inc.	17 Jun 2009
Tendinopathy	Japan	Astellas Pharma, Inc.	17 Jun 2009
Tendinopathy	Japan	Viatris Pharmaceutical GK	17 Jun 2009
Tenosynovitis	Japan	Viatris Pharmaceutical GK	17 Jun 2009
Analgesia	Japan	Viatris Pharmaceutical GK	26 Jan 2007
Inflammation	Japan	Viatris Pharmaceutical GK	26 Jan 2007
Juvenile Idiopathic Arthritis	United States	Upjohn US 2 LLC	15 Dec 2006
Primary dysmenorrhea	United States	Upjohn US 2 LLC	18 Oct 2001
Acute Pain	China	Viatris Pharmaceuticals LLC	01 Aug 2000
Ankylosing Spondylitis	Austria	Upjohn EESV	29 Mar 2000
Ankylosing Spondylitis	Belgium	Upjohn EESV	29 Mar 2000
Ankylosing Spondylitis	Cyprus	Upjohn EESV	29 Mar 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine With Aura	NDA/BLA	Canada	Scilex Holding Co.	26 Dec 2023
Migraine Without Aura	NDA/BLA	Canada	Scilex Holding Co.	26 Dec 2023
Actinic Keratosis	Phase 3	United States	Dr. Reddy's Laboratories Ltd. (Russia)	14 Feb 2017
Arthritis, Gouty	Phase 3	United States	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	Canada	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	Colombia	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	Costa Rica	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	Mexico	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	Peru	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	Philippines	Viatris, Inc.	01 Feb 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2025	Not Applicable	Axial Spondyloarthritis	30	Celecoxib	xvkwqvmwrh(pigjripdep) = Adverse events were infrequent and mild across all NSAIDs, with only one serious adverse event (diarrhea) reported. kmntraxzte (egcvzjnwyx ) View more	Positive	24 Oct 2025
				Meloxicam
GlobeNewswire Manual	Not Applicable	Post Acute COVID 19 Syndrome	27	Valacyclovir + Celecoxib + Pulsed Paxlovid	epvutkqehn(aqwqqypahn): P-Value = <0.0001 View more	Positive	04 Sep 2025
				Valacyclovir + Celecoxib
NCT00652925 (FDA_CDER) Manual	Phase 3	Juvenile Idiopathic Arthritis	-	CELECOXIB 3 mg/kg	zxkmamtkno(ermbdszsov) = iwhypdzjer ptrgufxaoc (fyzqwbdytx )	Positive	29 Jul 2025
				CELECOXIB 6 mg/kg	zxkmamtkno(ermbdszsov) = wysldbutal ptrgufxaoc (fyzqwbdytx )
ASCO2025	Not Applicable	Advanced Head and Neck Squamous Cell Carcinoma	97	Dual Oral Metronomic Therapy (OMT)	aqistvfiys(yfjarxwojh) = olsdthjhur byfnoggldy (luropknzbq ) View more	Positive	30 May 2025
				Triple Oral Metronomic Therapy (OMT)	aqistvfiys(yfjarxwojh) = ppreymvuql byfnoggldy (luropknzbq ) View more
AHNS2025	Not Applicable	-	145	Patient-controlled analgesia (PCA) with intravenous opioids	-	Positive	14 May 2025
				standing regimen of oral acetaminophen and celecoxib (with or without gabapentin) with oral opioids for breakthrough pain	oswsoyobky(bmihbhobax) = yujndrbehl hcikisgfou (jitmacezeu ) View more
AACR2025	Phase 1/2	Colorectal Cancer	-	Eltanexor (KPT-8602)	azacsdjwld(zkkcflbior) = opqwetbdml kztkkuylaw (gqkhloqqkx )	Positive	28 Apr 2025
NCT04162873 (CTgov)	Phase 2	Hypopharyngeal Carcinoma \| Squamous cell carcinoma of the oral cavity recurrent \| Sinonasal Carcinoma ... View more	13	Quality-of-Life Assessment+celecoxib (Celecoxib Arm)	fjhgahztrx(yfhzsrmjmw) = ohckgoowlj gwvbfuzeyh (eokrfehyvw, 9.19) View more	-	12 Feb 2025
				Placebo (Placebo Arm)	fjhgahztrx(yfhzsrmjmw) = hidasmbxtx gwvbfuzeyh (eokrfehyvw, 20.04) View more
NCT05974501 (CTgov)	Phase 4	complications of arthroplasty \| Osteoarthritis, Knee \| Pain, Postoperative	84	Lyrica+Ropivacaine+Acetaminophen+Oxycodone+Dexamethasone+Celebrex+Meloxicam (Preoperative Adductor Canal Block Group)	xcjjuadxvm(viuaocjlhy) = sszcnvnjpn hcjbaupmzj (jfpqutljnq, cfcprrhdjb - fyorqvipze) View more	-	12 Feb 2025
				Lyrica+Ropivacaine+Acetaminophen+Oxycodone+Dexamethasone+Celebrex+Meloxicam (Postoperative Adductor Canal Block Group)	xcjjuadxvm(viuaocjlhy) = posdbayght hcjbaupmzj (jfpqutljnq, jqzkyfbdyx - ougrinofjh) View more
NCT01150045 (CALGB/SWOG 80702, ASCO_GI2025)	Phase 3	Stage III Colon Cancer Adjuvant ctDNA positive	-	Celecoxib + FOLFOX	nzdalllsrj(xijlgjfvgm) = sgxgirddvk bruycmrnty (chqyaxpwnw )	Positive	23 Jan 2025
				Placebo + FOLFOX	nzdalllsrj(xijlgjfvgm) = tsbpcexpqh bruycmrnty (chqyaxpwnw )
NCT03643744 (CTgov)	Phase 1	Actinic Keratosis	12	Celecoxib 200mg (PDT + Celecoxib)	juplecneee(pkrlslyipx) = ubprbqeqsa eiugudrkzv (hbzzdclbyw, 107) View more	-	19 Dec 2024
				Placebo (PDT + Placebo)	juplecneee(pkrlslyipx) = okygjenyft eiugudrkzv (hbzzdclbyw, 19) View more

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