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Last update 08 Sep 2025

Celecoxib

Last update 08 Sep 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

+ [23]

Target

COX-2

Action

inhibitors

Mechanism

COX-2 inhibitors(Cyclooxygenase-2 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [7]

Active Indication

Migraine DisordersPainToothache+ [18]

Inactive Indication

Actinic KeratosisAdenocarcinoma of EsophagusAdenocarcinoma of prostate+ [49]

Originator Organization

Pfizer Inc.

Active Organization

Scilex Pharmaceuticals, Inc.

Carwin Pharmaceutical Associates LLCUpjohn EESV

+ [9]

Inactive Organization

Pfizer Inc.

Viatris, Inc.Dr. Reddy's Laboratories Ltd. (Russia)

+ [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

791

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

10,148

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 ; Zhang, Yonglin ; Shen, Li ; 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 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Protective effect of celecoxib against capecitabine induced hand and foot syndrome in patients with colorectal Cancer

Article

Author: Kettana, Ahmed M ; Mostafa, Tarek M ; Ghannam, Amr A ; El-Afify, Dalia R

BACKGROUND:

Hand-foot syndrome (HFS) is the most common adverse effect of capecitabine.

OBJECTIVE:

We aimed at evaluating the protective effect of celecoxib against capecitabine induced hand and foot syndrome in patients with colorectal cancer (CRC).

METHODS:

In this randomized controlled parallel study, 44 newly diagnosed patients with stage II CRC were randomly allocated into two groups; Group 1(control group; n = 22) which received 6 cycles of capecitabine-based chemotherapy (cycle is every 3 weeks) and group 2 (celecoxib group; n = 22) which received 6 cycles of capecitabine-based chemotherapy (cycle is every 3 weeks) in addition to 200 mg of oral celecoxib twice daily for 14 days of the 3-week cycle. At baseline and after the 6th chemotherapy cycle the patients' quality of life (QOL) was assessed using hand and foot syndrome (HFS) specific QOL questionnaire (HFS-14). Moreover, blood samples were collected in order to evaluate the serum levels of cyclooxygenase-2 (COX-2), tumour necrosis factor-alpha (TNF-α) and malondialdehyde (MDA). Data was analysed using paired and un-paired t-tests.

RESULTS:

At the end of the study and as compared to control group, celecoxib treated group showed significantly lower incidence of HFS (P = 0.015). Additionally, celecoxib treated group showed significant decline in the serum levels of TNF-α (P = 0.016) and MDA (P = 0.014) which was associated with non-significant difference in the serum level of COX-2 between the two groups (P = 0.476). Celecoxib was safe and well-tolerated throughout the study period.

CONCLUSION:

Celecoxib may represent a potential protective agent against capecitabine induced hand and foot syndrome in patients with colorectal cancer.

01 Dec 2025·BIOORGANIC & MEDICINAL CHEMISTRY

Virtual screening, synthesis, optimization and anti-inflammatory activity of novel chromones as specific COX-2 inhibitors

Article

Author: Yu, Shuyan ; Zhang, Mengdi ; Wang, Min ; Chen, Jianping ; Wang, Laibing ; Guo, Huiqing ; Qin, Meng ; Ma, Yuheng

In this study, we pioneered the use of SMARTS screening to construct a chromone database, and the Discovery Studio was used to achieve precise molecular docking of COX-2 through LibDock and CDOCKER, and successfully locked 7 hit compounds from the massive chromone library. In cell experiments, Q7 had a significant inhibitory effect on LPS-induced PGE₂ (IC₅₀ = 68.23 ± 8.94 μM) and NO (IC₅₀ = 44.83 ± 2.01 μM) in RAW264.7 cells, and its anti-inflammatory activity was superior to that of the traditional anti-inflammatory agents ibuprofen [IC₅₀(PGE₂) = 246.5 ± 3.8 μM] and L-canavanine [IC₅₀(NO) = 440.0 ± 7.9 μM]. Still, the activity was not as good as that of celecoxib [IC₅₀ (PGE₂) = 0.882 ± 0.021 μM], and the western blot of Q7 further confirmed its targeted inhibition of COX-2. On this basis, the structure of Q7 was optimized by flexible docking design, and 30 Q7 derivatives were synthesized one by one, all of which showed certain anti-inflammatory activities, among which Q7-9 [IC₅₀(PGE₂) = 0.209 ± 0.022 μM, IC₅₀(COX-2) = 0.121 ± 0.010 μM], Q7-25 [IC₅₀(PGE₂) = 0.267 ± 0.017 μM, IC₅₀(COX-2) = 0.228 ± 0.021 μM] and Q7-26 [IC₅₀(PGE₂) = 0.161 ± 0.018 μM, IC₅₀(COX-2) = 0.137 ± 0.004 μM] exhibited anti-inflammatory activity better than celecoxib and had a moderate selectivity index (SI_Q7_-₉ > 826). Q7-28 (IC₅₀ = 0.014 ± 0.001 μM) and Q7-29 (IC₅₀ < 0.0128 μM) had significant inhibitory effects on NO. In addition, by constructing a 3D-QSAR model, the anti-inflammatory structures of chromone and isoflavone molecules for COX-2 and iNOS targets were systematically revealed. This study provided an important reference and basis for the research and development of new chromone non-steroidal anti-inflammatory drugs, and Q7-9 was expected to be a candidate drug with high safety and specific COX-2 inhibitors.

346

News (Medical) associated with Celecoxib

04 Sep 2025

·www.globenewswire.com

Semnur Pharmaceuticals, Inc. (“Semnur”), a Majority-Owned Subsidiary of Scilex Holding Company (Nasdaq: SCLX, “Scilex”), and Denali Capital Acquisition Corp. Announce Approval from Denali’s Shareholders of the Previously Announced Business Combination

PALO ALTO, Calif, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Semnur Pharmaceuticals, Inc. (“Semnur”), a majority-owned subsidiary of 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 the shareholders of Denali Capital Acquisition Corp (“Denali”) approved the previously announced business combination with Semnur (the "Business Combination"). The Business Combination was approved by Denali’s shareholders at its Extraordinary General Meeting held on September 3, 2025 (the “Meeting”), along with all other proposals presented at the Meeting, each of which were set forth in the definitive proxy statement/prospectus filed by Denali with the U.S. Securities and Exchange Commission (the “SEC”) on August 13, 2025. The combined company will operate as Semnur Pharmaceuticals, Inc. upon consummation of the Business Combination, which is expected to close in September 2025, subject to satisfaction of customary closing conditions. Denali has filed a Current Report on Form 8-K with the SEC to disclose the full voting results of the Meeting. 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 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 Semnur Pharmaceuticals, Inc. Semnur is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California About Denali Capital Acquisition Corp. Denali is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. 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, the Business Combination between Semnur and Denali, the estimated or anticipated future results and benefits of the combined company following the Business Combination, including the likelihood and ability of the parties to successfully consummate the Business Combination, future opportunities for the combined company, and other statements that are not historical facts. These statements are based on the current expectations of management of the Company, Semnur and Denali 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 the Company, Semnur and Denali. These statements are subject to a number of risks and uncertainties regarding the Company’s, Semnur’s and Denali’s businesses and the Business Combination, and actual results may differ materially. These risks and uncertainties include, but are not limited to, general economic, political and business conditions; the inability of the parties to consummate the Business Combination or the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement for the Business Combination; the outcome of any legal proceedings that may be instituted against the parties following the announcement of the Business Combination; the receipt of an unsolicited offer from another party for an alternative business transaction that could interfere with the Business Combination; failure to realize the anticipated benefits of the Business Combination, including as a result of a delay in consummating the potential transaction or difficulty in integrating the businesses of Semnur or Denali; the risk that the Business Combination disrupts current plans and operations as a result of the announcement and consummation of the Business Combination; the ability of the combined company to develop and successfully market SP-102 or other products; the ability of the combined company to grow and manage growth profitably and retain its key employees; the inability to obtain or maintain the listing or trading of the post-acquisition company’s securities on The Nasdaq Stock Market LLC or the over-the-counter markets, as applicable, following the Business Combination; and costs related to the Business Combination. There may be additional risks that Semnur and the Company presently do not know or that Semnur or the Company currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Semnur’s, the Company’s and Denali’s expectations, plans or forecasts of future events and views as of the date of the communication. Semnur and the Company anticipate that subsequent events and developments will cause such assessments to change. However, while Semnur and the Company may elect to update these forward-looking statements at some point in the future, each of Semnur and the Company specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing Semnur’s or the Company’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 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.

Drug ApprovalPhase 2Fast TrackPhase 3

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

13 Aug 2025

·www.globenewswire.com

Dogwood Therapeutics Reports Second Quarter 2025 Financial Results

- Enrollment to-date of 52 patients in the ongoing Halneuron® Phase 2b Trial - - Halneuron® Chemotherapy-Induced Neuropathic Pain (“CINP”) Phase 2b study interim data readout remains on track for Q4 2025 - - Low discontinuation rate (5.8%) due to adverse events in the first 38 patients completing the trial suggests Halneuron® and placebo treatment have been generally well tolerated - - Cash on hand of $13.4 million provides operational runway through Q1 2026 - ATLANTA, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and fatigue-related disorders, today announced financial results for the second quarter ended June 30, 2025. “With no FDA approved treatments to manage the neuropathic pain often resulting from chemotherapy treatment, we have the opportunity to potentially enjoy the benefits of being the first and only approved CINP treatment,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Further, we believe Halneuron’s® clinically significant effects in treating both general cancer pain and chemotherapy induced neuropathic pain highlights the significant potential to expand our NaV 1.7 research pipeline to other forms of pain, including diabetic peripheral neuropathy, post herpetic neuralgia and acute surgical pain.” “The NaV 1.7 sodium channel plays a fundamental role in pain transmission, so modulation of this pathway is likely to be applicable to the treatment of both chronic and acute pain states” said Michael Gendreau, MD, PhD, Chief Medical Officer of Dogwood Therapeutics. “A genetic lack of functioning NaV 1.7 channels leads to a condition known as Congenital Insensitivity to Pain Syndrome, a disorder characterized by the inability to feel pain. Patients who suffer from this condition illustrate the critical role NaV 1.7 function represents as a pain treatment target.” Key Highlights To-date, the Company has enrolled 52 patients in its ongoing Halneuron® Phase 2b CINP program this quarter, with potential to be the first FDA approved therapy for the treatment of CINP. Dogwood Therapeutics Proprietary Pipeline Includes: Halneuron® is in Phase 2b development as a non-opioid, NaV 1.7 inhibitor to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the Food and Drug Administration (“FDA”) for the treatment of CINP. Interim data from the ongoing Phase 2b CINP study are expected in Q4 2025.IMC-1 (famciclovir + celecoxib) is ready for Phase 3 development as a combination antiviral treatment for Fibromyalgia (“FM”). IMC-1 has been granted fast track designation by the FDA for the treatment of FM.IMC-2 (valacyclovir + celecoxib) is in Phase 2a development as a combination antiviral treatment for Long-COVID. Given the importance of Health and Human Services and Medicaid and Medicare funding of both COVID research and reimbursement of treatment, pervasive reductions in government health funding have resulted in us pausing current external research funding and partnership discussions until we have greater clarity on the commitment of U.S. Government resources to COVID illness. Second Quarter 2025 Financial Results Research and development expenses for the second quarter of 2025 were $2.5 million, compared to $0.3 million for the second quarter of 2024. The $2.2 million increase quarter over quarter was primarily due to the impact of the business combination with Pharmagesic (the “Combination”) including increases in expenses for clinical trials of $1.6 million related to the Halneuron® CINP Phase 2b study, as well as drug development and manufacturing costs of $0.5 million and salaries and related personnel costs of $0.2 million, offset by a decrease in regulatory costs of $0.1 million. General and administrative expenses for the second quarter of 2025 were $1.3 million, compared to $0.7 million for the second quarter of 2024. The $0.6 million increase quarter over quarter was primarily due to increases in legal and accounting fees of $0.2 million, salaries and related personnel costs of $0.2 million, expenses associated with being a public company of $0.1 million and other general and administrative costs of $0.1 million. Net loss attributable to common stockholders for the second quarter of 2025 was $3.8 million, or $1.99 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $1.0 million, or $1.15 basic and diluted net loss per share, for the second quarter of 2024. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline includes two separate mechanistic platforms with a non-opioid analgesic program and an antiviral program. The proprietary, non-opioid, NaV 1.7 analgesic program is centered on our lead development candidate, Halneuron®, which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic chemotherapy-induced neuropathic pain (“CINP”). Interim data from the ongoing Halneuron® Phase 2 CINP study are expected in Q4 of 2025. Dogwood’s antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib. These combination antiviral approaches are being applied to the treatment of illnesses believed to be related to reactivation of previously dormant herpesviruses, including fibromyalgia (“FM”) and Long-COVID (“LC”). IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities. IMC-2 has been assessed in both active control and double-blind, placebo-controlled clinical trials and, in both cases, demonstrated successful reduction of the fatigue associated with LC. The company has reached an agreement with FDA on using reduction in fatigue as the primary endpoint for future IMC-2 LC research. For more information, please visit www.dwtx.com. Forward-Looking Statements: Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, 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,” “suggest,” “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 Dogwood’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Dogwood’s product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2024, which has been filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law. Investor Relations: CORE IR(516) 222-2560IR@dwtx.com -Financial Tables Follow- DOGWOOD THERAPEUTICSSelected Financial Data (unaudited) Condensed Statements of Operations DataThree Months EndedJune 30, Six Months EndedJune 30, 2025 2024 2025 2024 Revenue$— $— $— $— Operating expenses: Research and development 2,569,943 336,084 5,006,941 679,801 General and administrative 1,353,172 733,740 3,346,100 1,704,124 Total operating expenses 3,923,115 1,069,824 8,353,041 2,383,925 Loss from operations (3,923,115) (1,069,824) (8,353,041) (2,383,925)Other (expense) income: Loss on debt conversion with related party — — (6,134,120) — Interest income (expense), net 111,379 19,991 (35,711) 42,757 Exchange gain (loss), net 4,532 — (18,742) — Total other income (expense), net 115,911 19,991 (6,188,573) 42,757 Loss before income taxes (3,807,204) (1,049,833) (14,541,614) (2,341,168)Deferred income tax provision (149) — (190,691) — Net Loss (3,807,353) (1,049,833) (14,732,305) (2,341,168)Accrual of paid-in-kind dividends on Series A non-voting convertible preferred stock — — (1,256,662) — Net loss attributable to common stockholders$(3,807,353) $(1,049,833) $(15,988,967) $(2,341,168)Net loss per share of common stock — basic and diluted$(1.99) $(1.15) $(9.51) $(2.78)Weighted average shares outstanding — basic and diluted 1,911,128 916,031 1,680,827 843,174 Condensed Consolidated Balance Sheet DataJune 30, December 31, 2025 2024 Cash$13,402,809 $14,847,949 Total assets 96,692,527 94,308,246 Total liabilities 14,151,904 30,027,223 Total stockholders’ equity (deficit) 6,878,599 (10,124,339) Source: Dogwood Therapeutics, Inc.

Phase 2Financial StatementFast Track

100 Deals associated with Celecoxib

External Link

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


NCT00652925 (FDA_CDER) Manual	Phase 3	Juvenile Idiopathic Arthritis	-	CELECOXIB 3 mg/kg	wzqtaksckj(xzgaoixjuw) = szejdtmbfs tykqmoaero (dhjvwuydlt )	Positive	29 Jul 2025
				CELECOXIB 6 mg/kg	wzqtaksckj(xzgaoixjuw) = bnamsjsifh tykqmoaero (dhjvwuydlt )
ASCO2025	Not Applicable	Advanced Head and Neck Squamous Cell Carcinoma	97	Dual Oral Metronomic Therapy (OMT)	hzdgldfljw(cujobcvxbn) = xeeuzsoawo egkbvakklo (xbbkrkclov ) View more	Positive	30 May 2025
				Triple Oral Metronomic Therapy (OMT)	hzdgldfljw(cujobcvxbn) = crrfycqkjb egkbvakklo (xbbkrkclov ) View more
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)	zvoowqckaz(ghfbajguwl) = okiljfhuhb vdbfuupzqr (yghjzupogq, 9.19) View more	-	12 Feb 2025
				Placebo (Placebo Arm)	zvoowqckaz(ghfbajguwl) = losmteemzr vdbfuupzqr (yghjzupogq, 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)	gtyjjlynpn(byaixlutfd) = iklwixkkmf kmznqgwypa (prqziznvli, kwloukzsjw - guamfdupoh) View more	-	12 Feb 2025
				Lyrica+Ropivacaine+Acetaminophen+Oxycodone+Dexamethasone+Celebrex+Meloxicam (Postoperative Adductor Canal Block Group)	gtyjjlynpn(byaixlutfd) = uezaikjuss kmznqgwypa (prqziznvli, fclsjjaetj - lofrooropt) View more
NCT01150045 (CALGB/SWOG 80702, ASCO_GI2025)	Phase 3	Stage III Colon Cancer Adjuvant ctDNA positive	-	Celecoxib + FOLFOX	rjvzfildjr(wcdjwvyghs) = mwhviafmni kodfjhtlnn (pajkxtkqdl )	Positive	23 Jan 2025
				Placebo + FOLFOX	rjvzfildjr(wcdjwvyghs) = mtnpixbixs kodfjhtlnn (pajkxtkqdl )
NCT03643744 (CTgov)	Phase 1	Actinic Keratosis	12	Celecoxib 200mg (PDT + Celecoxib)	gmowwiehrv(usnvlbarkf) = aaqwuezcts fmdkokmoxi (nnwixemkqr, 107) View more	-	19 Dec 2024
				Placebo (PDT + Placebo)	gmowwiehrv(usnvlbarkf) = mlmbvgoxla fmdkokmoxi (nnwixemkqr, 19) View more
NCT04765644 (ASCENT, CTgov)	Phase 4	-	44	celecoxib+L-arginine (Celecoxib)	wnquojssld(kksbiousrv) = bafezcvmgv aupzembozi (urobresjeq, 0.35) View more	-	28 Oct 2024
				Placebo+L-arginine + placebo (Placebo)	wnquojssld(kksbiousrv) = sapbxqoybi aupzembozi (urobresjeq, 0.33) View more
NCT03859024 (CTgov)	Phase 4	Urethral Stricture \| Pain, Postoperative	48	Acetaminophen+Oxycodone+Ibuprofen 800 mg (Standard Protocol)	xtluqgjbfn(ghonmztpfz) = cbgqqdqsbb cwznyyghwm (jhlugambns, cvifnfmvup - yjpjdqfeyh) View more	-	19 Sep 2024
				Acetaminophen+Oxycodone+Dexamethasone+Ibuprofen 800 mg+Bupivacaine+celebrex+Gabapentin (Enhanced Recovery Protocol)	xtluqgjbfn(ghonmztpfz) = juztednchk cwznyyghwm (jhlugambns, dgcdvzpddu - peqvacrfsd) View more
NCT05077969 (CTgov)	Phase 2	SARS-CoV-2 acute respiratory disease	4	Famotidine+celecoxib (Group 1 (Study Product))	deksgupziu = kubilkxsaa qaymngemgy (fbsbieozqs, svvfwaifth - dobrbakezr) View more	-	09 Jul 2024
				Placebo (Group 2 (Reference Therapy))	deksgupziu = ithvcfjffv qaymngemgy (fbsbieozqs, nldfwkcgcy - vyxdqaiiyc) View more
NCT04015908 (CTgov)	Phase 4	-	100	Pregabalin+Acetaminophen+Oxycodone+celecoxib (Multi-modal)	baruajiocn(uricdvcgce) = cyynnbimmc khwjusecbu (xxhbkbwgum, entmhdbqxf - tzwspxitwh) View more	-	08 Jul 2024
				Percocet (Control)	baruajiocn(uricdvcgce) = zccgzzdsre khwjusecbu (xxhbkbwgum, vfdpghjbfi - stioihsfou) View more

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