Last update 21 Nov 2024

Celecoxib

Last update 21 Nov 2024

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

+ [22]

Target

COX-2

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+ [37]

Originator Organization

Pfizer Inc.

Active Organization

Scilex Pharmaceuticals, Inc.Viatris Pharmaceuticals LLC

Astellas Pharma, Inc.

+ [6]

Inactive Organization

Pfizer Inc.

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

+ [10]

Drug Highest PhaseApproved

First Approval Date

US (31 Dec 1998),

OsteoarthritisRheumatoid Arthritis

RegulationOrphan Drug (US), Priority Review (CN), Accelerated Approval (US)

Structure

Molecular FormulaC17H14F3N3O2S

InChIKeyRZEKVGVHFLEQIL-UHFFFAOYSA-N

CAS Registry169590-42-5

693

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

NCT04860635 / SuspendedPhase 2/3

An Open Label Safety Study of a Single Administration of F14 in Patients Undergoing Unilateral Total Knee Replacement

Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia

Start Date01 Jan 2025

Sponsor / Collaborator

Arthritis Innovation Corp.

100 Clinical Results associated with Celecoxib

100 Translational Medicine associated with Celecoxib

100 Patents (Medical) associated with Celecoxib

7,560

Literatures (Medical) associated with Celecoxib

01 Jan 2025·Anti-Cancer Agents in Medicinal Chemistry

Novel Celecoxib Derivative, RF26, Blocks Colon Cancer Cell Growth by Inhibiting PDE5, Activating cGMP/PKG Signaling, and Suppressing β-catenin-dependent Transcription

Article

Author: Da Silva, Luciana Madeira ; Abadi, Ashraf H. ; Abdel-Halim, Mohammad ; Piazza, Gary A. ; Keeton, Adam B. ; Sigler, Sara ; Zhou, Gang ; Maxuitenko, Yulia Y. ; Berry, Kristy L. ; Engel, Matthias ; Fathalla, Reem K.

Background:Previous studies have reported that the cGMP-specific PDE5 isozyme is overexpressed in colon adenomas and adenocarcinomas and essential for colon cancer cell proliferation, while PDE5 selective inhibitors (e.g., sildenafil) have been reported to have cancer chemopreventive activity.Aim:This study aimed to determine the anticancer activity of a novel PDE5 inhibitor, RF26, using colorectal cancer (CRC) cells and the role of PDE5 in CRC tumor growth in vivo.Objective:The objective of this study was to characterize the anticancer activity of a novel celecoxib derivative, RF26, in CRC cells previously reported to lack COX-2 inhibition but have potent PDE5 inhibitory activity.Methods:Anticancer activity of RF26 was studied using human CRC cell lines. Its effects on intracellular cGMP levels, cGMP-dependent protein kinase (PKG) activity, β-catenin levels, TCF/LEF transcriptional activity, cell cycle distribution, and apoptosis were measured. CRISPR/cas9 PDE5 knockout techniques were used to determine if PDE5 mediates the anticancer activity of RF26 and validate PDE5 as a cancer target.Results:RF26 was appreciably more potent than celecoxib and sildenafil to suppress CRC cell growth and was effective at concentrations that increased intracellular cGMP levels and activated PKG signaling. RF26 suppressed β-catenin levels and TCF/LEF transcriptional activity and induced G1 cell cycle arrest and apoptosis within the same concentration range. CRISPR/cas9 PDE5 knockout CRC cells displayed reduced sensitivity to RF26, proliferated slower than parental cells, and failed to establish tumors in mice.Conclusion:Further evaluation of RF26 for the prevention or treatment of cancer and studying the role of PDE5 in tumorigenesis are warranted.

01 Jan 2025·Journal of Ethnopharmacology

Yiqi Yangxue formula inhibits cartilage degeneration in knee osteoarthritis by regulating LncRNA-UFC1/miR-34a/MMP-13 axis

Article

Author: Zhao, Ting ; Li, Zhaofu ; Qin, Dongdong ; Wang, Xinchang

ETHNOPHARMACOLOGICAL RELEVANCEKnee osteoarthritis (KOA) is a prevalent and disabling clinical condition affecting joint structures worldwide. The Yiqi Yangxue formula (YQYXF) is frequently prescribed in clinical settings for the treatment of KOA. Existing research has primarily focused on alterations in drug metabolism, with limited investigation into the epigenetic effects of YQYXF, particularly in relation to non-coding RNA.AIM OF THE STUDYExploring the effects of YQYXF on critical factors of long chain non-coding RNA UFC1/miR-34a/matrix metalloproteinase-13 (MMP-13) axis and their interrelationships.METHODSUHPLC-QE-MS technology was used to identify the YQYXF ingredients in rat serum. KEGG and GO analysis were performed on the targets of blood components acting on KOA using a database. Simultaneously, a protein interaction network was constructed using target proteins and metabolites to identify the core components and key pathways of YQYXF. The KOA rat model was established using an improved Hulth method. SPF SD rats were randomly divided into normal group, sham surgery group, model group, celecoxib capsules group (18 mg/kg), YQYXF low, medium and high dose groups (4.6 g/kg, 9.2 g/kg, 18.4 g/kg). Observe the synovial and cartilage tissues of rats using pathological methods. RT-PCR was used to detect the levels of UFC1, miR-34a, and MMP-13 in cartilage. Immunohistochemistry was used to detect the levels of MMP-13 and ADAMTS-5 in cartilage. ELISA method was used to detect the levels of MMP-13 and ADAMTS-5 in serum. In addition, we further validated the regulation of crucial factor expression levels of UFC1/miR-34a/MMP-13 axis in rat chondrocytes and degenerative chondrocytes of KOA patients by YQYXF, providing a basis for its treatment of KOA.RESULTSThe compounds that YQYXF enters the bloodstream mainly contain flavonoids and phenylpropanoid compounds. The core components that act on OA include quercetin, fisetin, and demethylweldelolactone. The main target pathways are the IL-17 signaling pathway, lipid and atherosclerosis, cellular sensitivity, inflammatory mediator regulation of TRP channels, TNF signaling pathway, relaxin signaling pathway and C-type lectin receptor signaling pathway. YQYXF inhibited the expression of miR-34a and MMP-13 mRNA, and reduced the protein levels of MMP-13 and ADAMTS-5. In vitro studies have confirmed that 20% YQYXF serum promoted UFC1 and reduce miR-34a levels. In addition, miR-34a in sh-UFC1+10% YQYXF serum and sh-UFC1+20% YQYXF serum groups significantly decreased compared to the sh-UFC1 group.CONCLUSIONThe anti-KOA cartilage degeneration effect of YQYXF might be related to inhibiting cell apoptosis and promoting cell proliferation, which regulated the lncRNA-UFC1/miR-34a/MMP-13 axis.

01 Jan 2025·Journal of Ethnopharmacology

Screening bioactive compounds from Fangji Huangqi decoction for treating rheumatoid arthritis via COX-2 magnetic ligand fishing combined with in vivo validation

Article

Author: Duan, Ao ; Zhou, Zishan ; Li, Ping ; Yu, Qianqian ; Zhu, Quanhong ; Pan, Dongmei ; Zhu, Yongyan ; Tao, Huaming ; Tian, Shuo

ETHNOPHARMACOLOGICAL RELEVANCEFangji Huangqi Decoction (FHD) is a classical Chinese compound formula for treating rheumatoid arthritis (RA) with satisfactory effects. FHD is reputed for its ability to tonify qi with strengthening exterior, and dispel wind while removing dampness, but its mechanisms and bioactive compounds for treating RA remain unclear.AIM OF THE STUDYThe aim of this study was to explore the key target and bioactive compounds that were responsible for FHD-mediated improvements in RA.MATERIALS AND METHODSUsing network pharmacology, we discovered that cyclooxygenase-2 (COX-2) was the key target of FHD against RA. We utilized a ligand fishing technique with COX-2 immobilized magnetic beads to recognize the bioactive components that act on COX-2. Then we carried out an in vitro assay of COX-2 enzyme inhibition and in vivo assay of carrageenan-induced inflammation and collagen-induced arthritis (CIA) to validate the bioactive effects of these captured ingredients. In the CIA assay, micro-CT, hematoxylin‒eosin staining and safranin-O/fast green staining were employed to assess the influence of the captured ligand on bone damage, pathological injury and cartilage destruction, respectively. Immunohistochemistry (IHC) and enzyme-linked immunosorbent assays (ELISAs) were used to detect the expression of COX-2 target in the ankle joint. interleukin-6 (IL-6) levels in the serum were also detected by ELISA. Molecular docking was used to reveal the binding mechanism of the COX-2 protein and the captured ligand.RESULTSEleven ligands, including tetrandrine, fangchinoline, cyclanoline, licochalcone B, ononin, calycosin and liquiritin, were specifically bound to the COX-2 protein, as determined by ultrahigh-performance liquid chromatography-mass spectrometry (UPLC-MS), seven of which were present at high levels. One ligand, tetrandrine, not only had a great inhibitory effect on COX-2 enzyme activity but also significantly reduced carrageenan-induced inflammation. In the CIA assay, middle- and high-dose tetrandrine (25 and 50 mg/kg) had effects comparable to those of FHD and celecoxib on ameliorating RA symptoms in CIA mice via the COX-2 target. Furthermore, compared with the low-dose tetrandrine group (12.5 mg/kg), the FHD group exhibited significantly lower arthritis index scores and serum IL-6 expression, although the content of tetrandrine in FHD extract solution was approximately 0.1% of that in the low-dose tetrandrine group.CONCLUSIONSHence, we inferred that tetrandrine was the main bioactive component responsible for the effects of FHD against RA by suppressing the expression of the COX-2 protein and inhibiting the enzyme catalytic activity of COX-2. The reason for these effects may be that tetrandrine can interact with the residue Tyr385 of COX-2, the enzymatic catalytic site of COX-2 to transform arachidonic acid (AA) to prostaglandin E2 (PGE2), and thereby reduce the production of prostaglandins and inflammatory metabolites. Moreover, in addition to tetrandrine, FHD contains other compounds that could supplement the activity of tetrandrine when FHD was used to treat RA, which is manifested the "multi-component" characteristic of how Traditional Chinese Medicine formulas treat diseases.

244

News (Medical) associated with Celecoxib

18 Nov 2024

·www.globenewswire.com

Dogwood Therapeutics, Inc. Announces Low Dose IMC-2 Treatment Reduces Long-COVID Related Fatigue and Sleep Disturbance in an Investigator-Initiated Study

- IMC-2 treatment, dosed as valacyclovir 750 mg + celecoxib 200 mg twice daily, demonstrated clinically meaningful reduction in Long-COVID related fatigue and sleep disturbance as compared to placebo – - Top-line results from the Bateman Horne Center’s Long-COVID study provide key insights into final design of Dogwood’s planned Phase 2 study, projected to enroll approximately 200 participants - ATLANTA, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company advancing new medicines to treat pain and fatigue-related disorders, today announced top line data from the recently completed BHC IMC-2 Long-COVID study. The study was conducted via an investigator-initiated, investigational research grant provided to the Bateman Horne Center (“BHC”). The study demonstrated that the low dose combination antiviral therapy IMC-2 treated patient cohort (valacyclovir 750 mg + celecoxib dosed 200 mg twice daily) exhibited clinically meaningful reductions in Long-COVID associated fatigue and sleep disturbance, as compared with the placebo treated cohort. The high dose IMC-2 treated cohort (valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily) did not exhibit clinically meaningful differences versus placebo, believed to be related to higher levels of gastrointestinal (GI) adverse events associated with the higher dose regimen. “To date, there are no FDA approved medicines to treat Long-COVID symptoms,” said Lucinda Bateman, MD, Founder and Chief Medical Officer of the Bateman Horne Center and the study’s principal investigator. “This trial provides evidence that IMC-2 has the potential to improve fatigue and sleep symptoms associated with Long-COVID illness on a scale not previously observed in Long-COVID research. I believe this finding warrants further investigation of IMC-2 in larger scale, multi-center Long-COVID studies.” “The primary goals of this trial were to determine the IMC-2 treatment effect size versus placebo and the associated patient sample size to design our planned IMC-2 Phase 2 Long-COVID study in a manner that maximizes probability of success,” said R. Michael Gendreau, MD, Chief Medical Officer of Dogwood Therapeutics, Inc. “IMC-2 demonstrated a robust reduction in fatigue, the primary endpoint agreed with the Food & Drug Administration to advance IMC-2 into Phase 2 development. We look forward to finalizing these plans and providing further information on next steps in the coming months.” IMC-2 Long-COVID Development Program Summary: BHC Study 201: Investigator-initiated, open-label, matched control study assessing IMC-2 treatment versus patients matched by age, duration of effect, vaccination status and gender. In this study, completed in 2023, the combination of valacyclovir and celecoxib exhibited statistically significant reductions in Long-COVID related fatigue, orthostatic intolerance, pain and anxiety, while improving overall patient health. The dosage used in this study was valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily. BHC Study 202: This recently completed study was designed as an investigator-initiated, double-blinded, placebo controlled follow-on study to BHC 201. While not statistically significant given the small sample size recruited for this trial (14-15 per group), the study demonstrated that the low dose combination antiviral therapy IMC-2 exhibited clinically meaningful improvements in fatigue and sleep disruption as compared to placebo treated patients. Overall, the IMC-2 adverse event profile was favorable in this study. The high dose IMC-2 treatment (valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily) resulted in more GI related adverse events compared to the low dose and placebo cohorts. Additional Assets in Dogwood Therapeutics Proprietary Pipeline: Halneuron® is in Phase 2b development as a non-opioid, Nav 1.7 inhibitor to treat the neuropathic pain resultant from chemotherapy treatment. Halneuron® has been granted Fast Track Designation from the FDA for the treatment of Chemotherapy-Induced Neuropathic Pain (CINP).Next milestone: Interim data from the ongoing Phase 2 CINP study are expected in the second half of 2025. IMC-1 (famciclovir + celecoxib) is Phase 3 development ready as a combination antiviral treatment for fibromyalgia (FM). IMC-1 has been granted fast track designation by the FDA as a treatment for FM. Next milestone: Dogwood is exploring partnerships for IMC-1 to execute the Phase 3 FM program as agreed with the FDA. 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 lead development candidate, Halneuron® which is a voltage-gated sodium channel blocker, a mechanism known to be effective for reducing pain. Halneuron® treatment has demonstrated pain reduction of both general cancer related pain and CINP. Interim data from the forthcoming Phase 2 CINP study are expected in 2H 2025. The antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed dose combinations of nucleoside analog, anti-herpes antivirals and the anti-inflammatory agent, celecoxib, for the treatment of illnesses believed to be related to reactivation of previously dormant herpes viruses, including FM and LC. IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities. For more information, please visit www.dwtx.com. Follow Dogwood Therapeutics Email Alerts: https://ir.dwtx.com/resources/email-alerts LinkedIn: https://www.linkedin.com/company/dogwoodther/ Twitter: https://twitter.com/dogwoodther Facebook: https://www.facebook.com/dogwoodther 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 Amended Annual Report on Form 10-K/A for the year ended December 31, 2023 and the Company’s quarterly report on Form 10-Q for the quarterly period ended September 30, 2024, which are 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. Contact: IR@dwtx.com

Phase 2Clinical ResultFast TrackPhase 3

15 Nov 2024

·www.globenewswire.com

Scilex Holding Company Announces Presentation of Data at the 2024 American College of Rheumatology Convergence Conference to be held at the Walter E. Washington Convention Center in Washington, D.C. on November 14 – 19, 2024

PALO ALTO, Calif. , Nov. 15, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced presentation of data at the 2024 American College of Rheumatology Convergence conference to be held at the Walter E. Washington Convention Center in Washington, D.C. on November 14 – 19, 2024. Title: Prophylaxis of Gout Flares in Patients with Renal Impairment: Dosing Adjustments with Colchicine Oral Solution Informed by a Pharmacokinetic Model Authors: Jaymin Shah, PhD, FCP; Elaine K. Chan, PharmD; Dmitri Lissin, MD Presentation: Saturday, November 16, 2024, at 10:30 AM ET - 12:30 PM ET GLOPERBA® (colchicine oral solution) is the first and only liquid formulation of colchicine that offers precision dosing for at risk gout patients.Scilex recently received FDA approval for an updated GLOPERBA® label, which reflects dosing adjustments in various clinical situations. Unlike other colchicine formulations, GLOPERBA® allows reduction of daily dose in patients with severe renal impairment (0.3 mg/day).Data to be presented summarizes pharmacokinetic model-derived dosing for at-risk moderate and severe chronic kidney disease patients who require lower precision dosing, not offered by other colchicine formulations of tablets and capsules currently available on the market. A PDF accompanying this announcement is available at http://ml.globenewswire.com/Resource/Download/f5fbf217-49d5-426d-bae2-028acefb4dd3 For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability 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 Holding Company 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. 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 are 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) (“SEMDEXATM” or “SP-102”), 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, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. For more information on Scilex Holding Company, refer to www.scilexholding.com About Semnur Pharmaceuticals, Inc. 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 lead program, 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. For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s expectations for Gloperba to be the first liquid colchicine formulation allowing providers to prescribe precision dosing and reducing daily dose in patients with severe renal impairment. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets; general economic, political and business conditions; 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 will be unable to successfully market or gain market acceptance of its 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 outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. 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 wholly-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 Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

Fast TrackDrug ApprovalPhase 3Phase 1Phase 2

12 Nov 2024

·www.businesswire.com

Natera Announces Completion of Signatera™ Analysis from the CALGB (Alliance)/SWOG 80702 Randomized, Phase III Clinical Trial in Colorectal Cancer

AUSTIN, Texas--( BUSINESS WIRE )-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the completion of a study using Signatera from the CALGB (Alliance)/SWOG 80702 randomized, phase III clinical trial. CALGB (Alliance)/SWOG 80702 evaluated the benefit of adding celecoxib to FOLFOX in postoperative treatment of stage III colorectal cancer (CRC) in a biomarker unselected population. This pre-specified analysis includes 1,011 CRC patients with available post-surgical plasma samples and investigates Signatera’s ability to identify a subgroup of patients who may benefit from adding celecoxib to FOLFOX. Disease free survival (DFS) and overall survival (OS) are the study’s primary and secondary endpoints, respectively. Additional details on CALGB (Alliance)/SWOG 80702 In the CALGB (Alliance)/SWOG 80702 trial, patients were randomized to receive standard-of-care adjuvant chemotherapy FOLFOX (+/-) celecoxib, a non-steroidal anti-inflammatory drug (NSAID). Although the results showed that the addition of celecoxib did not significantly improve disease-free survival 1 , NSAIDs have shown promise in benefiting certain subpopulations in CRC, including reducing the risk of developing precancerous colon polyps. In addition, NSAIDs are typically well-tolerated, widely available, and generally low-cost. “ We see this trial as one of the most important in the space given its size, randomized design, and indication,” said Alexey Aleshin, MD, MBA, general manager of oncology and chief medical officer of Natera. “ There is a clear need for additional adjuvant treatment options for patients with colorectal cancer as there has not been a new drug approval in the space in over 20 years. We are hopeful that Signatera-guided therapy selection can help open the door to effective treatment options in CRC, personalized to the patients who are most likely to benefit.” Results have been accepted as a late-breaking abstract to be shared at the American Society of Clinical Oncology Gastrointestinal Symposium (ASCO GI), which takes place from Jan. 23-25, 2024 in San Francisco, CA. About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 90 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 200 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov . References Meyerhardt JA, Shi Q, Fuchs CS, et al. Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial. JAMA . 2021;325(13):1277-1286. doi:10.1001/jama.2021.2454

Phase 3ASCOClinical ResultImmunotherapy

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.

to view more data

Indication	Country/Location	Organization	Date
Pain	JP	Astellas Pharma, Inc.	22 Dec 2011
Toothache	JP	Viatris Pharmaceutical GK	22 Dec 2011
Bursitis	JP	Viatris Pharmaceutical GK	17 Jun 2009
Cervicobrachial syndrome	JP	Viatris Pharmaceutical GK	17 Jun 2009
Cervicobrachial syndrome	JP	Astellas Pharma, Inc.	17 Jun 2009
Low Back Pain	JP	Astellas Pharma, Inc.	17 Jun 2009
Low Back Pain	JP	Viatris Pharmaceutical GK	17 Jun 2009
Periarthritis	JP	Astellas Pharma, Inc.	17 Jun 2009
Tendinopathy	JP	Astellas Pharma, Inc.	17 Jun 2009
Tendinopathy	JP	Viatris Pharmaceutical GK	17 Jun 2009
Tenosynovitis	JP	Viatris Pharmaceutical GK	17 Jun 2009
Analgesia	JP	Viatris Pharmaceutical GK	26 Jan 2007
Inflammation	JP	Viatris Pharmaceutical GK	26 Jan 2007
Juvenile Idiopathic Arthritis	US	Upjohn US 2 LLC	15 Dec 2006
Primary dysmenorrhea	US	Upjohn US 2 LLC	18 Oct 2001
Acute Pain	CN	Viatris Pharmaceuticals LLC	01 Aug 2000
Ankylosing Spondylitis	CN	Viatris Pharmaceuticals LLC	01 Aug 2000
Adenomatous Polyposis Coli	US	Viatris Holdings LLC	23 Dec 1999
Osteoarthritis	US	Upjohn US 2 LLC	31 Dec 1998
Rheumatoid Arthritis	US	Upjohn US 2 LLC	31 Dec 1998

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Indication	Highest Phase	Country/Location	Organization	Date
Adenomatous Polyposis Coli	Phase 2	EU	Pfizer Ltd.	17 Oct 2003
Adenomatous Polyposis Coli	Phase 2	IS	Pfizer Ltd.	17 Oct 2003
Adenomatous Polyposis Coli	Phase 2	NO	Pfizer Ltd.	17 Oct 2003
Adenomatous Polyposis Coli	Phase 1	LI	Pfizer Ltd.	17 Oct 2003
Adenomatous Polyposis Coli	Phase 1	IS	Pfizer Ltd.	17 Oct 2003
Adenomatous Polyposis Coli	Phase 1	NO	Pfizer Ltd.	17 Oct 2003
Adenomatous Polyposis Coli	Discovery	LI	Pfizer Ltd.	17 Oct 2003

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04765644 (ASCENT, CTgov)	Phase 4	-	44	Celecoxib+L-arginine (Celecoxib)	cospzarywj(tzgsqhdozn) = mtqfvttlwx waknulkdwz (fbfmsexekf, rctpixhqhr - qonmllgyoq) View more	-	28 Oct 2024
				Placebo+L-arginine + placebo (Placebo)	cospzarywj(tzgsqhdozn) = pvyvwkuvqi waknulkdwz (fbfmsexekf, tvrzcswtpu - xdnegssfna) View more
NCT03859024 (CTgov)	Phase 4	Urethral Stricture \| Pain, Postoperative	48	Acetaminophen+Ibuprofen 800 mg+Oxycodone (Standard Protocol)	gehmhtzwkv(bfgwloydwz) = bkkngtmrtk nrwqudxhvz (ogipblrzpr, spnpgsqrdb - cllcndxddv) View more	-	19 Sep 2024
				Acetaminophen+Ibuprofen 800 mg+celebrex+Dexamethasone+Oxycodone+Bupivacaine+Gabapentin (Enhanced Recovery Protocol)	gehmhtzwkv(bfgwloydwz) = eextydhvrg nrwqudxhvz (ogipblrzpr, wmauqyvxgb - zsfkcqetqi) View more
NCT05077969 (CTgov)	Phase 2	SARS-CoV-2 acute respiratory disease	4	Famotidine+Celecoxib (Group 1 (Study Product))	kdmmfbwgpb(vkjjzxrrze) = qglzaabqpo ghyikjqknr (kcyqtvgsdj, nbedrdyzts - rokgtcimrm) View more	-	09 Jul 2024
				Placebo (Group 2 (Reference Therapy))	kdmmfbwgpb(vkjjzxrrze) = jwkvfdpnyh ghyikjqknr (kcyqtvgsdj, vbhnnuhtnq - ypmfquuqqe) View more
NCT04015908 (CTgov)	Phase 4	-	100	Pregabalin+Acetaminophen+Celecoxib+Oxycodone (Multi-modal)	hjomnzadml(zkuaclehsi) = kzbblasoea whxbpukooi (umvoknmbbc, mdyqsfajql - lcukpbppps) View more	-	08 Jul 2024
				Percocet (Control)	hjomnzadml(zkuaclehsi) = aubkrarqtm whxbpukooi (umvoknmbbc, mzlzsiadfq - ojvmyqoifz) View more
NCT05062083 (CTgov)	Phase 2	Multiple Sclerosis	7	11C-PS13+11C-MC1+Celecoxib+ketoprofen	mrpfnjsqna(mmnsiqsfjv) = ztxzgdehdj gjetbehdhd (ikrsxakpux, ryvvprumry - aqvgingsky) View more	-	27 Jun 2024
NCT01479829 (CTgov)	Phase 4	Depressive Disorder \| Inflammation	100	Escitalopram+Celecoxib (Intervention Cohort)	xqdqfqrfka(cienznmypp): Chi-square value = 5.3466, P-Value = 0.02 View more	-	09 Apr 2024
				Placebo+Escitalopram (Control Cohort)
NCT03818919 (CTgov)	Phase 2	Analgesia \| Rotator Cuff Tear Arthropathy	70	Acetaminophen+Diazepam+Ketorolac+Celecoxib+Gabapentin (Post-Operative Non Opioid Pain Protocol)	iasnezywuq(dmvqzumsds) = alwqzggyjm ytnjogafqt (lahxjwxxlf, scvmdyvvks - kikqyglgwe) View more	-	02 Apr 2024
				Hydrocodone-Acetaminophen (Post-Operative Traditional Pain Protocol)	iasnezywuq(dmvqzumsds) = jugpeyyust ytnjogafqt (lahxjwxxlf, bcrqzwahmz - wlmdpsfedo) View more
NCT04790812 (CTgov)	Phase 4	Toothache \| Pain, Postoperative	65	Placebo+Celecoxib (Celecoxib Plus Placebo)	jhppfwvhbx(kvpwtylbip) = uabsowgcgs duljztghfy (dglbhimkva, cwnlmdjepy - vwixfsmpuo) View more	-	27 Mar 2024
				Acetaminophen+Celecoxib (Celecoxib Plus Acetaminophen)	jhppfwvhbx(kvpwtylbip) = ebjcbheqne duljztghfy (dglbhimkva, hnzbkgfygp - ebcpwbglbv) View more
NCT02502006 (CTgov)	Phase 1	-	16	Celecoxib (Celecoxib)	kiufxxatuf(bwsafivrci) = xoeraoxwtw vjhygajeqz (txdywkwrro, judbddtiyl - mnruapgncc) View more	-	13 Dec 2023
				Naproxen (Naproxen)	kiufxxatuf(bwsafivrci) = mrliubvwhr vjhygajeqz (txdywkwrro, qtvpyraprs - ofrhprrrvd) View more

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