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Last update 07 Feb 2025

Celecoxib

Last update 07 Feb 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

+ [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+ [47]

Originator Organization

Pfizer Inc.

Active Organization

Astellas Pharma, Inc.Viatris Pharmaceutical GKUpjohn EESV

+ [7]

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

RegulationAccelerated Approval (US), Orphan Drug (US), Priority Review (CN)

Structure/Sequence

Molecular FormulaC17H14F3N3O2S

InChIKeyRZEKVGVHFLEQIL-UHFFFAOYSA-N

CAS Registry169590-42-5

696

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 Aug 2025

Sponsor / Collaborator

Arthritis Innovation Corp.

100 Clinical Results associated with Celecoxib

100 Translational Medicine associated with Celecoxib

100 Patents (Medical) associated with Celecoxib

11,300

Literatures (Medical) associated with Celecoxib

01 Apr 2025·Materials Today Bio

Hydrogel inspired by "adobe" with antibacterial and antioxidant properties for diabetic wound healing

Article

Author: Zhu, Shaobo ; Li, Zouwei ; Li, Jingfeng ; E, Yan ; Chen, Renxin ; Hao, Zhuowen ; Guo, Qi

With the aging population, the incidence of diabetes is increasing. Diabetes often leads to restricted neovascularization, antibiotic-resistant bacterial infections, reduced wound perfusion, and elevated reactive oxygen species, resulting in impaired microenvironments and prolonged wound healing. Hydrogels are important tissue engineering materials for wound healing, known for their high water content and good biocompatibility. However, most hydrogels suffer from poor mechanical properties and difficulty in achieving sustained drug release, hindering their clinical application. Inspired by the incorporation of fibers to enhance the mechanical properties of "adobe," core-shell fibers were introduced into the hydrogel. This not only improves the mechanical strength of the hydrogel but also enables the possibility of sustained drug release. In this study, we first prepared core-shell fibers with PLGA (poly(lactic-co-glycolic acid)) and PCL (polycaprolactone). PLGA was loaded with P2 (Parathyroid hormone-related peptides-2), developed by our group, which promotes angiogenesis and cell proliferation. We then designed a QTG (QCS/TA/Gel, quaternary ammonium chitosan/tannic acid/gelatin) hydrogel, incorporating the core-shell fibers and the anti-inflammatory drug celecoxib into the QTG hydrogel. This hydrogel exhibits excellent antibacterial properties and biocompatibility, along with good mechanical performance. This hydrogel demonstrates excellent water absorption and swelling capabilities. In the early stages of wound healing, the hydrogel can absorb the wound exudate, maintaining the stability of the wound microenvironment. This hydrogel promotes neovascularization and collagen deposition, accelerating the healing of diabetic wounds, with a healing rate exceeding 95 % by day 14. Overall, this study provides a promising strategy for developing tissue engineering scaffolds for diabetic wound healing.

04 Mar 2025·Journal of biomolecular structure & dynamics

Design and construction of novel pyridine-pyrimidine hybrids as selective COX-2 suppressors: anti-inflammatory potential, ulcerogenic profile, molecular modeling and ADME/Tox studies

Article

Author: Bakr, Rania B. ; Ghoneim, Mohammed M. ; Alsalahat, Izzeddin ; Alotaibi, Nasser Hadal ; Hazem, Sara H. ; Shaker, Mohamed E. ; Farouk, Amr ; Azouz, Amany A. ; Musa, Arafa ; El-Mesery, Mohamed E. ; Abdelgawad, Mohamed A. ; Goma, Hesham A. M. ; Abdel-Bakky, Mohamed Sadek ; Alzarea, Sami I. ; Elkanzi, Nadia A. A. ; Alsahli, Tariq G.

NSAIDs represent a mainstay in pain and inflammation suppression, and their actions are mainly based on inhibiting COX-1 and COX-2 enzymes.Due to the adverse effects of these drugs, especially on the stomach and heart, scientists efforts have been directed to manufacture selective COX-2 without cardiovascular side effects and with minimal effects on the stomach. The cardiovascular side effects are thought to be related to the chemical composition rather than mechanism of action of these drugs.Novel pyridopyrimidines, 9a-j, were prepared and their chemical structures were confirmed by NMR, mass and IR Spectra, and elemental analysis. The effect of the 9a-j compounds on COX-1 and COX-2 was assessed and it was found that 2-hydrazino-5-(4-methoxyphenyl)-7-phenyl-3H-pyrido[2,3-d)pyrimidin-4-one (9d) was the most potent COX-2 inhibitor (IC₅₀ = 0.54 uM) compared to celecoxib (IC₅₀ = 1.11 uM) with selectivity indices of 6.56 and 5.12, respectively.The in vivo inhibition of paw edema of novel compounds 9a-j was measured using carrageenan-induced paw edema method, and that 2-hydrazino-5-(4-methoxyphenyl)-7-phenyl-3H-pyrido[2,3-d)pyrimidin-4-one (9d) showed the best inhibitory activity in comparison with the other compounds and celecoxib.The gastroprotective effect of the potent derivatives 9d, 9e, 9f, 9 g and 9h was investigated. 2-Hydrazino-5-(4-methoxyphenyl)-7-phenyl-3H-pyrido[2,3-d)pyrimidin-4-one (9d) and 7-(chlorophenyl)-hydrazino-5-(4-methoxyphenyl)-3H-pyrido[2,3-d)pyrimidin-4-one (9e) showed ulcer indices comparable to celecoxib (1 and 0.5 vs 0.5, respectively). Docking studies were carried out and they confirmed the mechanistic action of the designed compoundsCommunicated by Ramaswamy H. Sarma.

01 Mar 2025·BIOORGANIC CHEMISTRY

Exploration of anti-inflammatory activity of pyrazolo[3,4-d]pyrimidine/1,2,4-oxadiazole hybrids as COX-2, 5-LOX and NO release inhibitors: Design, synthesis, in silico and in vivo studies

Article

Author: Ibrahim, Tarek S ; Salem, Ibrahim M ; Al-Awadh, Mohammed A ; Allam, Rasha M ; Alharbi, Abdulrahman S ; Aziz, Marwa A ; Ahmed, Osama A A ; Elsayed Abouzed, Deiaa E ; Abuo-Rahma, Gamal El-Din A ; Mohamed, Mamdouh F A

New pyrazolo[3,4-d]pyrimidine derivatives 7a-h and 8a-h were synthesized and evaluated for their in vitro inhibitory potential against COX-1, COX-2, 5-LOX along with the NO release inhibitory activity to assess their anti-inflammatory potential. Most compounds confered inhibitory activity at a micromolar level and exhibited prominent selectivity towards COX-2 especially in the 8a-h series. The most useful compound 8e as a COX-2/5-LOX dual inhibitor, exhibited IC₅₀ results of; 1.837 µM for COX-2, 2.662 µM for 5-LOX with an acceptable NO release inhibition rate of 66.02 %. Compounds 7e, 7f, 8e and 8f proved their efficiency as 5-LOX/NO release dual inhibitors; with IC₅₀ values of 2.833, 1.952, 2.662 and 1.573 µM, respectively for 5-LOX biotarget, and with superior NO inhibitory ratio of 73.85, 65.57, 66.02 and 72.28 %, respectively. The in vivo anti-inflammatory assay explored that 7e is the most effective with minimal gastric ulceration prevalence. Molecular docking in the active site of both COX-2 and 5-LOX showed that, the most active 8e and 7e are correctly oriented inside the COX-2 binding pocket with unique binding mode independently on the reference celecoxib. Also, they demonstrated superior binding affinities to the 5-LOX enzyme over both the Zileuton as a reference drug and the normal ligand 30Z. The stability of the complex formed between the most promising candidates 7e or 8e with the COX-2 and 5-LOX active sites, was considered using a typical atomistic 100 ns dynamic simulation study. Investigation of the SAR revealed the importance of both the sulfonamide group in the 8a-h series and the substituents of the 3-phenyl ring tethered on the 1,2,4-oxadiazole core.

258

News (Medical) associated with Celecoxib

25 Jan 2025

·www.businesswire.com

Natera Announces Successful Readout of Randomized, Phase III CALGB (Alliance) / SWOG 80702 Clinical Trial in Colorectal Cancer

AUSTIN, Texas,--( BUSINESS WIRE )-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, announced new data from the randomized, Phase III CALGB (Alliance) / SWOG 80702 study. The study will be presented today, Jan. 25, 2025 as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA. This first-of-its-kind study evaluated whether Signatera-positive patients benefit from an escalation in adjuvant treatment. In the trial, Signatera was used to evaluate the benefit of adding celecoxib, a non-steroidal anti-inflammatory drug (NSAID), to standard of care (SOC) adjuvant chemotherapy with FOLFOX in the management of stage III colorectal cancer (CRC). The pre-specified analysis included approximately 1,000 patients with available post-surgical plasma samples, who were randomized to receive FOLFOX (+/-) celecoxib. Key findings included: Signatera-positivity after surgery was predictive of a disease-free survival (DFS) and overall survival (OS) benefit with the addition of celecoxib to adjuvant FOLFOX. The addition of celecoxib to SOC chemotherapy significantly improved DFS compared to placebo (HR 0.55, 95% CI 0.39-0.80; p=0.001) among Signatera-positive patients with a three-year DFS of 44.1% versus 26.6%. Similar results were seen for OS (HR 0.58, 95% CI 0.38-0.90; p=0.013). No survival benefit was seen by adding celecoxib to chemotherapy in Signatera-negative patients. Signatera status after surgery and prior to starting adjuvant therapy was highly predictive of recurrence. Signatera-positivity was significantly associated with worse DFS (HR 7.14, 95% CI: 5.54-9.21; p<0.0001) and OS (HR 6.72, 95% CI: 4.91-9.18; p<0.0001). “ The results from the CALGB (Alliance) / SWOG 80702 study mark an unprecedented moment in personalized medicine for patients with colorectal cancer,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology for Natera. “ We demonstrated Signatera’s ability to predict a benefit in both disease-free survival and overall survival for Signatera-positive patients from the addition of celecoxib, an extremely accessible, affordable, and well-tolerated therapy. These data also offer compelling evidence to address an unmet need in adjuvant colorectal cancer treatment, where there has not been a new drug approval in over 20 years.” The results of the randomized, double-blind ALTAIR clinical trial will also be presented in a poster today. ALTAIR examined treatment escalation with Trifluridine/Tipiracil (FTD/TPI) in patients with stage I-IV colorectal cancer. In the trial, 243 Signatera-positive patients were randomized to FTD/TPI or placebo over a six-month treatment period. The results showed a trend toward benefit in the FTD/TPI group (median DFS of 9.3 months vs. 5.6 months in the placebo group), although it did not reach statistical significance (HR, 0.79; P = 0.107). There was a significant benefit for resected oligometastatic stage IV patients treated with FTD/TPI, showing a median DFS of 9.76 months as compared to 3.96 months in the placebo group (HR, 0.53; P = 0.012). This presents an opportunity for clinical benefit in stage IV patients who test positive for MRD. 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 over 100 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 250 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 .

Clinical ResultPhase 3ASCOImmunotherapy

20 Jan 2025

·www.globenewswire.com

AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones

– Continued execution across Ampligen® (rintatolimod) clinical development programs in areas with critical unmet needs, especially in the high-value pancreatic cancer and Long-COVID spaces – Expected milestones over the course of the next 18 months provide significant value-driving opportunities, including some trials being partially funded by the National Cancer Institute, AstraZeneca and Merck Jan. 15, 2025 -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today highlighted key clinical, regulatory and corporate milestones achieved over 2024 and outlined its expected upcoming milestones. “It is clear that 2024 was a foundational year for AIM on the clinical, regulatory and corporate fronts. Without a doubt, our team continued to drive our strategy forward and deliver results. We believe this progress has positioned AIM for an exciting 2025 and the opportunity to drive value for our stockholders,” stated Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. “Looking ahead, we believe we are poised for an exciting 2025 with a number of key milestones expected over the next 18 months across important clinical trials addressing major unmet medical needs. Certain of these trials are being funded in part by major oncology interests such as the National Cancer Institute, AstraZeneca and Merck, which we believe emphasizes their great potential to change lives for the better. Our team is committed to the seamless execution of our clinical development programs and, if successful, we believe each holds the potential to drive significant value in the near and long term.” Metastatic Pancreatic Ductal Adenocarcinoma Program Commenced enrollment and dosing in DURIPANC Phase 1b/2 study combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer; Announced that the first dose level was generally well-tolerated in the DURIPANC Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer; and Reported positive preliminary data from Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer. Phase 2 Locally Advanced Pancreatic Adenocarcinoma Program Received authorization from the Erasmus Medical Center Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer; and Announced the publication of new positive data analysis from a long-term Early Access Program studying Ampligen for the treatment of advanced pancreatic ductal adenocarcinoma. The Company sought FDA guidance on expansion of inclusion criteria and treatment arms, and then subsequently amended the study protocol. The study is recruiting patients. These adjustments are also expected to result in substantial reductions in clinical costs. Phase 2 Recurrent Ovarian Cancer Program Reported positive top-line, protocol-planned interim report data from the study of Ampligen combined with pembrolizumab for the treatment of recurrent ovarian cancer. Phase 2 Post-COVID Conditions Program Reported positive topline results from the Company’s Phase 2 study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the post-COVID condition of fatigue (“AMP-518”); and Reported an analysis of the AMP-518 clinical trial, based upon statistically significant data, which supports the Company’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe post-COVID-19 condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial. Further, the Company was also granted two important patents covering Ampligen for the treatment of: Endometriosis, a painful chronic condition that affects nearly 10% of women of reproductive age, or approximately 6.5 million women in the United States. This patent was granted in the United States. The Post-COVID Condition of Fatigue. This method and compositions patent was granted in the Netherlands. Additionally, AIM successfully completed cGMP manufacturing of 9,042 clinical vials of Ampligen. The Company announced the publication of new pre-clinical data of Ampligen as part of a combinational therapy in the treatment of melanoma. Metastatic Pancreatic Ductal Adenocarcinoma Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142); Funded through collaboration of AstraZeneca and Erasmus Medical Center Q1 2025: Complete Phase 1b Early Q2 2025: Launch of Phase 2 Q2/Q3 2026: Last patient enrolled in Phase 2 Locally Advanced Pancreas Cancer (LAPC) Phase 2 Ampligen Combined with Standard of Care (SOC) versus SOC Alone Following First-Line Therapy in Subjects with LAPC (NCT05494697); AIM funded Q1 2025: Buffet Cancer Center expected to enroll first subject H1 2025: first subject dosed Refractory Melanoma Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT04093323); Grant funded by National Cancer Institute H1 2025: First patient dosed Stage 4 Triple Negative Breast Cancer Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer (NCT05756166); Grant funded by Merck and National Cancer Institute Q2 2026: Expected completion of enrollment Advanced Recurrent Ovarian Cancer Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck H1 2025: Expected last patient dosed and completion of study Advanced Recurrent Ovarian Cancer Phase 2 Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (NCT02432378); Grant funded by the National Cancer Institute H1 2025: First patient dosed Post COVID Chronic Fatigue Conditions / Long Covid Phase 2 Study to Evaluate the Efficacy and Safety of Ampligen in Patients with Post-COVID Conditions (NCT05592418); AIM funded Q1 2025: Final approved study results to be published on clinicaltrials.gov AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyClinical ResultVaccine

13 Jan 2025

·www.globenewswire.com

Scilex Holding Company Announces Pain Medicine News Published Retrospective Claims Data on ZTlido® vs. Lidocaine 5% Patch

More patients treated with ZTlido® saw either a decrease or discontinuation of opioid use compared with those treated with the 5% patch (51.9% vs. 45.5%).Of all study patients reporting a decrease in opioid use, significantly more in the ZTlido® group experienced a 20% or greater reduction in opioid use, compared with those treated with 5% lidocaine patch (21.3% vs. 13.4%; P=0.0008).Patients on ZTlido® had a non-significant change in their baseline opioid use (+3.1%; P=0.146), while those using the 5% patch experienced a significant increase in opioid use from baseline (+42.9%; P<0.001). PALO ALTO, Calif., Jan. 13, 2025 (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 and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease, today announced that Pain Medicine News published retrospective claims data on ZTlido® vs. lidocaine 5% patch. Pain Medicine News, the premier trade publication in the pain management space, published decreased opioid utilization demonstrated with ZTlido® (lidocaine topical system 1.8%) in the magazine’s December edition. The article concluded that retrospective claims data showed that Scilex Pharmaceuticals’ flagship product, the branded ZTlido® lidocaine patch, was associated with less use of opioid analgesics in patients with neuropathic pain compared with the 5% lidocaine patch (generic). The researchers looked at claims with a diagnosis of neuropathic pain (postherpetic neuralgia, diabetic peripheral neuropathy or low back pain) in the Optum Claims database from May 1, 2018, to Sept. 30, 2023. Among the key conclusions were that: More patients treated with ZTlido® saw either a decrease or discontinuation of opioid use compared with those treated with the 5% patch (51.9% vs. 45.5%).Of all study patients reporting a decrease in opioid use, significantly more in the ZTlido® group experienced a 20% or greater reduction in opioid use, compared with those treated with 5% lidocaine patch (21.3% vs. 13.4%; P=0.0008).Patients on ZTlido® had a non-significant change in their baseline opioid use (+3.1%; P=0.146), while those using the 5% patch experienced a significant increase in opioid use from baseline (+42.9%; P<0.001). This study further affirms the difference between ZTlido®, as a second-generation lidocaine topical system, versus older, conventional lidocaine patches, and highlights the downstream impact conferred by advanced technology and improved adhesion. The full article may be accessed in the print edition of Pain Medicine News or online in the digital edition at this link: December issue of Pain Medicine News 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 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 and, following the formation of its proposed joint venture with IPMC Company, in 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) (“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. 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 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. 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 Pain Medicine News published retrospective claims data on ZTlido® vs. lidocaine 5% patch. 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 Board’s right to change the Record Date and/or revoke the Dividend; Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); 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 with the SEC, 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.

Clinical ResultPhase 3Fast TrackDrug ApprovalPhase 1

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
Migraine Disorders	US	Scilex Pharmaceuticals, Inc.	05 May 2020
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	Viatris Pharmaceutical GK	17 Jun 2009
Low Back Pain	JP	Astellas Pharma, Inc.	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	SE	Upjohn EESV	29 Mar 2000
Adenomatous Polyposis Coli	US	Viatris Holdings LLC	23 Dec 1999
Osteoarthritis	US	Upjohn US 2 LLC	31 Dec 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine With Aura	NDA/BLA	CA	Scilex Holding Co.	26 Dec 2023
Migraine Without Aura	NDA/BLA	CA	Scilex Holding Co.	26 Dec 2023
Actinic Keratosis	Phase 3	US	Dr. Reddy's Laboratories Ltd. (Russia)	14 Feb 2017
Arthritis, Gouty	Phase 3	US	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	CA	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	CO	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	CR	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	MX	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	PE	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	PH	Viatris, Inc.	01 Feb 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03643744 (CTgov)	Phase 1	Actinic Keratosis	12	Celecoxib 200mg (PDT + Celecoxib)	xdxldfhbfm(spjrqflhnw) = avmahiyyfr yaqtdwyzvz (bqylkibmdv, sodoinbstp - dewsmnyjcs) View more	-	19 Dec 2024
				Placebo (PDT + Placebo)	xdxldfhbfm(spjrqflhnw) = tuhonjjrxh yaqtdwyzvz (bqylkibmdv, exkfhoaxcc - shpescnzwn) View more
NCT04765644 (ASCENT, CTgov)	Phase 4	-	44	Celecoxib+L-arginine (Celecoxib)	hqhzhuuvwu(efugbputwo) = nmtovldbuh yfflevvjbr (qoqaeofuhz, nwdrsdocol - wqgsxnzarn) View more	-	28 Oct 2024
				Placebo+L-arginine + placebo (Placebo)	hqhzhuuvwu(efugbputwo) = hhfntkgntr yfflevvjbr (qoqaeofuhz, pjybxgfjin - tovabhguax) View more
NCT03859024 (CTgov)	Phase 4	Urethral Stricture \| Pain, Postoperative	48	Acetaminophen+Ibuprofen 800 mg+Oxycodone (Standard Protocol)	nbubuxqhau(ypcvsmpzwh) = vhuukyeczp youjmcsvcn (dwpgdxgzfi, zzqtvmrmbb - qrpscoxgit) View more	-	19 Sep 2024
				Acetaminophen+Ibuprofen 800 mg+celebrex+Dexamethasone+Oxycodone+Bupivacaine+Gabapentin (Enhanced Recovery Protocol)	nbubuxqhau(ypcvsmpzwh) = abhvovkaip youjmcsvcn (dwpgdxgzfi, zcsjtmypdf - gzervozukw) View more
NCT05077969 (CTgov)	Phase 2	SARS-CoV-2 acute respiratory disease	4	Famotidine+Celecoxib (Group 1 (Study Product))	lnhzlvloul(ciwebxgpeb) = urarpywhxg mkohxsiicy (uizgopfxtg, jkanzlunqj - atmjigrzsi) View more	-	09 Jul 2024
				Placebo (Group 2 (Reference Therapy))	lnhzlvloul(ciwebxgpeb) = qvwjdhudvv mkohxsiicy (uizgopfxtg, cqlalffzfq - alvrmlbsjc) View more
NCT04015908 (CTgov)	Phase 4	-	100	Pregabalin+Acetaminophen+Celecoxib+Oxycodone (Multi-modal)	dvcexxqfkh(wocwjvjkfe) = ramptgbljd eihnnmlsse (ojsavwpqwp, nupyulzsda - lozzfzidfi) View more	-	08 Jul 2024
				Percocet (Control)	dvcexxqfkh(wocwjvjkfe) = rqxhjijdht eihnnmlsse (ojsavwpqwp, hicmtndscs - srlbxsukfp) View more
NCT03006276 \| NCT03009019 (GlobeNewswire) Manual	Phase 3	Migraine Disorders	-	ELYXYB (Triptan Insufficient Responders)	jhblcwqhxd(ucjmixmupi) = oeajjqutdm hjlrsgijjf (nbnrkxcybu )	Positive	13 Jun 2024
				placebo (Triptan Insufficient Responders)	jhblcwqhxd(ucjmixmupi) = gvdrxiqzwk hjlrsgijjf (nbnrkxcybu )
NCT01479829 (CTgov)	Phase 4	Depressive Disorder \| Inflammation	100	Escitalopram+Celecoxib (Intervention Cohort)	bcgxbrfwmt(apudxhhsfj): 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)	coretvhqkb(rftasnkvat) = jnqalirktk vnkacgumeg (ecqioflmhb, fyiuepucdm - hysttjteth) View more	-	02 Apr 2024
				Hydrocodone-Acetaminophen (Post-Operative Traditional Pain Protocol)	coretvhqkb(rftasnkvat) = bzxhuisfap vnkacgumeg (ecqioflmhb, dysgxwqyuu - kwcldmilyw) View more
NCT04790812 (CTgov)	Phase 4	Toothache \| Pain, Postoperative	65	Placebo+Celecoxib (Celecoxib Plus Placebo)	mfhzcdupdf(zleuhnodaj) = llldsinuwt egctrhtlkk (plotzojrai, rxiglvgkkv - guarqicrpy) View more	-	27 Mar 2024
				Acetaminophen+Celecoxib (Celecoxib Plus Acetaminophen)	mfhzcdupdf(zleuhnodaj) = tqmhelojgv egctrhtlkk (plotzojrai, klslufxkxr - smwpizzycu) View more
NCT02502006 (CTgov)	Phase 1	-	16	Celecoxib (Celecoxib)	rirqktrokc(gfgtclfkth) = ftpcyfesoo skwyvrujwd (zzvaizucjb, lucjboeftt - pwygullhem) View more	-	13 Dec 2023
				Naproxen (Naproxen)	rirqktrokc(gfgtclfkth) = bwqofgcaxe skwyvrujwd (zzvaizucjb, buxtdtpzsl - oabxtnewgq) View more

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