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naproxen (naproxen, Elan / Naprelan / naproxen, IPDAS)

✓ Approved

Victory Pharma, Inc. · PTGS1 · Small Molecule

What is naproxen?

naproxen is a small molecule developed by Victory Pharma, Inc.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand Namesnaproxen, Elan, Naprelan, naproxen, IPDAS
CompanyVictory Pharma, Inc.
Drug ClassSmall Molecule
Molecular TargetPTGS1, PTGS2
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Victory Pharma, Inc.

Mechanism of Action

Molecular Targets

naproxen acts on 2 molecular targets:

PTGS1prostaglandin-endoperoxide synthase 1 (COX3, PCOX1)
PTGS2prostaglandin-endoperoxide synthase 2 (GRIPGHS, hCox-2)
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Therapeutic Indications

naproxen is developed for 7 unique indications across 4 therapeutic areas.

Therapeutic AreaConditionPhase
Gastrointestinal disordersAbdominal pain✓ Approved
Musculoskeletal and connective tissue disordersBursitis✓ Approved
Reproductive system and breast disordersDysmenorrhoea✓ Approved
Metabolism and nutrition disordersHyperuricaemia✓ Approved
Musculoskeletal and connective tissue disordersOsteoarthritis✓ Approved

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Related Research Articles

PubMedEnvironmental science & technology2026-10-20

Spatiotemporal Magnetic Decoupling Directs Spin-Dependent Cascade ROS Evolution for Electro-Fenton Water Decontamination.

Xu Tong T, Xia Pan P, Wang Jingwen J, Xiao Jiaqin J et al.

Heterogeneous electro-Fenton (HEF) systems hold great potential for decentralized water purification, yet concurrently achieving high catalytic activity, structural stability, and controlled reactive oxygen species (ROS) selectivity remains challenging. Herein, we propose a spatiotemporal magnetic decoupling strategy to concurrently address these design objectives. The carbon shell spatially separated exterior Fe0 satellites from the FeNx core, eliminating deleterious short-range magnetic quenching and altering the local magnetic environment to modulate the internal Fe(III) spin state. The resulting low-spin Fe(III) sites suppressed electron back-donation into the H2O2 σ∗ antibonding orbital, favoring an additional 1O2 generation pathway. Spatial decoupling also enabled a gradient cascade activation of H2O2 across the Fe0 and FeNx domains, synergistically boosting the evolution of both •OH and 1O2, with steady-state concentrations reaching 18.25 and 5.27 μM, respectively. Consequently, the FeNx@C-Fe0-based HEF achieved complete naproxen degradation within 60 min with significantly suppressed Fe leaching (0.85 mg L-1), outperforming all comparative systems. Comprehensive characterizations and density functional theory (DFT) calculations established a definitive relationship between topological engineering and spin-state dynamics. Furthermore, the system demonstrated proof-of-concept applicability in real hospital wastewater, highlighting the potential of spatiotemporal spin-state engineering for regulating ROS evolution in HEF systems.

PMID 42899650
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PubMedACS omega2026-10-17

Surface-Mediated Immunomodulation by Electrostatic Immobilization of Naproxen on Plasma-Aminated Poly(ε-caprolactone) Films Rescues Osteogenic Differentiation via Attenuation of NF-κB Signaling.

Kim Chang-Young CY, Khentii Namuun N, Seok Ji-Hun JH, Thuy Nguyen Tien Ngoc TN et al.

Chronic inflammation following biomaterial implantation often leads to fibrous encapsulation and compromised osseointegration, particularly in clinically inflamed environments. We developed a surface-functionalized poly-(ε-caprolactone) (PCL) platform to modulate the early inflammatory microenvironment via surface-mediated drug release. PCL films were aminated by plasma polymerization, enabling the electrostatic immobilization of naproxen. Surface characterization by zeta potential analysis, X-ray photoelectron spectroscopy (XPS), and atomic force microscopy (AFM) confirmed successful amine functionalization and subsequent naproxen loading. The functionalized films exhibited a pronounced early burst release of naproxen within the initial hours after immersion, addressing the early phase of post-surgical inflammation. In vitro studies using MC3T3-E1 pre-osteoblasts under lipopolysaccharide (LPS)-induced inflammatory conditions showed that naproxen released from the surface significantly reduced pro-inflammatory cytokine secretion, including IL-6 and IL-1β. The cytokine-suppressive effect of the naproxen-functionalized surface was further supported by mechanistic experiments showing that soluble naproxen attenuated LPS-induced NF-κB p65 phosphorylation and nuclear translocation. These results suggest that the anti-inflammatory response mediated by surface-released naproxen is, at least in part, attributable to the intrinsic NF-κB-modulating activity of naproxen. Modulation of the inflammatory microenvironment restored osteogenic differentiation, with increased expression of RUNX2, ALP, and OPN, and enhanced matrix mineralization, as confirmed by Alizarin Red S staining. These findings demonstrate that surface-mediated delivery of naproxen enables temporally controlled osteoimmunomodulation and supports osteogenic function under inflammatory stress, underscoring the potential of this surface-engineering strategy for bone-regenerative applications.

PMID 42889552
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PubMedMaterials (Basel, Switzerland)2026-10-16

Thermal Transformation of Selected Non-Steroidal Anti-Inflammatory Drugs Trapped in Silica Beads via Amine-Functionalised Silica Gel.

Sternik Dariusz D, Sienkiewicz Andrzej A, Gorgol Marek M, Lupa Joanna J et al.

This study presents solid dispersions of naproxen and sodium ibuprofen in porous SiO2 pellets (manufactured via the hard template method) before and after additional phase manufacture from amine-functionalised silica gel. Nanoscopic pore evolution of the investigated materials was examined at all stages of synthesis using positron annihilation lifetime spectroscopy (PALS). The TG-DSC-FTIR/MS in He and synthetic air provided information on the systems' thermal transformations. PALS showed that both drugs preferentially occupied smaller mesopores in SiO2 pellets. Thermal analysis revealed distinct atmosphere- and drug-dependent behaviour. Silica confinement delayed naproxen's thermal degradation but decreased sodium ibuprofen stability. Interestingly, thermal decomposition of sodium ibuprofen most likely also occurred through the evolution of volatile ibuprofen, as signals assigned to it were detected in both atmospheres, although less extensively in air. Encapsulation of naproxen in the investigated systems made it more resistant to high temperature, whereas for sodium ibuprofen the opposite tendency was observed. The amine-functionalized silica phase increased the overall thermal stability of both dispersions in helium, whereas oxidation in synthetic air seemed to be governed mainly by the NH2-SiO2 phase degradation.

PMID 42882691
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PubMedAnalytica chimica acta2026-10-16

Automatic analyses of quantitative dried material spots by on-line coupling of sequential injection to high-performance liquid chromatography: A proof-of-concept.

Dvořák Miloš M, Pagan-Galbarro Carlos C, Miró Manuel M, Kubáň Pavel P

The development and integration of platforms for reliable handling of dried material spots (DMSs) as a front-end to advanced analytical instrumentation continues to pose methodological challenges. Although robotic platforms have been developed for autonomous manipulation of dried blood spot (DBS) cards, these systems exhibit limited flexibility regarding ancillary unit operations and remain incompatible with quantitative DMS (qDMS) devices. Leveraging off-the-shelf fluidic components using advanced liquid handling, this proof-of-concept work exploits the versatility of sequential injection-high-performance liquid chromatography (SI-HPLC) coupling for automatic processing and analysis of DMSs. The flow setup features a multi-position rotary valve as the core of the SI manifold connected to two 3D-printed 60-position racks. This hyphenation enables flexible in-vial processing of various DBS, qDBS, qDMS, and volumetric absorptive microsampling (VAMS) samples by controlled dispensing of microliter volumes of methanol for the spot rehydration, protein precipitation, and analyte elution, followed by mixing and homogenization of the eluate with water for the HPLC compatibility. Demonstrated on model non-steroidal anti-inflammatory drugs, the fully synchronized SI-HPLC setup enabled entirely unsupervised analysis of up to 120 DMS samples with triplicate HPLC injections per eluate (8.2 min each). Using a matrix-matched calibration based on spiking 10 μL of analyte-free blood, multiple qDBSs were eluted with 135 μL of methanol, followed by the eluate composition adjustment with 135 μL of water for HPLC compatibility prior to reversed-phase HPLC analysis. Under these conditions, calibrations were linear over 15 - 60, 0.8 - 12, 0.8 - 6, and 6.2 - 100 μg mL-1 ranges, and LODs were 5.7, 0.3, 0.3, and 1.4 μg mL-1 for ibuprofen, ketoprofen, diclofenac, and naproxen, respectively. The method precision was 2.3 - 12.7% RSD for intra-day and 9.3 - 13.2% RSD for inter-day experiments. The reliability of the proposed automatic SI-HPLC setup was demonstrated for qDBSs with therapeutic naproxen levels, with no statistically significant concentration differences at the 0.05 level when compared to manual qDBS processing with off-line analysis by capillary electrophoresis. For the first time, the proposed analytical concept enables automatic handling and analysis of various DMS and qDMS samples, while using standard off-the-shelf SI and HPLC components and freely available control software.

PMID 42887977
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PubMedJournal of hazardous materials2026-10-15

Photodegradation of Naproxen augment the photosensitization and phototoxicity with attenuated COX-2 binding under ambient UVA and UVB exposure.

Bala Madhu M, Kamar Mohd Danish MD, Saji Joel J, Basu Tanmayee T et al.

Naproxen (NPX) is a widely prescribed non-steroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic, and anti-inflammatory effects. Owing to its structure, NPX is susceptible to photodegradation, a factor of particular concern for topical formulations where exposure to solar UV radiation is inevitable. In this study, we systematically investigated the photodegradation and phototoxic potential of NPX under environmentally relevant UVA and UVB irradiation. NPX underwent faster photodegradation under UVA than UVB. UHPLC and LC-QToF-MS/MS identified two major photoproducts, P1 (1-(6-methoxynaphthalen-2-yl)ethanol) and P2 (2-acetyl-6-methoxynaphthalene), with P1 comprising approximately 90% of the photoproduct profile in both UVA and UVB. Spectroscopic analyses using FTIR and Raman spectroscopy revealed characteristic structural alterations, while LC-QToF-MS, 1H NMR, 13C NMR, and 2D NMR elucidated the photodegradation pathway, dominated by side-chain cleavage and decarboxylation reactions. Computational studies, including molecular docking and molecular dynamics simulations with the COX-2 enzyme, indicated diminished binding efficacy of NPX photoproducts. Further, we checked the COX-2 inhibitory activity, with PGE₂ abundance increasing by 15.6% and 37.4% with degraded NPX (Deg-NPX) relative to NPX at 10 and 50 µg/mL, respectively. Cytotoxicity assays in HaCaT cells demonstrated that NPX is phototoxic but Deg-NPX is both cytotoxic and phototoxic and also induced greater intracellular ROS accumulation, membrane damage, apoptosis, and dsDNA breaks. Collectively, these results highlight that NPX photodegradation generates photoproducts with greater basal cytotoxicity and enhanced phototoxicity and diminished pharmacological activity. The study provides mechanistic insights into their role in cutaneous adverse effects and highlights the importance of evaluating phototoxic risks in the clinical management of NSAID-based topical therapies.

PMID 42879931
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PubMedJournal of hazardous materials2026-10-15

Crystallographic phase engineering of MnO2 for efficient peracetic acid activation: Unraveling the critical role of surface manganese oxidation state.

Sun Si S, Yang Shurun S, Li Ruoxin R, He Chuan-Shu CS et al.

This study systematically investigates the influence of MnO2 crystallographic phase on the activation efficiency of peracetic acid (PAA). Firstly, α-, β-, γ-, and δ-MnO2 were synthesized through tailored methods. The oxidative activity of these catalysts was evaluated based on the degradation kinetics of naproxen (NAP), revealing the following catalytic activity order: α-MnO2 > δ-MnO2 > γ-MnO2 > β-MnO2. Further analysis revealed that NAP oxidation in the different crystallographic phases MnO2/PAA process mainly depends on RO• and 1O2. Comprehensive characterization and density functional theory (DFT) calculations were employed to elucidate the surface chemistry, intrinsic redox properties, structural stability, crystal features, and Mn-O bonding interactions. The results demonstrated an inverse correlation between the average oxidation state of surface manganese sites and the activation efficiency of PAA, thereby elucidating the fundamental origin of the high activity observed in specific crystalline phases of MnO2. The surface-localized chemical environment, rather than bulk characteristics, serves as the dominant factor governing the catalytic performance. Surfaces featuring lower average oxidation states exhibit enhanced reducibility of manganese species, which facilitates more rapid initiation of the catalytic reaction. These insights offer valuable guidance for the rational design of efficient and cost-effective MnO2-based catalysts for advanced water treatment applications.

PMID 42879927
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