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ibuprofen + arginine (Spedifen / Zafen / Espedifen)

✓ Approved

Zambon · PTGS1 · Small Molecule

What is ibuprofen + arginine?

ibuprofen + arginine is a small molecule developed by Zambon. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesSpedifen, Zafen, Espedifen
CompanyZambon
Drug ClassSmall Molecule
Molecular TargetPTGS1, PTGS2
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Zambon

Mechanism of Action

Molecular Targets

ibuprofen + arginine acts on 2 molecular targets:

PTGS1prostaglandin-endoperoxide synthase 1 (COX3, PCOX1)
PTGS2prostaglandin-endoperoxide synthase 2 (GRIPGHS, hCox-2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

ibuprofen + arginine is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Gastrointestinal disordersAbdominal pain✓ Approved
Hepatobiliary disordersHepatitis✓ Approved

Related Research Articles

PubMedFrontiers in genetics2026-07-17

Identification of potential biomarkers and therapeutic targets for osteoarthritis associated with arginine and proline metabolism based on transcriptome sequencing and bioinformatics.

Chen Xiao-Hua XH, Liu Jun J, Qiu Ling L, Zhan Yang Y et al.

Osteoarthritis (OA) is a chronic degenerative joint disease. Approximately 300 million people worldwide suffer from OA, which shows a high incidence in middle-aged and elderly populations, with a prevalence of 50% among individuals aged over 60 years. Its core clinical symptoms consist of joint pain, swelling, and dysfunction. Studies have shown that arginine and proline metabolism play an important role in the pathogenesis and progression of OA, but the specific mechanism is still unclear. This study aimed to identify biomarkers and drug therapeutic targets for OA associated with arginine and proline metabolism. Synovial tissues of healthy individuals and OA patients were collected for transcriptome sequencing, and the differentially expressed genes (DEGs) between the two groups were compared and analyzed. Arginine and proline metabolism-related genes (APRGs) were obtained from the molecular signature database. The candidate genes were identified by weighted gene co-expression network analysis (WGCNA), and then gene ontology (GO), Kyoto encyclopedia of genes and genomes (KEGG) pathway analysis and protein-protein interaction (PPI) were performed. Expression validation was performed using machine learning and ROC analysis to identify key genes. Gene set enrichment analysis (GSEA), immune cell infiltration, and drug prediction were used to explore the mechanism of key genes in OA and potential therapeutic drugs. Finally, clinical samples were experimentally validated through RT-qPCR experiments. Two hub genes (MYOM2 and TCAP) involved in arginine and proline metabolism were identified. A nomogram constructed based on these genes indicated that MYOM2 and TCAP are key and reliable predictors for osteoarthritis risk. The RT-qPCR experiments on clinical samples showed that the expression levels of these hub genes were significantly downregulated in the synovial tissue of OA patients (p < 0.05), suggesting their potential as diagnostic biomarkers. MYOM2 and TCAP are hub genes in OA metabolism with arginine and proline, which may become new diagnostic markers and potential therapeutic targets for OA.

PMID 42466303
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PubMedJournal of the American Heart Association2026-07-17

Endotypes of Vascular Health Predict Transplantation-Free Survival in Pulmonary Hypertension.

Farha Samar S, Hu Bo B, Chen Ruoying R, Barnard John J et al.

The current classification of pulmonary hypertension (PH), based largely on expert opinion, has limitations in prognostication and guiding therapies. We hypothesize that novel PH clusters that predict survival will reveal mechanistic phenotypes associated with biomarkers of vascular health across all PH groups. We first identify novel PH clinical clusters by performing unsupervised clustering analysis on the CC-PH (Cleveland Clinic PH) registry (N=1529). We develop classification models to predict the new PH clusters and then apply them to the multicenter PVDOMICS (Pulmonary Vascular Diseases Phenomics) cohort (N=853) for validation. We compare transplantation-free survival across the new PH clusters. We quantify metabolites of the arginine-nitric oxide pathway and D-dimer levels and calculate global arginine bioavailability (arginine/[ornithine+citrulline]) to assess endothelial function and activation in the new clusters and link these biomarkers to clinical outcomes. Clustering analysis identify 3 clear clusters in CC-PH that are validated in PVDOMICS and outperform conventional classifications in predicting transplantation-free survival. The phenotype associated with the worst survival is characterized by reduced lung diffusion capacity, decreased arginine bioavailability and nitrate levels, and elevated D-dimer levels, consistent with loss of pulmonary microcirculation and endothelial dysfunction. We identify new informative PH phenotypes associated with mortality and defined by biomarkers of endothelial function and activation. Loss of endothelial health and pronounced pulmonary vascular rarefication contribute more substantially to mortality across the spectrum of PH than right heart function. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02980887.

PMID 42466490
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PubMedmedRxiv : the preprint server for health sciences2026-07-17

Oral and Maxillofacial Surgeon Accuracy in Anticipating Supplemental Opioid Use Following Third Molar Extraction.

van den Dries Sierra R SR, Panchal Neeraj N, Wang Steven S, Habib Rania A RA et al.

Accurately identifying patients who will require opioids after third molar extraction could improve pain management while supporting opioid stewardship. This study evaluated surgeon accuracy in predicting supplemental opioid use following treatment with ibuprofen and acetaminophen. Patients (N=85) undergoing third molar extraction were treated with a standardized analgesic regimen of ibuprofen+acetaminophen, with supplemental opioid if needed. Four surgeons independently reviewed preoperative radiographs, assessed surgical difficulty using the Pederson scale, and rated the likelihood of supplemental opioid use on a 5-point Likert scale. Inter-rater reliability was assessed using intraclass correlation coefficients (ICC). The relationship between surgeon ratings and postoperative opioid use was evaluated using logistic regression and receiver operating characteristic (ROC) analysis. Seventeen patients used supplemental opioid analgesics. Inter-rater reliability among surgeons was moderate (ICC3=0.606, 95%CI: 0.505-0.700), while reliability of the average rating across surgeons was good (ICC3k = 0.860, 95% CI: 0.804-0.903). Median surgeon rating was not associated with postoperative opioid use (OR: 0.800, 95% CI: 0.414-1.51, p=0.496) and demonstrated poor discrimination (AUC: 0.551, 95% CI: 0.392-0.710). Surgeon ratings were positively associated with Pederson score (β=0.073, 95%CI: 0.050-0.096; p<0.001). Surgeons demonstrated moderate agreement, but these assessments did not accurately identify patients who ultimately required supplemental opioids. Surgeon judgments appeared to be influenced by anticipated surgical difficulty. Clinicians should follow current recommendations against routine "just-in-case" opioid prescribing after third molar extraction. Future studies should focus on identifying clinical and biological predictors of inadequate analgesic response to NSAIDs to support individualized pain management strategies.

PMID 42465898
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PubMedAdvances in pharmacological and pharmaceutical sciences2026-07-17

Ibuprofen and Palmitic Acid-Based Solvent Exchange-Induced In Situ Forming Matrices With Gentian Violet for Oropharyngeal Candidiasis and Periodontitis Treatment.

Phaechamud Thawatchai T, Phattanawasin Panadda P, Senarat Setthapong S, Puapermpoonsiri Utsana U et al.

Gentian violet (GV) is a broad-spectrum antimicrobial agent with documented efficacy against oropharyngeal candidiasis and periodontal pathogens, but its clinical use is limited by poor local retention. In situ forming matrices (ISMs) offer a promising strategy for sustained, localized drug delivery. This study aimed to develop and evaluate GV-loaded ISMs using ibuprofen (IBU) and palmitic acid (PA) as dual-function matrix-forming agents in DMSO and NMP solvents for the localized treatment of oropharyngeal candidiasis and periodontitis. ISM formulations were prepared by simple mixing and characterized for viscosity, rheological behavior, injectability, mechanical properties, and in situ matrix formation. In vitro drug release of GV and IBU was quantified by a validated simultaneous HPLC method using an ACE C18 column with UV detection at 590 and 222 nm, respectively. Drug-release kinetics were modeled using zero-order, first-order, Higuchi, Korsmeyer-Peppas, and Peppas-Sahlin models. Antimicrobial activity against Staphylococcus aureus, Candida albicans, C. tropicalis, and Porphyromonas gingivalis was assessed by agar diffusion over 15 days. Molecular interactions were investigated using density functional theory (DFT) calculations at the B3LYP-D3BJ/6-31G(d,p) level. All formulations showed Newtonian-flow behavior and acceptable injectability (0.78-1.50 N). GV and IBU release followed the Peppas-Sahlin model, with NMP-based systems releasing GV and IBU faster due to more porous matrix architecture, while DMSO-based systems formed denser matrices with slower release. All GV-containing formulations maintained antimicrobial inhibition zones for up to 15 days. DFT calculations revealed strong GV-IBU (-1.63 eV) and GV-PA (-1.53 eV) binding energies, supporting sustained drug entrapment. GV-loaded IBU/PA-based ISMs demonstrate sustained antimicrobial efficacy for up to 15 days with solvent-dependent release behavior. These systems show potential as localized, single-injection therapies for oral infections. Stability evaluation and in vivo biocompatibility studies are identified as necessary future steps.

PMID 42466329
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PubMedCureus2026-07-17

Unravelling the Allergy Label: A Case of Successful Multi-drug Allergy De-labelling in a Patient.

Vassila Angeliki A, Teo Ying Y, Jones Michael A MA

We report the case of a 23-year-old woman with a pre-existing penicillin allergy label from childhood who presented with severe bilateral conjunctivitis and oral mucositis following a prodromal respiratory illness. Her symptoms worsened shortly after receiving doxycycline, raising concern for a drug reaction. Her condition progressed with significant ocular involvement requiring bilateral amniotic membrane grafting and subsequent immunosuppressive therapy. Investigations confirmed Mycoplasma pneumoniae infection, supporting a diagnosis most consistent with Mycoplasma-induced rash and mucositis (MIRM), although Stevens-Johnson syndrome (SJS) could not be fully excluded. Following recovery, a structured allergy work-up was undertaken, including patch testing, intradermal testing and graded oral provocation in accordance with established guidance. All tests were negative, and the patient successfully tolerated amoxicillin, doxycycline and ibuprofen without adverse reactions. This case demonstrates how a structured, multidisciplinary approach to drug allergy evaluation can facilitate de-labelling in patients with complex mucocutaneous presentations, restore access to first-line therapies and improve patient care.

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PubMedBiochemical and biophysical research communications2026-07-17

Mutational mapping of sequence variants within the arginine- and serine-rich domain of RNA binding motif protein 20.

Groß Joline J, Wiebe Caroline C, Felski Elina E, Landwehr Sandra S et al.

Mutations in the cardiac splicing factor RNA binding motif protein 20 (RBM20) are associated with severe forms of dilated cardiomyopathy. Mutations predominate within the highly conserved RSRSP-stretch and are characterized by a cytoplasmic mislocalization of RBM20. However, a sequence downstream of the RSRSP-stretch, the SRSLSP-stretch, is also phylogenetically highly conserved. The impact of the SRSLSP-stretch is unclear. In our study we investigated subcellular localization of RBM20 variants in HEK293 cells after transient transfection. We showed that variants within the RSRSP-stretch lead to significant cytoplasmic mislocalization. Aberrant TTN-splicing was observed in the explanted myocardium of an RBM20-p.R634W carrier. Within the SRSLSP-stretch, variants at amino acid position 641 are associated with partial mislocalization of RBM20. Molecular modelling of RBM20 and transportin-3 interaction by AlphaFold-3 suggests that the RSRSP stretch and arginine at position 641 are involved in transportin-3 interaction. In summary, our study supports the functional relevance of the RSRSP-stretch for the RBM20-TNPO3 interaction, whereas variants within the adjacent SRSLSP stretch have a minor impact on the nuclear localization. Furthermore, the data underscore the limitations of in silico-based pathogenicity predictions of RBM20 variants.

PMID 42462460
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