Drug Database
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fentanyl citrate (OX20 / Rapinyl / EN 3267)

✓ Approved

Kyowa Kirin Co., Ltd. · Small Molecule · Small Molecule

What is fentanyl citrate?

fentanyl citrate is a small molecule developed by Kyowa Kirin Co., Ltd.. It is approved for therapeutic indications via oral (po) or sublingual (sl)/oral transmucosal or topical.

Drug Profile

Brand NamesOX20, Rapinyl, EN 3267
CompanyKyowa Kirin Co., Ltd.
Drug ClassSmall Molecule
RouteOral (PO), Sublingual (SL)/Oral Transmucosal, Topical
StatusApproved
Sources: ClinicalTrials.gov, Kyowa Kirin Co., Ltd.

Therapeutic Indications

fentanyl citrate is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Cancer pain✓ Approved

Related Research Articles

PubMedJournal of anesthesia2026-05-24

Effect of fentanyl on laryngeal airway patency after sugammadex administration: a randomized controlled trial.

Ishibashi Katsuhiko K, Yamada Takayuki T, Ukiya Tomoharu T, Isono Shiroh S

Glottic narrowing after sugammadex administration has been reported in patients managed with supraglottic airway devices (SGAs). The influence of opioids on laryngeal airway patency during neuromuscular recovery in adults remains unclear. We tested the hypothesis that fentanyl attenuates vocal cord angle (VCA) narrowing after sugammadex administration. In this randomized controlled trial, 20 adult patients undergoing general anesthesia with SGAs were allocated to receive fentanyl (target effect-site concentration 1.0 ng/ml) or no fentanyl. The primary outcome was the change in VCA before and after sugammadex administration (Δ-VCA). Secondary outcomes included VCA at each time point and respiratory variables. 19 patients were analyzed per protocol. VCA narrowing after sugammadex occurred in all patients in the fentanyl group and in three in the no-fentanyl group. Δ-VCA was significantly greater in the fentanyl group than in the no-fentanyl group (median [IQR]: 23 [8-27] vs. 4 [0-18] degrees; P = 0.022), contrary to the original hypothesis. Tidal volume per body weight and minute ventilation decreased significantly after sugammadex in the fentanyl group. No patients in either group reported pain at emergence. In adults managed with SGAs, fentanyl administration was associated with greater VCA narrowing during recovery from neuromuscular blockade with sugammadex. Unnecessary or excessive opioid effect-site concentrations relative to the analgesic requirements might contribute to impaired laryngeal airway patency during emergence.

PMID 42177364
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PubMedDrug and alcohol dependence2026-05-24

Fentanyl overdose death rates are associated with regional differences in urine drug testing results.

Huhn Andrew S AS, Dunn Kelly E KE, Ciccarone Daniel D, Whitley Penn P et al.

Identifying methods to quickly surveil drug use trends is key for responding to constant changes in the illicit opioid supply. This study evaluated whether changes in the concentration and prevalence of fentanyl in urine drug tests (UDT) predict synthetic opioid-involved overdose mortality across U.S. geographic regions. UDT samples were analyzed via liquid chromatography tandem mass spectrometry for fentanyl concentration and prevalence (detection rate). UDT measures were evaluated as predictors of monthly regional (Northeast, Southern, Midwestern, Western) synthetic opioid related overdose deaths using correlation, linear regression and time-series analysis. Patients (N = 575,570) submitted a total of 2172,218 UDT specimens for substance use testing between January 2019 and December 2025. A 333% increase in fentanyl concentration and a 104% increase in fentanyl prevalence were identified nationally between 2019 and 2023, followed by decreases of 33% for concentration and 27% for prevalence through 2025. Results varied by region, with the West reporting the highest overall fentanyl concentration (123.3ng/mg) and prevalence (19.2%) in 2025. UDT concentration was most highly correlated with overdose in the West (Spearman r = 0.87), whereas prevalence was more highly correlated in the South (r = 0.8), Midwest (r = 0.76) and Northeast (r = 0.75). Regional time-series models trained on the preceding 12-months of UDT and overdose data were able to predict the following month within 8.8% of the observed overdose deaths on average. UDT results likely reflect fentanyl supply and consumption trends that change the risk of fatal overdose. Understanding changes in drug exposure may help local health departments and providers respond to overdose risk in their communities.

PMID 42176388
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PubMedMetabolomics : Official journal of the Metabolomic Society2026-05-24

NMR-based metabolomics profile during a soccer season of a sub-elite soccer team.

Marinho Alisson Henrique AH, de Barros Sousa Filipe Antonio FA, Balikian Junior Pedro P, de Souza Bento Edson E et al.

This study aimed to characterize metabolomic profiling, match performance, and GPS-derived variables across the competitive season of a sub-elite soccer team. Performance variables were recorded by GPS during matches. Urine samples were collected pre-match across 20 games. For integrative analysis, only players participating ≥ 25 min per match were included (n = 13 matches). Spectra were pre-processed using TopSpin®3.2, and metabolites were identified using Chenomx®. Heatmap analysis revealed two main metabolite clusters (C): C1 (choline to citrate - C1) and C2 (dimethylamine to trans-aconitate - C2). C1 showed lower concentrations at the beginning of the season with a progressive increase toward the end, whereas C2 displayed the opposite trend. A sub-cluster within C2 (trimethylamine to trans-aconitate) exhibited a three-phase pattern, decreasing mid-season and increasing thereafter. PCA and OPLS-DA demonstrated clear separation between early- and late-season matches, indicating a shift in the metabolomic profile. Distance covered across speed zones was higher in C1 and lower in C2. Leucine, guanidinoacetate, creatinine, and 3-hydroxyisovalerate were inversely associated with distance metrics, linking elevated protein catabolism markers to reduced performance. Glycerophosphocholine was also inversely correlated with most distance variables of GPS metrics, suggesting reduced muscle integrity. In contrast, glucose was positively associated with player load, accelerations, decelerations, and impacts, while citrate correlated with high-speed running and maximum velocity. Seasonal metabolomic shifts are associated with external load and performance. Markers of protein catabolism relate to reduced output, whereas energy-related metabolites support high-intensity actions, highlighting metabolomics as a complementary tool for monitoring recovery and performance in soccer.

PMID 42177734
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PubMedProbiotics and antimicrobial proteins2026-05-24

Multi-omics Analysis Reveals the Protection of a Quadruple Probiotic Mixture in Experimental Autoimmune Hepatitis.

Chen Yu Y, Wang Shuhui S, Chen Anzhuo A, Lin Zhuoying Z et al.

Autoimmune hepatitis (AIH) is a chronic progressive inflammatory liver disease with a rising global incidence. The treatment of AIH remains challenging because first-line drugs show limited efficacy and systemic side effects. Gut microbiota plays a crucial role in the pathogenesis of AIH, leading to growing interest in developing probiotic-based therapies. In this study, we used multi-omics analysis to investigate the therapeutic effects of a quadruple probiotic mixture (Probiotic-quad) consisting of Bifidobacterium infantis, Lactobacillus acidophilus, Enterococcus faecalis, and Bacillus cereus in a well-established chronic AIH murine model. Our results showed that Probiotic-quad treatment significantly alleviated AIH progression, as evidenced by lower serum liver enzyme levels, ameliorated hepatic inflammatory infiltration and histopathological damage. Metagenomic sequencing results showed that gut dysbiosis in AIH mice was partially reversed after Probiotic-quad administration. Additionally, the integrity of the intestinal epithelial barrier was restored, accompanied by a reduction in serum lipopolysaccharide levels. Untargeted metabolomic and transcriptomic analysis revealed that Probiotic-quad treatment was linked to alterations in hepatic metabolism, including the citrate cycle and tryptophan metabolism, and was associated with reduced activation of the NF-κB and NOD-like receptor signaling pathways. These findings suggest that Probiotic-quad treatment ameliorates AIH severity and is potentially associated with changes in hepatic immune responses, metabolism, gut microbiota, and intestinal barrier function, highlighting its potential as an adjuvant therapy for AIH.

PMID 42176246
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PubMedEuropean journal of pharmacology2026-05-24

Sulfonated peptide alleviates hypertensive renal injury via antioxidant, anti-inflammatory, and renal metabolomics.

Li Yuexiu Y, Song Siyi S, Lin Qianxia Q, Jin Huoxi H

Excessive dietary salt intake is a well-established risk factor for hypertension, with numerous underscoring its significant role in the pathogenesis of cardiovascular diseases. Dietary management is widely recognized as essential for both the prevention and treatment of hypertension. This study aimed to evaluate the preventive efficacy of a sulfonated peptide, Leucyl-glycyl-asparaginyl-glycyl-cysteinylsulfonic acid-proline (Leu-Gly-Asn-Gly-Cya-Pro, SLP), against high-salt-induced hypertension and renal injury, thereby providing new insights into hypertension prevention strategies. Compared with the unsulfonated peptide, Leucyl-glycyl- asparaginyl-glycyl-cysteinyl-proline (Leu-Gly-Asn-Gly-Cys-Pro, LP), SLP was more effective in attenuating the elevation of blood pressure, inhibiting renal fibrosis, improving markers of renal injury (alpha-1-microglobulin and uric acid), and reducing levels of inflammatory factors and adhesion molecules (intercellular adhesion molecule-1, vascular cell adhesion molecule-1, and interleukin-1β). Additionally, SLP upregulated endothelial nitric oxide synthase while downregulating inducible nitric oxide synthase in the kidney. Similarly, high levels of nuclear factor-kappa B and phosphorylated nuclear factor-kappa B induced by high-salt in the kidney were effectively prevented by SLP treatment. Furthermore, SLP exerted antihypertensive effects through the regulation of tryptophan, purine, glycerophospholipid, and cysteine metabolism, as well as the citrate cycle. Overall, sulfonation modification enhances the anti-inflammatory and metabolic regulatory activities of peptides, with the sulfonated peptides SLP significantly preventing high-salt-induced hypertension and its associated renal complications.

PMID 42176725
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PubMedApplied microbiology and biotechnology2026-05-24

A comparative analysis of monascin and ankaflavin biosynthesis in Monascus purpureus and its albino variant.

Lin Tzu-Hsing TH, Cheng Yi-Hao YH, Lin Chih-Hui CH

Red mold rice (RMR), a functional food ingredient, is produced via Monascus spp. fermentation, a process that yields a diverse range of bioactive compounds, most notably the Monascus yellow pigments monascin and ankaflavin. This study provides the first report of spontaneous albinism in Monascus species. Although the specific mechanisms and conditions triggering the transition to albino strains remain to be definitively elucidated, our analyses reveal that the albino strain of Monascus purpureus exhibits a faster growth rate and significantly lower yellow pigment production compared to the wild-type strain. This suggests that the emergence of albino strains poses a considerable risk to the stability of industrial M. purpureus cultures. Furthermore, comparative analysis of gene expression associated with monascin and ankaflavin biosynthesis between M. purpureus wild-type and albino strains under various culture conditions indicates that the malate-citrate shuttle, specifically the mitochondrial dicarboxylate carrier (DIC), may play a critical role in yellow pigment biosynthesis. The comparative analysis also revealed significant correlations among glyceraldehyde-3-phosphate dehydrogenase (GAPDH), DIC, mrpigH expression, and overall yellow pigment production, suggesting a potential metabolic approach for enhancing M. purpureus pigment biosynthesis. Ultimately, given the profound differences in pigment yield and fermentation characteristics, these findings demonstrate that the occurrence of spontaneous albinism represents not only a critical, previously overlooked risk factor for industrial M. purpureus production, but also a possible approach for elucidating the regulatory mechanisms of M. purpureus secondary metabolism. KEY POINTS: • This study provides the first report of spontaneous albinism in Monascus species. • Expression of GAPDH, DIC, and mrpigH, as well as MS/AK production were significantly correlated. • Albino strain represents an overlooked risk factor for industrial M. purpureus production.

PMID 42175998
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