Drug Database
FE

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

PubMedDrug design, development and therapy2026-08-30

Safety and Efficacy of Remimazolam Combined with Esketamine for Anesthesia in Elderly Patients Undergoing ERCP: A Randomized Controlled Trial.

Yu Yongbo Y, Wang Jiyuan J, Zhang Qianqian Q, Xia Xiaoqiong X et al.

Older adults undergoing ERCP are particularly susceptible to sedation-related respiratory and circulatory adverse events. This trial compared the safety and efficacy of remimazolam-esketamine with propofol-fentanyl, with identical standardized nasopharyngeal airway-assisted respiratory management in both groups. This single-center, prospective, randomized, parallel-group superiority trial enrolled 160 patients aged 60-80 years with American Society of Anesthesiologists physical status I-III who were scheduled for elective ERCP. Participants were randomly assigned 1:1 to remimazolam-esketamine (RE group; n=80) or propofol-fentanyl (PF group; n=80). Both groups received identical nasopharyngeal airway placement, oxygen delivery, capnography, and rescue algorithms; the randomized intervention was the anesthetic drug regimen. The primary outcome was composite sedation-related adverse events (SRAEs), comprising prespecified hypotension, bradycardia, hypoxemia, or respiratory depression from anesthesia induction to endoscope withdrawal. Analyses followed the intention-to-treat principle. Composite SRAEs occurred in 14 of 80 patients (17.5%) in the RE group and 28 of 80 patients (35.0%) in the PF group (RR, 0.50; 95% CI, 0.29-0.88; risk difference, -17.5 percentage points; 95% CI, -30.9 to -4.1; P=0.016). The adjusted RR was 0.49 (95% CI, 0.31-0.78; P=0.003). Anesthetic regimen success was similar between groups (97.5% vs 98.8%). Induction was modestly longer with RE, whereas eye-opening and modified Aldrete recovery time were slightly shorter. In this selected population of older patients undergoing ERCP, the remimazolam-esketamine regimen was associated with fewer composite SRAEs than propofol-fentanyl while achieving a similar anesthetic regimen success rate. Induction was modestly longer. Tachycardia, hypertension, and psychotomimetic symptoms were numerically more frequent with RE, but event counts were small and estimates were imprecise. Multicenter studies are required to confirm generalizability.

PMID 42668967
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PubMedCureus2026-08-29

Association Between Initial Injection Volume and Radiographic Catheter Alignment in Continuous Deep Serratus Anterior Plane Block for Minimally Invasive Cardiac Surgery: A Single-Center Retrospective Observational Study.

Toyama Ayano A, Iizuka Yusuke Y, Fukano Kentaro K, Saito Taishi T et al.

Background Continuous serratus anterior plane block (SAPB) is used for analgesia after thoracic and cardiac surgery. However, no standardized catheter placement method exists. This study investigated the association between initial injection volume and radiographic catheter alignment after minimally invasive cardiac surgery (MICS). Methods This retrospective cohort study included patients who underwent continuous SAPB after MICS between April 2021 and September 2024. Patients were divided into three groups based on initial bolus volume: low (≤ 30 mL), medium (40 mL), and high (≥ 50 mL). The primary outcome was radiographic catheter alignment assessed on frontal chest radiographs, categorized as favorable or unfavorable using predefined criteria. Secondary outcomes included fentanyl consumption and rescue analgesic administrations within 48 hours. Exploratory analysis evaluated associations between catheter alignment and analgesic use. Results The low-, medium-, and high-volume groups included 20, 33, and 45 patients, respectively. Favorable radiographic alignment was observed in 14 of 20 patients (70.0%) in the low-volume group, 32 of 33 patients (97.0%) in the medium-volume group, and 40 of 45 patients (88.9%) in the high-volume group (p = 0.015). Fentanyl consumption and rescue analgesic use did not differ significantly among groups. However, in an exploratory subgroup analysis, patients with favorable alignment required fewer rescue analgesic administrations than those with unfavorable alignment. Conclusion During continuous SAPB for MICS, an initial bolus volume of 40 mL or greater was associated with favorable radiographic alignment. The clinical relevance of these findings for postoperative analgesic outcomes warrants further prospective investigation.

PMID 42666743
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PubMedUltrasonics sonochemistry2026-08-29

Synergistic effects of ultrasound and yeast co-fermentation on microstructural, metabolic, and sensory properties of Robusta coffee.

Ni Jie J, Tang Huihua H, Tang Haoyuan H, Cao Cuihui C et al.

The study investigated an approach combining ultrasound with co-fermentation of P. fermentans and K. marxianus to improve the microstructural, metabolic, and sensory characteristics of Robusta coffee. Ultrasound treatment at 100, 200, and 300 W modified the surface microstructure of green coffee beans. Among them, 200 W exhibited the most pronounced promotion of yeast growth during fermentation (FU2). Compared with the control, the combined ultrasound and fermentation treatment increased total flavonoid and polyphenol contents while reducing caffeine and chlorogenic acid contents. In cupping tests, FU2 received the highest score (82.16 ± 0.58), noted for roasted, cocoa, floral, and honey aromas. Headspace solid-phase microextraction/gas chromatography-mass spectrometry (HS-SPME/GC-MS) analysis showed reduced undesirable volatile compounds (VCs) (pyrazines, pyridines and phenolic volatiles) and increased furans, alcohols, and esters in fermented samples. Metabolomics revealed significant alterations in metabolite profiles after ultrasound treatment. These metabolic changes were further regulated during fermentation, accompanied by significant enrichment of flavor precursor pathways, including phenylalanine metabolism, pyruvate metabolism, and the citrate cycle. These findings provide a potential strategy for improving the sensory quality and value-added utilization of Robusta coffee.

PMID 42667730
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PubMedThe International journal on drug policy2026-08-28

Same name, different drugs: variability of fentanyl ('dope') products sold under the same label.

Hochstatter Karli R KR, Nadel Talia T, Gryczynski Jan J, Waninger Brent B et al.

Unregulated opioid markets are increasingly characterized by complex and variable drug compositions. In North-eastern and Mid-Atlantic US street opioid markets, fentanyl-containing powders are commonly sold in stamped glassine bags. These "stamps" function as branding and are often used by people who use drugs, harm reduction programs and public health agencies as informal indicators of product composition or risk. This study quantified the extent to which stamp identity is associated with the presence and concentration of fentanyl and co-occurring compounds. We analyzed 1153 drug samples across 475 stamps collected during 2024-2025 in Philadelphia, Pennsylvania; Delaware; and Maryland. Laboratory testing identified compound presence and quantified concentrations. Multivariable logistic regression estimated stamp-specific probabilities of compound detection, and mixed-effects models generated intraclass correlation coefficients (ICCs) to assess clustering by stamp. Fentanyl was nearly ubiquitous (95.3%) but varied widely in concentration within stamps (<1% to >20%), indicating that branding was a poor indicator of potency. Several adulterants, including medetomidine (prevalence: 64.8%) and xylazine (prevalence: 42.2%), exhibited moderate-to-high clustering by stamp (ICCs up to 0.70), but substantial within-stamp inconsistency remained. Predicted probabilities varied widely, with two-thirds of compound-stamp combinations between 20% and 80%. Concentration analyses demonstrated inconsistent dosing, particularly for fentanyl (ICC=0.15). In this region, street opioid stamp branding is an unreliable indicator of fentanyl potency and only partially informative for some adulterants. Products sold under the same stamp often differ in composition and compound concentration, suggesting that stamp-based risk assessment is insufficient and reinforcing the value of sample-level drug checking.

PMID 42659903
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PubMedThe European respiratory journal2026-08-28

ERJ Podcast August 2026: Fentanyl or morphine for persistent dyspnoea in COPD.

PMID 42660612
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PubMedThe International journal on drug policy2026-08-28

Eight years of nationwide routine wastewater surveillance in New Zealand: Demonstrating its complementary role in public health policy.

Van Wichelen Natan N, Cliff Marisa M, Orton Ashley A, Masterton Hayden H et al.

Monitoring illicit drug consumption is challenging due to its hidden and stigmatised nature. However, objective consumption data are essential for a wide range of stakeholders, including policy makers. Wastewater-based epidemiology (WBE) offers population-level consumption estimates, but in-depth discussion and application for routine monitoring has been limited. This study demonstrates the practical implementation of high spatio-temporal resolution WBE as a complementary public health surveillance tool. 24-h composite influent wastewater samples (n = 23,158) were collected in New Zealand across 62 wastewater treatment plants between 2018 and 2025, representing around 80% of the New Zealand population. Per capita consumption (expressed in mg/day/1000 people) of methamphetamine, cocaine, MDMA, fentanyl and heroin was calculated. A marked nationwide surge in methamphetamine consumption was observed in influent wastewater in 2024, which ultimately contributed to the establishment of a Government action plan to combat methamphetamine harm in New Zealand. Similarly, a substantial increase in cocaine consumption was detected, with its use expanding from primarily urban and touristic centres to a widespread national distribution. A moderate rise in consumption was observed for MDMA, whereas no significant consumption trend changes were observed for fentanyl and heroin, with ongoing monitoring in place to enable a rapid response if necessary. WBE has become an integral component of New Zealand's public health surveillance infrastructure, serving as a data-driven tool for informing policymakers, understanding drug market dynamics, supporting harm reduction strategies, and enhancing toxicovigilance. Researchers play a crucial role in ensuring clear and targeted communication of results to non-specialist audiences to prevent over- or misinterpretation.

PMID 42664537
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