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dexamethasone (OT502 / IBI10090 / OT 502)

✓ Approved

Ocumension Therapeutics Co., Ltd. · NR3C1 · 类固醇

什么是 dexamethasone？

dexamethasone 是一种类固醇，由Ocumension Therapeutics Co., Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intraocular Injection。

药物档案

商品名OT502, IBI10090, OT 502
公司Ocumension Therapeutics Co., Ltd.
药物类别类固醇, 小分子
分子靶点NR3C1
给药途径Injectable (Others), Intraocular Injection
状态Approved
来源： ClinicalTrials.gov, Ocumension Therapeutics Co., Ltd.

作用机制

分子靶点

dexamethasone 作用于 1 个分子靶点：

NR3C1nuclear receptor subfamily 3 group C member 1 (GR, GCCR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

dexamethasone 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Eye disordersCataract✓ Approved

相关研究文献

PubMedJAMA network open2026-07-27

Intraarterial Dexamethasone for Pain Relief After Uterine Fibroid Embolization: A Randomized Clinical Trial.

Briley Kenneth K, Reddy Rohit R, Cavada Arais A, Alessandrino Francesco F et al.

Acute postprocedural pain remains a major barrier to uterine fibroid embolization (UFE). To assess whether intraarterial dexamethasone reduces postprocedural pain after UFE. This double-blind, placebo-controlled randomized clinical trial was conducted from July 2020 to December 2023, with follow-up through 3 months, at a single tertiary academic medical center. Participants were women, aged 20 to 50 years, undergoing UFE. Intraarterial dexamethasone (10 mg) or saline placebo administered during embolization. The primary outcome was postprocedural pain through 168 hours. Secondary outcomes included postembolization syndrome symptoms; fibroid-related symptoms and health-related quality of life, assessed using the UFE-Quality of Life questionnaire at baseline and at 1 and 3 months; and percentage reduction in uterine volumes on magnetic resonance imaging. Among 42 women randomized (mean [SD] age, 44.7 [4.7] years; 21 per group), 40 women were included in the final analysis (20 randomized to the dexamethasone group and 20 to the placebo group) after excluding 2 participants. In the dexamethasone group, 7 participants (35%) were African American, 6 (30%) were Hispanic, and 7 (35%) were White; in the placebo group, 9 (45%) were African American, 8 (40%) were Hispanic, and 3 (15%) were White. Intraarterial dexamethasone was associated with significantly lower mean (SD) pain scores immediately after the procedure (4.0 [3.3] vs 6.1 [3.1]; mean difference, -2.1 [95% CI, -4.14 to -0.06]; P = .04) and through 96 hours (2.4 [2.4] vs 4.5 [3.2]; mean difference, -2.1 [95% CI, -3.90 to -0.30]; P = .02) compared with placebo. The mean (SE) pain score over 168 hours was significantly lower in the dexamethasone group vs placebo (2.63 [2.28] vs 4.28 [2.27] visual analog scale units; mean difference, -1.64 [95% CI, -3.10 to -0.19]; P = .02). Among participants with paired magnetic resonance imaging follow-up, the mean (SD) uterine volume reduction from baseline to 3 months was 37.4% (17.7%) in the dexamethasone group vs 29.6% (20.2%) in the placebo group (P = .30), and the mean (SD) dominant fibroid volume reduction was 34.4% (22.8%) vs 38.6% (16.7%) (P = .60). No major complications occurred in either group. In this randomized clinical trial of 40 women undergoing UFE, intraarterial dexamethasone was associated with clinically meaningful reductions in postprocedural pain through 96 hours compared with placebo, without compromising treatment efficacy or increasing adverse events, which may offer a simple, low-cost strategy to reduce analgesic burden in individuals undergoing UFE. ClinicalTrials.gov Identifier: NCT04655144.

PMID 42507444
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PubMedZhonghua yi xue za zhi2026-07-27

[Comparison of predictive performance between midnight 1 mg dexamethasone suppression test combined with ACTH stimulation test and 3 prediction models for idiopathic hyperaldosteronism].

Ye L T LT, Yu Y Y, Zang L L, An P P et al.

Objective: To compare the predictive efficacy of the midnight 1 mg dexamethasone suppression test combined with the adrenocorticotropic hormone(ACTH) stimulation test versus three prediction models for idiopathic hyperaldosteronism (IHA). Methods: Clinical data of patients diagnosed with aldosterone-producing adenoma (APA) and IHA at the First Medical Center of Chinese PLA General Hospital from January 2020 to August 2025 were retrospectively analyzed. Patients were definitively diagnosed by adrenal vein sampling (AVS), adrenal surgical pathology, and postoperative follow-up, and were divided into APA group and IHA group. The midnight 1 mg dexamethasone suppression test combined with the ACTH stimulation test, the Xiao model, the Kobayashi 2018 model, and the Umakoshi model were respectively used to predict IHA. The McNemar test was used to compare the sensitivity and specificity of the midnight 1 mg dexamethasone suppression test combined with the ACTH stimulation test with those of the three prediction models for IHA. Results: A total of 175 patients were enrolled, aged 54.0 (45.0, 59.5) years, including 85 males and 90 females. Among them, 82 were in the APA group and 93 in the IHA group. Using the criterion of 90 min plasma aldosterone concentration (PAC)<39.05 ng/dl after the midnight 1 mg dexamethasone suppression test combined with ACTH stimulation test to predict IHA, the sensitivity and specificity were 90.3% and 93.9%, respectively. Using the recommended predictive probability≥0.9 of the Xiao model as the criterion to predict IHA, the sensitivity and specificity for diagnosing IHA were 47.3% and 95.1%, respectively. Using the recommended score≥ 8 points of the Kobayashi 2018 model as the criterion to predict IHA, the sensitivity and specificity for diagnosing IHA were 16.1% and 98.8%, respectively. The Umakoshi model showed a sensitivity of 17.2% and a specificity of 97.6% for diagnosing IHA. The sensitivity of the midnight 1 mg dexamethasone suppression test combined with the ACTH stimulation test in diagnosing IHA was significantly higher than that of the Xiao model, the Kobayashi 2018 model, and the Umakoshi model (all P<0.001), while there were no statistically significant differences in specificity between the combined test and the three models (all P>0.05). Conclusions: The midnight 1 mg dexamethasone suppression test combined with the ACTH stimulation test shows higher sensitivity for predicting IHA than the Xiao model, Kobayashi 2018 model, and Umakoshi model, and its specificity is comparable to these three prediction models.

PMID 42503922
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PubMedJournal of functional biomaterials2026-07-27

Drug Nanocrystal-Loaded Thermo-Reversible Hydrogels of Dexamethasone Palmitate for Intratympanic Drug Delivery.

Noh Su Yeon SY, Kang Jee Hyun JH, Yang In Gyu IG, Jeong Min Young MY et al.

Intratympanic (IT) injection of corticosteroids is a standard clinical treatment for sensorineural hearing loss; however, achieving both biocompatibility and efficient cochlea drug delivery remains a significant challenge. Herein, we engineered a novel drug nanocrystal (NS)-loaded thermo-reversible hydrogel (NS-TG) system of dexamethasone-21-palmitate (DEX-P), a lipophilic prodrug of dexamethasone (DEX), for improved IT delivery. NSs with a mean diameter of 835.0 nm were fabricated using a dual centrifugation process with polyvinyl alcohol as the stabilizer. The NS-TG system, comprising NSs in a 19% (w/v) Poloxamer 407 hydrogel, exhibited rapid gelation (2-3 min) and a 31-fold increase in drug solubility (1.57 ± 0.02 mg/mL) compared to NS alone, through micellar solubilization. In vitro cytotoxicity assays in HEI-OC1 cells revealed that NS-TG is highly biocompatible, maintaining cell viability, whereas the commercial lipid emulsion (Lipothason®) induced significant cytotoxicity. In vivo pharmacokinetic evaluation in mice revealed that IT NS-TG provided superior cochlear drug absorption compared to DEX-SP solutions and DEX-P NS, despite showing lower absorption than the lipid emulsion. These findings suggest that the DEX-P NS-TG system, pending further investigation, could serve as a promising platform for cochlear steroidal delivery, offering an optimal balance between delivery efficiency and local safety for treating inner ear diseases.

PMID 42506573
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PubMedDiseases (Basel, Switzerland)2026-07-27

Phase III Trial: Single Low-Dose 5 mg Dexamethasone with NEPA for Preventing 168 h Nausea and Vomiting of Diverse Highly or Moderately Emetogenic Chemotherapy (LD-NEPA).

He Yuting Y, Huang Xintian X, Rong Kaiyi K, Hong Yongxiang Y et al.

Reducing corticosteroid exposure has become an important objective in the management of chemotherapy-induced nausea and vomiting (CINV), given the dose-related toxicity of dexamethasone (DEX). This prospective phase III randomized (LD-NEPA: low-dose dexamethasone plus netupitant/palonosetron) study evaluated whether a reduced dose of 5 mg DEX could maintain antiemetic efficacy when combined with NEPA in patients receiving highly or moderately emetogenic chemotherapy (HEC/MEC). Adult patients were randomly assigned (1:1) to receive NEPA with either 5 mg DEX (5D group) or 8 mg DEX (8D group). Among 186 randomized patients, 180 were included in the analysis (89 in the 5D group and 91 in the 8D group). The primary endpoint was the complete response rate (CRR; no emesis and no rescue medication use) during the 0-168 h period. Secondary endpoints included phase-specific CRR, total control rate (TCR), complete control rate (CCR), daily incidence of nausea and vomiting, and safety outcomes. The overall CRR was 78.7% in the 5D group and 70.3% in the 8D group. The between-group difference was 8.4% (95% CI: -1.5% to 19.0%), demonstrating the reduced-dose regimen was non-inferior, with the lower bound exceeding the prespecified -15% margin. Consistent results were observed across secondary endpoints. Treatment-related adverse events were mostly grade 1-2 and occurred with broadly comparable frequencies between the two groups. A single lower dose of 5 mg DEX is noninferior to an 8 mg dose combined with NEPA for preventing 168 h nausea and vomiting of diverse HEC/MEC, offering comparable efficacy while reducing corticosteroid exposure.

PMID 42505559
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PubMedNanomaterials (Basel, Switzerland)2026-07-27

The Development of Four-Arm PEG-Based Thermoresponsive Dexamethasone Prodrugs for the Treatment of Osteoarthritis Pain.

Deng Yangwei Y, Arash Shabnam S, Rong Jie J, Althobaiti Salma Abdullah SA et al.

Thermoresponsive polymeric prodrugs represent a promising strategy for localized and sustained in vivo drug delivery. In this work, two polyethylene glycol (PEG)-based dexamethasone (Dex) prodrugs with different Dex contents were synthesized using a four-arm PEG scaffold. Prodrug 1, containing four Dex molecules, showed high aqueous solubility but no thermoresponsive gelation behavior. In contrast, eight-Dex Prodrug 2 exhibited temperature-dependent aggregation and formed hydrogels in aqueous media. The viscosity of the Prodrug 2 hydrogel was reduced by introducing 10% ethanol as a cosolvent, enabling an injectable formulation that rapidly forms a hydrogel depot upon contact with aqueous media. The hydrogel provides gradual Dex release via the cleavage of the acid-labile hydrazone bond linking Dex to the PEG. In a monosodium iodoacetate (MIA)-induced osteoarthritis (OA) pain model, intra-articular (IA) injection of Prodrug 2 produced rapid and sustained pain relief for up to 28 days. These findings indicate that the hydrogel-forming four-arm PEG-based Dex prodrug offers a potentially effective approach for prolonged local corticosteroid (CS) delivery, applicable to the treatment of many local pathologies, including OA and OA pain.

PMID 42506526
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PubMedCurrent oncology (Toronto, Ont.)2026-07-27

Aprepitant and Fosaprepitant for Preventing Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy-A Real-World Study.

Ünlü Beyza B, Demir Hacer H, Davarcı Sena Ece SE, Culha Yaşar Y et al.

Chemotherapy-induced nausea and vomiting substantially impair patients' quality of life despite considerable advances in supportive care. Neurokinin-1 receptor antagonists, including oral aprepitant and intravenous fosaprepitant, constitute essential components of antiemetic regimens for highly emetogenic chemotherapy. In this prospective, non-randomized observational study, we compared the efficacy of oral aprepitant and intravenous fosaprepitant administered in combination with 5-hydroxytryptamine-3 receptor antagonists and dexamethasone in 136 chemotherapy-naive patients receiving cisplatin- or doxorubicin-cyclophosphamide-based regimens. Complete response rates during the acute (0-24 h), delayed (24-120 h), and overall (0-120 h) phases were comparable between the two groups, with no statistically significant differences in emesis severity. Multivariable analyses further demonstrated similar effectiveness irrespective of age, sex, or chemotherapy regimen. These findings indicate that no statistically significant differences in antiemetic efficacy were observed between aprepitant and fosaprepitant in routine clinical practice. Fosaprepitant may therefore represent a practical alternative when oral administration is not feasible.

PMID 42505183
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