Delving into the Latest Updates on Hydrocortisone Butyrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

11β,21-dihydroxy-17α-butyryloxy-4-pregnene-3,20-dione, 17-O-butyrylcortisol, Cortisol 17-butyrate

+ [14]

Target

GR

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases

Active Indication

Dermatitis, AtopicDermatitis, SeborrheicSkin Diseases

Inactive Indication-

Originator Organization

Astellas Pharma Europe BV

Active Organization

Bausch Health Americas, Inc.Bausch Health US LLC

PreCision Dermatology, Inc.

+ [1]

Inactive Organization

Dignity Sciences Ltd.

Drug Highest PhaseApproved

First Approval Date

US (31 Mar 1982),

Skin Diseases

Regulation-

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Structure

Molecular FormulaC25H36O6

InChIKeyBMCQMVFGOVHVNG-TUFAYURCSA-N

CAS Registry13609-67-1

（1）通过初步剂量持续时间-效应的探索研究测定丁酸氢化可的松乳膏参比制剂在中国健康受试者中的剂量持续时间-效应关系；（2）结合初步剂量持续时间-效应探索研究结果，设计合适的研究条件，通过比较受试制剂与参比制剂的药效学参数，评价两制剂的生物等效性。（3）研究局部给药后受试制剂与参比制剂的体内暴露量比，从而评价受试制剂的安全性。

[Translation]

(1) Determine the dose-duration-effect relationship of the reference preparation of hydrocortisone butyrate cream in Chinese healthy subjects through a preliminary dose-duration-effect exploratory study; (2) Design appropriate study conditions based on the results of the preliminary dose-duration-effect exploratory study, and evaluate the bioequivalence of the two preparations by comparing the pharmacodynamic parameters of the test preparation and the reference preparation. (3) Study the in vivo exposure ratio of the test preparation to the reference preparation after topical administration to evaluate the safety of the test preparation.

Start Date12 Aug 2024

Sponsor / Collaborator

Sinomune Pharmaceutical Co., Ltd.

NCT03766997 / Unknown statusPhase 4IIT

A Randomized Controlled Study on the Effectiveness of Local Injection Combined With Topical Steroids vs. Topical Steroids Mono-therapy in the Treatment of Idiopathic Granulomatous Mastitis

This study evaluates the clinical response rate of local steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive local injection combined with topical steroids and the other half will receive topical steroids mono-therapy.

Start Date19 Feb 2019

Sponsor / Collaborator

Peking Union Medical College Hospital

NCT02959580 / Unknown statusPhase 4IIT

Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis

This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.

Start Date01 Jan 2017

Sponsor / Collaborator

Peking Union Medical College Hospital

100 Clinical Results associated with Hydrocortisone Butyrate

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100 Translational Medicine associated with Hydrocortisone Butyrate

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100 Patents (Medical) associated with Hydrocortisone Butyrate

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3,100

Literatures (Medical) associated with Hydrocortisone Butyrate

01 Dec 2024·Marine Pollution Bulletin

An overview on the legacy and risks of Polychlorinated Biphenyls (PCBs) and Organochlorinated Pesticides (OCPs) in the polar regions

Review

Author: Xing, Rongguang ; Zhang, Peng ; Ma, Hongrui ; Sweetman, Andrew ; Yan, Jingfeng ; Xu, Sisi ; Cui, Yaqing ; Wang, Jing ; Ji, Hao ; Ge, Linke ; Xiao, Qian

Polychlorinated Biphenyls (PCBs) and Organochlorinated Pesticides (OCPs) are 'trapped' in a variety of environmental media and can therefore undergo further processing by geochemical cycles. By reviewing a wide range of research studies, we present and discuss the main progresses that affect legacy contaminants, such as migration and transformation processes, biological effects assessment across all Arctic media. PCBs and OCPs demonstrated an overall decreasing concentration trend over time in the Arctic. Ecological risk assessment was undertaken by comparison with two standards, suggesting that there was no ecological risk in either soil or sediment. The concentrations of HCB, ΣHCHs, ΣDDTs, chlordane, mirex, and ΣPCBs increased with trophic levels (TLs), showing a significant linear correlation (P < 0.001). The calculated trophic magnification factors (TMFs) values ranged from 0.0004 to 26.63, among which DDTs had the highest value. Future research need to focus on the long-term fate of PCBs and OCPs.

01 Dec 2024·Histochemistry and Cell Biology

In focus in HCB

Author: Taatjes, Douglas J. ; Taatjes, Douglas J ; Roth, Jürgen

01 Dec 2024·Environmental Research

Preconception and/or preimplantation exposure to a mixture of environmental contaminants altered fetoplacental development and placental function in a rabbit model

Article

Author: Rousseau-Ralliard, Delphine ; Léandri, Roger ; Joly, Thierry ; Helies, Virginie ; Couturier-Tarrade, Anne ; Chavatte-Palmer, Pascale ; El Fouikar, Sara ; Gelin, Valérie ; Dahirel, Michèle ; Richard, Christophe ; Prézelin, Audrey ; Bozec, Jeanne ; Jouneau, Luc ; Fournier, Natalie

Pregnant women are daily exposed to environmental contaminants, including endocrine disruptors that can impact the offspring's health. This study aimed to evaluate the effects of maternal oral exposure to a mixture of contaminants at a dose mimicking women's exposure, during folliculogenesis and/or preimplantation period (FED and ED groups, respectively) on the fetoplacental phenotype in a rabbit model. The mixture (DEHP, pp'DDE, β-HCH, HCB, BDE-47, BPS, PFOS, PFOA) was defined based on data from HELIX and INMA cohorts. FED and ED females or unexposed females (control) were inseminated, their embryos were collected and transferred to unexposed control recipient rabbits at 80 h post-insemination. The effects of maternal FED and ED exposure were evaluated on fetoplacental growth and development by ultrasound, fetoplacental biometry, fetal metabolism, placental structure and function. The results demonstrated that the mixture weakly affected ultrasound measurements, as only placental volume increased significantly in FED vs ED. Analysis of placental structure demonstrated that the volume fraction of the maternal blood space was increased in FED vs control. Pre- and/or periconception exposure did not affect biometric at the end of gestation, but affected FED fetal biochemistry. Plasma triglyceride concentration was reduced compared to control. However, total cholesterol, urea, ASAT and ALAT in fetal blood were affected in both exposed groups. Multiple factor analysis, including biometric, biochemical, and stereological datasets, indicated that the three groups were significantly different. Additionally, several placental genes were differentially expressed between groups, compared two by two, in a sex-specific manner, with more difference in females than in males. The differentially expressed genes were involved in lipid, cholesterol, and drug/xenobiotic metabolism in both sexes. These results indicate that maternal exposure to environmental contaminants during crucial developmental windows only mildly impaired fetoplacental development but disturbed fetal blood biochemistry and placental gene expression with potential long-term effects on offspring phenotype.

100 Deals associated with Hydrocortisone Butyrate

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External Link

KEGG	Wiki	ATC	Drug Bank
D01619	Hydrocortisone Butyrate	D07AB02	DB14540

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	US	PreCision Dermatology, Inc.	08 Sep 1997
Dermatitis, Seborrheic	US	Bausch Health Americas, Inc.	25 Feb 1987
Skin Diseases	US	Bausch Health US LLC	31 Mar 1982

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Preclinical	IE	Dignity Sciences Ltd.	01 Oct 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00693693 (CTgov)	Phase 4	Dermatitis, Atopic	26	hydrocortisone 17-butyrate 0.1% Ointment preparation (Ointment)	vumalckamb(frjvyepbgs) = diwkbufwat luleerftsb (ddddlrayay, pxvbnxmrld - amfhjlnnag)	-	17 Mar 2017
				hydrocortisone 17-butyrate 0.1% Lipocream preparation (Lipocream)	vumalckamb(frjvyepbgs) = tqpvuwgtxe luleerftsb (ddddlrayay, mpjtzojsok - slmlbssdak)