Delving into the Latest Updates on Methylprednisolone aceponate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Methylprednisolone aceponate (INN)

+ [3]

Target

Arachidonic acid

Action

inhibitors

Mechanism

Arachidonic acid inhibitors

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases

Active Indication

PsoriasisDermatitis, AtopicEczema

Inactive Indication

Neurodermatitis

Originator Organization

Bayer AG

Active Organization

Leo Pharma, Inc.LEO Pharmaceutical Products OOO

Bayer AG

Inactive Organization

Tianjin Pharm Research Inst Pharm Co Ltd.

Drug Highest PhaseApproved

First Approval Date

Switzerland (19 Dec 1991),

Dermatitis, AtopicEczema

Regulation-

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Structure/Sequence

Molecular FormulaC27H36O7

InChIKeyDALKLAYLIPSCQL-YPYQNWSCSA-N

CAS Registry86401-95-8

1) 通过初步剂量持续时间-效应的探索研究测定醋丙甲泼尼龙乳膏参比制剂（规格：0.1%、Leo Pharma A/S持证、商品名：Advantan®）在中国健康受试者中的剂量持续时间-效应关系，确定后续体内生物等效性试验中的剂量持续时间（ED50）和预期满足AUEC值的D2/D1最小比值的受试者比例； 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，以广东华润顺峰药业有限公司提供的醋丙甲泼尼龙乳膏（规格：0.1%（15 g））为受试制剂、以Leo Pharma A/S持证的醋丙甲泼尼龙乳膏（规格：0.1%、商品名：Advantan®）为参比制剂进行人体生物等效性试验，通过比较两制剂的药效学参数，评价两制剂的生物等效性。 3) 以广东华润顺峰药业有限公司提供的醋丙甲泼尼龙乳膏（规格：0.1%（15 g））为受试制剂，以Leo Pharma A/S持证的醋丙甲泼尼龙乳膏（规格：0.1%；商品名：Advantan®）为参比制剂，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) The dose-duration-effect relationship of the reference preparation of methylprednisolone acetonide cream (specification: 0.1%, licensed by Leo Pharma A/S, trade name: Advantan®) in Chinese healthy subjects was determined through a preliminary dose-duration-effect exploratory study, and the dose-duration (ED50) and the proportion of subjects expected to meet the minimum D2/D1 ratio of the AUEC value in the subsequent in vivo bioequivalence test were determined; 2) Based on the results of the preliminary dose-duration-effect exploratory study, appropriate research conditions were designed, and the methylprednisolone acetonide cream (specification: 0.1% (15 g)) provided by Guangdong China Resources Shunfeng Pharmaceutical Co., Ltd. was used as the test preparation, and the methylprednisolone acetonide cream (specification: 0.1%, trade name: Advantan®) licensed by Leo Pharma A/S was used as the reference preparation for human bioequivalence testing. The pharmacodynamic parameters of the two preparations were compared to evaluate the bioequivalence of the two preparations. 3) Using methylprednisolone acetonide cream (specification: 0.1% (15 g)) provided by Guangdong China Resources Shunfeng Pharmaceutical Co., Ltd. as the test preparation and methylprednisolone acetonide cream (specification: 0.1%; trade name: Advantan®) certified by Leo Pharma A/S as the reference preparation, the in vivo exposure ratio of the test preparation and the reference preparation after topical administration was studied to evaluate the safety of the test preparation.

Start Date02 Aug 2024

Sponsor / Collaborator

Guangdong Shunfeng Pharmaceutical Co., Ltd.

CTIS2024-511390-30-00

/ RecruitingPhase 3

Double-blind, randomised clinical study comparing efficacy and safety of Methylprednisolone Aceponate 0.1% Cream (Test) vs. Advantan(R) 0.1% Cream (Reference) vs. Vehicle in patients with mild to moderate atopic dermatitis - 22-01/MPA-C

Start Date17 Aug 2023

Sponsor / Collaborator

Dermapharm AG

ACTRN12623000272695

/ CompletedPhase 4

A pilot dose duration-response study using a branded (marketed) formulation methylprednisolone aceponate called Advantan® fatty ointment to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study and using participants who demonstrate adequate vasoconstriction to topical steroids.

Start Date13 May 2023

Sponsor / Collaborator

Zenith Technology Corp. Ltd.

100 Clinical Results associated with Methylprednisolone aceponate

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100 Translational Medicine associated with Methylprednisolone aceponate

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100 Patents (Medical) associated with Methylprednisolone aceponate

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223

Literatures (Medical) associated with Methylprednisolone aceponate

01 Feb 2025·Dermatology and Therapy

Baricitinib Provides Significant Improvements in Quality of Life and Functioning in Adults with Moderate-to-Severe Atopic Dermatitis with Baseline Body Surface Area ≤ 40% and Severe Itch

Article

Author: Kleyn, C Elise ; Reguiai, Ziad ; Grond, Susanne ; Izu-Belloso, Rosa ; Silvia Sabatino ; Otero-Asman, Joaquin R ; Napolitano, Maddalena ; Nomura, Toshifumi ; Liu, Chunyuan ; Augustin, Matthias

INTRODUCTIONPatients with moderate-to-severe atopic dermatitis (AD), a body surface area (BSA) of ≤ 40%, and an itch numerical rating scale (NRS) score of ≥ 7 ("BARI itch dominant") have been characterized as an important group to consider for the oral janus kinase (JAK) 1/2 inhibitor baricitinib (BARI). Herein we aim to evaluate quality of life (QoL) and functioning outcomes in adult patients with BSA ≤ 40% and itch NRS ≥ 7 at baseline (BL) who received BARI 4 mg in the topical corticosteroid (TCS) combination trial BREEZE-AD7.MATERIALSBREEZE-AD7 was a randomized, double-blind, placebo-controlled, parallel-group outpatient study involving adult patients with moderate-to-severe AD who received once-daily placebo or 2-mg or 4-mg BARI in combination with TCS for 16 weeks. Patients eligible for enrollment had to have BSA ≥ 10%. This post-hoc analysis focused on placebo and BARI 4 mg for patients with BSA ≤ 40% and itch NRS ≥ 7. QoL impairment was measured using a Dermatology Life Quality Index (DLQI) of ≤ 5, and functioning outcomes were assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire. Data were reported descriptively. Last observation carried forward (LOCF) data were reported, excluding data collected after the first rescue therapy date or permanent study drug discontinuation. Non-responder imputation was used to account for missing data.RESULTSAt BL, patients with BSA ≤ 40% and itch NRS ≥ 7 had high QoL impairment. The mean DLQI score at BL for patients who received BARI 4 mg and placebo indicates a very large effect of AD on patients' QoL. Patients who received BARI and placebo experienced a significant itch burden and reported a similar itch NRS. At week 16, 61.5% of patients treated with BARI 4 mg indicated that it had no to only a small effect on their QoL (DLQI ≤ 5), versus 24.1% for patients receiving placebo (p < 0.01). A decrease in WPAI work impairment score of - 41.6 for BARI patients and - 7.0 for placebo patients was observed at week 16 (p < 0.01). Patients receiving BARI also observed a noticeable improvement in WPAI daily activity impairment of - 30.4 from baseline at week 16 compared to patients on placebo, who achieved - 12.2 (p < 0.01).CONCLUSIONDespite having high QoL impairment at baseline, patients with itch-dominant AD treated with BARI 4 mg showed marked benefits in QoL, daily life activity, and work function compared to placebo after 16 weeks of treatment. Limitations include the small sample size analyzed.

01 Dec 2024·BMJ Open

Effectiveness of potent topical corticosteroids versus mild ones in primary care for children with moderate flare-ups of atopic dermatitis; results of a randomised controlled trial

Article

Author: Elshout, Gijs ; Pasmans, Suzanne G M A ; van Halewijn, Karlijn F ; Bohnen, Arthur M ; Bindels, Patrick J E

ObjectiveTo assess the effectiveness of a potent topical corticosteroid (TCS) as an initial treatment in primary care for children with moderate flare-ups of atopic dermatitis (AD), compared to starting on a mild TCS.DesignAn observational prospective cohort study with an embedded pragmatic multicentre open-label randomised controlled trial.SettingA total of 53 general practices in the southwest of the Netherlands took part in the study.Participants209 children aged 3 months to 17 years diagnosed with AD (International Classification of Primary Care codes S87 or S88) who visited their general practitioner (GP) for AD or received repeat prescriptions for AD in the previous 12 months were included in the cohort study through the general practices. Finally, 32 patients (15%) were randomised and assigned to the trial (13 girls; 19 boys; median age 4.0 years).InterventionsIf cohort participants experienced a moderate flare-up (ie, need to intensify topical treatment from the child’s and/or parents’ point of view of AD and a three-item severity score from three to<6 scored by their GP) during cohort follow-up, they were randomised to either the intervention group, a strong TCS (class III, fluticasone propionate 0.05%), or the control group, a mild TCS (class I, hydrocortisone acetate 1%).Primary and secondary outcome measuresWe measured outcomes at baseline and at 1, 4 and 24 weeks. The primary outcome was AD-related symptoms (Patient-Oriented Eczema Measure (POEM) score) measured over 24 weeks of follow-up. Secondary outcomes included the Eczema Area and Severity Index, the Investigators Global Assessment, quality of life (QoL), Patient Global Assessment, Numeric Itch Intensity Score and TCS use.ResultsThe primary outcome showed a significant difference in the POEM scores over 24 weeks of follow-up between the intervention group (n=17) and the control group (n=15) (3.3 vs 9.4, p=0.023). The potent TCS also significantly improved the POEM at 1 week (5.5 vs 12.0, p=0.042) and 4 weeks (4.3 vs 12.7, p=0.030). Improvement in the QoL was significant at 4 weeks (1.0 vs 4.5, p=0.014) and 24 weeks (0.0 vs 2.0, p=<0.000).ConclusionDespite the small sample size, the data suggests a clinical benefit from starting with a potent TCS rather than a mild TCS when a flare-up of AD is moderate.Trial registrationThe Netherlands National Trial Register: NTR6679.

01 Dec 2024·Georgian medical news

GRAHAM-LITTLE-PICCARDI-LASSEUR SYNDROME IN A BULGARIAN PATIENT: CASE REPORT AND SHORT PATHOGENETIC UPDATE IN RELATION TO THE CONNECTION TO ANTIGEN/ MOLECULAR MIMICRY.

Article

Author: Broshtilova, V ; Tchernev, G ; Kordeva, S

Graham-Little-Piccardi-Lasseur syndrome (GLPLS) is a rare lichenoid dermatosis classified as a variant of follicular lichen planus, also known as classic lichen planopilaris. The condition is characterized by the triad of cicatricial scalp alopecia, noncicatricial alopecia in the axillary and groin regions, and numerous follicular papules distributed across the body. We present a 64-year-old female with clinically and histologically confirmed GLPLS. Two biopsies were conducted, resulting in lichen planopilaris/ pseudopelade Brocq and lichen planus hypertrophicus. Initial therapy included loratadine and topical clobetasol propionate. Due to the suspicion of possible drug-induced reaction, the antihypertensive therapy, which consisted of valsartan, bisoprolol, spironolactone, and chlorthalidone, was discontinued and replaced with moxonidine. Urinary infection caused by Escherichia coli and dental infection were noted. Prescribed outpatient treatment included acitretin, bilastine, and topical prednisolone for the scalp. Improvement was observed in the lesions located on the trunk and upper and lower extremities following betamethasone/salicylic acid ointment was prescribed, and methylprednisolone aceponate cream. Re-application or return of the old systemic medication on an outpatient basis resulted in a worsening/exacerbation of the clinical picture and a re-need to change medication. It is this fact that suggests that polymedication could also be considered as a trigger of lichen planus and its subforms such as GLPLS. The hypothesis surrounding alterations in tissue homeostasis as a potential trigger factor for autoimmunity is being discussed, with a specific focus on infectious and drug-induced forms of lichen planus, as well as Graham-Little-Lasseur syndrome.

100 Deals associated with Methylprednisolone aceponate

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External Link

KEGG	Wiki	ATC	Drug Bank
D07203	Methylprednisolone aceponate	D07AC14	DB14643

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Psoriasis	Australia	Leo Pharma, Inc.	11 Jul 1994
Eczema	Switzerland	LEO Pharmaceutical Products OOO	19 Dec 1991
Dermatitis, Atopic	-	Bayer AG	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 1	China	Tianjin Pharm Research Inst Pharm Co Ltd.	30 Oct 2013
Eczema	Phase 1	China	Tianjin Pharm Research Inst Pharm Co Ltd.	30 Oct 2013
Neurodermatitis	Phase 1	China	Tianjin Pharm Research Inst Pharm Co Ltd.	30 Oct 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02798523 (CTgov)	Phase 1	-	33	Methylprednisolone sodium succinate(Solu-Medrol) (Up to 2 Hours Post Infusion)	hknxqxxrei(nahbmebgzp) = bnmplriynv arnebywajq (xmblhtducw, vrphowspbr - asyjwkdxpu) View more	-	22 Jun 2023
				Methylprednisolone sodium succinate(Solu-Medrol)+Topical methylprednisolone (Advantan emulsion 0 /1%) (Up to 4 Hours Post Infusion)	hknxqxxrei(nahbmebgzp) = qbvcfnppba arnebywajq (xmblhtducw, wshwznshsv - ebsuzcfzel) View more
NCT02260986 (LIBERTY AD CHRONOS \| CHRONOS \| ###DELETE, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	740	Placebo (for Dupilumab)+betamethasone valerate+methylprednisolone aceponate+mometasone furoate (Placebo qw)	rpfxopfvdm(qwvuzjbcak) = bwrgxcassy opcbtvnyhv (fvyjykurps, qwvoemcvup - qxbghrhczu) View more	-	17 Oct 2017
				Placebo (for Dupilumab)+betamethasone valerate+Dupilumab+methylprednisolone aceponate+mometasone furoate (Dupilumab 300 mg q2w)	rpfxopfvdm(qwvuzjbcak) = fduvvcjkaq opcbtvnyhv (fvyjykurps, jlyqnkpzyh - qxnwokguaa) View more
NCT01639040 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	31	Placebo (for Dupilumab)+betamethasone valerate+methylprednisolone aceponate+mometasone furoate (Placebo QW)	vualgxwape(bvfbrsorzl) = lheftvadmr ulyjhbrjiu (umsrpdgnnk, olviudcrvl - xcmiqocjeu) View more	-	13 Oct 2017
				betamethasone valerate+Dupilumab+methylprednisolone aceponate+mometasone furoate (Dupilumab 300 mg QW)	vualgxwape(bvfbrsorzl) = khzzwavqrp ulyjhbrjiu (umsrpdgnnk, xjcewypnjk - ndlarzxsag) View more