Delving into the Latest Updates on Flupenthixol Hydrochloride/Melitracen Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Flupentixol and Melitracen, 盐酸氟哌噻吨/盐酸美利曲辛, Deanxit

+ [1]

Target

DRDs x MATs

Action

antagonists

Mechanism

DRDs antagonists(Dopamine receptors antagonists), Monoamine reuptake inhibitor

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Anxiety DisordersDepressive Disorder

Inactive Indication

Opioid-Related Disorders

Originator Organization

H. Lundbeck A/S

Active Organization-

Inactive Organization

Nanchang Lijian Pharmaceutical Co. Ltd.

Tianjin Institute of Pharmaceutical Research Co., Ltd.Reckitt Benckiser Healthcare (UK) Ltd.

+ [1]

License Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

Login to view timeline

Structure/Sequence

Molecular FormulaC52H67F3N4O2S

InChIKeyMKWJDUAOJQMMSS-UHFFFAOYSA-N

CAS Registry214556-54-4

Gastroesophageal reflux disease (GERD) is a common chronic digestive system disorder with a high prevalence and a notably increasing trend. It imposes significant costs in terms of treatment expenses and impacts patients' quality of life. Acid suppression remains the primary treatment for GERD. However, numerous clinical studies have shown that 20-30% of patients still exhibit poor response to proton pump inhibitors (PPIs) even after completing a standard course of acid-suppressive therapy. Many studies have demonstrated that the incidence of abnormal psychological conditions, such as anxiety, depression, and obsessive-compulsive disorder, is higher in GERD patients compared to the general population. Current international consensus acknowledges that the application of psychosomatic medicine principles and the use of neuromodulators can effectively alleviate symptoms in patients with gut-brain interaction disorders. Nevertheless, with the growing emphasis on digestive-psychosomatic-holistic medicine in clinical practice and the deepening of research on "gut-brain interactions," recent studies in the field of psycho-gastroenterology have challenged the notion that psychological processes are unique to gut-brain interaction disorders. Instead, these processes may play a universal role in symptom generation across the entire spectrum of GERD. Previous experiments have confirmed that Flupentixol-Melitracen (FM) can improve symptoms in GERD patients with a low incidence of adverse reactions. Therefore, we aim to verify the efficacy and safety of neuromodulators in patients with GERD, reduce healthcare costs, and provide new insights for optimizing treatment strategies for GERD patients in the future.

Start Date10 May 2025

Sponsor / Collaborator-

NCT06931223

/ Not yet recruitingNot ApplicableIIT

Efficacy of Gut-rain Neuromodulators in the Treatment of Functional Dyspepsia: a Randomized Controlled Study

The use of Neuromodulators is now recognized by international consensus as effective in improving Disorders of Gut-Brain Interaction (DGBIs). However, the digestive mind-body concept of therapeutic drugs is still in the experience-based treatment stage, and there is a lack of clinical studies in the field of DGBIs. Although numerous studies have been conducted to confirm the safety of Neuromodulators for the treatment of DGBIs, the current functional dyspepsia (FD) treatment is still awaiting further explorations and accumulations. In addition, neuromodulators, like Flupentixol-Melitracen (FM), are often used as a second-line treatment option for FD after the failure of acid-suppressive therapy with proton pump inhibitors, etc. However, the efficacy of conventional drugs for FD is mediocre, which often leads to recurrent and prolonged symptoms, seriously affecting patients' confidence in treatment and their quality of life, and the repeated visits to the clinic also create a huge economic burden for the society. Therefore, we conducted a clinical trial to verify whether FM can be used as the first-line therapy to improve the efficacy of FD patients.

Start Date10 Apr 2025

Sponsor / Collaborator-

CTR20243814

/ CompletedNot Applicable

氟哌噻吨美利曲辛片生物等效性试验

[Translation] Bioequivalence study of flupentixol-melitracen tablets

主要研究目的评价中国健康成年受试者空腹及餐后条件下单次单剂量口服氟哌噻吨美利曲辛片受试制剂（规格：每片含氟哌噻吨0.5mg和美利曲辛10mg，申办者：广东健信制药股份有限公司）和参比制剂（商品名：黛力新®，规格：氟哌噻吨0.5mg和美利曲辛10mg/片，持证商：H.Lundbeck A/S）后的药代动力学特点和生物等效性。次要研究目的研究氟哌噻吨美利曲辛片受试制剂（规格：每片含氟哌噻吨0.5mg和美利曲辛10mg）和参比制剂（商品名：黛力新®，规格：氟哌噻吨0.5mg和美利曲辛10mg/片）在中国健康成年受试者中的安全性。

[Translation]

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of flupentixol-melitracen tablets (specification: each tablet contains 0.5 mg flupentixol and 10 mg melitracen, applicant: Guangdong Jianxin Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Deanxit®, specification: 0.5 mg flupentixol and 10 mg melitracen/tablet, licensee: H. Lundbeck A/S) in healthy Chinese adult subjects after a single oral dose under fasting and postprandial conditions. Secondary study objectives To study the safety of the test formulation of flupentixol-melitracen tablets (specification: each tablet contains 0.5 mg flupentixol and 10 mg melitracen) and the reference formulation (trade name: Deanxit®, specification: 0.5 mg flupentixol and 10 mg melitracen/tablet) in healthy Chinese adult subjects.

Start Date10 Nov 2024

Sponsor / Collaborator

Guangdong Jianxin Pharmaceutical Co., Ltd.

100 Clinical Results associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

Login to view more data

100 Translational Medicine associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

Login to view more data

100 Patents (Medical) associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

Login to view more data

114

Literatures (Medical) associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

01 Jan 2025·Clinical Laboratory

A Case of Pseudo Prolactin Elevation Caused by Medication

Article

Author: He, Li-Qin ; Sun, Hong-Gang ; Liu, Lan-Bing

BACKGROUND:

After the patient had a long course of disease and symptoms of bilateral breast milk secretion, the doctor first considered that the patient had breast cancer. After screening and excluding the breast, he found that the patient had high prolactin, and suspected that the patient had a pituitary tumor. After breast cancer and pituitary adenoma were excluded, the doctor suspected that there might be interference of macroprolactin. After PEG treatment, we also excluded the interference of macroprolactin. After repeated communication with doctors and patients, we found that the patient had gone to a psychiatric hospital for treatment and taken the antidepressant drug Deanxit (Flupentixol and Melitracen tablets).

METHODS:

Flupentixol acts by antagonizing hypothalamic prolactin releasing inhibitory factors, reducing dopamine release, leading to hyperprolactinemia.

RESULTS:

The patient's examination found that prolactin was 3,172.9 mIU/L (normal range 108.80 - 557.10 mIU/L), and after PEG treatment, it was 2,692.86 mIU/L. Patient stopped using Deanxit for one month, and prolactin levels were 302.8 mIU/L.

CONCLUSIONS:

Only effective communication between laboratory and clinical departments can make laboratory results more accurate and provide strong guarantees for clinical diagnosis and treatment.

01 Nov 2024·Genes & Diseases

The efficacy and safety of NeuroWell antidepressant dietary supplement, Deanxit, and their combination in the treatment of mild-to-moderate depression: A randomized clinical trial

Article

Author: Wang, Wenwen ; Guo, Shang ; Wen, Xuejun ; Zhou, Qiqi ; Liu, Yue ; Li, Zhen ; Ning, Yaochao ; Zhang, Hui ; Liu, Dechen ; Wang, Qinglu ; Geng, Shuang ; Wang, Yutong ; Sui, Zhuxin ; Wang, Shanshan ; Sun, Lei ; Yin, Honglei ; Liu, Ping ; Wang, Hongwei ; Wang, Yunliang ; Wei, Dianfang ; Deng, Youping ; Liu, Yanqiu ; Liu, Yajun ; Zhang, Huaibo ; Wang, Yanchao ; Li, Jinfeng ; Zhang, Kezhong ; Yin, Hongtao

Then,a total of 242 participants were recruited,and 200 were eventually enrolled and randomly grouped (n Z 50)for the study.None of the patients in any of the four groups had dropped out by 12 wk.

01 Oct 2024·Molecular neurobiology

Paroxetine Effect on Nerve Growth Factor, Human Neurotrophin-4, Brain-Derived Neurotrophic Factor Levels in Post-stroke Depression

Article

Author: Jin, Yuhua ; Yu, Lamei ; Li, Yan

The aim of this study is to explore paroxetine's effect on nerve growth factor (NGF), human neurotrophin-4 (NT-4), and brain-derived neurotrophic factor (BDNF) levels in post-stroke depression. Ninety-two post-stroke depression patients from April 2021 to April 2023 in our hospital were selected and numbered 1 to 92 after enrollment. Forty-six patients with odd number and 46 patients with even number were, respectively, included in the control and observation group. In addition to basic treatment, control group was treated with flupentixol melitracen tablets orally, and observation group received paroxetine hydrochloride orally. The levels of NGF, NT-4, BDNF, 5-hydroxytryptamine (5-HT), homocysteine (Hcy), noradrenaline (NE), Hamilton Depression Scale (HAMD) changes of National Institute of Health Stroke Scale (NIHSS). NGF, NT-4, and BDNF levels were compared between groups at T0, T1, and T2 levels were higher, and the levels at T2 were higher than those at T1, and observation group levels were higher (P < 0.05); NGF, NT-4, and BDNF levels were compared among groups, time, and interaction. 5-HT, Hcy, and NE levels at T0 were compared between groups; 5-HT and NE levels at T1 and T2 were higher than those at T0, the levels at T2 were higher than those at T1, and observation group levels were higher (P < 0.05); Hcy level at T1 and T2 was lower, its level at T2 was lower than those at T1, and observation group levels were lower (P < 0.05); 5-HT, Hcy, and NE levels were compared among groups, time, and interaction (P < 0.05). HAMD and NIHSS at T0 were compared; T1 and T2 were lower than T0, T2 was lower than T1, and observation group was lower (P < 0.05); HAMD and NIHSS were compared among groups, time, and interaction (P < 0.05). For post-stroke depression, paroxetine treatment can effectively improve NGF, NT-4, BDNF, 5-HT, Hcy, and NE levels and effectively reduce the degree of neurological damage and depression, which has high clinical application value.

100 Deals associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	Flupenthixol Hydrochloride/Melitracen Hydrochloride	N06CA02	-

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Anxiety Disorders	China	-	-
Depressive Disorder	China	-	-

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Opioid-Related Disorders	Phase 3	China	Reckitt Benckiser Healthcare (UK) Ltd.	14 Oct 2014

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2019	Not Applicable	Postoperative Nausea and Vomiting	160	Control group	qtlbejpgmz(ckuoozytjs) = hvmdecqqfc dgddlilleq (mcigjiljtw )	-	15 Jun 2019
				Lupentixol melitracen group	qtlbejpgmz(ckuoozytjs) = qmmnygzvkm dgddlilleq (mcigjiljtw )
UEGW2018	Not Applicable	Dyspepsia	-	Fluoxetine	gocayhpivg(oyunnpmlhi) = ofhtimcvlh chkiwdaeik (uigmcnskjt )	-	01 Oct 2018
				Flupenthixol melitracen	gocayhpivg(oyunnpmlhi) = zruoorozzr chkiwdaeik (uigmcnskjt )
NCT01851863 (CTgov)	Phase 4	Depressive Disorder \| Dyspepsia	262	Omeprazole	obqnisljjv(omnncrfoft) = fgqmlaefkn dxxzpvqsdd (qewlageipb, qazcgefuuh - crfuswcxmf) View more	-	23 Feb 2015