5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), 5-HT1B receptor agonists(Serotonin 1b (5-HT1b) receptor agonists), 5-HT1D receptor agonists(Serotonin 1d (5-HT1d) receptor agonists)

Therapeutic Areas

Digestive System DisordersMouth and Tooth DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication

DyspepsiaGastroesophageal Reflux

Inactive Indication-

Originator Organization

Almirall SA

Active Organization

Eisai China, Inc.

Almirall SA

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

ES (16 Apr 2010),

DyspepsiaGastroesophageal Reflux

Regulation-

Structure

Molecular FormulaC25H36N4O10

InChIKeyHVANMRCHFMTSEG-LREBCSMRSA-N

CAS Registry96623-56-2

View All Structures (2)

Clinical Trials associated with Cinitapride Tartrate

CTR20243845 / Not yet recruitingNot Applicable

酒石酸西尼必利片人体生物等效性研究

[Translation] Study on the bioequivalence of Cinipride tartrate tablets in healthy volunteers

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定安徽益普克医药科技发展有限公司持证的酒石酸西尼必利片给药后血浆中的西尼必利在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以Almirall, S.A.持证生产的酒石酸西尼必利片【商品名：希笛尼（Cidine）®，规格：1mg（按西尼必利计）】为参比，评价制剂间的生物等效性，并观察酒石酸西尼必利片在中国健康受试者中的安全性。

[Translation]

Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of plasma concentration of Cinipride in healthy subjects after administration of Cinipride Tartrate Tablets licensed by Anhui Yipke Pharmaceutical Technology Development Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Cinipride Tartrate Tablets licensed by Almirall, S.A. [Trade name: Cidine®, specification: 1 mg (calculated as Cinipride)] were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of Cinipride Tartrate Tablets in healthy Chinese subjects.

Start Date-

Sponsor / Collaborator

An Hui Yi Pu Ke Yi Yao Ke Ji Fa Zhan You Xian Gong Si

CTR20240373 / CompletedNot Applicable

浙江远力健药业有限责任公司研制的酒石酸西尼必利片（规格：1 mg）与持证商为Almirall, S.A.的酒石酸西尼必利片（商品名：希笛尼®/Cidine®，规格：1 mg）在中国健康受试者中进行的单中心、随机、开放、两制剂、单次给药、两周期、两序列、双交叉设计的空腹生物等效性研究，以及在中国健康受试者中进行的单中心、随机、开放、两制剂、单次给药、四周期、两序列、完全重复交叉设计的餐后生物等效性研究

[Translation] A fasting bioequivalence study of Cinipride Tartrate Tablets (strength: 1 mg) developed by Zhejiang Yuanlijian Pharmaceutical Co., Ltd. and Cinipride Tartrate Tablets (trade name: Cidine®/Cidine®, strength: 1 mg) from Almirall, S.A. was conducted in healthy Chinese subjects using a single-center, randomized, open-label, two-dose, single-dose, two-period, two-sequence, double-crossover design; and a fed bioequivalence study of Cinipride Tartrate Tablets (strength: 1 mg) was conducted in healthy Chinese subjects using a single-center, randomized, open-label, two-dose, single-dose, four-period, two-sequence, fully repeated crossover design.

以浙江远力健药业有限责任公司研制的酒石酸西尼必利片（规格：1 mg）为受试制剂，以持证商为Almirall, S.A.的酒石酸西尼必利片（商品名：希笛尼®/Cidine®，规格：1 mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

The Cinipride Tartrate Tablets (Specification: 1 mg) developed by Zhejiang Yuanlijian Pharmaceutical Co., Ltd. were used as the test preparation, and the Cinipride Tartrate Tablets (trade name: Cidine®/Cidine®, specification: 1 mg) from the licensed manufacturer Almirall, S.A. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date27 Feb 2024

Sponsor / Collaborator

Zhejiang Yuanlijian Pharmaceutical Co., Ltd.

NCT01355276 / CompletedPhase 3

A Randomized, Double-blind, Double-dummy, Active Drug Parallel Controlled, Multi-center Clinical Trial on the Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia

The purpose of this study is to compare Cinitapride tablets with domperidone tablets (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment of mild to moderate functional dyspepsia.

Start Date01 Oct 2010

Sponsor / Collaborator

Eisai China, Inc.

100 Clinical Results associated with Cinitapride Tartrate

100 Translational Medicine associated with Cinitapride Tartrate

100 Patents (Medical) associated with Cinitapride Tartrate

Literatures (Medical) associated with Cinitapride Tartrate

31 Oct 2023·BMC gastroenterology

Prokinetics for the treatment of functional dyspepsia: an updated systematic review and network meta-analysis.

Review

Author: Liu, Han ; Qi, Qingqing ; Li, Yanqing ; Wang, Nana

BACKGROUNDSince the previous network meta-analysis assessing the efficacy of prokinetics for functional dyspepsia (FD), there have been a number of new studies and cinitapride is a new prokinetic agent for FD. This updated meta-analysis aimed to explore the efficacy and safety of prokinetics for FD.METHODSAn updated study search in Pubmed, EMBASE, Cochrane Library and Web of Science was conducted in literatures published from July 2015 to March 2023. Randomized controlled trials investigating the use of prokinetics in adult FD patients were included. The primary outcome was the total efficacy rate and the secondary outcome was adverse events. A Bayesian network meta-analysis was performed using R software.RESULTSA total of 28 studies were included. Network meta-analysis showed that metoclopramide had a higher total efficacy rate than mosapride (OR: 3.53, 95%CI: 1.70-7.47), domperidone (OR: 2.29, 95%CI: 1.16-4.63), itopride(OR: 2.77, 95%CI: 1.41-5.59), acotiamide(OR: 2.63, OR: 1.33-5.36), and placebo(OR: 5.68, 95%CI: 2.98-11.10), however similar to cinitapride (OR: 1.62, 95%CI: 0.75-3.53). Cinitapride had a higher total efficacy rate than mosapride (OR: 2.18, 95%CI: 1.16-4.14) and placebo (OR: 3.52, 95%CI: 2.01-6.24). Cinitapride had lower risk of total adverse events than domperidone. There was no difference in the risk of drug-related adverse events between the prokinetics.CONCLUSIONSMetoclopramide and cinitapride may have a better efficacy than other prokinetics in the treatment of FD, and cinitapride may have a lower risk of total adverse events. Further studies using uniform definitions or validated tools to measure the total efficacy rate are needed.

01 Jan 2023·Caspian journal of internal medicine

Efficacy of prokinetic agents in diabetic gastroparesis comparing symptomatology and scintigraphy - An open-label trial.

Article

Author: Dhingra, Vandana ; Pratti, Madhuri ; Khapre, Meenakshi ; Kant, Ravi ; Yadav, Poonam

BackgroundIt is pertinent to objectively assess the severity of diabetic gastroparesis and tailor treatment accordingly. The current study was planned to document gastroparesis by gastric emptying scintigraphy (GES) objectively and see the effect of medications and diet control on clinical and GES after four weeks.MethodsA prospective, open-label randomized trial was conducted in the Department of Internal Medicine at a tertiary care teaching hospital over twelve months. Type 2 diabetic patients aged 18-65 years diagnosed with a case of delayed gastric emptying by gastric scintigraphy were included. All baseline GSCI was recorded, and then they were allotted to 3 groups - Group-1 (Levosulpiride 25mg once daily), group-2 (Cinitapride 1mg thrice daily), and Group-3 (Waitlisted control) by block randomization and followed-up weekly till four weeks. After four weeks duration, if not improved clinically, then Group-3 on diet and diabetic control only, were randomized into Levosulpiride 25mg once daily (Group 1), and Cinitapride 1mg Thrice daily (Group 2) for the next four weeks.ResultsForty confirmed cases with diabetic gastroparesis documented by Gastroparesis Symptom Cardinal Index (GCSI) scoring and later by Scintigraphy (GES) were included in this study. However, there was no statistically significant difference between the Levosulpiride and Cinitapride groups when all symptoms were taken into account. Levosulpiride was significantly more effective than Cinitapride in improving individual symptoms like nausea, vomiting, stomach fullness, and early satiety.ConclusionLevosulpiride is better than Cinitapride in improving the symptoms of diabetic gastroparesis but no significant effect on gastric scintigraphy.

01 Nov 2022·Clinical and Translational Science

CYP2C8*3 and *4 define CYP2C8 phenotype: An approach with the substrate cinitapride

Article

Author: Martín‐Vílchez, Samuel ; Villapalos‐García, Gonzalo ; Gómez‐Fernández, Antía ; Navares‐Gómez, Marcos ; Campodónico, Diana María ; Mejía‐Abril, Gina ; Soria‐Chacartegui, Paula ; Román, Manuel ; Zubiaur, Pablo ; Abad‐Santos, Francisco ; Ochoa, Dolores ; Casajús, Ana ; Parra‐Garcés, Raúl

AbstractCinitapride is a gastrointestinal prokinetic drug, prescribed for the treatment of functional dyspepsia, and as an adjuvant therapy for gastroesophageal reflux disease. In this study, we aimed to explore the impact of relevant variants in CYP3A4 and CYP2C8 and other pharmacogenes, along with demographic characteristics, on cinitapride pharmacokinetics and safety; and to evaluate the impact of CYP2C8 alleles on the enzyme's function. Twenty‐five healthy volunteers participating in a bioequivalence clinical trial consented to participate in the study. Participants were genotyped for 56 variants in 19 genes, including cytochrome P450 (CYP) enzymes (e.g., CYP2C8 or CYP3A4) or transporters (e.g., SLC or ABC), among others. CYP2C8*3 carriers showed a reduction in AUC of 42% and Cmax of 35% compared to *1/*1 subjects (p = 0.003 and p = 0.011, respectively). *4 allele carriers showed a 45% increase in AUC and 63% in Cmax compared to *1/*1 subjects, although these differences did not reach statistical significance. CYP2C8*3 and *4 alleles may be used to infer the following pharmacogenetic phenotypes: ultrarapid (UM) (*3/*3), rapid (RM) (*1/*3), normal (NM) (*1/*1), intermediate (IM) (*1/*4), and poor (PM) metabolizers (*4/*4). In this study, we properly characterized RMs, NMs, and IMs; however, additional studies are required to properly characterize UMs and PMs. These findings should be relevant with respect to cinitapride, but also to numerous CYP2C8 substrates such as imatinib, loperamide, montelukast, ibuprofen, paclitaxel, pioglitazone, repaglinide, or rosiglitazone.

100 Deals associated with Cinitapride Tartrate

External Link

KEGG	Wiki	ATC	Drug Bank
D07701	Cinitapride Tartrate	A03FA08	DB08810

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dyspepsia	ES	Almirall SA	16 Apr 2010
Gastroesophageal Reflux	ES	Almirall SA	16 Apr 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01355276 (Pubmed \| J Clin Gastroenterol)	Phase 3	Postprandial distress syndrome	383	Cinitapride 1 mg	bzslknrujm(pnrkidsiwk) = Cinitapride-related adverse events were observed in 9.1% of patients, including 1 patient with extrapyramidal symptoms mnyhtpiaoj (ooowwzpiob ) View more	-	01 Apr 2014
				Domperidone 10 mg

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