Delving into the Latest Updates on Lafutidine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Lafutidine (JP17/INN), loctidine, Stogar

+ [7]

Target

H2 receptor

Mechanism

H2 receptor antagonists(Histamine H2 receptor antagonists)

Therapeutic Areas

Digestive System DisordersMouth and Tooth DiseasesOtorhinolaryngologic Diseases

Active Indication

Esophagitis, PepticGastritisDuodenal Ulcer+ [2]

Inactive Indication

Erosive esophagitisInflammatory Bowel Diseases

Originator Organization

UCB SA

Active Organization

Boryung Corp.

Sichuan Kelun Pharmaceutical Co., Ltd.

Taiho Pharmaceutical Co., Ltd.

+ [1]

Inactive Organization

UCB Pharma GmbH

Salix Pharmaceuticals, Inc.

Drug Highest PhaseApproved

First Approval Date

JP (08 Jan 2000),

Duodenal UlcerGastroesophageal RefluxStomach Ulcer

Regulation-

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Structure

Molecular FormulaC22H29N3O4S

InChIKeyKMZQAVXSMUKBPD-DJWKRKHSSA-N

CAS Registry206449-93-6

主要目的：以济川药业集团有限公司提供的拉呋替丁片为受试制剂，按照有关生物等效性试验规定，与大鹏药品工业株式会社生产的拉呋替丁片（Protecadin®，参比制剂）进行空腹及餐后状态下人体生物利用度与生物等效性试验，评估受试制剂和参比制剂在空腹及餐后状态下给药时的生物等效性。次要目的：观察受试制剂拉呋替丁片和参比制剂拉呋替丁片（Protecadin®）在健康受试者中的安全性。

[Translation]

Primary objective: To use Lafutidine Tablets provided by Jichuan Pharmaceutical Group Co., Ltd. as the test preparation, and conduct human bioavailability and bioequivalence tests with Lafutidine Tablets (Protecadin®, reference preparation) produced by Dapeng Pharmaceutical Industry Co., Ltd. in the fasting and fed state, in accordance with relevant bioequivalence test regulations, to evaluate the bioequivalence of the test preparation and the reference preparation when administered in the fasting and fed state. Secondary objective: To observe the safety of the test preparation Lafutidine Tablets and the reference preparation Lafutidine Tablets (Protecadin®) in healthy subjects.

Start Date05 Jul 2022

Sponsor / Collaborator

Hubei Jumpcan Pharmaceutical Co., Ltd.

ChiCTR2200055479 / RecruitingPhase 4IIT

Efficacy of nocturnal symptoms and esophageal acid exposure in GERD patients: a randomized controlled study of PPI combined with lafutidine versus PPI alone

Start Date20 Jan 2022

Sponsor / Collaborator-

CTR20181930 / Completed

拉呋替丁片单中心、随机、开放、双周期、双交叉设计在中国健康受试者空腹和餐后的生物等效性试验

[Translation] A single-center, randomized, open-label, two-period, double-crossover bioequivalence study of lafutidine tablets in Chinese healthy volunteers with fasting and fed diet

主要目的：评价湖北舒邦药业有限公司的拉呋替丁片（规格：5mg/片）与大鹏药业工业株式会社的拉呋替丁片（规格： 5mg/片）在健康成年受试者空腹和餐后状态下单次口服给药的人体生物等效性。次要目的：评价拉呋替丁片在健康成年受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of lafutidine tablets (specification: 5 mg/tablet) of Hubei Shubang Pharmaceutical Co., Ltd. and lafutidine tablets (specification: 5 mg/tablet) of Dapeng Pharmaceutical Industry Co., Ltd. in healthy adult subjects after single oral administration in fasting and fed state. Secondary objective: To evaluate the safety of lafutidine tablets in healthy adult subjects.

Start Date15 Oct 2018

Sponsor / Collaborator

Hubei Shubang Pharmaceutical Co Ltd.

100 Clinical Results associated with Lafutidine

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100 Translational Medicine associated with Lafutidine

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100 Patents (Medical) associated with Lafutidine

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114

Literatures (Medical) associated with Lafutidine

01 Nov 2023·Annals of palliative medicine

A randomized trial to evaluate the preventive effect of lafutidine on chemotherapy-induced peripheral neuropathy in patients treated with carboplatin and paclitaxel for lung cancer

Article

Author: Takahashi, Fumiaki ; Nagashima, Hiromi ; Fujimura, Itaru ; Akiyama, Masachika ; Yakuwa, Kazuhiro ; Utsumi, Yu ; Maemondo, Makoto ; Cho, Katsuya ; Owada, Yoshihiro ; Hashimoto, Tatsuya ; Katagiri, Hiroshi ; Saikawa, Hirotaka

BACKGROUND:

Chemotherapy-induced peripheral neuropathy (CIPN) has a significant impact on the therapeutic efficacy of chemotherapy and patients' quality of life. The aim of this study was to assess the preventive effect of lafutidine on CIPN.

METHODS:

Patients were randomly assigned (1:1) to carboplatin and paclitaxel chemotherapy with lafutidine 10 mg twice daily (lafutidine group) or without lafutidine (control group). Peripheral neuropathy in both groups was assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and two patient-based questionnaires, the Patient Neurotoxicity Questionnaire (PNQ) and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx). The primary outcome was the incidence of grade 2 or higher peripheral neuropathy in CTCAE version 5.0. The target number of cases was set at approximately 40.

RESULTS:

In total, 18 patients were screened, and 16 patients were assigned to the lafutidine group (n=9) or control group (n=7) between January 2021 and January 2023. Due to poor recruitment, the target number of cases was not reached. Grade 2 or higher neuralgia was 22.2% in the lafutidine group and 14.3% in the control group. Grade 2 or higher peripheral sensory neuropathy was 100% in the lafutidine group and 71.4% in the control group (P=0.175). Grade 3 or higher peripheral neuropathy was not detected in either group. There was no significant difference in PNQ scores between the two groups. Median FACT/GOG-Ntx scores after the fourth cycle tended to be lower in the lafutidine group than in the control group. There was no statistically significant difference in progression free survival (PFS) between the two groups. There were no adverse events due to lafutidine administration.

CONCLUSIONS:

Although the preventive effect of lafutidine on CIPN could not be demonstrated statistically, lafutidine FACT/GOG-Ntx scores showed a trend toward decreased neurotoxicity as chemotherapy proceeded. More reliable studies using lafutidine on the prevention of CIPN should be conducted.

TRIAL REGISTRATION:

Japan Registry of Clinical Trials, identifier: jRCTs021200031.

05 Sep 2023·JAMA network open

Ranitidine Use and Incident Cancer in a Multinational Cohort.

Article

Author: Park, Rae Woong ; Hripcsak, George ; Falconer, Thomas ; Nguyen, Phung-Anh ; Duarte-Salles, Talita ; Pratt, Nicole ; Reich, Christin G ; Posada, Jose D ; Lee, Hang Lak ; Seager, Sarah ; Ko, Heejoo ; Suchard, Marc A ; Van Zandt, Mui ; Seo, Seung In ; Yanover, Chen ; Shin, Woon Geon ; Park, Chan Hyuk ; Shah, Nigam H ; Hsu, Jason C ; Hsu, Min-Huei ; You, Seng Chan ; Prieto-Alhambra, Daniel ; Kim, Yeesuk

Importance:

Ranitidine, the most widely used histamine-2 receptor antagonist (H2RA), was withdrawn because of N-nitrosodimethylamine impurity in 2020. Given the worldwide exposure to this drug, the potential risk of cancer development associated with the intake of known carcinogens is an important epidemiological concern.

Objective:

To examine the comparative risk of cancer associated with the use of ranitidine vs other H2RAs.

Design, Setting, and Participants:

This new-user active comparator international network cohort study was conducted using 3 health claims and 9 electronic health record databases from the US, the United Kingdom, Germany, Spain, France, South Korea, and Taiwan. Large-scale propensity score (PS) matching was used to minimize confounding of the observed covariates with negative control outcomes. Empirical calibration was performed to account for unobserved confounding. All databases were mapped to a common data model. Database-specific estimates were combined using random-effects meta-analysis. Participants included individuals aged at least 20 years with no history of cancer who used H2RAs for more than 30 days from January 1986 to December 2020, with a 1-year washout period. Data were analyzed from April to September 2021.

Exposure:

The main exposure was use of ranitidine vs other H2RAs (famotidine, lafutidine, nizatidine, and roxatidine).

Main Outcomes and Measures:

The primary outcome was incidence of any cancer, except nonmelanoma skin cancer. Secondary outcomes included all cancer except thyroid cancer, 16 cancer subtypes, and all-cause mortality.

Results:

Among 1 183 999 individuals in 11 databases, 909 168 individuals (mean age, 56.1 years; 507 316 [55.8%] women) were identified as new users of ranitidine, and 274 831 individuals (mean age, 58.0 years; 145 935 [53.1%] women) were identified as new users of other H2RAs. Crude incidence rates of cancer were 14.30 events per 1000 person-years (PYs) in ranitidine users and 15.03 events per 1000 PYs among other H2RA users. After PS matching, cancer risk was similar in ranitidine compared with other H2RA users (incidence, 15.92 events per 1000 PYs vs 15.65 events per 1000 PYs; calibrated meta-analytic hazard ratio, 1.04; 95% CI, 0.97-1.12). No significant associations were found between ranitidine use and any secondary outcomes after calibration.

Conclusions and Relevance:

In this cohort study, ranitidine use was not associated with an increased risk of cancer compared with the use of other H2RAs. Further research is needed on the long-term association of ranitidine with cancer development.

01 Jan 2023·Annals of Palliative Medicine

Assessing lafutidine’s potential to protect lung cancer patients from chemotherapy-induced neuropathy

Article

Author: Khan, Saim Mahmood ; Hussain, Jawairya Muhammad ; Sultan, Ramsha

100 Deals associated with Lafutidine

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External Link

KEGG	Wiki	ATC	Drug Bank
D01131	Lafutidine	A02BA08	DB12770

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Esophagitis, Peptic	JP	Taiho Pharmaceutical Co., Ltd.	07 Oct 2014
Gastritis	JP	Taiho Pharmaceutical Co., Ltd.	06 Apr 2000
Duodenal Ulcer	JP	Taiho Pharmaceutical Co., Ltd.	08 Jan 2000
Gastroesophageal Reflux	JP	Taiho Pharmaceutical Co., Ltd.	08 Jan 2000
Stomach Ulcer	JP	Taiho Pharmaceutical Co., Ltd.	08 Jan 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Erosive esophagitis	Phase 3	-	Boryung Corp.	01 Nov 2011
Inflammatory Bowel Diseases	Preclinical	JP	-	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01499368 (CTgov)	Phase 3	Erosive esophagitis	495	Lafutidine (Lafutidine)	gyzxhpjjyn(bpwzpuhaia): P-Value = 0.05 View more	-	16 Sep 2020
				Famotidine (Famotidine)
JPRN-UMIN000002703 (AEOLUS, ASCO_GI2018)	Not Applicable	Stomach Cancer Adjuvant	-	S-1 with lafutidine	flxsvxtqnd(ebxdutulrv) = jwoaiovpzs kbjpbpjqlw (keehiesbia ) View more	Positive	26 Feb 2018
				S-1	flxsvxtqnd(ebxdutulrv) = zeyspgsbhs kbjpbpjqlw (keehiesbia ) View more
NCT00229424 (Pubmed)	Phase 3	Esophagitis, Peptic	-	Lafutidine 20mg	mxxkxmogat(fuyroramds) = ifynjeheta inagacuwju (lwddyoowba ) View more	-	01 Apr 2010
				Famotidine 40mg	mxxkxmogat(fuyroramds) = ydxqgnyoxi inagacuwju (lwddyoowba )