Delving into the Latest Updates on Ramosetron Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ramosctron Hydrochloride, Ramosetron, Ramosetron Hydrocchloride

+ [13]

Target

HTR3

Action

antagonists

Mechanism

5-HT3 receptor antagonists(5-hydroxytryptamine receptors, ionotropic (HTR3) antagonists)

Therapeutic Areas

Digestive System DisordersOther DiseasesNeoplasms

Active Indication

Irritable Bowel SyndromeNauseaVomiting+ [3]

Inactive Indication

Chemotherapy-induced nausea and vomitingIrritable bowel syndrome with diarrhea

Originator Organization

Astellas Pharma, Inc.

Active Organization

Zhejiang Academy of Medical Sciences

LTL Pharma Co., Ltd.Hangzhou Paqisi Pharmaceutical Technology Co., Ltd.

+ [2]

Inactive Organization

Astellas Pharma Europe Ltd.Astelas Pharma Korea, Inc.Yamanouchi Pharmaceutical Co., Ltd.

License Organization

Daiichi Sankyo Co., Ltd.

Astellas Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

Japan (10 Jul 1996),

Irritable Bowel SyndromeNauseaVomiting

Regulation-

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Structure/Sequence

Molecular FormulaC17H18ClN3O

InChIKeyXIXYTCLDXQRHJO-RFVHGSKJSA-N

CAS Registry132907-72-3

Fecal incontinence (FI) significantly impairs patient quality of life and creates substantial distress not only for affected individuals but also for nurses and caregivers. The prevalence of FI among older adults is estimated at up to 20%, although the sensitive nature of the condition often prevents active reporting by patients. This article reviews risk factors and pharmacotherapies for FI, emphasizing the therapeutic potential of Daikenchuto (DKT). The etiology of FI is multifactorial and lacks a singular definition. Currently, no prescription drugs specifically approved for FI are available, leaving treatment options limited. Nonetheless, major clinical guidelines have identified several viable pharmacological approaches. Strongly recommended treatments include the antidiarrheal agent loperamide and stool bulking or solidifying agents, such as dietary fiber and polycarbophil. Other therapeutic options include ramosetron, a 5-HT3 receptor antagonist; amitriptyline, a tricyclic antidepressant; and sodium valproate and diazepam, which are GABAergic neuromodulators. Recently, research has explored the efficacy and mechanism of action of DKT, a traditional Japanese medicine Kampo. Historically used for abdominal symptoms like bloating and known for promoting intestinal motility, emerging evidence suggests DKT may also effectively manage FI.

01 Oct 2025·INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS

Review

Author: Dong, Huajun ; Liu, Lingyan ; Xu, Hongxia ; Xing, Jiankun ; Chen, Xiaotao ; Yang, Shaohui ; Rong, Lingyan ; Liu, Huihui

Abstract:

Background:

Gynecological surgery is generally associated with a high risk of postoperative nausea and vomiting (PONV), for which a combination of antiemetic therapies is advised, but adherence to these protocols is often low. Given the current reality, a preferred 5‐HT 3 receptor antagonist for preventing PONV as a result of gynecological operations might be desirable. However, the efficiency of different 5‐HT 3 receptor antagonists in gynecological operations was not clear.

Objective:

To assess the effectiveness of different 5‐HT 3 antagonists in preventing PONV after gynecological surgery.

Search Strategy:

Electronic databases, including PubMed, Embase, the Cochrane Library, and Web of Science, were searched for randomized clinical trials (RCTs) from their inception up to September 20, 2023.

Selection Criteria:

Patients who received only 5‐HT 3 antagonists to prevent nausea and vomiting following gynecologic surgical procedures were included. Only RCT articles and English language literature were included.

Data Collection and Analysis:

Two investigators independently assessed the study quality and performed data extraction. R software and STATA 17 were used for this network meta‐analysis to compare treatments using a frequentist approach.

Main Results:

Palonosetron demonstrated superior efficacy compared with ondansetron, with a significant difference in “acute nausea,” “overall nausea,” “acute vomiting,” “late vomiting,” “late PONV,” “overall PONV,” “late rescue medicine” and “>24 h rescue medicine.” There was a significant difference between palonosetron and ramosetron in “acute nausea,” between ramosetron and ondansetron in “>24 h nausea,” and between granisetron and ondansetron in “late vomiting.” Additionally, granisetron and palonosetron are generally ranked higher in the P‐score system.

Conclusions:

In gynecological surgery, palonosetron demonstrated superior efficacy to ondansetron. Granisetron seemed to be the most effective alternative to palonosetron in our study.

01 Aug 2025·Journal of PeriAnesthesia Nursing

Pharmacological Strategies for Postdischarge Nausea and Vomiting: Evidence-based Review Update

Review

Author: Kane, Terri D ; Tubog, Tito D

PURPOSE:

Evaluate the effectiveness of various drugs in preventing postdischarge nausea and vomiting (PDNV).

DESIGN:

Systematic review.

METHODS:

A search for evidence was conducted in PubMed, CINAHL, Cochrane Collaboration, and Google Scholar and gray literature. Only randomized controlled trials examining a pharmacological agent to prevent PDNV were included in the study. The quality appraisal of the literature was conducted using the proposed algorithm described in the Johns Hopkins Nursing Evidence-Based Practice Evidence Level and Quality Guide.

FINDINGS:

A total of 8 randomized controlled trials involving 1,441 patients were analyzed. The efficacy of pharmacological agents, including dexamethasone, olanzapine, ondansetron, palonosetron, ramosetron, promethazine, and casopitant in the prevention of PDNV, varied. Additionally, a combination of two or more drugs is a more effective therapy than using a single drug in mitigating PDNV. The review also underscored the individual patient factors that can play a significant role in identifying appropriate prevention and treatment modalities.

CONCLUSIONS:

There is limited evidence on the efficacy of pharmacological agents in preventing PDNV. The scarcity of large-scale, clinical trials specifically focusing on PDNV restricts the ability to recommend prophylactic drug therapy for reducing its incidence.

5

News (Medical) associated with Ramosetron Hydrochloride

11 Oct 2021

·www.astellas.com

World's First Use of Environmentally Friendly Biomass-based Plastic for Blister Packages, the Primary Packaging for Drugs

TOKYO, October 11, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) begin using biomass-based plastics made from plant-derived materials in blister packages as the primary packaging for pharmaceutical products. This is the world's first use of biomass plastic for blister packages for drugs. The blister package is made of biomass-based plastic, polyethylene derived from sugarcane, as 50% of its raw material. It is an environmentally friendly packaging that agree with the concept of "carbon neutrality," which is the idea of balancing greenhouse gas emissions and absorption. Blister packages as tablet packaging containers are required to have high tablet protection and usability. For example, strength that can withstand impact and sealability that will keep outside air from entering, while maintaining enough softness so that the tablets can be easily taken out. The visibility of the packaged tablets and the ease in which it can be separated is also required. Astellas, by fully using its packaging technology cultivated over many years, has actualized the production of the biomass-based plastic sheets that can be mass-produced while achieving tablet protection function and usability. In FY2021, Astellas will start using the biomass-based plastic blister package for the "Irribow® Tablet 5µg" (generic name: ramosetron hydrochloride, indication: diarrhea-predominant irritable bowel syndrome) in Japan. In the future, Astellas will continue to switch from the conventional petroleum-derived plastic blister package to the biomass-based plastic blister package for other products as well, and it will also seek new packaging materials that are superior in terms of sustainability. Astellas has set "Deepen our Engagement in Sustainability" as one of its strategic goals in its Corporate Strategic Plan 2021*1. The adoption of biomass-based plastics in blister packages is one of the efforts toward this end. Astellas also believe that this will contribute to Goal 13 of the SDGs (Sustainable Development Goals), "Take urgent action to combat climate change and its impacts”. Astellas continues to further promote sustainability activities and expand information disclosure under its basic policy, which is to improve the sustainability of both the global society and Astellas while keeping ESG [environmental (E), social (S), governance (G)] in mind*2. *1: Astellas Corporate website “Corporate Strategic Plan 2021”. Available at: https://www.astellas.com/jp/en/about/csp2021 *2: Astellas Corporate website “Sustainability Approach”. Available at: https://www.astellas.com/jp/en/sustainability/sustainability-approach Click below for a copy of the full press release

15 Oct 2019

·www.daiichisankyo.com

Daiichi Sankyo Announces Transfer from Astellas Pharma of Three Products in Asia

PDF (112KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Sunao Manabe, Representative Director, President and CEO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Junichi Onuma, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 https://www.daiichisankyo.com Tokyo, Japan (October 15, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it agreed with Astellas Pharma Inc. (hereafter, Astellas Pharma) that Astellas Pharma local subsidiaries companies in six Asian countries will transfer three products to Daiichi Sankyo. The products to be transferred and the countries where they are sold are as follows. Product [generic name (brand name)] Korea China Taiwan Thailand Philippines Indonesia Ramosetron (Nasea) Antiemetic ○ ○ ○ ○ Nicardipine (Perdipine) Anti-hypertensive ○ ○ ○ Barnidipine (Oldeca) Anti-hypertensive ○ Product [generic name (brand name)] Korea China Taiwan Thailand Philippines Indonesia Ramosetron (Nasea) Antiemetic ○ ○ ○ ○ Nicardipine (Perdipine) Anti-hypertensive ○ ○ ○ Barnidipine (Oldeca) Anti-hypertensive ○ ○ indicate the countries where the products are sold The antiemetics are expected to have synergistic effects with mirogabalin and the cancer drugs that Daiichi Sankyo is currently developing in Asia, and the two antihypertensives are expected to effectively utilize Daiichi Sankyo’s current infrastructures in combination with its cardiovascular products, such as olmesartan and edoxaban. The total net sales of Astellas Pharma's three products in fiscal year 2018 were approximately 5.0 billion yen. Daiichi Sankyo will take over the rights and obligations, including manufacturing and marketing approvals, for each of the products, and from December 2019 onwards, the manufacturer, LTL Pharma Co., Ltd., will supply them for sale in Asia by Daiichi Sankyo’s local subsidiaries and other companies. Daiichi Sankyo will pay 9.6 billion yen to Astellas Pharma for the products to be taken over; moreover, in order to ensure continuous supplies of the products to patients, both companies will cooperate to smoothly transfer manufacturing and marketing approvals in the targeted countries. Daiichi Sankyo is strengthening its presence in each region by providing a rich range of regional value products in line with the market characteristics in each region, and the company strengthens its presence in Asia and plans to further contribute to healthcare in the region by acquiring these products. About Daiichi Sankyo Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.

Drug ApprovalBiosimilar

08 Aug 2012

·www.astellas.com

Astellas Pharma: Application for Orally Disintegrating Tablet YM060, a Treatment for Diarrhea-predominant Irritable Bowel Syndrome, in Japan

Tokyo, August 8, 2012 - Astellas Pharma Inc. (“Astellas Pharma”; Tokyo:4503; President and CEO: Yoshihiko Hatanaka) today announced that it submitted an application for market authorization for “orally disintegrating tablet YM060 (generic name: ramosetron hydrochloride)” to the Ministry of Health, Labour and Welfare in Japan. It has submitted for approval for an additional formulation of Irribow with the indication of the diarrhea-predominant irritable bowel syndrome 1) in male. “Orally disintegrating tablet YM060” is the irritable bowel syndrome treatment developed using WOWTAB 2) which is one of the Astellas' proprietary drug delivery technologies. It can be ingested without water since it quickly disintegrates upon contact with saliva in the mouth. It can be easily taken even by elderly patients and patients with impaired swallowing function. It is also useful for patients with avoided water consumption and meets various needs of patients. Astellas offers Gaster ®D for the treatment for peptic ulcers and gastritis, Harnal ®D for the treatment for functional symptoms of benign prostatic hyperplasia and Vesicare ®OD 3) for overactive bladder, which were developed with using WOWTAB technology. Irribow is a serotonin 5-HT3 receptor antagonist discovered by Astellas. Serotonin is a member of neurotransmitter which is greatly related to gastrointestinal motility, secretion and sensation. Stress may stimulate the serotonin release and activate the 5-HT3 receptors on enteric nerve, which induces the acceleration of intestinal transit resulting in diarrhea. In addition, the increase in intracolonic pressure also induces serotonin release, and it will bind to 5-HT3 receptor at the terminal of afferent neuron, causing intestinal nociceptive transmission to central nervous system. Irribow improves abnormal defecation associated with the acceleration of intestinal transit by inhibiting 5-HT3 receptor selectively. It also improves visceral hypersensitivity by suppressing the transmission of intestinal nociception. Astellas expects to further contribute to irritable bowel syndrome treatment by introducing into Japanese market “orally disintegrating tablet YM060” which can further improve the compliance with its more convenient dosing option. 1) Irritable bowel syndrome (IBS) is a functional but not organic disorder which causes abdominal pain and/or discomfort with abnormal defecation including diarrhea and constipation. These gastrointestinal symptoms persist for a long period with frequent remissions and exacerbations. Abdominal pain/discomfort and abnormal defecation are often associated with many factors such as stress, which is considered to cause the acceleration of intestinal transit resulted from the over-activation of enteric nervous system. 2) WOWTAB=Without Water Tablet 3) OD=Orally Disintegrating

Drug Approval

100 Deals associated with Ramosetron Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D02016	Ramosetron Hydrochloride	A04AA	DB09290

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Irritable Bowel Syndrome	Japan	Astellas Pharma, Inc.	10 Jul 1996
Nausea	Japan	Astellas Pharma, Inc.	10 Jul 1996
Nausea	Japan	LTL Pharma Co., Ltd.	10 Jul 1996
Vomiting	Japan	LTL Pharma Co., Ltd.	10 Jul 1996
Vomiting	Japan	Astellas Pharma, Inc.	10 Jul 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Irritable bowel syndrome with diarrhea	Phase 3	Japan	Astellas Pharma, Inc.	01 Sep 2012
Neoplasms	Phase 3	South Korea	Astelas Pharma Korea, Inc.	01 Jun 2011
Chemotherapy-induced nausea and vomiting	Phase 3	Taiwan Province	Astellas Pharma, Inc.	01 Jan 2006
Drug-induced nausea and vomiting	Phase 1	China	Hangzhou Hekang Pharmaceutical Co., Ltd.	14 Jul 2025
Postoperative Nausea and Vomiting	Phase 1	China	Hangzhou Hekang Pharmaceutical Co., Ltd.	14 Jul 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04297293 (Pubmed \| Perioper Med (Lond))	Phase 4	Anesthesia	138	Ramosetron ODT 0.1 mg	pkvbxvdjkk(oalkiozjup) = rdpcewsshb ffeveuowbz (bzpimnvytn )	Positive	12 May 2022
				Metoclopramide 10 mg	pkvbxvdjkk(oalkiozjup) = xjjjlpujur ffeveuowbz (bzpimnvytn )
KCT0005441 (Pubmed \| Curr Pharm Des)	Not Applicable	Cough \| Anesthesia	-	Ramosetron 0.3 mg	vtfkxckugy(mpdecxqmfx) = pjnbfxvmml wtmsxzehkf (bemrldvhtw ) View more	-	12 Apr 2022
				Normal saline	vtfkxckugy(mpdecxqmfx) = mtzwihfojr wtmsxzehkf (bemrldvhtw ) View more
NCT02849483 (Pubmed \| Int J Gynaecol Obstet)	Phase 4	-	88	Control group (10 mg dexamethasone)	cwvxddlopp(ewypwtwtaf) = kcftbpfsoh qjklncpnsu (nhaiogpavl ) View more	-	06 Oct 2021
				Study group (0.6 mg ramosetron)	cwvxddlopp(ewypwtwtaf) = sqpgxldhwd qjklncpnsu (nhaiogpavl ) View more
NCT02869984 (Pubmed \| Br J Surg)	Early Phase 1	Rectal Cancer	100	Ramosetron	leqyqqpwyz(bkshnsyvpu) = xcjpggctna rrxpoavaho (esaetkzmwo )	Positive	13 May 2021
				ramosetron (Conservative treatment)	leqyqqpwyz(bkshnsyvpu) = lfpugwpzrf rrxpoavaho (esaetkzmwo )
NCT02011659 (Pubmed)	Phase 3	Postoperative Nausea and Vomiting	-	Ramosetron	szkbtabbve(okiidnfgal) = vvfogaaarj yekwixfsid (mjtyjnsyhm )	-	01 Sep 2019
				Placebo	szkbtabbve(okiidnfgal) = ykdywdekui yekwixfsid (mjtyjnsyhm )
NCT02532634 (ESMO2018)	Phase 4	Chemotherapy-induced nausea and vomiting	279	Ramosetron, Aprepitant, and Dexamethasone (RAD)	hurrtgnfwg(nrjyyckzbw) = jhdbmvwgnv nzqvqujzgd (ljovyxsoqr ) View more	Positive	22 Oct 2018
				Palonosetron, Aprepitant, and Dexamethasone (PAD)	hurrtgnfwg(nrjyyckzbw) = zsbbttyask nzqvqujzgd (ljovyxsoqr ) View more
NCT01274000 (Pubmed \| Neurogastroenterol Motil)	Phase 2	Irritable bowel syndrome with diarrhea	409	2.5 μg of ramosetron	mkbalotkvh(gakwwmebva) = xzcuyxbati egdextulwa (aoconglgzd )	-	01 Jun 2017
NCT00918411 (Pubmed \| Biopsychosoc Med)	Phase 4	Irritable bowel syndrome with diarrhea	98	Ramosetron 5 μg	vyusfsedkn(ollgaruqta) = mtypbafpdw xyhfjkpipx (obvztxqbqi ) View more	-	01 Jan 2017
				Placebo	vyusfsedkn(ollgaruqta) = karvirajxx xyhfjkpipx (obvztxqbqi ) View more
NCT01736423 (Pubmed \| J Gastroenterol) Manual	Phase 3	Irritable bowel syndrome with diarrhea	123	ramosetron	locijbywtm(lqmgdbseav) = 19.7 % in 2.5 μg and 10.5 % in 5 μg cacfjkpopt (dnlwacirtp ) View more	Positive	01 Sep 2016
				Ramosetron 5 μg
NCT02139241 (Pubmed)	Not Applicable	-	114	Ramosetron	dlxdtmcapm(zgzbykucxa): P-Value = 0.040; P-Value = 0.021	-	03 Aug 2016
				Placebo