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 Diseases

Active Indication

Irritable Bowel SyndromeNauseaVomiting+ [2]

Inactive Indication

Chemotherapy-induced nausea and vomitingIrritable bowel syndrome with diarrheaNeoplasms

Originator Organization

Astellas Pharma, Inc.

Active Organization

LTL Pharma Co., Ltd.

Astellas Pharma, Inc.

Hangzhou Hekang Pharmaceutical Co., Ltd.

Inactive Organization

Astellas Pharma Europe Ltd.Astelas Pharma Korea, Inc.

Zhejiang Academy of Medical Sciences

+ [2]

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

Irritable bowel syndrome (IBS) tends to be a lifelong disorder and it is often frustrating to both patients and physicians. This study aim of improving symptom control, reducing healthcare burden and upgrading the quality of life of patient with diarrhea predominant IBS-D.
Patients of both sex of age group 18-65 years attending gastroenterology outpatient department Dhaka Medical College Hospital (DMCH) meeting the inclusion criteria of Diarrhea predominant irritable bowel syndrome (IBS-D) will be initially enrolled for the study. Their history, clinical examination & initial investigations will be done. Report will be noted in the standard data sheet. Any alternative diagnosis if proven by clinical examination or laboratory investigation will be excluded from the study.
Each patient will go through a run-in period of 7 days. Number of subjects will be recruited according to sample size. Randomization into two groups will be performed by online randomizer websites.
One group will receive tablet ramosetron 2.5 mcg one time daily at morning before breakfast while the other group will receive identical looking placebo one tablet once daily at same time. Both groups will be adviced for low FODMAP diet along with lifestyle modification. The tablets will be administered for total 4 weeks. Before starting treatment, each individual will undergo a baseline assessment during which demographic data, base line investigations, IBS symptoms by IBS Symptom Severity Score (IBS-SSS) will be recorded. Patients will be followed-up after 4 weeks and 8 weeks by IBS-SSS questionnaire. Any adverse effect will be reported quickly and documented at the same time.
IBS-SSS is a 5 item tools. It is primarily measures the IBS symptoms which includes abdominal pain and distension as well as bowel satisfaction. This scale evaluates IBS symptoms: abdominal pain, abdominal distension, stool frequency and consistency and interference with life in general. The IBS-SSS calculates the sum of these 5 items scored on a visual analogue scale from 0-100.

Start Date30 Apr 2026

Sponsor / Collaborator

Dhaka Medical College

CTRI/2026/01/101436

/ CompletedPhase 2IIT

Comparision of efficacy of ondansetron versus palanosetron versus ramosetron for prevention of post operative nausea and vomiting (PONV) in elective craniotomy surgeries- A randomized double blinded prospective study - PONV

Start Date28 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Ramosetron Hydrochloride

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100 Translational Medicine associated with Ramosetron Hydrochloride

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100 Patents (Medical) associated with Ramosetron Hydrochloride

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433

Literatures (Medical) associated with Ramosetron Hydrochloride

01 Aug 2026·CLINICAL PHARMACOLOGY & THERAPEUTICS

Clinical Pharmacogenetics Implementation Consortium ( CPIC ) Guideline for CYP2D6 Genotype and Use of 5‐ HT ₃ Receptor Antagonists: 2026 Update

Review

Author: Moore, Claire ; Caudle, Kelly E. ; Bourque, Melissa S. ; Gaedigk, Andrea ; Halman, Andreas ; Diekstra, Meta H.M. ; Hikino, Keiko ; Oxencis, Carolyn J. ; Schwab, Matthias ; Chauhan, Dharmisha ; Long, Susie E. ; Whirl‐Carrillo, Michelle ; Agúndez, José A. G. ; Klein, Teri E. ; Conyers, Rachel ; Bell, Gillian C. ; Prows, Cynthia A.

5‐hydroxytryptamine type 3 (5‐HT 3 ) receptor antagonists are used to treat nausea and vomiting and in the prevention of chemotherapy‐induced, radiation‐induced, and postoperative nausea and vomiting. Most of the 5‐HT 3 receptor antagonists (i.e., ondansetron, tropisetron, dolasetron, palonosetron, and ramosetron) are metabolized by CYP2D6, but the extent of CYP2D6 involvement varies. CYP2D6 genetic variation can influence the metabolism of these medications, particularly ondansetron and tropisetron, thereby affecting drug efficacy. This guideline is an update to the 2016 Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for CYP2D6 genotype and use of ondansetron and tropisetron and includes updated information on CYP2D6 genetic testing and evidence tables. We summarize evidence from the published literature supporting these associations and provide therapeutic recommendations for 5‐HT 3 receptor antagonists based on CYP2D6 genotype, particularly where genetic variation is associated with reduced drug efficacy (updates at https://www.clinpgx.org/guideline/PA166251457 ).

04 May 2026·Expert Opinion On Drug Safety

Potential drugs for reducing the occurrence of immune checkpoint inhibitor-induced interstitial lung disease: an exploratory study using the JADER and FAERS databases

Article

Author: Koseki, Takenao ; Kondo, Masashi ; Hatano, Masakazu ; Utsunomiya, Ayaka ; Yamada, Shigeki ; Imaizumi, Kazuyoshi

BACKGROUND:

Immune checkpoint inhibitors (ICIs) play a central role in cancer immunotherapy. However, the occurrence of immune-related adverse events, especially ICI-induced interstitial lung disease (ICI-ILD), is life-threatening and affects the effectiveness of ICI treatment. This study aimed to explore potential drugs to mitigate ICI-ILD occurrence using data from the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS [JAPIC AERS]).

RESEARCH DESIGN AND METHODS:

We investigated concomitant drugs that reduce ILD associated with four ICIs - nivolumab, pembrolizumab, atezolizumab, and durvalumab - across the JADER and FAERS databases. Subsequently, the identified common concomitant drugs that reduce the occurrence of ICI-ILD were detected and analyzed.

RESULTS:

We found omega-3 fatty acids, loperamide, and amlodipine as common concomitant drugs that reduced ICI-ILD occurrence in both the JADER and FAERS databases. Omega-3 fatty acids reportedly have many effects in animal models of drug-induced ILD, including their association with ILD in humans and anti-inflammatory effects against ICI-ILD. However, loperamide and amlodipine reportedly have minimal effects against ILD, thereby necessitating further evaluation.

CONCLUSION:

Omega-3 fatty acids have emerged as potential agents for reducing ICI-ILD occurrence, as evidenced by findings from two different pharmacovigilance databases.

01 Apr 2026·INTERNAL MEDICINE

Ramosetron as a Supportive Agent to Continue Nintedanib in Patients with Interstitial Lung Disease

Article

Author: Komiya, Kosaku ; Shigenaga, Takehiko ; Satonaga, Yoshio ; Hata, Masahiro ; Kudoh, Ryohei

Objective Although nintedanib is commonly used to treat interstitial lung disease (ILD), its clinical utility is often limited by adverse gastrointestinal events. Ramosetron, a selective 5-HT₃ receptor antagonist, has shown efficacy in managing irritable bowel syndrome; however, its effects on nintedanib-associated abdominal symptoms remain unclear. This study evaluated the effect of ramosetron on continuation of nintedanib therapy. Methods This retrospective analysis enrolled patients with ILD who received nintedanib at our institute between August 2018 and October 2024, and the clinical courses of those receiving nintedanib with or without ramosetron were compared. The duration of nintedanib administration was evaluated using the log-rank test, and a multivariate Cox proportional hazards regression analysis was performed to identify the factors associated with the duration of nintedanib treatment. Results Among the 142 patients included in the analysis, 55 were administered ramosetron and 87 were not. The duration of nintedanib therapy was significantly longer in the ramosetron group than in the non-ramosetron group (1,269 vs. 497 days; p=0.005). Ramosetron administration was an independent factor associated with prolonged nintedanib treatment even after adjusting for clinical variables. Notably, ramosetron treatment initiated after nintedanib therapy was more effective than its prophylactic use. Conclusion Ramosetron administration significantly correlated with prolonged duration of nintedanib therapy. The selective use of ramosetron may improve adherence to nintedanib treatment. However, prospective studies are required to validate these findings.

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	wnydhfozql(ghqnpmquvk) = wetwsuwern jnasxicwhx (ajzldgjfzp )	Positive	12 May 2022
				Metoclopramide 10 mg	wnydhfozql(ghqnpmquvk) = siukvbzvga jnasxicwhx (ajzldgjfzp )
KCT0005441 (Pubmed \| Curr Pharm Des)	Not Applicable	Cough \| Anesthesia	-	Ramosetron 0.3 mg	qcqhfymacr(vixsuihcrl) = hpfcxdmhqr rhgcuvpepi (sxnaojbrgz ) View more	-	12 Apr 2022
				Normal saline	qcqhfymacr(vixsuihcrl) = tfqtkzetzr rhgcuvpepi (sxnaojbrgz ) View more
NCT02849483 (Pubmed \| Int J Gynaecol Obstet)	Phase 4	-	88	Control group (10 mg dexamethasone)	biqwiufwpn(hsqsvjjkxk) = fdpnkqjwkh nclrxcjtoz (efkxvvhjmx ) View more	-	06 Oct 2021
				Study group (0.6 mg ramosetron)	biqwiufwpn(hsqsvjjkxk) = etfyavbqts nclrxcjtoz (efkxvvhjmx ) View more
NCT02869984 (Pubmed \| Br J Surg)	Early Phase 1	Rectal Cancer	100	Ramosetron	vmjtfcwcth(uieivqajwz) = xveuyixzqg cwnirthuhx (pvflwfazno )	Positive	13 May 2021
				ramosetron (Conservative treatment)	vmjtfcwcth(uieivqajwz) = cunrkecnaj cwnirthuhx (pvflwfazno )
NCT02011659 (Pubmed)	Phase 3	Postoperative Nausea and Vomiting	-	Ramosetron	mdiuxeaacc(bfhfvmcqyj) = atcrckpbkc inywzdswrn (hgyveukqnl )	-	01 Sep 2019
				Placebo	mdiuxeaacc(bfhfvmcqyj) = inbqpwzkcx inywzdswrn (hgyveukqnl )
NCT02532634 (ESMO2018)	Phase 4	Chemotherapy-induced nausea and vomiting	279	Ramosetron, Aprepitant, and Dexamethasone (RAD)	ivlxvjdikw(kcczkwitce) = jffxzqiore retlmmdkrj (ebxjgohsyw ) View more	Positive	22 Oct 2018
				Palonosetron, Aprepitant, and Dexamethasone (PAD)	ivlxvjdikw(kcczkwitce) = jdudmhvjmo retlmmdkrj (ebxjgohsyw ) View more
NCT01274000 (Pubmed \| Neurogastroenterol Motil)	Phase 2	Irritable bowel syndrome with diarrhea	409	2.5 μg of ramosetron	qvmjysugeu(fmflfjjpei) = kvptluyayz nairmexaas (igibzlurfh )	-	01 Jun 2017
NCT00918411 (Pubmed \| Biopsychosoc Med)	Phase 4	Irritable bowel syndrome with diarrhea	98	Ramosetron 5 μg	yoedsczopa(etfqgvhboy) = pduhtvajxa hvoyavqivp (ddorvdjzrp ) View more	-	01 Jan 2017
				Placebo	yoedsczopa(etfqgvhboy) = doeiqzekqe hvoyavqivp (ddorvdjzrp ) View more
NCT01736423 (Pubmed \| J Gastroenterol) Manual	Phase 3	Irritable bowel syndrome with diarrhea	123	ramosetron	lcalhblltx(cqlopcudms) = 19.7 % in 2.5 μg and 10.5 % in 5 μg oiohttmqbb (lbxspicmbh ) View more	Positive	01 Sep 2016
				Ramosetron 5 μg
NCT02139241 (Pubmed)	Not Applicable	-	114	Ramosetron	sxmpltvavz(lqormozkzq): P-Value = 0.040; P-Value = 0.021	-	03 Aug 2016
				Placebo