Delving into the Latest Updates on Ramosetron Hydrochloride with Synapse

This clinical trial aims to assess the effectiveness of Ramosetron compared to Psyllium, a gold standard therapy, in patients with fecal incontinence. The primary questions it seeks to answer are:
1. Does Ramosetron improve the symptoms of fecal incontinence?
2. Is Ramosetron superior to Psyllium in terms of symptom improvement and its impact on quality of life?
Participants will be randomly assigned to one of two groups, either taking Ramosetron or Psyllium for one month. They will be asked to complete a questionnaire. Researchers will then compare the Fecal Incontinence Severity Index between the Ramosetron and Psyllium groups to determine whether Ramosetron provides superior symptom relief compared to Psyllium.

Start Date15 Dec 2023

Sponsor / Collaborator

Seoul National University Hospital

NCT05577845

/ RecruitingNot ApplicableIIT

Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial

Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial

Start Date27 Mar 2023

Sponsor / Collaborator

Seoul National University Hospital

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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511

Literatures (Medical) associated with Ramosetron Hydrochloride

25 Apr 2025·The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi

Treatment of Irritable Bowel Syndrome with Predominant Diarrhea

Review

Author: Kim, Min Cheol ; Park, Yehyun ; Lee, Hong Sub

Irritable bowel syndrome with predominant diarrhea (IBS-D) is a subtype of irritable bowel syndrome that causes frequent loose stools. Although the precise pathophysiology remains unclear, factors, such as gut microbiota imbalance, visceral hypersensitivity, intestinal permeability changes, and stress, play significant roles. Recent studies have suggested that dysbiosis is a key contributor to IBS-D pathogenesis, emphasizing the need for targeted therapeutic strategies. The treatment of IBS-D involves pharmacological and non-pharmacological approaches. Pharmacological treatments include antidiarrheal agents, such as loperamide, which reduce stool frequency but have limited effects on pain relief. Antispasmodics, such as octylonium bromide and hyoscine butylbromide, alleviate abdominal pain by modulating intestinal motility. Rifaximin, a non-absorbable antibiotic, has shown efficacy in symptom reduction by altering the gut microbiota. Selective serotonin receptor antagonists, such as ramosetron, have benefits in symptom control, particularly in male patients. In addition, low-dose tricyclic antidepressants help manage pain and stool irregularities by modulating the gut-brain interactions. Non-pharmacological strategies include dietary modifications, with the low-FODMAP diet showing potential benefits despite concerns about long-term nutritional adequacy. Psychological interventions, such as cognitive behavioral therapy and gut-directed hypnotherapy, are recommended for patients with persistent symptoms unresponsive to medication. Mild physical activities, such as yoga and walking, relieve symptoms by improving gut motility and reducing stress. Personalized treatment approaches are essential because IBS-D presents a wide spectrum of symptoms. Clinicians should tailor therapeutic plans based on individual patient characteristics, balancing the benefits and risks of each intervention to optimize symptom control and improve the quality of life.

01 Apr 2025·Korean Journal of Pain

Physicochemical stability of mixtures of non-steroidal anti-inflammatory drugs such as ketorolac and diclofenac and antiemetics such as ondansetron and ramosetron: an in vitro study

Article

Author: Lee, Chung Hun

Background:

Drugs administered intravenously during the postoperative period can mix before entering the bloodstream. This study assessed the stability of mixtures of non-steroidal anti-inflammatory drugs (ketorolac and diclofenac) and antiemetics (ondansetron and ramosetron) to determine their suitability for concurrent administration.

Methods:

Ketorolac or diclofenac was combined with ondansetron or ramosetron at a 1:1 volume ratio. Each mixture was stored in a propylene syringe at 24°C for 2 hours. The mixtures were assessed visually, and the pH was measured. Additionally, the drug concentrations were determined using high-performance liquid chromatography (HPLC).

Results:

Mixtures of ketorolac or diclofenac and ramosetron showed no crystal formation or pH changes, and HPLC analysis confirmed that the drug concentrations remained stable. In contrast, mixtures of ketorolac or diclofenac and ondansetron exhibited the visible formation of 10-50 μm crystals under a microscope. However, there were no changes in the pH levels, and HPLC analysis indicated that the drug concentrations remained stable for both the mixtures.

Conclusions:

Mixtures of ketorolac or diclofenac and ramosetron demonstrated physical and chemical stability for up to 2 hours, indicating that their concurrent use is feasible. Conversely, mixtures of ketorolac or diclofenac and ondansetron should be avoided due to the formation of crystals, even though the concentration of each drug remained stable.

14 Mar 2025·MEDICINE

Impact of basal infusion on postoperative nausea and vomiting in fentanyl-based intravenous patient-controlled analgesia: A randomized controlled trial

Article

Author: Jeon, Yeong-Gwan ; Kim, Sujin ; Cho, Yun Hyung ; Song, Seung Woo ; So, Jung Hyun ; Park, Ji-Hyoung

Background::

Fentanyl-based intravenous patient-controlled analgesia (IV PCA) is widely prescribed postoperatively. Basal infusion of fentanyl through IV PCA is associated with postoperative nausea and vomiting. However, the role of basal infusion in fentanyl-based IV PCA is not well-established.

Methods::

This parallel-group, randomized controlled trial was conducted at a tertiary university medical center in the Republic of Korea from September 2022 to April 2023. Patient inclusion criteria were: age 20 to 65 years, intraperitoneal laparoscopic gynecologic surgery, patient-controlled analgesia (PCA) request from the surgical department, and written informed consent for PCA. Patients were allocated to basal infusion (BAS group) and bolus-only (BOL group) groups in a 1:1 ratio.A sum of 100 mL of analgesic mixture containing fentanyl 18.5 µg/kg, nefopam 120 mg, and ramosetron 0.3 mg was mixed in PCA pumps of both groups. For BAS group, basal infusion rate, bolus volume, and lock-out interval were 2 mL/hour, 1 mL, and 15 minutes, respectively. BOL group received no basal infusion; bolus volume and lock-out interval were 1 mL and 6 minutes, respectively.The primary outcome was postoperative nausea, measured using a self-response questionnaire 24 hours after operation and expressed as a 100-mm visual analog scale score. We also determined frequency of postoperative vomiting, quality of postoperative recovery (using Korean version of 15-item Quality of Recovery [QoR-15K] scale), and overall patient satisfaction with anesthetic service.

Results::

A sum of 82 of the 88 patients enrolled were included. The visual analog scale score for postoperative nausea was 31.4 ± 31.3 mm; the condition was more severe in the BAS group than in the BOL group (95% confidence interval of difference: 2.1–28.9 mm, P = .024). The QoR-15K score, patient satisfaction, and rescue opioid doses used were similar across groups.

Conclusion::

Fentanyl-based IV PCA without basal infusion resulted in less postoperative nausea and vomiting than IV PCA with basal infusion and maintained adequate analgesia. Basal infusion can be omitted to reduce postoperative nausea using IV PCA by applying an appropriate lock-out interval. Further research comparing variable PCA settings is warranted.

3

News (Medical) associated with Ramosetron Hydrochloride

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

06 Oct 2008

·www.astellas.com

Astellas Launches Irribow® for the Treatment of Irritable Bowel Syndrome

Japan, October 6, 2008 - Astellas Pharma Inc. (headquarters: Tokyo, president and CEO: Masafumi Nogimori, “Astellas”) today announced that its serotonin 5-HT3 receptor antagonist Irribow® Tablets 2.5μg, 5μg (generic name: ramosetron hydrochloride) will become available in Japan on October 7, 2008, with the indication of “diarrhea-predominant irritable bowel syndrome in male.” Irritable bowel syndrome (IBS) is a functional but not organic disorder which causes abdominal pain and/or discomfort with abnormal bowel movement including diarrhea and constipation. These gastrointestinal symptoms persist for a long period with frequent remissions and exacerbations. Abdominal pain/discomfort and abnormal bowel movement 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. IBS is classified into three types consisted of diarrhea, constipation and both alternating between diarrhea and constipation. In Japan, it is reported that prevalence rate of all type of IBS in adult is expected to be 12.5% and the number of patients is estimated to be approximately 12 million. IBS is more likely to be observed in younger people, and the symptoms in male tend to develop diarrheal type. 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 bowel movement 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 Irribow to provide a new option for IBS medication. Details of Irribow are as follows: Brand name: Irribow® Tablets 2.5μg, 5μg Generic name: ramosetron hydrochloride Indication: diarrhea-predominant irritable bowel syndrome in male Dosage and administration: For oral use, the usual adult male dosage is 5 μg of ramosetron hydrochloride once daily. The dosage may be adjusted according to the patient’s symptoms. The maximum daily dose is 10 μg. Approval holder: Astellas Pharma Inc. Packaging: Tablets 2.5μg: 100 tablets (10T×10 PTP), 140 tablets (14T×10, PTP), 500 tablets (bottle), 700tablets (14T×50 PTP) Tablets 5μg: 100 tablets (10T×10 PTP), 140 tablets (14T×10, PTP), 500 tablets (bottle), 700tablets (14T×50 PTP) NHI reimbursement prices 86.30 Japanese yen/2.5μg tablet 141.10 Japanese yen/5μg tablet Date of NHI price listed : September 12, 2008 Date of launch: October 7, 2008 *100 tablets (10T×10 PTP) and 500 tablets (bottle) will be available around December.

Drug Approval

31 Jan 2006

·www.astellas.com

Recent Progress in the New Drug Development

Japan, January 31, 2006 - Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) today announced that it has recently achieved the following progress in its efforts to develop new drugs: -Marketing authorization application (MAA) for the immunosuppressant FK506 Modified Release Formulation in Europe The European subsidiary of Astellas has submitted an MAA for the immunosuppressant FK506 Modified Release Formulation (generic name: tacrolimus) to the European Medicines Agency (EMEA) with the proposed indication of the inhibition of rejection in organ transplantation. FK506 Modified Release Formulation is a once-daily version of Prograf. Because this formulation is more convenient than the existing twice-daily formulation, it is expected to improve compliance and thereby improve the long-term efficacy in the protection of transplanted organs. Its safety is also expected to be comparable to or even superior to that of the existing formulation since peak blood concentrations can be controlled at lower levels. It also makes it possible to titrate the dosage based on blood concentrations. -Application of YM060 for the Irritable Bowel Syndrome Treatment in Japan Astellas filed an application of YM060 (generic name: ramosetron hydrochloride) for the irritable bowel syndrome (IBS) treatment in Japan with a proposed indication of diarrhea-predominant IBS. IBS is a functional gastrointestinal disorder consisting of two major complaints of abdominal pain and abnormal bowel habit. It is generally classified into three types: diarrhea-predominant-type, constipation-predominant-type and alternate-predominant-type. YM060 improves colonic functions via its 5-HT3 (serotonin) receptor antagonism with the proposed indication of IBS associated with diarrhea. If approved, it will be Japanfs first 5-HT3 receptor antagonist for this indication. The clinical development of YM060 (Phase II) is also under way in Europe. The development status of other compounds is announced today as a supplement to the financial result release package for 3Q of FY2005.

Phase 2Drug ApprovalImmunotherapyNDAIND

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	LTL Pharma Co., Ltd.	10 Jul 1996
Nausea	Japan	Astellas Pharma, Inc.	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	United States	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	wlshpxubwz(dreuspuupa) = gupodjedsu ddhngkmyrp (txhtbqgjmo )	Positive	12 May 2022
				Metoclopramide 10 mg	wlshpxubwz(dreuspuupa) = xxurysygvy ddhngkmyrp (txhtbqgjmo )
KCT0005441 (Pubmed \| Curr Pharm Des)	Not Applicable	Cough \| Anesthesia	-	Ramosetron 0.3 mg	arlpnirood(mcualzndim) = qienvadlnr mpdvhoktug (mtjyianzaz ) View more	-	12 Apr 2022
				Normal saline	arlpnirood(mcualzndim) = tunndelvzp mpdvhoktug (mtjyianzaz ) View more
NCT02849483 (Pubmed \| Int J Gynaecol Obstet)	Phase 4	-	88	Control group (10 mg dexamethasone)	wbmmtqgvmp(noaebqadmc) = nkoqcywbbz jerclrclmd (kjmmeqkqtx ) View more	-	06 Oct 2021
				Study group (0.6 mg ramosetron)	wbmmtqgvmp(noaebqadmc) = oexuccjnqz jerclrclmd (kjmmeqkqtx ) View more
NCT02869984 (Pubmed \| Br J Surg)	Early Phase 1	Rectal Cancer	100	Ramosetron	xtmhdliejc(djqprpvcad) = qbyszllkgd guxaacngnb (npsrlodkkq )	Positive	13 May 2021
				ramosetron (Conservative treatment)	xtmhdliejc(djqprpvcad) = ihmnflbppt guxaacngnb (npsrlodkkq )
NCT02011659 (Pubmed)	Phase 3	Postoperative Nausea and Vomiting	-	Ramosetron	rqykavgfjb(lruuhxzgrm) = foeufcehcb npdbnynoik (plqjvapzol )	-	01 Sep 2019
				Placebo	rqykavgfjb(lruuhxzgrm) = gstqlhkchc npdbnynoik (plqjvapzol )
NCT02532634 (ESMO2018)	Phase 4	Chemotherapy-induced nausea and vomiting	279	Ramosetron, Aprepitant, and Dexamethasone (RAD)	qzerbesmos(moqbwjeavy) = rxvnqtpmov tnyfgpynfx (jbgzexvxwr ) View more	Positive	22 Oct 2018
				Palonosetron, Aprepitant, and Dexamethasone (PAD)	qzerbesmos(moqbwjeavy) = yasikamowl tnyfgpynfx (jbgzexvxwr ) View more
NCT01274000 (Pubmed \| Neurogastroenterol Motil)	Phase 2	Irritable bowel syndrome with diarrhea	409	2.5 μg of ramosetron	xxvwqlttnm(popivzochp) = vgudgmoyfz lmxmldrpdv (keydrracod )	-	01 Jun 2017
NCT00918411 (Pubmed \| Biopsychosoc Med)	Phase 4	Irritable bowel syndrome with diarrhea	98	Ramosetron 5 μg	wjrxkuvqhp(sbgrciuquq) = fkaxwnmpgz leeiuugqay (ybjsxwfurk ) View more	-	01 Jan 2017
				Placebo	wjrxkuvqhp(sbgrciuquq) = medtwlytae leeiuugqay (ybjsxwfurk ) View more
NCT01736423 (Pubmed \| J Gastroenterol) Manual	Phase 3	Irritable bowel syndrome with diarrhea	123	ramosetron	gibntwlrki(vytvmhqzry) = 19.7 % in 2.5 μg and 10.5 % in 5 μg pgphiwhccb (flvchcmzmz ) View more	Positive	01 Sep 2016
				Ramosetron 5 μg
NCT02139241 (Pubmed)	Not Applicable	-	114	Ramosetron	mjjcctevnk(pvnhnhlqtz): P-Value = 0.040; P-Value = 0.021	-	03 Aug 2016
				Placebo