This study looks at how well a medicine called naldemedine works for people with cancer who become constipated while taking opioids. Opioids are medications prescribed to treat persistent or severe pain. Opioids can slow down the bowel and make it hard to pass stool. About 6 out of 10 people who use opioids have constipation. Laxatives such as lactulose or macrogol are described to help with this problem. If laxatives do not work, doctors may use special medicines called opioid blockers that act only in the gut. These medicines help relieve constipation without reducing pain relief. Naldemedine is one of these opioid blockers. It became available in the Netherlands in 2024 but is not yet widely used. The goal of this study is to learn how well naldemedine works in everyday care and how people feel while using it. Researchers will collect information on both medical results and participants' experiences.

Start Date02 Jan 2026

Sponsor / Collaborator

Viatris, Inc.

NCT07038551

/ RecruitingPhase 4

Prophylactic Use of Naldemedine on Opioid-Induced Nausea and Vomiting in Patients With Cancer: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study

Opioid analgesics can cause side effects such as constipation, nausea, and vomiting by acting on opioid receptors widely distributed in the peripheral nervous system. This can sometimes make it difficult to achieve and maintain pain relief and continue pain treatment. Among these side effects, nausea and vomiting are specifically referred to as opioid-induced nausea and vomiting (OINV). OINV is known to occur during the initial administration or dose escalation of opioid analgesics, and it not only decreases the quality of life for patients but also reduces adherence to opioid analgesics, which can have a negative impact on pain management. Therefore, appropriate management is crucial.
While the administration of conventional antiemetic drugs is recommended for the treatment of OINV, there is a lack of high-quality studies evaluating their effectiveness, and studies comparing treatment effects with a placebo have not been reported.
The objective is to verify the effectiveness of nalbuphine in preventing OINV in patients starting opioid analgesics for cancer

Start Date06 Jun 2025

Sponsor / Collaborator

International University of Health & Welfare

[+1]

NCT06334198

/ RecruitingPhase 2IIT

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction. An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled, Cross-over Clinical Trial

Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol

Start Date12 Mar 2024

Sponsor / Collaborator

Aalborg University Hospital

100 Clinical Results associated with Naldemedine Tosylate

100 Translational Medicine associated with Naldemedine Tosylate

100 Patents (Medical) associated with Naldemedine Tosylate

169

Literatures (Medical) associated with Naldemedine Tosylate

01 Feb 2026·United European Gastroenterology Journal

Naldemedine for the Prevention of Recurrent Acute Pancreatitis: A Randomised, Double‐Blind, Placebo‐Controlled Trial

Article

Author: Knoph, Cecilie S. ; Drewes, Asbjørn M. ; Cook, Mathias E. ; Novovic, Srdan ; Jørgensen, Maiken Thyregod ; Bruun, Niels H. ; Davidsen, Line ; Berner‐Hansen, Mark ; Olesen, Søren S. ; Frøkjær, Jens B. ; Schaffalitzky, Ove ; Mortensen, Michael B. ; Hadi, Amer ; Nielsen, Liv B. J.

ABSTRACT:

Background and aims:

No medications are currently approved for the prevention of recurrent acute pancreatitis. This trial evaluated whether naldemedine, a peripherally acting μ ‐opioid receptor antagonist, reduces the risk of acute pancreatitis in patients with recurrent acute pancreatitis.

Methods:

This was a multicentre, double‐blinded, placebo‐controlled randomised trial conducted at four Danish pancreatitis referral centres. Participants aged 18–75 years with recurrent acute pancreatitis, both with and without a diagnosis of chronic pancreatitis, were randomised to receive naldemedine 0.2 mg or a matching placebo daily for up to 12 months. The primary outcome was acute pancreatitis recurrence, defined by the revised Atlanta Criteria. Secondary outcomes included pain flares, gastrointestinal symptoms, and quality of life. At the end of follow‐up, the participant's global impression of change, safety and tolerability outcomes, new‐onset diabetes and pancreatic exocrine insufficiency were assessed.

Results:

74 participants (mean age: 46 years; 41% female) were randomised to naldemedine ( n = 36) or placebo ( n = 38). During a median follow‐up time of 365 days (IQR, 352–370), participants in the naldemedine group had a numerically lower risk of acute pancreatitis compared to placebo (HR 0.54; 95% CI, 0.29–1.01; p = 0.05). No differences were observed between the groups for secondary efficacy, safety, and tolerability outcomes. Participants treated with naldemedine for at least 1 year had a lower risk of acute pancreatitis (HR 0.49; 95% CI, 0.24–0.97; p = 0.04).

Conclusions:

Treatment with naldemedine was safe and well‐tolerated and may reduce the risk of recurrent acute pancreatitis. A larger confirmatory trial is needed to verify these findings.

Trial registration:

ClinicalTrials.gov Identifier: PAMORA‐RAP: NCT04966559

01 Dec 2025·SUPPORTIVE CARE IN CANCER

Establishing the minimal important change for Patient Assessment of Constipation Quality of Life questionnaire for the prevention of opioid-induced constipation in patients with cancer pain

Article

Author: Hamano, Jun ; Yamaguchi, Takuhiro ; Oyamada, Shunsuke ; Kessoku, Takaomi ; Morita, Tatsuya ; Higashibata, Takahiro

PURPOSE:

The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire measures constipation-specific quality of life; however, how small changes in the PAC-QOL scales are clinically meaningful for the prevention of opioid-induced constipation (OIC) is unknown. This study aimed to determine the minimal important change (MIC) of the PAC-QOL scales for the prevention of OIC in patients initiating opioids for cancer pain.

METHODS:

MICs were calculated using data from a multicenter, randomized controlled trial of naldemedine for OIC prevention. MICs for the PAC-QOL overall scale and satisfaction subscale scores were calculated using an anchor-based method with two anchors, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL) constipation scale and the Bowel Function Index (BFI), as well as a distribution-based method.

RESULTS:

A total of 77 patients were analyzed. The optimal cut-points for the MICs in the overall scale and satisfaction subscale based on two anchors were 0.14 and 0.20 for the QLQ-C15-PAL and 0.41 and 1.80 for the BFI, respectively. A 0.5 standard deviation and 1 standard error of measurement for the PAC-QOL were 0.26 and 0.22 for the overall scale and 0.46 and 0.53 for the satisfaction subscale, respectively.

CONCLUSION:

The MIC values for the PAC-QOL scales for OIC prevention ranged from 0.14 to 0.41 for the overall scale and from 0.20 to 1.80 for the satisfaction subscale. These findings enable the assessment of the preventive effect of interventions for OIC in patients initiating opioids for cancer pain.

02 Sep 2025·JOURNAL OF BIOMOLECULAR STRUCTURE & DYNAMICS

TOLEDO: enhancing Maestro GUI for non-expert users to perform massive MD simulations

Article

Author: Banegas-Luna, Antonio Jesús ; Carmena-Bargueño, Miguel ; Martínez-Cortés, Carlos ; Pérez-Sánchez, Horacio

Classical Molecular Dynamics (MD) simulates the dynamical evolution of biological systems at the atomic level. Using MD in conjunction with high-performance computing (HPC) architectures, we can evaluate the possible interactions between a ligand library against one protein target to find a drug that can influence a protein target to cure a disease. Simultaneously, we can also obtain information about their dynamic evolution. One of the primary software packages for MD simulations is Desmond, which employs Maestro for the setup, execution, and analysis of MD through a graphical user interface (GUI), which is suitable even for non-expert users. However, using the GUI, users can typically run only one short (less than 1000 ns) MD each time. Our work aims to create a method/protocol to run several MD simulations simultaneously on a remote HPC cluster within Maestro-Desmond. In this work, we provide TOLEDO (Throughput Optimization of Ligand-Protein Systems Exploration through Dynamics simulation in Optimized HPC systems) to overcome such limitations and run several MD simulations simultaneously. The best feature of TOLEDO is its independence from the usual time constraints of many clusters, with storage space being the only limitation. To run TOLEDO, we prepare/set up the protein-ligand complex before running MD via Maestro GUI. Next, we run the main TOLEDO script for several MD simulations on a supercomputer. When TOLEDO finishes, users obtain reports and graphics. The obtained results are easily interpretable. In essence, TOLEDO significantly enhances MD throughput beyond the capabilities of the Maestro GUI.

News (Medical) associated with Naldemedine Tosylate

30 May 2025

·www.shionogi.com

Acceptance of a New Drug Application for Naldemedine, a Treatment for Opioid-Induced Constipation, in China

OSAKA, Japan, May 30, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that the New Drug Application (NDA) for naldemedine tosilate (hereinafter “naldemedine”), a treatment for opioid-induced constipation (OIC), has been accepted in China. Naldemedine is a peripherally acting μ-opioid receptor antagonist (PAMORA) originally developed by our company. It has been launched in countries and regions such as Japan, the United States, Europe, and Taiwan, contributing to the improvement of symptoms in many patients suffering from opioid-induced constipation (OIC). In cancer pain management, opioid analgesics play a central role; however, their side effects can sometimes make continued treatment difficult. Among these, constipation is a common adverse effect observed in 40–80% of patients using opioid analgesics¹, ². It imposes a significant physical burden and greatly affects patients’ quality of life (QOL), making it a major challenge in pain management³, ⁴. In China, treatment options for OIC are limited, and current approaches mainly involve symptomatic treatments such as dose adjustments of opioids or the use of laxatives⁵. Therefore, there is a strong need for new therapeutic options to achieve better pain management. The approval of naldemedine in China is expected to contribute to improving the QOL of patients suffering from OIC. This new drug application is based on favorable results from a Phase III clinical trial⁶ conducted in China targeting patients with OIC. The application was submitted through our group company, Shionogi China Co., Ltd. (Head Office: Shanghai, China; Chairman and CEO: Tatsumori Yoshida.; hereafter "SCN"), Following approval, the sales of naldemedine in China will be handled by SCN which has entered into an exclusive license agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ((Head Office: Jiangsu Province, China; CEO: Eric Tse.; hereinafter “CTTQ”) for the import and domestic distribution of the product⁷. CTTQ will be responsible for sales in mainland China, and our company will receive a certain amount of revenue based on sales volume. Shionogi has identified “contributing to a healthier and more prosperous life” as a key material issue and is committed to creating a society where everyone can live longer, more vibrant lives in their own way. We will continue to contribute to improving the QOL of patients suffering from various types of pain. About Naldemedine Naldemedine is a peripherally acting μ-opioid receptor antagonist that binds to μ-opioid receptors in the gastrointestinal tract and counteracts the peripheral effects of opioids, thereby improving OIC. Naldemedine has been approved in countries and regions including Japan, the United States, Europe, and Taiwan. It is marketed under the brand name Symproic® in Japan, the United States, and Taiwan, and as Rizmoic® in Europe. About Chia Tai Tianqing (CTTQ) CTTQ is a subsidiary of China Biopharma and serves as the core pharmaceutical company of the Chia Tai Group in China. It is engaged in the integrated research, development, manufacturing, and sales of pharmaceuticals, with over 14,000 employees. The company offers a wide range of products for infectious diseases, respiratory diseases, cancer, liver diseases, endocrine disorders, and more. Over 7,000 academic and sales staff are involved in providing medical information. Overview of the Phase III Clinical Trial in China This Phase III clinical trial was a multicenter, randomized, double-blind, placebo-controlled study conducted in China to evaluate the efficacy and safety of naldemedine in adult patients with opioid-induced constipation (OIC) who were receiving opioid analgesic therapy. The primary endpoint of the study was the proportion of patients who achieved three or more spontaneous bowel movements (SBMs) per week, along with an increase of at least one SBM per week from baseline. The naldemedine treatment group demonstrated a statistically significant improvement compared to the placebo group. Reference: 1. Droney, J. et al. : Support Care Cancer, 2008, 16 (5), 453 2. Kalso, E. et al. : Pain, 2004, 112 (3), 372 3. Abramowitz, L. et al. : J Med Econ., 2013, 16 (12), 1423 4. Bell TJ, et al. : Pain Med 10 (1), 35-42, 2009 5. Chinese Medical Association, et al. Guidelines for primary care of chronic Constipation (2019) [J]. Chinese General Practitioners Journal, 2020, 19(12): 1100–1107. 6. Chinese Clinical Trial Registry: Phase III clinical trial registration number: ChiCTR2400089290 7. Shionogi China Co., Ltd. Press release on January 2, 2025 Ping An-Shionogi Signs an Exclusive License Agreement with Chia Tai Tianqing Pharmaceutical, a Core Enterprise of Sino Biopharmaceutical, for Import and Domestic Distribution of Naldemedine, a Therapeutic Drug for Opioid-Induced Constipation Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

Phase 3License out/inDrug ApprovalNDAClinical Result

07 May 2021

·www.biospace.com

BioDelivery Sciences Reports First Quarter 2021 Results

Total Company Net Revenue of $41 Million, an Increase of 7% versus Prior Year Net Income of $5.2 Million, EBITDA Margin of 22% and Operating Cash Generation of $11 Million Conference Call and Webcast Scheduled for 8:30 AM EST Today RALEIGH, N.C., May 06, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International (NASDAQ: BDSI), a growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today reported strong financial results for the first quarter ended March 31, 2021, including the following operational and performance highlights. Key Business Highlights Total Company net revenue for the first quarter increased by 7% versus the prior year period to $41.0 million. This growth was driven by BELBUCA® net sales of $36.4 million, which increased 9%, and Symproic® net sales of $4.4 million, which increased 5%. BELBUCA continued to deliver an all-time high quarterly market share, despite pandemic challenges and the impact of winter storm Uri. Total BELBUCA prescriptions were approximately 113,000 during the first quarter, representing year-over-year prescription volume growth of 9%. Total Symproic prescriptions were approximately 17,000 in the first quarter, consistent with prescriptions for the prior year period. Continued to achieve strong profitability, delivering $5.2 million of GAAP Net Income and an attractive 22% EBITDA margin in the first quarter of 2021. The Company repurchased 1.6 million shares in the quarter under its share buyback program, at an average price of $3.87 per share. “We again delivered solid top and bottom-line growth in a challenging quarter against the backdrop of the pandemic and weather-related disruptions, resulting in 22% EBITDA margin and $11 million operating cash flow generation,” stated Jeff Bailey, CEO of BDSI. “Our performance highlights the strength of our commercial team and the persistent market demand for our highly differentiated products. We expect continued success as the selling environment improves throughout the year, including increases of in-office patient visits and more face-to-face interactions with health care providers by our sales representatives.” First Quarter 2021 Financial Results Total Company Net Revenue for the first quarter of 2021 was $41.0 million, an increase of 7% compared to $38.3 million in the first quarter of 2020. Total product net revenue, including sales of BELBUCA and Symproic, grew 8% year over year. Severe winter weather conditions, especially in the South-Central region where the Company has strong market presence, affected patients’ access to their physicians and pharmacies. Additionally, the severe weather delayed shipments of the Company’s products to pharmacy distribution centers of the major wholesalers. BELBUCA Net Sales for the first quarter of 2021 were $36.4 million, an increase of 9% compared to $33.5 million in the first quarter of 2020. As we typically experience each year, BELBUCA gross to net deductions were lower in the first quarter, largely due to the Medicare coverage gap impact. Symproic Net Sales for the first quarter were $4.4 million, an increase of 5% compared to $4.2 million in the first quarter of 2020. Symproic net sales benefited from reduced gross to net deductions in the first quarter due to the typical decreases seen for Medicare coverage gap, as well as updates to our gross to net deductions related to channel estimates. Total Operating Expenses for the first quarter of 2021 were $27.8 million, compared to $26.7 million in the first quarter of 2020. The increase in spending as compared to fourth quarter of 2020 was driven by increased investments in sales and marketing and $3.0 million higher legal spend in the quarter, primarily due to costs associated with the Paragraph IV patent litigation. GAAP Net Income for the first quarter of 2021 was $5.2 million, or $0.05 per share, compared to GAAP net income of $5.0 million, or $0.05 per share, in the first quarter of 2020. EBITDA for the first quarter of 2021 was $9.2 million, or 22% of net sales, compared to $7.8 million or 20% of net sales, in the first quarter of 2020. Non-GAAP Net Income for the first quarter of 2021 was $8.5 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets as compared to non-GAAP net income of $8.3 million in the first quarter of 2020, excluding the same items Cash Position: As of March 31, 2021, cash and cash equivalents were approximately $116.4 million, compared to $111.6 million as of December 31, 2020. The total cash flow generation over the quarter of $4.9 million includes continued strong operating cash generation of $11.1 million, partially offset by $6.1 million used to repurchase shares in the quarter. Financial Guidance The Company reiterates its 2021 financial guidance, with full year 2021 total Company net sales of $170 - $180 million, including full year 2021 BELBUCA net sales of $155 - $165 million. Total operating expenses are expected to be in the range of $115 - $120 million, as the Company continues to invest to support the growth of its brands, and EBITDA is expected to be in the range of $40 - $50 million in 2021. The Company expects to continue delivering positive operating cash flow throughout 2021. “Our confidence in the continued growth of our brands and the profitability of our business remains unchanged. This is demonstrated by our continuing investments behind our portfolio, together with the share repurchase program which is underway. We remain on track to drive long-term shareholder value, and are actively considering potential business development opportunities,” stated Jeff Bailey. Conference Call & Webcast Details BioDelivery Sciences will host a conference call and webcast today, May 6, 2021, at 8:30 a.m. ET to present first quarter 2021 results and to provide a business update. Dial-in details are as follows: ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC. BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain and opioid-induced constipation. CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS This press release and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. (“BDSI”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to BDSI’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of BDSI’s management and are subject to significant risks and uncertainties, including those detailed in BDSI’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the expectations for total company net sales, BELBUCA net sales, operating expenses, EBITDA and operating cash flows in 2021) may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond BDSI’s control) including the risk that the current coronavirus pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcare facilities in which they work, and our personnel are greater than we anticipate, as well as those set forth in our 2020 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States, or GAAP, including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for one-time and non-cash charges by excluding the following from GAAP net income: stock-based compensation expense and non-cash amortization of intangible assets. EBITDA excludes net interest, including both interest expenses and interest income, provision for (benefit from) income taxes, depreciation, and amortization. The Company's management and board of directors utilize these non-GAAP financial measures to evaluate the Company's performance. The Company provides these non-GAAP measures of the Company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of our liquidity. A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release. © 2021 BioDelivery Sciences International, Inc. All rights reserved. Contact: Bob Yedid LifeSci Advisors 646-597-6989 Bob@LifeSciAdvisors.com BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS) (Unaudited) BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS) (Unaudited) BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (U.S. DOLLARS, IN THOUSANDS) (Unaudited) BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES RECONCILIATION OF NON-GAAP METRICS (U.S. DOLLARS, IN THOUSANDS) (Unaudited)

Financial StatementCollaborate

100 Deals associated with Naldemedine Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Naldemedine Tosylate	A06AH05	DB11691

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Opioid-Induced Constipation	United States	BioDelivery Sciences International, Inc.	23 Mar 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 3	China	Ping An Shionogi Co., Ltd.	15 Jul 2022
Constipation	Phase 3	China	Ping An Shionogi Co., Ltd.	15 Jul 2022
Chronic Pain	Phase 3	United States	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	Austria	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	Czechia	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	Germany	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	Poland	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	Spain	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	United Kingdom	Shionogi, Inc.	29 Aug 2013
Gastrointestinal dysfunction	Phase 2	United States	Shionogi, Inc.	06 Nov 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04966559 (PAMORA-RAP, Pubmed \| United European Gastroenterol J)	Phase 3	Pancreatitis	74	Naldemedine 0.2 mg	wycelicojm(dptkywqcyn) = No differences were observed between the groups for safety outcomes cnrfmnqthu (raxpntnwah ) View more	Positive	01 Feb 2026
				Placebo
JPRN-jRCTs031200397 (ASCO2024) Manual	Phase 3	Opioid-Induced Constipation	99	naldemedine	vrarmjqaba(krlyylrdeu) = rgxiqrzqax rkhfksnwkc (xemlsosnor, 19.8)	Positive	02 Jun 2024
				Placebo	vrarmjqaba(krlyylrdeu) = tqlhyzvdna rkhfksnwkc (xemlsosnor, 20.0)
NCT04355169 (CTgov)	Phase 2	Gastrointestinal dysfunction	2	Naldemedine (Naldemedine 1.25 mg)	sodowsqgoz(mviajaqecc) = zrqewcdmhd xonzdnjmnf (ekyripbsrm, sknqpghxwm - iiblakhzhr) View more	-	18 Jan 2022
				Naldemedine (Naldemedine 2.5 mg)	sodowsqgoz(mviajaqecc) = rcdcjrymbt xonzdnjmnf (ekyripbsrm, cdewwhofgi - jdvpccvizh) View more
NCT01965652 \| NCT01993940 \| NCT01965158 (Pubmed \| Drugs Aging)	Phase 3	Opioid-Induced Constipation	2,328	Naldemedine 0.2 mg	vcjrseerpn(rejpzmufsv) = btoyhhxnfm hcxfrrzjlp (jcpiolvniu ) View more	-	01 Apr 2020
				Placebo	vcjrseerpn(rejpzmufsv) = vdrsbqdsda hcxfrrzjlp (jcpiolvniu ) View more
NCT01965652 \| NCT01993940 \| NCT01965158 (Pubmed \| J Pain Res)	Phase 3	Renal Insufficiency \| Opioid-Induced Constipation \| Chronic Pain	2,328	Naldemedine 0.2 mg	hkmvixgvqw(phfvbmzcnw) = ctimwfcvwx zzkqiibxdu (lmvkayqnkr ) View more	-	01 Jan 2020
				Placebo	hkmvixgvqw(phfvbmzcnw) = iqepdxkvyh zzkqiibxdu (lmvkayqnkr ) View more
UEGW2019	Not Applicable	Opioid-Induced Constipation	-	Naldemedine 0.2 mg	xfylrtmacm(qiccihewcu) = zchjdoqrrv pjujnnxiri (hffdihgkie ) View more	-	01 Oct 2019
				Placebo	xfylrtmacm(qiccihewcu) = sptrsieuif pjujnnxiri (hffdihgkie, 3.4 - 9.5) View more
UEGW2019	Not Applicable	Opioid-Induced Constipation \| Chronic Pain	-	Naldemedine 0.2 mg	bjwtiunhga(eeaylpuyus) = lwbhfcddhw bhqrviqcya (nylaglgddk ) View more	-	01 Oct 2019
				Placebo	bjwtiunhga(eeaylpuyus) = nfinmgbqgl bhqrviqcya (nylaglgddk ) View more
JPRN-JapicCTI-132340 \| JPRN-JapicCTI-111510 (ESMO2018)	Phase 2/3	Opioid-Induced Constipation	-	Naldemedine 0.2mg QD	euthxevvyg(xofwgphjol) = Although the difference of the incidence of diarrhea between the groups was relatively larger in the possible disruption of BBB group, there was no difference between with or without possible BBB disruption for NRS and COWS. sykuijiang (dxrmbozxup )	Positive	22 Oct 2018
				Placebo
UEGW2018	Not Applicable	Opioid-Induced Constipation	-	Naldemedine 0.2 mg	kerebsfqhx(aaujxjoznv) = TEAEs were comparable between the NAL and PBO in both LIR and non-LIR groups. The most common TEAEs were gastrointestinal-related. udguncskkz (nodlvcqdme )	-	01 Oct 2018
NCT01443403 (Pubmed \| Pain Med)	Phase 2	Opioid-Induced Constipation	244	Naldemedine 0.1 mg	llhdnuxkap(vqabumvlkp) = swytkefxmb rlzupddceu (lkgortnnbi )	Positive	01 Dec 2017
				Naldemedine 0.2 mg	llhdnuxkap(vqabumvlkp) = mtggbulndt rlzupddceu (lkgortnnbi )

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis