A Multi-center, Open-label, Randomized, Phase IV Clinical Trial to Compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis

The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis

Start Date30 Sep 2021

Sponsor / Collaborator

Daewoong Pharmaceutical Co., Ltd.

NCT03509831 / Unknown statusPhase 1

A Randomized, Open-label, Crossover Clinical Study to Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 After Oral Administration to Healthy Adult Male Subjects

Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects

Start Date02 Nov 2017

Sponsor / Collaborator

KUKJE PHARMA Co., Ltd.

CTR20140508 / Completed

24名健康男性受试者单中心，随机，交叉口服尼扎替丁胶囊人体生物等效性试验

[Translation] A single-center, randomized, crossover oral bioequivalence study of nizatidine capsules in 24 healthy male subjects

通过分别观察健康成年男性在空腹或在进食高脂肪试验餐状态下单剂量交叉口服由汕头经济特区鮀滨制药厂提供的尼扎替丁胶囊试验制剂和参比制剂后，尼扎替丁的体内经时过程，估计其药代动力学参数，评价受试制剂的相对生物利用度，判断受试制剂与参比制剂是否具有人体生物等效性，指导临床用药。

[Translation]

By observing the in vivo time course of nizatidine in healthy adult males after single-dose oral crossover of the test preparation and reference preparation of nizatidine capsules provided by Shantou Special Economic Zone Qibin Pharmaceutical Factory on an empty stomach or after eating a high-fat test meal, its pharmacokinetic parameters were estimated, the relative bioavailability of the test preparation was evaluated, and whether the test preparation and the reference preparation were bioequivalent in humans was determined to guide clinical drug use.

Start Date12 Jul 2014

Sponsor / Collaborator

Shantou SEZ Tuobin Pharmaceutical Factory

100 Clinical Results associated with Nizatidine

100 Translational Medicine associated with Nizatidine

100 Patents (Medical) associated with Nizatidine

468

Literatures (Medical) associated with Nizatidine

01 Jan 2025·Journal of Environmental Sciences

Adsorption of typical NDMA precursors by superfine powdered activated carbon: Critical role of particle size reduction

Article

Author: Zhang, Zhichen ; Wang, Ying ; Wang, Jun ; Yin, Zhihang ; Zhang, Xiaojian ; Chen, Chao

Control of N-nitrosodimethylamine (NDMA) in drinking water could be achieved by removing its precursors as one practical way. Herein, superfine powdered activated carbons with a diameter of about 1 µm (SPACs) were successfully prepared by grinding powdered activated carbon (PAC, D₅₀=24.3 µm) and applied to remove model NDMA precursors, i.e. ranitidine (RAN) and nizatidine (NIZ). Results from grain diameter experiments demonstrated that the absorption velocity increased dramatically with decreasing particle size, and the maximum increase in k₂ was 26.8-folds for RAN and 33.4-folds for NIZ. Moreover, kinetic experiments explained that rapid absorption could be attributed to the acceleration of intraparticle diffusion due to the shortening of the diffusion path. Furthermore, performance comparison experiments suggested that the removal of RAN and NIZ (C₀=0.5 mg/L) could reach 61.3% and 60%, respectively, within 5 min, when the dosage of SAPC-1.1 (D₅₀=1.1 µm) was merely 5 mg/L, while PAC-24.3 could only eliminate 17.5% and 18.6%. The adsorption isotherm was well defined by Langmuir isotherm model, indicating that the adsorption of RAN/NIZ was a monolayer coverage process. The adsorption of RAN or NIZ by SAPC-1.1 and PAC-24.3 was strongly pH dependent, and high adsorption capacity could be observed under the condition of pH > pk_a+1. The coexistence of humic acid (HA) had no significant effect on the adsorption performance because RAN/NIZ may be coupled with HA and removed simultaneously. The coexistence of anions had little effect on the adsorption also. This study is expected to provide an alternative strategy for drinking water safety triggered by NDMA.

15 Oct 2024·RAPID COMMUNICATIONS IN MASS SPECTROMETRY

Novel method for monitoring of carcinogenic impurity of N‐nitrosamine in nizatidine pharmaceutical products using ultra high‐pressure liquid chromatography triple quadrupole mass spectrometry

Article

Author: Dudhatra, Bhumika ; Thummar, Kashyap ; Dhorajiya, Shivani ; Goswami, Janki

Nitrosamine compounds pose a significant concern as potential carcinogens, prompting heightened scrutiny from regulatory bodies, particularly regarding their presence in pharmaceuticals. The detection of unacceptable levels of N‐nitrosodiethylamine (NDMA) in ranitidine has led to widespread recalls, driving interest in alternative medications such as nizatidine, which shares a similar pharmacological class and is used to treat various gastrointestinal conditions. Despite fewer reports on NDMA levels in nizatidine, its structural similarity to ranitidine, characterized by a tertiary amine, underscores the potential for NDMA formation. Addressing the analytical challenges associated with nitrosamine detection, this study focuses on developing and validating an ultra‐high pressure liquid chromatography triple quadrupole mass spectrometry (UHPLC–MS/MS) method for quantifying NDMA in both nizatidine active pharmaceutical ingredients and tablet formulations. Method validation adheres to International Council for Harmonisation recommendations, with a demonstrated linear range of 0.25–100 ng/mL for NDMA, exhibiting excellent linearity (regression coefficient >0.999) and efficient recovery rates ranging from 95.98% to 109.57%. The method shows high sensitivity, with limits of detection and quantification of 0.25 and 0.5 ng/mL, respectively. The developed UHPLC–MS/MS method offers a simple, precise, accurate, and selective approach for monitoring NDMA levels in nizatidine formulations available in Australia, promising enhanced sensitivity and specificity with limits of quantification in the ppb and sub‐ppb ranges.

01 Sep 2024·GENERAL HOSPITAL PSYCHIATRY

Pharmacological interventions for antipsychotic-induced weight gain in schizophrenia: A network meta-analysis

Article

Author: Srinivasan, Anand ; Hegde, Naveen Chandrashekar ; Mohapatra, Debadatta ; Mishra, Biswa Ranjan ; Mishra, Archana ; Maiti, Rituparna

OBJECTIVE:

Antipsychotic-induced weight gain (AIWG) is a significant but frequently neglected adverse effect of first- and second-generation antipsychotic therapy, which may lead to cardiovascular disturbances. The present network meta-analysis (NMA) was conducted to evaluate and compare the effects of available treatment options in antipsychotic-induced weight gain (AIWG).

METHODS:

The data was extracted from 68 relevant clinical trials after a literature search on MEDLINE/PubMed, Embase, Scopus, Cochrane databases and clinical trial registries. Random-effects Bayesian NMA was done to pool the effects across the interventions for the change in body weight from baseline. A network graph was built, a consistency model was run, node split analysis was performed, treatments were ranked as per the SUCRA score and meta-regression was done for the duration of therapy, baseline body weight and treatment strategy as the predictor variables. Finally, the results were sorted based on the certainty of evidence.

RESULTS:

The drugs showing significant reduction in body weight in order of magnitude of effect size include sibutramine 10 mg (-8.0 kg; -16. to -0.21), metformin 750 mg + lifestyle modification (-7.5 kg; -12 to -2.8), topiramate 200 mg (-7 kg; -10 to -3.4), metformin 750 mg (-5.7 kg; -9.3 to -2.1), topiramate 100 mg (-5.7 kg; -8.8 to -2.5), topiramate 50 mg (-5.2 kg; -10 to -0.57), liraglutide 1.8 mg (-5.2 kg; -10., -0.080), sibutramine 15 mg (-4.5 kg; -8.9 to -0.59), nizatidine 300 mg (-3.0 kg; -5.9 to -0.23) and metformin 1000 mg (-2.3 kg; -4.6 to -0.0046). There was no effect of duration of follow-up, baseline body weight and, preventive versus therapeutic strategy on weight reduction in AIWG.

CONCLUSION:

Metformin 750 mg with lifestyle modification was the most effective treatment for AIWG, followed by topiramate 200 mg, metformin 750 mg, and topiramate 100 mg with moderate certainty of evidence.

News (Medical) associated with Nizatidine

28 Jul 2023

·www.jnj.com

Janssen Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy EDURANT ®

TITUSVILLE, N.J., July 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT® (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe. These applications reflect Janssen’s longstanding commitment to address the needs of adults, adolescents and children affected by the global HIV epidemic.If the new applications are approved, EDURANT®, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children. “We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC. “These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”The expanded pediatric applications are supported by data from the Phase 2 PAINT (NCT00799864) and PICTURE (NCT04012931) studies, which showed that EDURANT®, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive pediatric patients, respectively. Given these data, Janssen is seeking an expanded indication to allow use in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) and treatment-experienced virologically suppressed children (with HIV-1 RNA <50 copies/mL) weighing 10 kg or more.The expansion of the EDURANT® indication would mark the latest step forward in Janssen’s efforts to make its HIV medicines available to young people living with HIV. In 2022, the FDA approved the world’s first long-acting injectable HIV-1 treatment option for adolescents 12 years of age and older. This regimen consists of Janssen’s long-acting rilpivirine and ViiV Healthcare’s long-acting cabotegravir and requires as few as six treatments per year.Johnson & Johnson’s Commitment to HIVIn addition to driving innovation in HIV care, Johnson & Johnson also works with vulnerable communities on the global frontlines of the HIV epidemic, and has supported collaborative initiatives like Positively Fearless, the DREAMS Partnership and the MenStar Coalition. We also support the New Horizons Collaborative, which is working to address the unmet needs of HIV treatment-experienced children, adolescents and young adults in sub-Saharan Africa.To learn more about Johnson & Johnson’s commitment to combating HIV, please visit jnj.com/HIV.About EDURANT®EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, nonnucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. Limitations of Use:EDURANT is indicated in combination with VOCABRIA (cabotegravir), for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.Please see full Prescribing Information for important safety information.Important Safety InformationWho should not take EDURANT®?Do not take EDURANT® if you also take:What should I tell my healthcare provider before taking EDURANT®?Before taking EDURANT®, tell your healthcare provider about all your medical conditions, including if you:Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Some medicines interact with EDURANT®. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with EDURANT®.Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EDURANT® with other medicines.How should I take EDURANT®?What are the possible side effects of EDURANT®?EDURANT® can cause serious side effects including:Stop taking EDURANT® and get medical help right away if you develop a rash with any of the following signs or symptoms:Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT®. Liver problems have also happened during treatment with EDURANT® in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with EDURANT®. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.The most common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away.You are encouraged to report side effects of prescription drugs to the FDA. www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).Please read the full Product Information for EDURANT® and discuss any questions you have with your healthcare provider.About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Sciences Ireland Unlimited Company and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and other treatments for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland Unlimited Company, Janssen Research & Development, LLC, the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.###© Janssen Therapeutics, Division of Janssen Products, LP

Drug ApprovalPhase 2

10 Aug 2022

·www.biospace.com

Merck's Blockbuster Diabetes Drug Found Contaminated with Potential Carcinogen

Courtesy of Katherine Welles/Getty Images The U.S. Food and Drug Administration announced Tuesday that certain samples of sitagliptin were contaminated with the nitrosamine Nitroso-STG-19 (NTTP). Sitagliptin is the main compound in Merck's blockbuster type 2 diabetes drug Januvia. The regulatory body said it will allow continued distribution of sitagliptin even if the nitrosamine impurities are present at levels above the acceptable intake limits. This is to prevent a drug shortage and ensure that people with diabetes can continue to access their medicines. The FDA has set a daily acceptable intake limit of 37 ng per day but is expanding this to an interim threshold of 246.7 ng per day. As per agency scientists, this higher limit poses only a minimal additional risk of cancer compared to the stricter cut-off. Sitagliptin, dispensed only through prescriptions, helps control blood sugar levels in people suffering from type 2 diabetes mellitus. Because this condition can overload the bloodstream with too much glucose, eventually leading to complications in the circulatory and nervous systems, it can prove dangerous to cut off medication in patients. The FDA recommends that physicians continue to prescribe sitagliptin as appropriate. In a statement to Bloomberg, Merck confirmed that it has "recently detected a nitrosamine identified as NTTP in some batches of our sitagliptin-containing medicines." Aside from Januvia, the company has also detected impurity in certain batches of Janumet, which combines sitagliptin with metformin, and Steglujan, containing both sitagliptin and ertugliflozin. All three drugs are indicated for type 2 diabetes. The company is working with health authorities across the globe and is implementing additional quality control mechanisms to meet the FDA's interim thresholds of NTTP. "We remain confident in the safety, efficacy and quality of our sitagliptin-containing medicines," Merck said. "No significant impact on supply of these medicines for patients is anticipated." Januvia and Janumet are Merck's best-selling drugs, behind only its melanoma medicine Keytruda (pembrolizumab) and its HPV vaccine Gardasil. In the second quarter of 2022, Januvia and Janumet delivered combined earnings of more than $1.2 billion, a mild decline of 2% from the same period the year prior. Merck lost market exclusivity for Januvia and Janumet in China earlier this year and is expected to face the same challenge in the European Union in September. Still, the news of impurities in its top assets dealt a blow to the company. Its shares dropped by 1.9% after the FDA's announcement. NTTP falls under a class of compounds called nitrosamine. Some nitrosamines, such as nitrosodimethylamine (NDMA) and N-nitrosodiethylamine, have shown carcinogenic activity in animal studies. No such data is yet available for NTTP, however, and the FDA's move to flag this impurity as a safety concern in sitagliptin may be a decision to err on the side of caution. In 2018, the agency detected unacceptable levels of NDMA in valsartan, an angiotensin II receptor blocker used to control high blood pressure and treat heart failure. This set off a years-long investigation process that also found unacceptable levels of NDMA in other commonly used drugs, such as the heartburn medications ranitidine and nizatidine. In early 2020, the FDA also found certain batches of metformin, another diabetes drug, to be contaminated with NDMA, though at acceptable levels. In February 2021, the agency published a comprehensive guidance document to help drug manufacturers detect, prevent and address unacceptable levels of nitrosamine contaminations in their products.

Vaccine

20 Jul 2021

·endpts.com

Industry groups warn of drug shortages linked to widespread carcinogen testing as FDA doubles down on its approach

With the recent and unexpected discovery of probable human carcinogen impurities prompting recalls of popular heartburn drugs like Zantac and nizatidine, as well as metformin diabetes medicines, ARBs and more, the FDA has made clear the need for an industry-wide risk assessment for the so-called nitrosamines in even more drugs that may be at risk. But industry groups are pushing back on the need for such widespread testing, arguing that the FDA should be more consistent and collaborative with other regulators in its approach, and that the timelines for such testing are too constricted and may lead to serious drug shortages.

100 Deals associated with Nizatidine

External Link

KEGG	Wiki	ATC	Drug Bank
D00440	Nizatidine	A02BA04	DB00585

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Esophagitis	US	Braintree Laboratories, Inc.	25 May 2004
gastric ulcer benign	AU	Arrow Pharmaceuticals Pty Ltd.Startup	18 Sep 2003
Gastroesophageal Reflux	CN	Lilly del Caribe, Inc.	08 Mar 1999
Duodenal Ulcer	US	Smithkline Beecham Plc	12 Apr 1988
Erosive esophagitis	US	Smithkline Beecham Plc	12 Apr 1988
Heartburn	US	Smithkline Beecham Plc	12 Apr 1988
Stomach Ulcer	US	Smithkline Beecham Plc	12 Apr 1988
Ulcerative esophagitis	US	Smithkline Beecham Plc	12 Apr 1988

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