[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of galantamine hydrobromide orodisintegrating tablets (8 mg) in Chinese healthy subjects under fasting and fed conditions

按有关生物等效性试验的规定，选择ヤンセンファーマ株式会社持证的氢溴酸加兰他敏口腔崩解片（商品名：Reminyl®，规格：8mg）为参比制剂，对北京星昊医药股份有限公司生产并提供的受试制剂氢溴酸加兰他敏口崩片（规格：8mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。

[Translation]

In accordance with the relevant provisions of bioequivalence tests, the certified galanthamine hydrobromide orodisintegrating tablets (trade name: Reminyl®, specification: 8 mg) produced by Yancenta Pharmaceutical Co., Ltd. were selected as the reference preparation, and the test preparation galanthamine hydrobromide orodisintegrating tablets (specification: 8 mg) produced and provided by Beijing Xinghao Pharmaceutical Co., Ltd. were subjected to human bioequivalence tests on fasting and fed administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under fasting and fed administration conditions was evaluated.

Start Date09 Jul 2024

Sponsor / Collaborator

Beijing Sunho Pharmaceutical Co., Ltd.

NCT03454646 / Not yet recruitingPhase 4IIT

Comparison of Therapeutic Strategies With Cholinesterase Inhibitors: Stop or Still (SOS) Trial

Cholinesterase inhibitors (CI) remain the only drugs with a recognized efficacy in mild to moderate Alzheimer's disease (AD) in spite of enormous research efforts. However, these drugs presented as "symptomatic treatment" of AD are considered as having only a weak effect on the course of AD. The reimbursement of these drugs is regularly challenged due to the lack of evidence for the impact of these drugs on milestones stages of AD evolution (survival without severe dementia, restriction in Basic Activities of Daily Living - BADL) and on major consequences in public health (hospitalization and institutionalization). The great majority of previous randomized controlled trials conducted with CI have had a too short duration and the end points were limited to cognition (ADAS Cog scale), IADL (Instrumental Activities of Daily Living) function and Global Impression of Change. New evidences from the DOMINO trial (1) conducted in UK, independently of the pharmaceutical industry, showed that the true effect of CI might be more to avoid or to delay the cognitive or functional decline in AD than to improve patients; the institutionalisation (2) was also delayed. However, this trial was conducted in patients with moderate to severe AD, and the interest of the drugs at the mild to moderate stage remains questionable.
The investigators have shown that a good surrogate marker of survival without severe dementia would be an increase of ADAS Cog scale of more than six points (3). A post hoc reanalysis of the pivotal RCT with two CI showed that in mild to moderate patients, CI was associated with a 15% decrease of patients with a deterioration of ADAS-Cog of more than six points in six months. Thus at the beginning of dementia the real effect of CI might be more of delaying the cognitive and functional decline, than to improve the patients. The main objective of the SOS trial is to demonstrate that the benefit of CI at the early phase of dementia is the same as at the later phase.

Start Date01 Jun 2024

Sponsor / Collaborator-

ChiCTR2400081930 / RecruitingPhase 4IIT

A real-world study of the safety and efficacy of galanthamine hydrobromide in the treatment of cognitive impairment

Start Date15 Mar 2024

Sponsor / Collaborator-

100 Clinical Results associated with Galantamine Hydrobromide

100 Translational Medicine associated with Galantamine Hydrobromide

100 Patents (Medical) associated with Galantamine Hydrobromide

2,575

Literatures (Medical) associated with Galantamine Hydrobromide

01 Mar 2025·TALANTA

Sensitive and eco-friendly voltammetric detection of galantamine using a screen-printed sensor with a functional boron-doped diamond electrode

Article

Author: Gawor, Andrzej ; Bulska, Ewa ; Dubenska, Liliya ; Panas, Krystyna ; Vojs, Marian ; Marton, Marian ; Matvieiev, Oleksandr ; Dushna, Olha

The presented study focused on developing and optimizing a modern electroanalytical platform for the direct quantitative determination of galantamine. This work used different voltammetric methods to use a screen-printed sensor with a working boron-doped diamond electrode (SP/BDDE). Beneficial analytical performance for detecting galantamine was achieved in a Britton-Robinson buffer with pH 3.0. The oxidation peaks at 0.92 V and 1.20 V were followed for electrochemical quantification of galantamine. High-resolution mass spectrometry was used for the first time to analyze the products of preparative electrolysis, and a mechanism for the electrochemical oxidation of galantamine was proposed, which describes the demethylation of galantamine and the further oxidation of the hydroxyl group to a ketone group in the galantamine molecule. Coupled with the optimized parameters of differential pulse voltammetry and square-wave voltammetry on the SP/BDDE detected galantamine in two linear ranges (the first range was from 1.22 μM to 10 μM; the second range was from 10 μM to 200 μM), providing the limit of detection and limit of quantification on a micromolar level (0.50 μM and 1.48 μM, respectively). Amperometry and chronoamperometry were employed to develop a rapid detection method for galantamine. In this approach, galantamine can be detected at a level of 1.08 μM (amperometry at the second peak). The selectivity of the optimized amperometric methods was found to be excellent in the presence of ten times higher concentrations of certain interferences. The practical applicability of the SP/BDDE for detecting galantamine was demonstrated through the analysis of pharmaceutical products and human urine samples. The proposed procedure fully complies with the latest requirements of green analytical chemistry.

06 Dec 2024·Journal of biomolecular structure & dynamics

Epigenetic regulation exerted by Caliphruria subedentata and galantamine: an in vitro and in silico approach for mimic Alzheimer’s disease

Article

Author: Castillo Ordoñez, Willian Orlando ; Giuliatti, Silvana ; Alves, Levy Bueno ; Aristizabal-Pachon, Andrés F.

At the interface between genes and environment, epigenetic mechanisms, including DNA methylation and histone modification, regulate neurogenic processes such as differentiation, proliferation, and maturation of neural stem cells. However, these mechanisms are altered in Alzheimer's disease (AD), a neurodegenerative condition that mainly affects older adults. Since epigenetic mechanisms are known to be reversible, a number of molecules from natural sources are being studied as epigenetic regulators in AD. Recently, in vitro and in silico studies have shown that C. subedentata and its alkaloids modulated neurotoxicity. However, studies exploring the epigenetic activity of these alkaloids are limited. We conducted a set of bioassays to evaluate neuronal differentiation and the sensitivity of undifferentiated SH-SY5 cells against a neurotoxic stimulus. In addition, we analyzed the methylation profiles in genes such as APP, PSI, and BACE1 due to their role in amyloid processing. Docking and molecular dynamic analysis were used to explore the effect exerted by C. subedentata alkaloids on the regulation of histone deacetylases (HDAC2, HDAC3 and HDAC7). The results demonstrated that C. subedentata and galantamine induce neuronal differentiation and protect the undifferentiated SH-SY5Y cells against Aβ_(1-42)-induced neurotoxicity. The methylation profiles of the studied genes show no statistically significant differences between C. subedentata, galantamine. However, these findings should be interpreted with caution, since small changes in methylation promoters in the brain could not be easily detected. Results from in silico approaches describe for the first time the potential promissing epigenetic effects of galantamine by regulating HDAC3 and HDAC7 modification.Communicated by Ramaswamy H. Sarma.

01 Dec 2024·FITOTERAPIA

Identification of isoquinoline alkaloids from Corydalis mucronifera and their acetylcholinesterase inhibitory effects

Article

Author: Ren, Meng ; Wang, Zixuan ; Wang, Yurun ; Cao, Taoshuai ; Qin, Xiangdong ; Zhang, Jun ; Song, Jie ; Luo, Du-Qiang

Four new spirobenzylisoquinoline mucroniferanines N - Q (1-4) and a rare chlorinated isoquinoline mucroniferanine R (5) were isolated from Corydalis mucronifera Maxim. Their structures were elucidated based on extensive spectroscopic data analysis of HRESIMS, 1D and 2D NMR, and their absolute configurations were confirmed by ECD data. The isolated compounds were evaluated for acetylcholinesterase (AChE) inhibitory activities. Mucroniferanine R showed significant activities with IC₅₀ values of 0.78 μM compared to galanthamine (1.34 μM). The AChE inhibitory activity was further supported by the molecular docking analysis that exhibited the accommodation of mucroniferanine R in the active site of human AChE.

News (Medical) associated with Galantamine Hydrobromide

26 Nov 2024

·www.prnewswire.com

Down's Syndrome Market to Exhibit Growth at a CAGR of 3.81% by 2034 | DelveInsight

According to DelveInsight's analysis, the market for Down syndrome is anticipated to increase during the forecast period (2024–2034), owing to the launch of emerging therapies such as AEF0217, ACI-24.060, LEUCETTINIB-21, BUNTANETAP, and others and healthcare spending globally. LAS VEGAS, Nov. 26, 2024 /PRNewswire/ -- DelveInsight's Down's Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, Down's syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Down's Syndrome Market Report According to DelveInsight's analysis, the market size for Down's syndrome was found to be USD 241 million in the US in 2023. In 2023, the United States accounted for nearly 220K prevalent cases of Down's syndrome. The types of Down's syndrome include Trisomy 21, Robertsonian translocation, and Mosaicism. In 2023, among all types, Trisomy 21 accounted for the highest number of prevalent cases in the 7MM. Leading Down's syndrome companies such as AELIS FARMA, AC IMMUNE, PERHA PHARMACEUTICALS, ANNOVIS BIO, APHIOS THERAPEUTICS, and others are developing novel Down's syndrome drugs that can be available in the Down's syndrome market in the coming years. The promising Down's syndrome therapies in the pipeline include AEF0217, ACI-24.060, LEUCETTINIB-21, BUNTANETAP, APH-1104, and others. Discover which therapies are expected to grab the major Down's syndrome market share @ Down's Syndrome Market Report Down's Syndrome Overview Down's syndrome, also known as trisomy 21, is a genetic disorder caused by the presence of an extra copy of chromosome 21. This chromosomal anomaly disrupts normal development, resulting in a range of physical and cognitive differences. The condition is primarily caused by random genetic mutations during the formation of reproductive cells or early embryonic development, though advanced maternal age increases the likelihood of having a child with Down's syndrome. People with Down's syndrome typically exhibit distinct facial features, such as a flattened face, almond-shaped eyes that slant upward, and a small nose. Other common symptoms include developmental delays, intellectual disabilities, and a variety of health issues like heart defects, respiratory and hearing problems, and a higher susceptibility to infections. Despite these challenges, many individuals with Down's syndrome lead fulfilling lives with appropriate support. Diagnosis of Down's syndrome can occur prenatally through screening and diagnostic tests, such as blood tests and ultrasounds in the first and second trimesters, or through more definitive tests like chorionic villus sampling (CVS) and amniocentesis. Postnatal diagnosis is typically confirmed by a physical examination and a karyotype analysis to identify the extra chromosome. Early diagnosis and intervention can help address developmental needs and improve the quality of life for individuals with Down's syndrome. Down's Syndrome Epidemiology Segmentation The Down's syndrome epidemiology section provides insights into the historical and current Down's syndrome patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Down's syndrome market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Down's Syndrome Gender-specific Diagnosed Prevalent Cases of Down's Syndrome Type-specific Diagnosed Prevalent Cases of Down's Syndrome Age-specific Diagnosed Prevalent Cases of Down's Syndrome Diagnosed Cases of Down's Syndrome by Clinical Manifestations Down's Syndrome Treatment Market There is no single treatment for Down's syndrome; instead, care plans are customized to address each person's unique physical and intellectual needs, emphasizing their strengths and accommodating their limitations. For some individuals, immediate surgery may be needed after birth to correct heart defects or long-term dietary modifications may be required for digestive concerns. Common interventions include assistive devices such as hearing aids, mobility aids, and adaptive technology to support learning and daily tasks. People with Down's syndrome often face an earlier and more pronounced cognitive decline than the general population. Treatments for Down syndrome-associated dementia (DSAD) may include medications like rivastigmine, galantamine, memantine, and donepezil, which inhibit acetylcholine breakdown, providing notable benefits. Seizure management for those with Down syndrome may involve anticonvulsants like carbamazepine and phenytoin, although these can exacerbate other Down syndrome-related issues. Respiratory problems are also common due to immune deficiencies and respiratory tract abnormalities, often requiring antibiotics or inhaled bronchodilators for effective management. Along with pharmacological treatments, non-pharmacological therapies such as physical, speech, occupational, and behavioral therapies play a vital role in the early development of children with Down syndrome, promoting independence and productivity. Physical therapy aims to improve motor skills, build muscle strength, and enhance posture and balance, laying the groundwork for key abilities. Speech-language therapy focuses on boosting communication skills and addressing physical challenges like low muscle tone to avoid long-term complications. Occupational therapy adapts daily tasks to suit the individual's abilities, teaching crucial skills such as eating, dressing, writing, and using a computer. Emotional and behavioral therapies tackle challenges like frustration from communication barriers, compulsive behaviors, and ADHD by identifying triggers and creating strategies to foster positive behaviors and reduce undesirable ones. To know more about Down's syndrome treatment guidelines, visit @ Down's Syndrome Management Down's Syndrome Pipeline Therapies and Key Companies AEF0217: AELIS FARMA ACI-24.060: AC IMMUNE LEUCETTINIB-21: PERHA PHARMACEUTICALS BUNTANETAP: ANNOVIS BIO APH-1104: APHIOS THERAPEUTICS Discover more about Down's syndrome drugs in development @ Down's Syndrome Clinical Trials Down's Syndrome Market Dynamics The Down's syndrome market dynamics are expected to change in the coming years. The prevalence of Down syndrome has increased with the rise in lifespan over the past three decades. This, along with the combination of several neurological features in Down syndrome patients—such as language impairment, cognition, learning, and memory—has sparked intense neurodevelopmental research. Studies in this area hold promise for improving clinical care and quality of life for individuals with Down syndrome and their families, as well as for assessing ways to enhance communication between parents and children. A thorough understanding of the factors affecting pharmacotherapy in Down syndrome could significantly contribute to better clinical outcomes for these individuals. Furthermore, potential therapies are being investigated for the treatment of Down's syndrome, and it is safe to predict that the treatment space will significantly impact the Down's syndrome market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Down's syndrome market in the 7MM. However, several factors may impede the growth of the Down's syndrome market. Down syndrome presents unique challenges in clinical treatment, as there is currently no medical cure or approved products available in the market, complicating the treatment process. This complexity is compounded by the lack of appropriate, validated scales to measure progress or side effects in participants with learning disabilities, making it difficult to gauge treatment impact effectively. Furthermore, recruiting participants and their families is challenging, adding to the difficulties in conducting research. Down syndrome is also associated with numerous health problems and high healthcare costs, and individuals may require more intensive monitoring for adverse effects, adherence, and treatment efficacy when managing medications. Conducting clinical studies on the efficacy of psychotropic medications in individuals with Down syndrome is particularly challenging due to the unique language and communication characteristics of this population. Moreover, Down's syndrome treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, Down's syndrome market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact Down's syndrome market growth. Scope of the Down's Syndrome Market Report Therapeutic Assessment: Down's Syndrome current marketed and emerging therapies Down's Syndrome Market Dynamics: Key Market Forecast Assumptions of Emerging Down's Syndrome Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Down's Syndrome Market Access and Reimbursement Download the report to understand which factors are driving Down's syndrome market trends @ Down's Syndrome Market Trends Table of Contents Related Reports Down's Syndrome Epidemiology Forecast Down's Syndrome Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the Down's syndrome epidemiology trends. Down's Syndrome Pipeline Down's Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Down's syndrome companies, including Alzheon, Inc, Connecta Therapeutics, among others. Alport Syndrome Market Alport Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alport syndrome companies, including Eloxx Pharmaceuticals, Chinook Therapeutics (A Novartis company), Bayer, Calliditas Therapeutics, Evotec , among others. Alport Syndrome Pipeline Alport Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Alport syndrome companies, including Eloxx Pharmaceuticals, Inc., Chinook Therapeutic/Novartis, River 3 Renal Corp., Travere Therapeutics, Inc., Reata Pharmaceuticals, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

13 Aug 2024

·www.businesswire.com

Alpha Cognition, Inc. On Track to Secure Financing for Continued Growth

VANCOUVER, British Columbia & DALLAS--( BUSINESS WIRE )-- Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, announced today its decision to temporarily delay its planned capital raise and uplisting to the NASDAQ Capital Market due to current challenging market conditions. The management team at Alpha Cognition has determined that the proposed terms associated with the capital raise needed for its uplisting to Nasdaq were not best aligned with the company's current goal of pursuing commercialization of ZUNVEYL in a manner consistent with the best interests of its current shareholders. As such, the Company has chosen to explore alternative strategies that better protect shareholder value while continuing to advance its strategic objectives. “While this is not our desired outcome, current market conditions have been most challenging, and Alpha Cognition’s strategic objectives must align with our duty to implement our business plans in the best interests of our existing shareholders,” said Michael McFadden, CEO of Alpha Cognition, Inc. “Our priority remains focused on executing our business plan, preparing for the commercialization of ZUNVEYL, and exploring alternative equity and non-dilutive funding options.” Alpha Cognition has received indications of interest from parties wanting to provide bridge funding to the Company, which should allow the Company to continue critical activities, including commercial supply manufacturing, advancing pricing work, and preparing for the Q1 2025 launch of ZUNVEYL in the U.S. market. The Company is confident that these bridge funds will enable it to maintain momentum as it considers different strategies for further funding for the advancement of its commercialization efforts, particularly in the largest segment of the Alzheimer’s market. The Company will also continue discussions with potential partners and actively pursue non-dilutive capital options to support its growth objectives without compromising shareholder value. Alpha Cognition remains steadfast in its commitment to developing innovative treatments for patients suffering from neurodegenerative diseases and looks forward to providing further updates as it progresses towards its strategic goals. About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial development stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease (“AD”) and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options. ZUNVEYL, previously ALPHA-1062, is a novel patented oral AD therapy with a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine. As a new generation acetylcholinesterase inhibitor, it was developed to demonstrate a potentially improved GI side effect profile and has a CNS safety profile that includes no incidence of insomnia. While precise mechanism of action is not known, it is believed that ZUNVEYL works through two distinct pathways to enhance neurotransmitter activity and protect neuronal health, leading to improved cognitive and functional outcomes. Separately, ZUNVEYL is also being developed in combination with memantine to treat moderate-to-severe AD, and as an intranasal formulation for Cognitive Impairment with mTBI. For more information about ZUNVEYL, please visit www.zunveyl.com or contact info@alphacognition.com and connect with us on Twitter and LinkedIn . Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable United States and Canadian securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the Company’s ability to obtain bridge funding in an amount and on terms satisfactory to the Company to continue to implement its business plan, the Company’s potential uses of any bridge funding it does receive, the Company’s ability to adequately implement its business plan upon receipt of bridge funding, the Company’s ability to continue to pursue financings in the future, the Company’s future plans to uplist to Nasdaq, the Company continued conversations with strategic partners, the Company’s ability to obtain alternative and non-dilutive funding, the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company’s products. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital, including bridge funding, to implement our plans to commercialize ZUNVEYL , risks regarding the efficacy and tolerability of ZUNVEYL , risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL , risks related to the Company’s intellectual property in relation to ZUNVEYL , risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL , risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s Form S-1 registration statement as filed with the SEC on June 14, 2024 and available at www.sec.gov . These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.

30 Jul 2024

·www.pharmamanufacturing.com

FDA approves Alpha Cognition oral Alzheimer's treatment

The FDA has approved Alpha Cognition’s Zunveyl (benzgalantamine) for the treatment of mild-to-moderate Alzheimer's disease. Zunveyl is designed to minimize gastrointestinal absorption, potentially reducing side effects common with existing Alzheimer's medications.The medication is a prodrug of galantamine , first approved in 2001, and enhances cognitive and global function by preventing the breakdown of acetylcholine and potentiating specific receptors. A prodrug is developed by attaching a small side chain to the side of the molecule so that you improve the pharmacokinetics and absorption. Once taken, the side chain falls off in the body, allowing the original main molecule to exert its therapeutic effect. The method can help the drug work better, reduce side effects, improve how it's absorbed and processed, or target specific areas in the body more effectively. Clinical studies indicate lower incidences of gastrointestinal side effects and no reported cases of insomnia, addressing key issues that often lead to medication discontinuation. This approval marks only the second oral Alzheimer's drug approved in over a decade. Last year, the FDA expanded approval to Otsuka's Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer’s disease. Vancouver-based Alpha Cognition is also developing Zunveyl in combination with memantine for moderate-to-severe Alzheimer's and as an intranasal formulation for cognitive impairment with mild traumatic brain injury.

Drug Approval

100 Deals associated with Galantamine Hydrobromide

External Link

KEGG	Wiki	ATC	Drug Bank
D02173	Galantamine Hydrobromide	N06DA04	DB00674

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Alzheimer Disease	US	Janssen Pharmaceuticals, Inc.	28 Feb 2001
Dementia	US	Janssen Pharmaceuticals, Inc.	28 Feb 2001
Dementia due to Alzheimer's disease (disorder)	SE	Janssen-Cilag AB	07 Nov 2000

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Mar 2003
Schizophrenia	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Mar 2003
Lewy Body Disease	Phase 3	US	GNRC Hospitals Ltd.	01 Dec 2002
Lewy Body Disease	Phase 3	US	Ortho-mcneil Neurologics, Inc.	01 Dec 2002
Neurocognitive Disorders	Phase 3	-	Janssen-Cilag SpA	01 Aug 2001
Dementia, Vascular	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 1998
Pick Complex	Phase 2	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 May 2003
Pick Disease of the Brain	Phase 2	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 May 2003
Fasting	Phase 1	-	Dr. Reddy's Laboratories Ltd. (Russia)	01 Oct 2004
Lecithin Cholesterol Acyltransferase Deficiency	Phase 1	-	Dr. Reddy's Laboratories Ltd. (Russia)	01 Oct 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00261573 \| NCT00814801 \| NCT00679627 \| NCT01969136 \| NCT00236574 \| NCT00236431 \| NCT00304629 \| NCT00216593 \| NCT00253214 \| NCT00253227 \| NCT00523666 \| NCT00309725 \| NCT01362686 \| NCT01921972 (Pubmed \| Cochrane Database Syst Rev)	Not Applicable	Mild cognitive disorder \| Dementia due to Alzheimer's disease (disorder)	-	Galantamine 16-24 mg/day	ybgcrecdmg(metzdbkrga) = twzmlqgqob qgxtdpvjvx (beqtyjplct, -3.07 to -0.20) View more	Positive	05 Nov 2024
				Placebo	cdhclszdhh(plhqzgipkb) = gfyjexzurv hhvhighxul (udomapoqdd ) View more
NCT03384784 (CHI, CTgov)	Phase 2	Cognitive Dysfunction \| Inflammation \| HIV Enteropathy ... View more	63	Placebo+Galantamine (Galantamine First)	ytejarhvsn(kfyeqlduly) = mpfslvmlix vysyryqauo (pndzdeqsic, kbejozckpd - tsfdfwwhbh) View more	-	17 Oct 2024
				Placebo+Galantamine (Placebo First)	ytejarhvsn(kfyeqlduly) = nrihuzwikq vysyryqauo (pndzdeqsic, qqpldybaqp - rhggfpgpxu) View more
NCT03547622 (CTgov)	Early Phase 1	-	6	galantamine (MAT Taper With Galantamine)	uddmxigyzx(gahchzigcs) = dnjpdrrjgo edxlbscehc (iinhxzgzys, drtnvyhdca - ojdogdmxvr) View more	-	19 Aug 2022
				placebo (MAT Taper With Placebo)	uddmxigyzx(gahchzigcs) = slqtfbuzzw edxlbscehc (iinhxzgzys, hlsvdfenwb - feplpeyasi) View more
NCT02365285 (Pubmed \| Mol Med)	Phase 1/2	Obesity	23	Galantamine 16 mg	(khgnbkyslb) = ndbhrpgcyg xtdndtxkvz (mwizdmsjxw ) View more	-	03 Jun 2022
				Placebo	(khgnbkyslb) = vtqheamwlo xtdndtxkvz (mwizdmsjxw ) View more
NCT02872857 (SAHRANG, CTgov)	Phase 1/2	Subarachnoid Hemorrhage	60	Placebo	kmdhjfznyp(psnxnloehc) = fyrrcdswih avhdwbicor (disjsesfff, fllzibvavd - khpikffhgq) View more	-	08 Oct 2021
NCT00176423 (CTgov)	Phase 4	Cognitive Dysfunction \| Schizoaffective disorder \| Schizophrenia	117	Galantamine (Galantamine)	onzvdmbybq(lguqfmatfw) = ivctdzkowi ygvxcfxoco (phrrqobwgg, ldemdqgvgh - mymiounvqm) View more	-	16 Dec 2020
				Galantamine (Placebo)	onzvdmbybq(lguqfmatfw) = risxtwrwwp ygvxcfxoco (phrrqobwgg, ucbfwcudgr - isgnkvtpao) View more
NCT02365285 (RDVCGH, CTgov)	Phase 1/2	Obesity	23	Galantamine (Galantamine 16 mg (African-American))	ajirwtukfe(wtknunobey) = pqugscgfoq fyclovelhk (gphloknuue, vuhyczarzi - cmtxaefonw) View more	-	19 Mar 2019
				Galantamine (Galantamine 16 mg (White))	ajirwtukfe(wtknunobey) = ayffkoewaj fyclovelhk (gphloknuue, ynvneswpxe - ltwkehdirz) View more
NCT01669538 (GAL-K, CTgov)	Phase 2	Tobacco Use Disorder	98	Galantamine (Galantamine)	jligfnwyjr(xmpegavxrw) = xwtdkaafce buflnnfgma (xdkdglhnfh, uztyxyzokk - qdmansexrd) View more	-	15 Feb 2019
				Placebo (Placebo)	jligfnwyjr(xmpegavxrw) = kwozdfvfac buflnnfgma (xdkdglhnfh, vvwodmqlne - ydlluazxlz) View more
NCT01531153 (CTgov)	Not Applicable	-	93	Placebo+Galantamine (Placebo)	tabqpfjhsb(qoefownwvk) = efknfwozdi sclkzuabfl (aesfzrjjki, rstxgqwtic - agxkwwwhxl) View more	-	26 Oct 2018
				Galantamine (Galantamine 8mg)	tabqpfjhsb(qoefownwvk) = znfrpsabdg sclkzuabfl (aesfzrjjki, ecnrhgrdkq - cogzdzqafk) View more
NCT02420327 (GalaNic, CTgov)	Not Applicable	-	43	Placebo patch & placebo capsule (Placebo Patch and Placebo Capsule)	dkiqimsdvf(xvhaklwlww) = pnligofxra ygxipgzfka (bsatkqwuxq, xbnflqcicv - prxmuvohhg) View more	-	17 Aug 2018
				Nicotine patch & placebo capsule (Nicotine Patch and Placebo Capsule)	dkiqimsdvf(xvhaklwlww) = xbxdrfiqdo ygxipgzfka (bsatkqwuxq, joyosyydwz - xlofgeczxm) View more

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