[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

2,564

Literatures (Medical) associated with Galantamine Hydrobromide

06 Dec 2024·Journal of Biomolecular Structure and Dynamics

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

Article

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

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·Central Nervous System Agents in Medicinal Chemistry

Effectiveness of Novel Drug Delivery System using Curcumin in Alzheimer’s Disease

Review

Author: Mathure, Dyandevi ; Aswar, Urmila ; Rathod, Kundlik

:Alzheimer's disease (AD) is a form of brain degeneration that gradually impairs a person's memory and cognitive skills, eventually making it harder for them to perform everyday activities. Its pathophysiology has been attributed to the deposition of amyloid β (Aβ), neurofibrillary tangles (NFT), and α-synuclein (A-s) in some cases. Presently, 4 drugs have been approved for the treatment. They are Donepezil, Rivastigmine, Galantamine and Memantine. The first three are acetylcholinesterase inhibitors, while memantine is an NMDA receptor antagonist. Even though these medications are successful in treating mild to moderate Alzheimer's disease, they have not been able to reverse the disease or even slow its progression completely. Hence, natural products are gaining more popularity due to the advantage of the multitarget intervention effect. The most investigated spice, Curcuma longa's bioactive component, curcumin, has demonstrated anti-amyloid, anti-NFT, and anti-Lewy body properties and substantial antiinflammatory, antioxidant, and antiapoptotic properties. However, its proven neuroprotective activity is hampered by many factors, such as poor water solubility and bioavailability. Therefore, many novel formulations have been designed to improve its bioavailability with methods such as 1) Micellar Solubilization, 2) Cyclodextrin Complexation, 3) Crystal Modification, and 4) Particle Size Reduction, etc. The current chapter aims to summarize various novel formulations of curcumin and their effectiveness in treating AD.

01 Dec 2024·Bioorganic Chemistry

Naphthyl-functionalized acetamide derivatives: Promising agents for cholinesterase inhibition and antioxidant therapy in Alzheimer’s disease

Article

Author: Camargo-Ayala, Paola Andrea ; Delgado, Gerzon E ; Jimenez, Claudio A. ; Camargo-Ayala, Lorena ; Polo-Cuadrado, Efraín ; Zúñiga-Arbalti, Felipe ; Gutiérrez, Margarita ; Delgado, Gerzon E. ; Brito, Iván ; Osorio, Edison ; Prent-Peñaloza, Luis ; Jimenez, Claudio A

This study presents the synthesis and characterization of a series of 13 novel acetamides. These were subjected to Ellman's assay to determine the efficacy of the AChE and BChE inhibitors. Finally, we report their antioxidant activity as an alternative approach for the search for drugs to treat AD. These studies revealed that compounds 1a-1k and 2l-2m were obtained in moderate yield. Four amides (1h, 1j, 1k, and 2l) were selective for one of the enzymes (BChE); thus, those that inhibited BChE were more active than the positive control (galantamine) and showed better IC₅₀ values (3.30-5.03 µM). The theoretical free binding energies calculated by MM-GBSA indicated that all inhibitors were more stable than rivastigmine, and the inhibition mechanisms involved the entire active site: peripheral anionic site, oxyanion hole, acyl-binding pockets, and catalytic site. We examined the cytotoxicity of compounds 1h, 1j, 1k, and 2l in human dermal cells and found that they did not exhibit any toxic effects under the tested conditions. Additionally, these compounds, which also inhibited BChE, displayed mixed inhibition and did not exhibit hemolytic effects on human erythrocytes. Furthermore, the ABTS and DPPH assays indicated that, although none of the compounds showed activity in the DPPH assay, the EC₅₀ values for radical trapping by the ABTS method showed that compounds 1a, 1d, 1e, and 1g had EC₅₀ values lower than 10 µg/mL, indicating their strong radical scavenging capacity. We also report the crystal structures of compounds 1c, 1d, 1f, and 1g, which are found in monoclinic crystal systems.

News (Medical) associated with Galantamine Hydrobromide

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

29 Jul 2024

·pipelinereview.com

Alpha Cognition’s Oral Therapy ZUNVEYL® Receives FDA Approval to Treat Alzheimer's Disease

The Second Oral Therapy Approved This Decade, ZUNVEYL’s Dual MOA Was Designed to Eliminate Drug Absorption in the Gastrointestinal (GI) Tract, Potentially Addressing Certain Tolerability Issues with Leading Alzheimer’s Disease (AD) Medications, Combined with a Long-Term Efficacy Profile ZUNVEYL’s Innovative Approach Targets AD Symptoms Directly, Designed to Provide Patients with Significant Benefits to Cognitive and Global Function and the Ability to Perform Daily Living Activities Alzheimer’s Disease, the Most Common Form of Dementia, Affects Nearly 7 Million People in the United States, including 70% of All Nursing Home Residents and is the Leading Cause of Nursing Home Admissions and Deaths VANCOUVER, Canada & DALLAS. TX, USA I July 29, 2024 I Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF)(Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, announces that the U.S. Food and Drug Administration (FDA) has granted approval for ZUNVEYL® (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer’s disease. Alzheimer’s disease (AD) is a progressive brain disorder that slowly destroys memory, thinking skills, and eventually the ability to do simple tasks, like carry on a conversation.AD is the most common form of dementia affecting nearly 7 million people, and is the leading cause of nursing home admissions and deaths, with 70% of all nursing home residents suffering with AD. A novel oral therapy, ZUNVEYL has a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentiallyaddressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine. Tolerability affects therapy adherence, with data showing that 55% of AD patients discontinue their medication after one year, mainly due to GI side effects and insomnia. Medication discontinuation can cause risk to patients themselves, and dissatisfaction and burden among nursing home staff, physicians, and caregivers. ZUNVEYL, a prodrug of AD treatment galantamine and an acetylcholinesterase inhibitor (AChEI), is postulated to exert its therapeutic effect by preventing the breakdown of acetylcholine, the important brain neurotransmitter involved in memory, motivation, and attention functions. It is also an allosteric potentiator of α-7 nicotinic acetylcholine and α4β2 receptors. This action facilitates the release of acetylcholine from the presynaptic neurons, giving clinical significance to its dual mode of action. ZUNVEYL targets AD symptoms, to provide patients with long-lasting benefits to cognitive and global function and the ability to perform daily activities that are impaired by AD. Galantamine, FDA-approved since 2001, has extensive and positive data related to long-term outcomes, demonstrating activity among multiple brain receptors, anti-inflammatory effects, and is associated with improved memory, attention, and a significantly lower risk of death. It also has the strongest effect on cognitive decline in the AChEI class of medications and demonstrated significant risk reduction of developing severe dementia. Due to its prodrug properties, ZUNVEYL is effectively converted into the active moiety of galantamine after it passes through the GI tract, therefore achieving the same therapeutic effects of galantamine. It was also uniquely designedto eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues and has a CNS safety profile that includes no incidence of insomnia. Information about ZUNVEYL’s pivotal clinical studies are included further in this press release, and in the ZUNVEYL prescribing information. “I am very excited about the approval of ZUNVEYL, which we believe offers better tolerability for patients with Alzheimer’s disease. We have always believed in the efficacy of galantamine but have been limited in its use due to tolerability issues. To now have an agent with the efficacy of galantamine, but that also offers the hope of better tolerability, will provide physicians a great option to treat patients,” said Elaine Peskind, MD, the Friends of Alzheimer’s Research Professor of Psychiatry at the University of Washington School of Medicine. “This advancement marks a meaningful step forward in improving the quality of life for those living with Alzheimer’s and their families. As a geriatric psychiatrist specializing in Alzheimer’s disease, I am eager to incorporate this new treatment into our practice and see the positive difference it will make.” “The approval of ZUNVEYL is a pivotal moment in the fight against Alzheimer’s disease as it is only the second oral AD treatment to be approved in more than a decade. ZUNVEYL was designed to addresses a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes,” stated Alpha Cognition Chief Executive Officer Michael McFadden. “We are delighted, as this represents a major breakthrough in Alzheimer’s treatment, providing hope to millions of patients, families, and caregivers affected by this devastating disease.” About the Pivotal ZUNVEYL Clinical Studies ZUNVEYL’s approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of ZUNVEYL compared to galantamine immediate-release tablets and galantamine extended-release capsules. Importantly, there were minimal adverse events reported in these trials. Availability ZUNVEYL will be available by prescription in pharmacies nationwide in Q1 2025. Alpha Cognition is committed to ensuring broad access to this innovative treatment and will work closely with healthcare providers, insurers, and patient advocacy groups to support its distribution. “We are excited to launch ZUNVEYL and bring this much-needed treatment option to patients suffering from Alzheimer’s disease,” said Lauren D’Angelo, Alpha Cognition’s Chief Operating Officer. “Over the coming months, our team will work diligently to prepare for this launch, ensuring that healthcare providers have the information and patients have the resources and support they need. ZUNVEYL offers dual-action benefits with the established efficacy of galantamine and no insomnia. It was uniquely designed to bypass the gut with the potential of minimizing GI side effects. We believe that ZUNVEYL’s unique combination of these attributes will make a meaningful difference in the lives of those affected by this debilitating disease. We look forward to collaborating with our partners to ensure a successful rollout and broad accessibility.” About Alpha Cognition Inc. Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease 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 Alzheimer’s disease 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 Alzheimer’s dementia, 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 . INDICATION ZUNVEYL (benzgalantamine) is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION INDICATION ZUNVEYL® (benzgalantamine) is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION Contraindications ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or any inactive ingredients in ZUNVEYL. Warnings and Precautions Adverse Reactions The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Drug Interactions Cholinesterase inhibitors, including galantamine, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information . SOURCE: Alpha Cognition

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	Hikma Pharmaceuticals USA, Inc.	30 Jan 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pick Disease of the Brain	Phase 2	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 May 2003
Schizophrenia	Phase 2	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Mar 2003
Alzheimer Disease	Preclinical	US	Janssen Pharmaceuticals, Inc.	28 Feb 2001
Cognitive Dysfunction	Discovery	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Mar 2003
Lewy Body Disease	Discovery	US	GNRC Hospitals Ltd.	01 Dec 2002
Lewy Body Disease	Discovery	US	Ortho-mcneil Neurologics, Inc.	01 Dec 2002
Neurocognitive Disorders	Discovery	-	Janssen-Cilag SpA	01 Aug 2001
Alzheimer Disease	Discovery	US	Janssen Pharmaceuticals, Inc.	28 Feb 2001
Dementia, Vascular	Discovery	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 1998

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00261573 \| NCT00679627 \| NCT00814801 \| NCT00236574 \| NCT01969136 \| 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	soxejquhmn(rbegxxpypz) = zggbnmffnc kosgyjejwr (dsexpfbpvf, -3.07 to -0.20) View more	Positive	05 Nov 2024
				Placebo	tcxnylmjri(cptsyeokqi) = eiqimorzxq riayhfgakp (ureaxmgdom ) View more
NCT03384784 (CHI, CTgov)	Phase 2	Cognitive Dysfunction \| Inflammation \| HIV Enteropathy \| AIDS Dementia Complex	63	Placebo+Galantamine (Galantamine First)	hucfdkotmj(psiwtnwgdq) = rnbjuuvedu nlbdrqgwle (akszcadsuj, ocoidxbann - jsaimwrzhc) View more	-	17 Oct 2024
				Placebo+Galantamine (Placebo First)	hucfdkotmj(psiwtnwgdq) = eyvxdhfhfb nlbdrqgwle (akszcadsuj, urcmrpaque - nwwrucqmmj) View more
NCT03547622 (CTgov)	Early Phase 1	-	6	galantamine (MAT Taper With Galantamine)	tjtqobhtur(ydjoibqctb) = dtabismgid sqpphcebvn (nwbzqsloyx, vnlshrflqz - fvdtmjrgws) View more	-	19 Aug 2022
				placebo (MAT Taper With Placebo)	tjtqobhtur(ydjoibqctb) = qwldmhegiv sqpphcebvn (nwbzqsloyx, dfrmblweab - mjxeafzrdw) View more
NCT02872857 (SAHRANG, CTgov)	Phase 1/2	Subarachnoid Hemorrhage	60	Placebo	teajjeubit(yxpaiuzqqa) = shgnbbdsfg uzotbuyhls (unobtlzbjw, xcsffqshqu - wpuyjeovjt) View more	-	08 Oct 2021
NCT00176423 (CTgov)	Phase 4	Cognitive Dysfunction \| Schizoaffective disorder \| Schizophrenia	117	Galantamine (Galantamine)	zgxpopznyu(bzywrhplod) = ebcjsqxbdf uehcvlqcgr (sxfjrembkw, olfbewatty - fbkrzhergv) View more	-	16 Dec 2020
				Galantamine (Placebo)	zgxpopznyu(bzywrhplod) = gtmnusqpgd uehcvlqcgr (sxfjrembkw, lavgjsjwhq - rzfydvdrpk) View more
NCT02365285 (RDVCGH, CTgov)	Phase 1/2	Obesity	23	Galantamine (Galantamine 16 mg (African-American))	nnxzlsvzqa(grnkylxusp) = iifhijqlkg xdjtwndbfo (uswzkrcjxg, cgbwgxaake - qrlngaiesr) View more	-	19 Mar 2019
				Galantamine (Galantamine 16 mg (White))	nnxzlsvzqa(grnkylxusp) = pluennvkvh xdjtwndbfo (uswzkrcjxg, vwkeclstmf - gkqtrwdmvt) View more
NCT01669538 (GAL-K, CTgov)	Phase 2	Tobacco Use Disorder	98	Galantamine (Galantamine)	zfpbwfoeyk(lqbwvqzzbd) = ummcqtkilc vbmfqbyprq (umtknudwhu, ovfbzlxwrb - mjqfvvtshn) View more	-	15 Feb 2019
				Placebo (Placebo)	zfpbwfoeyk(lqbwvqzzbd) = tsgjtgcvoh vbmfqbyprq (umtknudwhu, tlavtioadj - jbwrpoanuq) View more
NCT01531153 (CTgov)	Not Applicable	-	93	Placebo+Galantamine (Placebo)	wmzckyorol(inenhqvaie) = nlcaneuqtq wdxkzalcrb (hgoujpvnjy, wfxnctefjd - gqhcxipvkg) View more	-	26 Oct 2018
				Galantamine (Galantamine 8mg)	wmzckyorol(inenhqvaie) = awxmmihbvl wdxkzalcrb (hgoujpvnjy, vrgsiijhnl - tegqrslkzx) View more
NCT02420327 (GalaNic, CTgov)	Not Applicable	-	43	Placebo patch & placebo capsule (Placebo Patch and Placebo Capsule)	wzfpbnivsh(gttgxsgodz) = dpkfnoujcp chagspkuhi (epxajayhjc, tewgyxqzsw - yydxrxuvte) View more	-	17 Aug 2018
				Nicotine patch & placebo capsule (Nicotine Patch and Placebo Capsule)	wzfpbnivsh(gttgxsgodz) = uyotaqxeta chagspkuhi (epxajayhjc, uzsvraytue - uvgcvzpcjf) View more
STREAM-VCI (AAIC2018)	Not Applicable	Cognitive Dysfunction	30	Methylphenidate	pwspaqzxxg(ezyrynpsrs) = ctaofkmnke mlorbjomje (okapzuwejf, 0.03 - 1.15)	Positive	01 Jul 2018
				Galantamine	pwspaqzxxg(ezyrynpsrs) = ryrxzfptmx mlorbjomje (okapzuwejf, 0.56 - 1.67)

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