A Drug-Drug Interaction, Single-arm, Open-label Study to Assess the Effect of Quinidine on the Pharmacokinetics of Orforglipron in Healthy Participants

The purpose of this study is to determine the effect of quinidine on the levels of orforglipron in the blood stream and how long it takes the body to eliminate it, when administered orally in healthy participants.
The study will last up to approximately 8 weeks including screening.

Start Date01 Dec 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT06493409 / RecruitingPhase 1

A Phase I, Two-part, Single-center, Open-label, Drug-drug Interaction Study to Assess the Effect of Voriconazole (Part 1) and Quinidine (Part 2) on the Pharmacokinetics of a Single Dose of Repotrectinib (BMS-986472) in Healthy Participants

The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics (PK) of repotrectinib in healthy male and female (individual not of childbearing potential [INOCBP]) participants.

Start Date26 Aug 2024

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT05594602 / CompletedPhase 1

A NON-RANDOMIZED, OPEN-LABEL, THREE-PART, DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECTS OF ITRACONAZOLE, CARBAMAZEPINE, AND QUINIDINE ON THE PHARMACOKINETICS AND SAFETY OF EDP-235 IN HEALTHY PARTICIPANTS

A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.

Start Date06 Oct 2022

Sponsor / Collaborator

Enanta Pharmaceuticals, Inc.

100 Clinical Results associated with Quinidine Gluconate

100 Translational Medicine associated with Quinidine Gluconate

100 Patents (Medical) associated with Quinidine Gluconate

7,040

Literatures (Medical) associated with Quinidine Gluconate

01 Dec 2024·FISH PHYSIOLOGY AND BIOCHEMISTRY

Potency and mechanism of p-glycoprotein chemosensitizers in rainbow trout (Oncorhynchus mykiss) hepatocytes

Article

Author: Kennedy, Christopher J ; Johnston, Christina U

The membrane efflux transporter P-glycoprotein (P-gp, [ABCB1, MDR1]) exports a wide range of xenobiotic compounds, resulting in a continuous first line of defense against toxicant accumulation at basal expression levels, and contributing to the multixenobiotic resistance (MXR) phenotype at elevated expression levels. Relatively little information exists on P-gp inhibition in fish by chemosensitizers, compounds which lower toxicity thresholds for harmful P-gp substrates in complex mixtures. The effects of four known mammalian chemosensitizers (cyclosporin A [CsA], quinidine, valspodar [PSC833], and verapamil) on the P-gp-mediated transport of rhodamine 123 (R123) and cortisol in primary cultures of rainbow trout (Oncorhynchus mykiss) hepatocytes were examined. Competitive accumulation assays using 25 µM R123 or cortisol and varying concentrations of chemosensitizers (0-500 µM) were used. CsA, quinidine, and verapamil inhibited R123 export (IC50 values ± SE: 132 ± 60, 83.3 ± 27.2, and 43.2 ± 13.6 µM, respectively). CsA and valspodar inhibited cortisol export (IC50 values: 294 ± 106 and 92.2 ± 34.9 µM, respectively). In an ATP depletion assay, hepatocytes incubated with all four chemosensitizers resulted in lower free ATP concentrations, suggesting that they act via competitive inhibition. Chemosensitizers that inhibit MXR transporters are an important class of environmental pollutant, and these results show that rainbow trout transporters are inhibited by similar chemosensitizers (and mostly at similar concentrations) as seen in mammals and other fish species.

14 Nov 2024·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of Potent and Selective Blockers Targeting the Epilepsy-Associated K_Na1.1 Channel

Article

Author: Zheng, Ruqiu ; Huang, Zhuo ; Li, Zhongtang ; Zhang, Liangren ; Zhu, Guiwang ; Liu, Shiqi ; Li, Yiyan ; Liu, Ningfeng ; Liu, Zhenming ; Wang, Qiufeng

Gain-of-function (GOF) mutations of the sodium-activated potassium channel K_Na1.1 (Slack, Slo2.2, or K_Ca4.1) induce severe, drug-resistant forms of epilepsy in infants and children. Although quinidine has shown promise in treating KCNT1-related epilepsies compared to other drugs, its limited efficacy and substantial side effects necessitate the development of new K_Na1.1 channel inhibitors. In this study, we developed a novel class of K_Na1.1 inhibitors using combined silico approaches and structural optimization. Among these inhibitors, compound Z05 was identified as a selective potential K_Na1.1 inhibitor, especially against the hERG channel. Moreover, its binding site and potential counteraction to a GOF mutant Y796H were identified by the mutation studies. Our data also showed that Z05 had significant pharmacological profiles, including high brain penetration and moderate oral bioavailability, offering a valuable in vitro tool compound for further drug development in treating KCNT1-related epilepsies.

01 Nov 2024·BMJ Supportive & Palliative Care

Pathological emotionality in neurodegenerative conditions treated with dextromethorphan and quinidine: patients and carers impact

Letter

Author: Husbands, Emma

News (Medical) associated with Quinidine Gluconate

02 Dec 2024

·www.prnewswire.com

Endo Launches ADRENALIN® Ready-to-Use Premixed Bag, the First and Only FDA-Approved, Manufacturer-Prepared Epinephrine Premixed IV Bag

MALVERN, Pa., Dec. 2, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of its ADRENALIN® (epinephrine in 0.9% sodium chloride injection) ready-to-use premixed bag, the first and only FDA-approved, manufacturer-prepared epinephrine premixed intravenous (IV) bag. "The first-ever ready-to-use epinephrine premixed bag represents an advancement for both providers and patients thanks to a delivery system that provides greater workflow efficiency, saves time, and reduces the risk of medication error," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions & Generics. "We are proud to provide critical care products like ADRENALIN® bags—ready when and where our customers need them—through our TruDelivery® portfolio." The ADRENALIN® premixed bag is the latest addition to Endo Injectable Solutions' TruDelivery® product line and platform. Ready-to-use products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow, and reduce the chance for preparation error—all of which support quality patient care. The ADRENALIN® premixed bag does not require compounding, diluting, mixing, or transferring, which may reduce waste. The single-port IV tubing reduces risk of inadvertently adding other medications to bag. The product also has a 24-month shelf life at room temperature. Endo also offers ADRENALIN® (epinephrine injection, USP) in 1 mL single-dose vials and 30 mL multi-dose vials. ADRENALIN® is used in the treatment of hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When Adrenalin is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough. Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein. Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. ADVERSE REACTIONS: Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. DRUG INTERACTIONS: Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, and ergot alkaloids. Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, catechol-O-methyltransferase (COMT) inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides, and quinidine. Observe for development of cardiac arrhythmias. Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. USE IN SPECIFIC POPULATIONS: Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. INDICATION AND USAGE Hypotension associated with Septic Shock Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Click for Full Prescribing Information. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Mr. Sims and any statements relating to product launch, quality, efficacy, improved treatment, workflow efficiencies, reduced risks, waste or costs, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, regulatory compliance, unexpected litigation or disputes, Endo's ability to successfully implement and execute on its strategies and initiatives, and changes in competitive, market or regulatory conditions. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

23 May 2024

·www.pharmaceutical-technology.com

Otsuka cuts development for AVP-786 following Phase III flop

Otsuka Pharmaceuticals ended clinical development for AVP-786 for agitation associated with Alzheimer’s disease following a negative Phase III readout. Credit: SOPA Images via Getty Images. Otsuka Pharmaceutical has axed the development of its dementia drug, AVP-786, following a disappointing Phase III readout (NCT03393520). Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The Japanese company was investigating the therapy as a potential treatment for patients with agitation associated with dementia due to Alzheimer’s disease (AD). Otsuka completed the recent Phase III study in December 2023, reporting the official study results in February 2024. In the randomised, double-blind study, AVP-786 demonstrated no significant difference in the primary endpoint of mean change in the Cohen-Mansfield Agitation Inventory total score compared to the placebo. As per the 22 May press release, the decision to terminate the drug’s development followed a complete data analysis of the Phase III trial. AVP-786 is a dextromethorphan/quinidine combination that works by antagonising NMDA receptors and agonising Sigma-1 receptors amongst other effects. The therapy is a second-generation treatment, derived from Avanir Pharmaceuticals ’ Nuedexta (AVP-923). Otsuka acquired Avanir in a $3.5bn deal in December 2014. Nuedexta is a first-in-class dual-action glutamate inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including multiple sclerosis, in December 2010. Otsuka is the developer of the only FDA-approved treatment for the agitation associated with dementia due to AD, Rexulti (brexpiprazole), which received approval in November 2023. See Also: Pfizer starts $1.5bn cost-cutting initiative amidst declining Covid-19 revenues Patients and caregivers driving innovation in drug development According to GlobalData, there are seven therapies in Phase III trials for dementia associated with Alzheimer’s disease. This includes trials studying Auvelity— Axsome Therapeutics bupropion / dextromethorphan combination therapy, and Novo Nordisk ’s semaglutide. Novo Nordisk’s drug is approved for the treatment of weight loss and diabetes, under the brand names Wegovy and Ozempic. Pharma companies are actively trying to push the scope of these GLP-1 receptor agonists , with trials now exploring them as treatments for neurological disorders and fatty liver disease. Novo Nordisk predicts that the Phase III AD trial with semaglutide will be completed in October 2026. GlobalData is the parent company of Pharmaceutical Technology. As per the recent press release, Otsuka has declared that it will continue developing therapies for agitation associated with AD. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. By GlobalData Submit Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Phase 3Drug ApprovalClinical ResultNDAPhase 2

22 May 2024

·www.biospace.com

Otsuka Drops Alzheimer’s Agitation Drug Following Phase III Failure

Pictured: Husband consoles agitated wife/iStock, Piksel Otsuka Pharmaceuticals announced Wednesday it is terminating development of its Alzheimer’s-related agitation drug candidate following a failed late-stage trial. Top-line Phase III results in February revealed AVP-786 did not provide improvement over placebo in patients’ Cohen-Mansfield Agitation Inventory (CMAI) total score in treating agitation associated with dementia due to Alzheimer’s disease (AD). The asset was acquired by Otsuka in late 2014 in a $3.5 billion acquisition of Avanir Pharmaceuticals. The combination formula of ultra-low dose quinidine plus deuterium-modified dextromethorphan was expected to boost bioavailability and be less susceptible to metabolism. Previously tested by Avanir in major depressive disorder, Otsuka was assessing AVP-786 only in AD agitation. The Japanese pharma already has a drug on the market for the indication with partner Lundbeck. Rexulti (brexpiprazole) was first approved in schizophrenia and as an adjunctive therapy for MDD. In May 2023, it became the first drug approved for agitation associated with dementia from AD. The additional indication is driving growth of the drug sales for the partners, with 18.8% monthly demand growth, Lundbeck reported. However, the competitive landscape in AD agitation is heating up. In April 2024, IGC Pharma announced interim data from its Phase II trial in the indication. The Maryland-based company is the first to trial a THC-based formulation in AD and showed significant reduction in agitation at week two compared to placebo. Axsome Therapeutics’ Phase III trial of twice-daily AXS-05 is slated to be completed in the first half of 2024. The company plans to apply for approval after the trial, following prior FDA feedback for long-term safety data. An estimated 6.9 million Americans suffer from AD with around 76% experiencing from agitation. Symptoms include pacing, restlessness, and verbal and physical aggression, adding significant burden to caregivers. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

Phase 3AcquisitionClinical ResultDrug ApprovalPhase 2

100 Deals associated with Quinidine Gluconate

External Link

KEGG	Wiki	ATC	Drug Bank
D00642	Quinidine Gluconate	C01BA01	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Arrhythmias, Cardiac	US	Eli Lilly & Co.	12 Jul 1950

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	Phase 1	US	Eli Lilly & Co.	01 Oct 2011

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2024	Not Applicable	Paroxysmal Ventricular Fibrillation	-	Quinidine 200 mg	tppxxaoqxx(jumnrlzpmg) = svqjlierxw kiejmobklq (tdwrkupobj ) View more	-	07 Apr 2024
ESC2019	Not Applicable	Brugada Syndrome	-	Quinidine	pyhnilxnwr(rzldfalvca): HR = 0.74 (95% CI, 0.22 - 2.48), P-Value = 0.62	-	03 Sep 2019
				quinidine
NCT01460381 (CTgov)	Phase 1	Depressive Disorder, Major	18	LY2216684 (LY2216684 (CYP2C19 Extensive Metabolizers))	dpmxwxluqj(hxctrnzdxf) = tnemtqsday xwnwltzuro (dgsedvtcub, cuhfpvqqru - zbjyajjtjq) View more	-	26 Oct 2018
				Quinidine+LY2216684 (LY2216684 + Quinidine (CYP2C19 Poor Metabolizers))	dioxhmyvbl(cbcoehjtug) = mgxccrfqge qpronvftdk (tnlvqckuts, rwrszdebdt - xsukilhssk) View more
ANA2018	Not Applicable	KCNT1 gene mutation	1	Phenytoin	tjystfcyro(wnwrjeexen) = bveciicubt rlvlyguqse (qxfktfjthf )	Positive	05 Oct 2018
IEC2017	Not Applicable	Epilepsy KCNT1 mutation	6	Quinidine 900 mg	dkrqxwqvnm(krhdctuztr) = ergpszakdv blpyuzodfb (zxpxpwlyiw, -0.25 to 4.25)	Negative	04 Sep 2017
				Quinidine 600 mg	dkrqxwqvnm(krhdctuztr) = eyfxdzljot blpyuzodfb (zxpxpwlyiw, -0.25 to 4.25)
EULAR2002	Not Applicable	-	-	Quinidine	vrowuxeerx(sfralrqxsg) = nnzisadrcl lgostaathp (tunyprzlmx, ± 12.4)	-	12 Jun 2002

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