Quinidine
Small molecule targets CYP2D6 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Nuedexta | — | 2016-02-15 | europa.eu ↗ |
| Approved | EU (EMA) | Nuedexta | — | 2013-06-24 | europa.eu ↗ |
| Label expansion | US (FDA) | QUINIDEX | — | 1977-10-11 | fda.gov ↗ |
| Approved | US (FDA) | QUINIDEX | — | 1962-02-21 | fda.gov ↗ |
Trials 41
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 116 trials | ||||||
| Phase 1 | NCT06974565 | May → Jul 2025 | liver disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT07305779 | Mar → May 2025 | schizophrenia | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06704763 | Dec 2024 → Feb 2025 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06493409 | Aug → Dec 2024 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT07838987 | Dec 2023 → Jun 2026 | — | Terns, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05594602 | Oct → Dec 2022 | COVID-19 | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT05444556 | Jul → Nov 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04783753 | Nov 2020 → Jun 2021 | hepatitis B virus infection | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT03755778 | Nov 2018 → Jan 2019 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT03610945 | Jul → Aug 2018 | metabolic dysfunction-associated steatohepatitis | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT03381664 | Nov 2017 → Jan 2018 | — | Avanir Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01873950 | May → Jul 2013 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT01712828 | Oct 2012 → Jan 2013 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01460381 | Oct 2011 → Aug 2012 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02171624 | Mar → Apr 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171546 | Nov 2007 → Jan 2008 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03883581 | Jul 2019 → Sep 2021 | amyotrophic lateral sclerosis | University of Florida | Completed | Mixed |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT05593757 | Oct 2022 → Sep 2025 | ventricular fibrillation | Academic Medical Center - University of Amsterdam | Unknown | No outcome recorded |
| Phase 2 | NCT03420222 | Jan → Dec 2018 | intermittent explosive disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02153502 | Jul 2014 → Feb 2016 | major depressive disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01584440 | Aug 2012 → Jul 2014 | Alzheimer disease | Avanir Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01630811 | Jan 2012 → Dec 2015 | autism | Sutter Health | Completed | No outcome recorded |
| Phase 2 | NCT01324232 | Sep 2011 → Sep 2013 | multiple sclerosis, neuropathy, painful | Avanir Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03896945 | Feb 2019 → May 2023 | schizophrenia | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded |
| Phase 2/3 | NCT00789165 | Dec 2009 → Feb 2020 | cardiac rhythm disease | International Registry of Asymptomatic Brugada Syndrome | Withdrawn | No outcome recorded |
| Phase 312 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT04464564 | Sep 2020 → Jun 2024 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04408755 | Jul 2020 → Jun 2024 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03393520 | Oct 2017 → Nov 2023 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02442778 | Nov 2015 → Aug 2019 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | Missed primary |
| Phase 3 | NCT02442765 | Jul 2015 → Jan 2019 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | Mixed |
| Phase 3 | NCT00113620 | Jul 2005 → Feb 2007 | diabetic polyneuropathy | Avanir Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00056524 | Feb 2003 → Jun 2007 | Alzheimer disease, Parkinson disease, stroke disorder, traumatic brain injury | Avanir Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00050232 | Dec 2002 → Jun 2004 | multiple sclerosis | Avanir Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00021697 | Jan 2001 → Apr 2002 | amyotrophic lateral sclerosis | Avanir Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00000556 | Mar 1995 → Sep 2002 | atrial fibrillation | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000464 | Apr 1987 → Dec 1992 | cardiac arrest, myocardial infarction, ventricular fibrillation | University of Washington | Completed | No outcome recorded |
| Phase 3 | NCT00000518 | Jul 1985 → Dec 1992 | sudden cardiac arrest, ventricular fibrillation, ventricular tachycardia | University of Utah | Completed | No outcome recorded |
| Phase 43 trials · 1 met primary | ||||||
| Phase 4 | NCT02496039 | Sep 2015 → May 2016 | pseudobulbar palsy | Avanir Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01799941 | Feb 2013 → May 2015 | dementia, pseudobulbar palsy, stroke disorder, traumatic brain injury | Avanir Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT01832350 | Aug 2012 → Dec 2015 | Alzheimer disease, pseudobulbar palsy | St. Joseph's Hospital and Medical Center, Phoenix | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00578617 | Sep 2006 → Feb 2009 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT06979388 Background | May → Jul 2025 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06847464 Background | Jan → May 2025 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01533155 Comparator | Mar → Sep 2012 | constipation disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02176018 Comparator | Aug 2014 → Feb 2017 | migraine disorder | Cady, Roger, M.D. | Completed | No outcome recorded |
| Phase 2 | NCT01767129 Background | Oct 2013 → Feb 2015 | Parkinson disease, movement disorder | Avanir Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT01882829 Background | Jul 2013 → Mar 2016 | major depressive disorder | James Murrough | Completed | No outcome recorded |
| Phase 3 | NCT02446132 Background | Nov 2015 → Sep 2024 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00573443 Background | Dec 2007 → Jun 2009 | pseudobulbar palsy | Avanir Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00589303 Comparator | Dec 2007 → Jul 2011 | atrial fibrillation, heart failure | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT00540787 Comparator | Aug 2003 → Jun 2006 | paroxysmal atrial fibrillation | Biosense Webster, Inc. | Completed | No outcome recorded |
| — | NCT00911508 Comparator | Nov 2009 → Dec 2017 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-03-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka's Subsidiary Avanir Pharmaceuticals Reports Phase 3 Data Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia otsuka.co.jp ↗
Similar improvements were also observed on the key secondary endpoint. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-03-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka's Subsidiary Avanir Pharmaceuticals Reports Phase 3 Data Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia otsuka.co.jp ↗ |
| 2019-02-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Avanir Pharmaceuticals, Inc. Reaches Agreement in Principle with U.S. Department of Justice Regarding NUEDEXTA (dextromethorphan HBr and quinidine sulfate) 20 mg/10 mg capsule otsuka.co.jp ↗ |
Evidence & citations 31 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | quinidine | “A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide...” NCT04408755 ↗51“The authors conducted a multicenter, randomized, double-blind, controlled, parallel, three-arm study to test a defined combination of dextromethorphan hydrobromide (DM) and...” PMID 15505150 ↗ Oct 2004 “A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the...” NCT02446132 ↗ “Dextromethorphan 20 mg / quinidine 10 mg (DM/Q) was approved to treat pseudobulbar affect (PBA) based on phase 3 trials conducted in participants with amyotrophic lateral...” PMID 29477412 ↗ Feb 2018 “capsules containing dextromethorphan [DM] and quinidine [Q]) compared with placebo, taken twice daily, for the treatment of pseudobulbar affect over a 12-week period in...” PMID 16634036 ↗ May 2006 “the sigma-1 receptor-agonist and glutamatergic/monoaminergic modulator, dextromethorphan plus quinidine (to inhibit rapid dextromethorphan metabolism), for treating...” PMID 28370447 ↗ Mar 2017 “AVP-923-45 (dextromethorphan 45 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of...” NCT01324232 ↗ “Clinical trials establishing dextromethorphan and quinidine (DM/Q) as PBA treatment were conducted in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).” PMID 25062507 ↗ Jul 2014 “Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease” NCT01584440 ↗ “The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.” NCT00113620 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type” NCT03393520 ↗ |
| Known as | (8r,9s)-quinidine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | .beta.-quinidine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Cin-quin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Conquinine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Kinidin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | NSC-10004 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Pitayine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinact | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinalan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinatime | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinicardine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidex extentabs | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | QUINIDINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | quinidine sulfate | “Participants received AVP-786-28/4.9 (deudextromethorphan hydrobromide (d6-DM) 28 milligrams (mg)/quinidine sulfate (Q) 4.9 mg) capsule, along with AVP-786 matching placebo...” NCT03896945 ↗10“A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide...” NCT04408755 ↗ “The authors conducted a multicenter, randomized, double-blind, controlled, parallel, three-arm study to test a defined combination of dextromethorphan hydrobromide (DM) and...” PMID 15505150 ↗ Oct 2004 “A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the...” NCT02446132 ↗ “NUEDEXTA capsules (20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate) administered orally, once a day from Days 1 to 7 and twice a day from Days 8 to 180” NCT02496039 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type” NCT03393520 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)” NCT03420222 ↗ “18 mg of Deudextromethorphan hydrobromide (d6-DM) and 4.9 mg of Quinidine sulfate (Q)” NCT02442778 ↗ “AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)” NCT02153502 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q])” NCT04464564 ↗ “Quinidine sulfate tablets” NCT02171546 ↗ |
| Known as | Quinidine sulfate anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | QUINIDINE SULFATE COMPONENT OF AVP-786 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidine sulfate component of nuedexta | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidine sulfate dihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidine sulfate hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidine sulphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidine sulphate anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidine sulphate dihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidine, sulfate (2:1) (salt) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinidini sulfas | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Known as | Quinora | ChEMBL registry synonym — accepted as the source's own label CHEMBL1294 ↗ |
| Action | Inhibit | “Q inhibits the rapid first-pass metabolism of DM.” PMID 15505150 ↗ Oct 2004 |
| Modality | Small molecule | — CHEMBL1294 ↗ |
| Route | Oral | “300 mg quinidine sulfate controlled release was administered orally” NCT01460381 ↗ |
| Target | CYP2D6 | “potent inhibitor of cytochrome P450 2D6 (CYP2D6)” NCT00573443 ↗ |