Drugs / Codeine
Codeine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PHENERGAN W/ CODEINE | — | 1952-01-21 | fda.gov ↗ |
Trials 39 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT03335423 | Mar 2018 → Jun 2020 | codeine toxicity, phenformin 4-hydroxylation | University of Southern Denmark | Completed | No outcome recorded |
| Phase 1 | NCT02572375 | Oct → Nov 2014 | — | Nexgen Pharma, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01788254 | Jan 2012 → May 2015 | — | Matthias Schwab | Completed | No outcome recorded |
| Phase 1 | NCT01845194 | Dec 2009 → Oct 2013 | mitochondrial membrane transport disorder | Institute of Application-oriented Research and Clinical Trials GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01322204 | Aug 2008 → Mar 2013 | neonatal respiratory failure | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 1 | NCT01009697 | Mar → Apr 2008 | — | Roxane Laboratories | Completed | No outcome recorded |
| Phase 1 | NCT01009853 | Jan 2008 | — | Roxane Laboratories | Completed | No outcome recorded |
| Phase 1 | NCT01010152 | Jan 2008 | — | Roxane Laboratories | Completed | No outcome recorded |
| Phase 1 | NCT00456898 | Jan → Mar 2007 | diabetic neuropathy, fibromyalgia, major depressive disorder | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00174538 | Mar → Dec 2005 | sickle cell disease | PriCara, Unit of Ortho-McNeil, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05477875 | Feb 2024 → Jan 2025 | hyperopia, myopia | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT05463367 | Jan 2021 → Jun 2025 overdue | chronic pain syndrome, opiate dependence, substance abuse | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00281684 | Dec 2005 → Oct 2007 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00029770 | Sep 2001 → May 2007 | — | National Center for Complementary and Integrative Health (NCCIH) | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04641338 | Mar 2023 → Mar 2024 | neuropathy, painful | Brazilian Clinical Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT01676493 | Apr → Aug 2012 | — | Roxane Laboratories | Terminated | No outcome recorded |
| Phase 3 | NCT00147355 | Nov 2005 → Nov 2008 | HIV infectious disease | Kirby Institute | Terminated | No outcome recorded |
| Phase 414 trials | ||||||
| Phase 4 | NCT06907355 | May → Nov 2025 | respiratory tract infectious disorder | Pontificia Universidad Catolica de Chile | Completed | No outcome recorded |
| Phase 4 | NCT05770960 | Jun 2018 → May 2019 | opioid-induced constipation | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT04066426 | Mar 2018 → Apr 2019 | temporomandibular joint disorder | Yuzuncu Yil University | Completed | No outcome recorded |
| Phase 4 | NCT03784105 | Sep 2017 → Dec 2018 | dyskinesia of esophagus | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT02255955 | Oct → Dec 2014 | — | Diskapi Yildirim Beyazit Education and Research Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02547896 | Sep 2014 → Jun 2015 | impacted teeth, multiple | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT02501564 | May 2013 → Nov 2014 | osteoarthritis | Istanbul Medeniyet University | Completed | No outcome recorded |
| Phase 4 | NCT01672112 | Jul 2012 → Jan 2015 | — | Tan Tock Seng Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01267136 | Jan 2011 → May 2012 | tonsillitis | Children's Hospitals and Clinics of Minnesota | Completed | No outcome recorded |
| Phase 4 | NCT01055704 | Nov 2009 → Feb 2010 | functional gastric disease | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT00921700 | Jun 2009 → Nov 2014 | neuropathy, painful | Ullevaal University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01189773 | Feb 2008 → Oct 2009 | — | St. Justine's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00378937 | Jan 2004 → Feb 2006 | cancer of unknown primary site | University Hospitals Bristol and Weston NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT00386269 | Jan 2004 → Sep 2007 | cleft palate | Institute of Child Health | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT04202406 | Jan → May 2021 | pulpitis | Cairo University | Completed | No outcome recorded |
| — | NCT04937101 | Jan → Dec 2021 | inflammatory disease | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT03478423 | Feb 2018 → Sep 2019 | — | Mount Sinai Hospital, Canada | Terminated | No outcome recorded |
| — | NCT02665533 | Jan 2016 | — | Federal University of the Valleys of Jequitinhonha and Mucuri | Completed | No outcome recorded |
| — | NCT00386243 | Dec 2007 → May 2012 | chronic pain syndrome | VA Office of Research and Development | Completed | No outcome recorded |
| — | NCT01010139 | Aug → Sep 2006 | — | Roxane Laboratories | Completed | No outcome recorded |
| — | NCT00245375 | Jan → Dec 2005 | gallbladder disorder | Nova Scotia Health Authority | Completed | No outcome recorded |
| — | NCT00474721 | Nov 2002 → Feb 2004 | — | University of California, San Diego | Completed | No outcome recorded |
Also used as a comparator or background therapy in 40 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT02737059 Comparator | Jul 2016 → May 2017 | opioid-induced constipation | Michael Camilleri | Completed | No outcome recorded |
| Phase 1 | NCT02157649 Comparator | Jun → Aug 2014 | — | Nexgen Pharma, Inc | Completed | No outcome recorded |
| Phase 1 | NCT02033707 Background | Apr 2014 → Feb 2019 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT01009892 Comparator | Jan 2008 | — | Roxane Laboratories | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02858310 Background | Jan 2017 → Jul 2025 | cervical intraepithelial neoplasia, human papilloma virus infection, in situ carcinoma, vulvar neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06095258 Comparator | Dec 2023 → Nov 2025 | long COVID-19 | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT03173456 Comparator | Nov 2017 → Nov 2019 | musculoskeletal system disorder | Albert Einstein College of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT02845271 Background | Jul 2016 → Jun 2017 | osteoarthritis | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT05081102 Comparator | Mar → May 2024 | — | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 3 | NCT04972292 Background | Nov 2023 → May 2024 | — | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 3 | NCT05229965 Comparator | Nov 2022 → Jun 2023 | — | University of Monastir | Completed | No outcome recorded |
| Phase 3 | NCT05626140 Comparator | Sep 2021 → May 2022 | sciatica | Pakistan Institute of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02625753 Comparator | Nov 2014 → Jun 2015 | myopia | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01402375 Comparator | Jan 2012 → Nov 2014 | — | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01229449 Comparator | Jan → Sep 2009 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00694369 Comparator | Jun → Dec 2008 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00299039 Comparator | May 2006 → Jun 2008 | breast disorder | Nova Scotia Health Authority | Completed | No outcome recorded |
| Phase 416 trials | ||||||
| Phase 4 | NCT06916234 Comparator | Jan → Dec 2023 | periodontitis | ibrahim doğru | Completed | No outcome recorded |
| Phase 4 | NCT04259333 Comparator | Mar → Dec 2020 | neuropathy, painful, substance-related disorder | Blake Raggio | Unknown | No outcome recorded |
| Phase 4 | NCT03472469 Comparator | Apr 2018 → Jul 2019 | — | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT04730297 Comparator | Jan 2018 → Sep 2020 | — | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 4 | NCT04399122 Comparator | Mar 2017 → Oct 2019 | — | 59th Medical Wing | Completed | No outcome recorded |
| Phase 4 | NCT03080493 Comparator | Mar 2017 → Nov 2018 | — | University of California, Davis | Completed | No outcome recorded |
| Phase 4 | NCT02647788 Comparator | Dec 2015 → Jan 2018 | neuropathy, painful | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT02455518 Comparator | Jul 2015 → Aug 2016 | — | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02032927 Comparator | Jun 2013 → Jun 2015 | chronic pain syndrome | Fondazione IRCCS Policlinico San Matteo di Pavia | Withdrawn | No outcome recorded |
| Phase 4 | NCT03049878 Comparator | Feb 2013 → Sep 2015 | — | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 4 | NCT01952652 Comparator | Jan → Jun 2013 | — | Baskent University | Completed | No outcome recorded |
| Phase 4 | NCT01782846 Comparator | Mar 2011 → Feb 2013 | — | Hopital Foch | Completed | No outcome recorded |
| Phase 4 | NCT00784810 Comparator | Feb 2009 → Mar 2010 | osteoarthritis | Napp Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 4 | NCT00699114 Comparator | Jun 2007 → Dec 2009 | — | Ullevaal University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00513864 Comparator | Nov 2006 → Mar 2012 | sickle cell disease | Children's National Research Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT00324038 Comparator | Mar 2006 → Dec 2007 | osteoarthritis | Napp Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT04874675 Comparator | Mar → Dec 2023 | impacted teeth, multiple | University of Zimbabwe | Suspended | No outcome recorded |
| — | NCT03902340 Comparator | Dec 2018 → Jun 2019 | osteoarthritis, knee | Sublimed | Unknown | No outcome recorded |
| — | NCT03239821 Comparator | Sep 2017 → Mar 2018 | movement disorder | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| — | NCT02883569 Background | Sep 2016 → Dec 2020 | — | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT02750696 Comparator | Apr 2013 → Dec 2014 | suppurative periapical periodontitis | Federal University of Rio Grande do Sul | Completed | No outcome recorded |
| — | NCT01605240 Comparator | Jul 2012 → Dec 2013 | — | University of Manitoba | Unknown | No outcome recorded |
| — | NCT02295280 Comparator | Jan 2012 → Nov 2014 | headache disorder | St. Louis University | Completed | No outcome recorded |
Evidence & citations 38 cited values
Every value below carries the sentence it was read from. 80 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Codeine | “Eligible participants received a single dose of Co-Codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via...” NCT00281684 ↗71“The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone...” NCT00245375 ↗ “cough medicine (such as codeine), bronchodilators (such as ventolin), expectorants (such as fluimucil) and so on are used to treat cough, shortness of breath, or other...” NCT06095258 ↗ “a Combination of Ibuprofen 400 mg Plus Codeine 25.6 mg (Nurofen Plus®); a Combination of Paracetamol 1000 mg Plus Codeine 30 mg (Panadeine® Extra)” NCT01229449 ↗ “Administration of IR Tablets combination of Codeine Phosphate/Guaifenesin 20mg/400mg every 4 hours for 12 hours total.” NCT02157649 ↗ “Combination of paracetamol and codeine in a fixed combination every 6 hours; maximum posology of codeine: 300mg/24h.” NCT03902340 ↗ “Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone)” NCT03472469 ↗ “Opioids: heroin, morphine, oxycodone, hydrocodone, methadone, codeine” NCT02033707 ↗ “Acetaminophen/codeine (300mg/30mg). Take 1 or 2 tablets qid prn pain” NCT00386243 ↗ “Diclofenac Sodium 50 mg associated with Codeine 50 mg” NCT02665533 ↗ “Tylex® (codeine 30 mg/paracetamol 500 mg)” NCT05081102 ↗ “codeine” NCT05463367 ↗ |
| Known as | Ambenyl cough syrup | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Bepro | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine hemisulfate sesquihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | CODEINE MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine Phosphate | “Drug: Codeine Phosphate” NCT05626140 ↗ |
| Known as | Codeine phosphate anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate bp | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate cii | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate component of ambenyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate component of bromanate dc | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate component of bromanyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate component of codrix | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate component of dimetane-dc | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate component of myphetane dc | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate component of triacin-c | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate hemihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine phosphate hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | CODEINE POLISTIREX | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine polistirex component of codeprex | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine polistirex component of penntuss | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | codeine sulfate | “Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral...” NCT01009853 ↗ |
| Known as | Codeine sulfate anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine sulfate cii | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine sulfate trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeine sulphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeini phosphas | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeinum | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Codeinum monohydricum | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Colrex compound | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Dea no. 9050 | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Dicodeine monosulfate trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Evacode | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | Galcodine | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Known as | IDS-NC-005(SECT.-2) | ChEMBL registry synonym — accepted as the source's own label CHEMBL485 ↗ |
| Action | Inhibit | “the increased risk of early discontinuation of metformin during co-administration with codeine is primarily due to local inhibition of OCT1 via codeine at the intestinal level” NCT03335423 ↗ |
| Modality | Small molecule | — CHEMBL485 ↗ |
| Route | Oral | “oral pain medications” NCT00174538 ↗ |