Drugs / Oxycodone
Oxycodone
also known as
Oxycodone Hydrochloride · oxycodone HCl · OxyContin · OxyNorm · OXY PR · oxycodone hydrochloride (HCl) · PF 00345439 · oxycodon · +25 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | OXYCODONE HYDROCHLORIDE | — | 2021-07-21 | fda.gov ↗ |
| Label expansion | US (FDA) | XTAMPZA ER | — | 2017-11-06 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | OXYCONTIN | — | 2013-04-16 – 2015-08-13 | fda.gov ↗ |
| Approved | US (FDA) | PERCODAN | — | 1950-04-12 | fda.gov ↗ |
Trials 210 · started per year
today
US approved 1950
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 06 trials | ||||||
| Phase 0 | NCT05846451 | Jun 2023 → Nov 2026 expected | — | Washington State University | Recruiting | No outcome recorded |
| Phase 0 | NCT03958474 | Aug 2019 → Jul 2025 | opiate dependence | University of Kentucky | Completed | No outcome recorded |
| Phase 0 | NCT03317730 | May 2018 → Dec 2019 | head and neck cancer | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 0 | NCT03393364 | Apr 2018 → Jun 2020 | urinary system disorder | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 0 | NCT06484439 | Feb 2018 → Nov 2021 | impacted teeth, multiple, neuropathy, painful | United States Naval Medical Center, San Diego | Completed | No outcome recorded |
| Phase 0 | NCT04587115 | Jun 2017 → Jun 2019 | drug dependence | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 138 trials · 1 met primary | ||||||
| Phase 1 | NCT07824258 | Sep 2026 → Dec 2030 expected | — | Columbia University | Recruiting | No outcome recorded |
| Phase 1 | NCT07223450 | Jun → Oct 2025 | — | Parc de Salut Mar | Completed | No outcome recorded |
| Phase 1 | NCT05485012 | Aug 2023 → Mar 2025 | cannabis dependence | Shanna Babalonis, PhD | Completed | No outcome recorded |
| Phase 1 | NCT05730062 | Mar 2023 → Jan 2025 | anxiety disorder, depressive disorder, respiratory underresponsiveness to hypoxia and hypercapnia | Leiden University Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT05742256 | Mar 2023 → Jul 2024 | — | Qianfoshan Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT03705559 | Jun 2019 → Feb 2024 | cannabis dependence | Shanna Babalonis, PhD | Completed | No outcome recorded |
| Phase 1 | NCT03679949 | Apr 2019 → Dec 2022 | substance abuse | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 1 | NCT04315181 | Mar 2019 → May 2023 | substance-related disorder | Sharon Walsh | Completed | No outcome recorded |
| Phase 1 | NCT03640247 | Nov 2018 → Dec 2019 | parathyroid gland disorder, thyroid gland disorder | MetroHealth Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03802227 | Oct 2018 → Dec 2019 | — | Nektar Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03475862 | May → Jul 2017 | opioid abuse | Pain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02824276 | Jan 2017 → Dec 2022 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02966860 | Aug → Sep 2016 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 1 | NCT02536209 | Aug → Nov 2015 | — | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02531906 | Apr 2015 → Jun 2018 | head and neck squamous cell carcinoma, stomatitis | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02165930 | Jul → Aug 2014 | — | Pain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02880475 | Jun 2014 → Jun 2015 | chronic pain syndrome | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02089295 | Apr → Jun 2014 | — | Pain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02117583 | Apr → Aug 2014 | — | Pain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02059915 | Apr → Jul 2014 | — | Pain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01924676 | Aug → Oct 2013 | — | Pain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01779492 | Apr → Jun 2013 | — | GL Pharm Tech Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01717027 | Nov 2012 → Jan 2013 | — | Pain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01552850 | Apr → Jun 2012 | — | Pain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01557257 | Mar → May 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01552863 | Mar → Sep 2012 | — | Pain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01456507 | Oct 2011 → Jan 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01643772 | May 2011 → Jul 2012 | — | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 1 | NCT01160614 | Jul 2010 → Aug 2011 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 1 | NCT01530542 | Jul → Sep 2010 | chronic pain syndrome, opioid abuse | Pfizer | Completed | Met primary |
| Phase 1 | NCT01127906 | Jun → Sep 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01482936 | May 2010 → Apr 2011 | — | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 1 | NCT00864526 | Oct 2006 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00864357 | Oct 2006 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00853892 | Apr 2005 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 1 | NCT00853320 | Feb 2003 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 1 | NCT00853736 | Feb 2003 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 1 | NCT00853216 | Jan → Feb 2003 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 1/24 trials · 1 missed | ||||||
| Phase 1/2 | NCT06757140 | Apr 2025 → Jan 2029 expected | — | Shanna Babalonis, PhD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04791761 | Apr 2021 → Jul 2023 | adenoid hypertrophy, substance-related disorder | David Chi, MD | Terminated | Missed primary Stop: Enrollment |
| Phase 1/2 | NCT04223609 | Feb 2020 → Apr 2022 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT03618823 | Oct 2018 → May 2020 | adenoid hypertrophy | David Chi, MD | Terminated | No outcome recorded |
| Phase 216 trials · 2 missed | ||||||
| Phase 2 | NCT05265052 | Dec 2026 expected | — | 3D Medicines | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06837857 | Apr 2025 → Jul 2029 expected | chronic pain syndrome | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT04676802 | Dec 2021 → Feb 2027 expected | neuropathy, painful, osteoarthritis, hand | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT04316559 | Dec 2021 → Feb 2025 | opiate dependence | National Institute on Drug Abuse (NIDA) | Terminated | No outcome recorded |
| Phase 2 | NCT03792295 | Jul → Dec 2021 | — | Khashayar Vaziri | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 | NCT03906721 | Feb 2019 → Nov 2021 | spinal cord injury | Spaulding Rehabilitation Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03588910 | Aug 2018 → Jul 2019 | — | Montefiore Medical Center | Completed | Missed primary |
| Phase 2 | NCT02541396 | Oct → Dec 2015 | — | iX Biopharma Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01871285 | Jun 2013 → Jul 2014 | — | BioDelivery Sciences International | Completed | Missed primary |
| Phase 2 | NCT01030406 | Jan → Feb 2010 | opioid abuse | Acura Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00818493 | Feb → Jul 2009 | — | QRxPharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00637975 | Sep 2007 → Dec 2010 | cancer | Associazione Progetto Oncologia UMAN.A | Completed | No outcome recorded |
| Phase 2 | NCT00734461 | Aug 2007 → Mar 2009 | opioid abuse | Pain Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00478101 | Feb 2006 → Apr 2007 | — | Gachon University Gil Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00000273 | Aug 1995 → Nov 2005 | heroin dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2/33 trials · 1 missed | ||||||
| Phase 2/3 | NCT03805386 | Jan 2019 → Apr 2020 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 2/3 | NCT02601586 | Sep 2016 → Nov 2020 | Parkinson disease | University Hospital, Toulouse | Completed | Missed primary |
| Phase 2/3 | NCT02321397 | Nov 2014 → Mar 2016 | — | Mundipharma Research GmbH & Co KG | Completed | No outcome recorded |
| Phase 345 trials · 9 met primary | ||||||
| Phase 3 | NCT07017452 | Aug → Dec 2025 overdue | benign prostatic hyperplasia | University of Manitoba | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07323914 | Mar 2025 → Jan 2027 expected | Alzheimer disease | Xuanwu Hospital, Beijing | Recruiting | No outcome recorded |
| Phase 3 | NCT05081102 | Mar → May 2024 | — | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 3 | NCT04808531 | Nov 2023 → Feb 2024 | — | Medlab Clinical | Unknown | No outcome recorded |
| Phase 3 | NCT05463809 | Jul 2022 → Jan 2023 | tenosynovitis of foot and ankle | Nanjing First Hospital, Nanjing Medical University | Unknown | No outcome recorded |
| Phase 3 | NCT04429022 | Nov 2020 → May 2022 | — | State University of New York at Buffalo | Completed | No outcome recorded |
| Phase 3 | NCT04296396 | Sep 2020 → Apr 2022 | pregnancy disorder, substance-related disorder | The George Washington University Biostatistics Center | Completed | Met primary |
| Phase 3 | NCT03586934 | Jun 2018 → Jun 2019 | substance-related disorder | Rush University Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03059238 | Sep 2016 → Mar 2019 | liver cancer | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 3 | NCT02732262 | Apr 2016 → Jul 2018 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02603705 | Mar 2016 → Jun 2017 | — | Egalet Ltd | Completed | No outcome recorded |
| Phase 3 | NCT02716857 | Mar 2016 → Aug 2017 | — | Egalet Ltd | Completed | No outcome recorded |
| Phase 3 | NCT02240602 | Jul 2015 → Oct 2016 | — | Seoul National University Hospital | Withdrawn | No outcome recorded |
| Phase 3 | NCT02401750 | Jun → Jul 2015 | — | Elite Laboratories, Inc | Completed | No outcome recorded |
| Phase 3 | NCT02084355 | Apr 2014 → Dec 2015 | cancer | Gyeongsang National University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01918098 | Sep 2013 → Mar 2017 | — | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | Met primary |
| Phase 3 | NCT02277678 | Aug 2013 → Dec 2014 | — | KK Women's and Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01885182 | Jun 2013 → Aug 2015 | cancer | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01685684 | Aug 2012 → Jun 2014 | chronic pain syndrome | Collegium Pharmaceutical, Inc. | Completed | Met primary |
| Phase 3 | NCT01402375 | Jan 2012 → Nov 2014 | — | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01369615 | Oct 2011 → Dec 2013 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT01451385 | Sep 2011 → Jun 2012 | osteoarthritis | Mallinckrodt | Completed | No outcome recorded |
| Phase 3 | NCT01427270 | Aug 2011 → Oct 2014 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT01675635 | Jul 2011 → Jun 2012 | — | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01358526 | May 2011 → Oct 2012 | — | Purdue Pharma LP | Completed | Met primary |
| Phase 3 | NCT01280331 | Jan → Apr 2011 | — | QRxPharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01675622 | Jan 2011 → Jun 2012 | cancer | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01428583 | Dec 2010 → May 2012 | chronic pain syndrome | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01192295 | Nov 2010 → Jul 2014 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT01112644 | Apr 2010 → Jun 2011 | — | Mundipharma Research GmbH & Co KG | Completed | Met primary |
| Phase 3 | NCT01304134 | Mar → Aug 2010 | — | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01055015 | Feb → Dec 2010 | — | QRxPharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01167699 | Jun 2009 → Apr 2011 | — | Mundipharma Pharmaceuticals B.V. | Completed | No outcome recorded |
| Phase 3 | NCT03365817 | Feb 2009 → Dec 2014 | chronic pain syndrome, substance-related disorder | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 3 | NCT00813488 | Dec 2008 → Nov 2009 | chronic pain syndrome | Cephalon | Completed | Met primary |
| Phase 3 | NCT00771758 | Sep 2008 → Dec 2009 | — | Ortho-McNeil Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00626600 | May 2008 → May 2009 | — | Mundipharma Research Limited | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00560183 | Nov 2007 → Apr 2008 | — | QRxPharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00463047 | Jul 2007 → Feb 2009 | chronic pain syndrome | Cephalon | Completed | Met primary |
| Phase 3 | NCT01559701 | Apr 2006 → Feb 2008 | — | Pain Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00412100 | Apr 2006 → Jul 2008 | — | Mundipharma Research GmbH & Co KG | Completed | Met primary |
| Phase 3 | NCT00313014 | Feb 2004 → Sep 2005 | — | Purdue Pharma LP | Terminated | Met primary |
| Phase 3 | NCT00092326 | Jun → Sep 2002 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092313 | Jun → Sep 2002 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00399048 | ? → May 2001 | osteoarthritis, hip, osteoarthritis, knee | Alza Corporation | Completed | No outcome recorded |
| Phase 471 trials · 2 met primary · 7 missed | ||||||
| Phase 4 | NCT07796152 | Sep 2026 → Dec 2027 expected | — | Endeavor Health | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07435077 | Aug → Dec 2026 expected | substance-related disorder | Wake Forest University Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07527039 | Apr 2026 → May 2028 expected | hypertrophy of breast | Carilion Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT07326683 | Dec 2025 → Jan 2026 | — | Xin Chen | Completed | No outcome recorded |
| Phase 4 | NCT06897917 | Apr → Dec 2025 overdue | opioid-induced constipation | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06671002 | Jan 2025 → Oct 2026 expected | — | University of Michigan | Recruiting | No outcome recorded |
| Phase 4 | NCT06731348 | Dec 2024 → Jul 2026 overdue | — | Walter Reed National Military Medical Center | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07750639 | Aug 2024 → Nov 2027 expected | drug dependence, opioid abuse, poisoning | AdventHealth | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06444997 | Jun 2024 → Feb 2025 | — | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT07001709 | Apr 2024 → Dec 2025 overdue | prostate cancer | Deventer Ziekenhuis | Recruiting | No outcome recorded |
| Phase 4 | NCT06864312 | Oct 2023 → Jan 2025 | — | University College Cork | Completed | No outcome recorded |
| Phase 4 | NCT06041425 | Aug → Dec 2023 | hepatocellular carcinoma | The First Affiliated Hospital with Nanjing Medical University | Completed | No outcome recorded |
| Phase 4 | NCT05929937 | Jul 2023 → Jun 2027 expected | — | Clayton Petro | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05722002 | Feb 2023 → Dec 2026 expected | neuropathy, painful | University of Michigan | Recruiting | No outcome recorded |
| Phase 4 | NCT05602519 | Nov 2022 → May 2023 | — | Al-Azhar University | Completed | No outcome recorded |
| Phase 4 | NCT05598905 | Oct 2022 → Jan 2024 | respiratory underresponsiveness to hypoxia and hypercapnia | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05515822 | Oct 2022 → Apr 2024 | — | Qiang Fu | Unknown | No outcome recorded |
| Phase 4 | NCT05142267 | Mar 2022 → Feb 2026 | substance-related disorder | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT06247488 | Jan 2022 → Apr 2023 | substance abuse | Arbor Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT05235503 | Dec 2021 → Dec 2022 | respiratory underresponsiveness to hypoxia and hypercapnia, substance-related disorder | Leiden University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT04285853 | Sep 2020 → Sep 2022 | — | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT04522206 | Aug 2020 → Jun 2021 | vertebral column disorder | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT04396587 | May 2020 → Jan 2023 | substance-related disorder | Peking University People's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04177342 | Jan → Dec 2020 | achalasia | Chen Wannan | Unknown | No outcome recorded |
| Phase 4 | NCT05327777 | Nov 2019 → Jul 2021 | opioid abuse | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT03179475 | Sep 2019 → Nov 2021 | chronic pain syndrome | University of British Columbia | Completed | No outcome recorded |
| Phase 4 | NCT03987022 | Aug 2019 → Apr 2022 | — | MetroHealth Medical Center | Completed | Missed primary |
| Phase 4 | NCT03783702 | Apr 2019 → Jul 2020 | drug dependence, opioid abuse, sinusitis | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT03685188 | Dec 2018 → Dec 2024 overdue | — | West China Hospital | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT03639415 | Oct 2018 → Oct 2020 | — | Fujian Cancer Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03145272 | Oct 2018 → Aug 2020 | — | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT03549611 | Aug 2018 → Jun 2019 | nephrolithiasis | Kevin J Flynn MD | Withdrawn | No outcome recorded |
| Phase 4 | NCT03592485 | Jun → Aug 2018 | mitral valve disorder | Medical University of Lublin | Completed | Met primary |
| Phase 4 | NCT03616639 | Jun → Dec 2018 | impaired renal function disease | Maastricht University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT03588806 | May 2018 → Jul 2019 | chronic pain syndrome, substance-related disorder | Ajay Wasan, MD, Msc | Terminated | No outcome recorded |
| Phase 4 | NCT03510910 | Apr 2018 → Dec 2019 | — | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT03415555 | Feb → Apr 2018 | mitral valve disorder | Medical University of Lublin | Completed | No outcome recorded |
| Phase 4 | NCT05363436 | Jan 2018 → Dec 2028 | opioid abuse | Thomas Jefferson University | Suspended | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03121963 | Nov 2017 → Nov 2020 | — | University of Alabama at Birmingham | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03139240 | May 2017 → May 2018 | — | Oregon Health and Science University | Completed | Missed primary |
| Phase 4 | NCT03019562 | Dec 2016 → Dec 2017 | — | Kyunghee University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT03176121 | Oct 2016 → Dec 2018 | cancer | Taiwan Mundipharma Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT02936934 | Oct → Dec 2016 | — | Hospital Civil de Guadalajara | Unknown | No outcome recorded |
| Phase 4 | NCT02741076 | Sep 2016 → Apr 2018 | opiate dependence, opioid abuse | Member Companies of the Opioid PMR Consortium | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02728648 | Apr 2016 → Nov 2017 | — | University of Malaya | Completed | No outcome recorded |
| Phase 4 | NCT02508935 | Nov 2015 → Apr 2017 | — | Mallinckrodt | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02660229 | Nov 2015 → Jul 2016 | — | Mundipharma Korea Ltd | Completed | Missed primary |
| Phase 4 | NCT02484352 | Jul → Oct 2015 | — | Yong-Hee Park | Completed | No outcome recorded |
| Phase 4 | NCT02452437 | May → Sep 2015 | chronic kidney disease | Emerio & Lourdes Linares Research and Education Center | Unknown | No outcome recorded |
| Phase 4 | NCT02573831 | Feb 2015 → Dec 2023 | — | Kuopio University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02573909 | Jan 2015 → Dec 2023 | neuropathy, painful | Kuopio University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02391844 | May 2014 → Dec 2015 | — | International Clinical Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02044497 | May 2014 → May 2027 expected | — | Boston Children's Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01959204 | Oct 2013 → Aug 2019 | — | VistaPharm, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01675531 | Dec 2012 → Dec 2013 | cancer | Mundipharma Korea Ltd | Completed | No outcome recorded |
| Phase 4 | NCT01719757 | Jul 2012 → Oct 2013 | cancer | Mundipharma Korea Ltd | Completed | No outcome recorded |
| Phase 4 | NCT01536301 | Jun 2012 → Nov 2016 | osteoarthritis, hip | Nîmes University Hospital | Completed | Missed primary |
| Phase 4 | NCT02573922 | May 2012 → Dec 2014 | constipation disorder | Kuopio University Hospital | Completed | Missed primary |
| Phase 4 | NCT02238340 | Mar → Aug 2012 | — | Hospital Central Dr. Luis Ortega | Completed | No outcome recorded |
| Phase 4 | NCT01809106 | Apr 2011 → Oct 2014 | cancer | Mario Negri Institute for Pharmacological Research | Completed | Missed primary |
| Phase 4 | NCT00964808 | Sep 2009 → May 2013 | neuropathy, painful | Vejle Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01115101 | Jul → Nov 2009 | — | Max Dieterich | Completed | No outcome recorded |
| Phase 4 | NCT00784810 | Feb 2009 → Mar 2010 | osteoarthritis | Napp Pharmaceuticals Limited | Completed | Met primary |
| Phase 4 | NCT00681174 | Jul 2008 → Nov 2010 | — | University of Parma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00480142 | Jul 2007 → Jul 2008 | hernia, double inguinal | Kaplan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00499460 | Nov 2006 → Aug 2008 | — | Fred Hutchinson Cancer Center | Completed | Missed primary |
| Phase 4 | NCT00369811 | Aug 2006 → Sep 2007 | — | Danish Pain Research Center | Completed | No outcome recorded |
| Phase 4 | NCT00271973 | Feb 2006 → Jan 2007 | — | Odense University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00260260 | Jun 2005 → Dec 2007 | — | Odense University 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 | NCT00027014 | Sep 2001 → May 2005 | — | National Center for Complementary and Integrative Health (NCCIH) | Completed | No outcome recorded |
| Phase not applicable27 trials · 2 met primary · 1 missed | ||||||
| — | NCT07651722 | Jun → Sep 2026 overdue | paralytic ileus | Tianjin First Central Hospital | Recruiting | No outcome recorded |
| — | NCT06721988 | Jan 2025 → Dec 2026 expected | chronic pain syndrome | Ailin Luo | Not yet recruiting | No outcome recorded |
| — | NCT06665048 | Dec 2024 → Dec 2025 overdue | — | Shantou University Medical College | Not yet recruiting | No outcome recorded |
| — | NCT06534801 | Sep 2024 → Jul 2025 overdue | — | Jianbo Wu | Not yet recruiting | No outcome recorded |
| — | NCT06517069 | May 2024 → Jun 2025 overdue | — | Yangzhou University | Recruiting | No outcome recorded |
| — | NCT06240390 | May → Aug 2024 | neuropathy, painful | Universidad Europea de Canarias | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT06276179 | Feb → Aug 2024 | — | Kafrelsheikh University | Unknown | No outcome recorded |
| — | NCT05795478 | Oct 2023 → Dec 2024 overdue | chronic pain syndrome | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT05548582 | Jan 2023 → Dec 2026 expected | neuropathy, painful, opioid abuse | Johns Hopkins University | Active not recruiting | No outcome recorded |
| — | NCT05510986 | Oct 2022 → Oct 2024 | — | General Hospital of Ningxia Medical University | Unknown | No outcome recorded |
| — | NCT06485817 | Nov 2021 → Apr 2022 | acute stress disorder, opioid abuse | University of Oslo | Completed | No outcome recorded |
| — | NCT04523623 | Jul 2020 → Jun 2021 | childhood acute lymphoblastic leukemia | Washington University School of Medicine | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT04295109 | Mar → Jul 2020 | adenomyosis, endometrial cancer, leiomyoma, uterine cervix neoplasm | The First Affiliated Hospital with Nanjing Medical University | Unknown | Met primary |
| — | NCT05393414 | Nov 2019 → Mar 2020 | — | University of Puerto Rico | Completed | No outcome recorded |
| — | NCT03959969 | Jul → Dec 2019 | — | Medstar Health Research Institute | Completed | Met primary |
| — | NCT04121416 | Apr → Aug 2019 | cardiovascular disorder | Shengjing Hospital | Completed | No outcome recorded |
| — | NCT04044820 | Mar 2019 → Dec 2026 expected | substance-related disorder | University Health Network, Toronto | Recruiting | No outcome recorded |
| — | NCT03024515 | Aug 2018 → Dec 2020 | — | Chinese University of Hong Kong | Completed | No outcome recorded |
| — | NCT04176783 | Mar 2018 → Jul 2021 | — | OrthoCarolina Research Institute, Inc. | Completed | No outcome recorded |
| — | NCT03478423 | Feb 2018 → Sep 2019 | — | Mount Sinai Hospital, Canada | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT03120962 | May 2017 → May 2020 | herpes zoster, postherpetic neuralgia | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT03045484 | May 2016 → May 2018 | nasopharyngeal carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| — | NCT02455726 | Sep 2015 → Dec 2017 | peripheral arterial disease | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Unknown | No outcome recorded |
| — | NCT01016821 | Nov 2009 → Dec 2010 | — | Kuopio University Hospital | Completed | No outcome recorded |
| — | NCT00999544 | Oct 2009 → Apr 2011 | opioid abuse | Sharon Walsh | Completed | No outcome recorded |
| — | NCT00726830 | Mar 2009 → Sep 2010 | cancer of unknown primary site, central nervous system neoplasm, leukemia, lymphoproliferative syndrome +5 | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00337792 | Jun 2006 → Jul 2007 | — | Planned Parenthood League of Massachusetts | Terminated | Missed primary Stop: Enrollment |
| Comparator or background therapy267 trials | ||||||
| Phase 0 | NCT05761860 Comparator | Sep 2023 → Dec 2026 expected | — | University of Florida | Recruiting | No outcome recorded |
| Phase 0 | NCT04218409 Comparator | Sep 2021 → Dec 2026 expected | — | University of Florida | Recruiting | No outcome recorded |
| Phase 0 | NCT04612920 Background | Dec 2020 → Mar 2023 | — | University of Oklahoma | Completed | No outcome recorded |
| Phase 0 | NCT03845881 Comparator | Apr 2019 → Jul 2020 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT03837860 Comparator | Apr 2019 → Mar 2021 | opiate dependence, opioid abuse | The University of Texas Health Science Center at San Antonio | Terminated | No outcome recorded |
| Show all 267 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 50
| Date | Issuer | Release |
|---|---|---|
| 2024-02-15 | Ensysce Biosciences | Results Ensysce Biosciences Announces Publication of Clinical Bioequivalence Manuscript ensysce.com ↗
The BE arm showed that plasma oxycodone bioequivalence was successfully achieved between 100 mg PF614 and 40 mg OxyContin. |
| 2022-05-05 | Ensysce Biosciences | Results Ensysce Biosciences Announces New Clinical Results from Trials PF614-102 and PF614-MPAR-101 ensysce.com ↗
A distinguishing feature of PF614 is its terminal half-life which on Day 5 ranged from 13.75 to 28.4 hour as compared to 4.5 to 7.8 hour for OxyContin. |
| 2022-01-04 | Ensysce Biosciences | Results Ensysce Biosciences Achieves Successful Completion of Part A of Multiple-Ascending Dose (MAD)/Bioequivalents (BE) Trial for its Next Generation Opioid, PF614 ensysce.com ↗
PK data confirmed similar dose-proportionate increases in plasma oxycodone following PF614 and OxyContin and there were no unexpected adverse events in either the PF614 or OxyContin dose groups. |
| 2020-10-26 | BioDelivery Sciences International | Results Collegium Announces Publication of “Postmarketing Analysis of Misuse, Abuse, and Diversion of Xtampza® ER” in Pain Medicine collegiumpharma.com ↗
The publication presents certain real-world evidence related to abuse, misuse and diversion of Xtampza ER assessed using Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS ® ) system data sources. |
| 2018-10-29 | BioDelivery Sciences International | Results Collegium Announces Publication of Data on Oral Abuse Potential of Xtampza ER collegiumpharma.com ↗
The results demonstrated that intact and chewed Xtampza ER (fed or fasted) had statistically significantly lower peak "Drug Liking" when compared with crushed immediate-release oxycodone. |
| 2018-09-17 | Ensysce Biosciences | Results Ensysce Biosciences Receives Multi-Year NIDA Grant to Study and Deliver Opioid Overdose Protection ensysce.com ↗
The trial results in 60 subjects randomized to receive PF614 or OxyContin™, showed over 90% efficient release of oxycodone from PF614 and an improved safety profile over OxyContin™. |
| 2017-11-07 | BioDelivery Sciences International | Regulatory Collegium Receives FDA Approval for sNDA for Xtampza® ER collegiumpharma.com ↗
With approval of the sNDA, the updated label for Xtampza ER includes three main changes: |
| 2017-11-06 | BioDelivery Sciences International | Regulatory Collegium Notified that the FDA Will Not Meet PDUFA Goal Date for sNDA for Xtampza® ER collegiumpharma.com ↗ |
| 2017-09-27 | Lannett Company, Inc. | Regulatory Lannett Receives FDA Approval For Oxycodone And Acetaminophen Tablets USP, 5 mg/325 mg And 10 mg/325 mg investorroom.com ↗
Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg and 10 mg/325 mg, the therapeutic equivalent to the reference listed drug, Percocet® Tablets, 5 mg/325 mg and 10 mg/325 mg, of Vintage Pharmaceuticals, LLC. |
| 2017-06-14 | Lupin Limited | Regulatory Lupin receives FDA approval for generic Roxicodone® Tablets lupin.com ↗ |
| 2017-02-28 | Lupin Limited | Regulatory Lupin Receives FDA Approval for Generic Percocet® Tablets lupin.com ↗ |
| 2017-02-01 | BioDelivery Sciences International | Results Collegium Announces Positive Topline Results of Human Abuse Potential Clinical Trial Evaluating the Oral Abuse of Xtampza ER collegiumpharma.com ↗
The study met its primary and secondary endpoints of lower “Drug Liking” and “Take Drug Again”. |
| 2016-11-10 | BioDelivery Sciences International | Regulatory Collegium Reports Third Quarter Financial Results and Provides Corporate Update collegiumpharma.com ↗
Furthermore, we submitted a Supplemental New Drug Application to enhance the label for Xtampza ER and submitted a New Drug Submission to Health Canada seeking marketing approval for Xtampza ER in an important market outside of the U.S. |
| 2016-10-05 | BioDelivery Sciences International | Regulatory Collegium Submits Supplemental New Drug Submission to FDA for Xtampza® ER collegiumpharma.com ↗ |
| 2016-10-03 | BioDelivery Sciences International | Regulatory Collegium Submits New Drug Submission to Health Canada for Xtampza® ER, an Analgesic with Abuse-Deterrent Properties for the Treatment of Chronic Pain collegiumpharma.com ↗ |
| 2016-09-29 | BioDelivery Sciences International | Results Collegium Announces Publication of Data on Oral Abuse Potential of Xtampza ER collegiumpharma.com ↗
The study results demonstrated that chewed Xtampza ER had significantly lower peak "Drug Liking" (Emax) when compared with crushed immediate-release oxycodone (p < 0.0001). |
| 2016-08-19 | Pfizer | Regulatory FDA Approves TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules CII with Abuse-Deterrent Properties for the Management of Pain pfizer.com ↗
the U.S. Food and Drug Administration (FDA) has approved TROXYCA ® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules |
| 2016-08-16 | BioDelivery Sciences International | Results Collegium Announces Publication of Data on Alternative Modes of Administration of Xtampza ER collegiumpharma.com ↗
The results of these studies suggest that Xtampza ER could provide a valuable treatment option, especially in those patients who have dysphagia or an aversion to swallowing tablet formulations and for whom alternative therapies are not a viable therapeutic option. |
| 2016-06-08 | Pfizer | Regulatory Pfizer Announces FDA Advisory Committees’ Recommend ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules for Approval pfizer.com ↗
The Committees recommended the inclusion of abuse-deterrent labeling for intranasal (11 to 4) and intravenous (9 to 6) routes of abuse. |
| 2016-05-04 | BioDelivery Sciences International | Results Collegium Announces Positive Topline Results of Comparative Clinical Trial Evaluating the Effect of Crushing Xtampza™ ER Compared with OxyContin® collegiumpharma.com ↗
Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced positive topline results from a comparative clinical trial evaluating the effect of physical manipulation by crushing of Xtampza™ ER (oxycodone extended-release capsules) compared with the abuse-deterrent version of OxyContin ® (oxycodone hydrochloride extended-release tablets). |
| 2016-04-26 | BioDelivery Sciences International | Regulatory Collegium Receives FDA Approval for Xtampza™ ER, an Analgesic with Abuse-Deterrent Properties for the Treatment of Chronic Pain collegiumpharma.com ↗
The FDA approval of Xtampza ER is a major milestone for Collegium. |
| 2016-04-07 | BioDelivery Sciences International | Results Collegium Announces Publication of Data on the Durability of Pain Relief with Xtampza ER collegiumpharma.com ↗
The analysis of the data from the Phase 3 randomized withdrawal, double-blind, placebo-controlled, enriched-enrollment, parallel-group, multicenter, 12-week clinical study in patients with chronic low back pain showed limited use of acetaminophen, the only rescue medication used in the study. |
| 2015-12-16 | BioDelivery Sciences International | Results Collegium Announces Publication of Nasal Human Abuse Potential Study in American Academy of Pain Medicine collegiumpharma.com ↗
Xtampza ER (both crushed intranasal and intact oral) had significantly lower maximum (peak) drug liking (Emax) when compared with intranasal crushed IR oxycodone (p ≤ 0.0001). |
| 2015-11-09 | BioDelivery Sciences International | Regulatory Collegium Announces FDA Tentative Approval for Xtampza(TM) ER, a Novel Abuse-Deterrent Analgesic for Chronic Pain collegiumpharma.com ↗
We are very pleased that the FDA has granted tentative approval for Xtampza ER. |
| 2015-10-12 | BioDelivery Sciences International | Regulatory Collegium Provides Update on FDA Review of Xtampza(TM) ER, an Abuse-Deterrent Analgesic for the Treatment of Chronic Pain collegiumpharma.com ↗ |
| 2015-09-11 | BioDelivery Sciences International | Regulatory Collegium Announces FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER(TM), an Abuse-Deterrent Analgesic for Chronic Pain collegiumpharma.com ↗
Collegium Pharmaceutical, Inc. (NASDAQ:COLL) today announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration ( FDA ) voted unanimously to support the approval of Xtampza ER™ (oxycodone extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| 2015-08-24 | BioDelivery Sciences International | Results Collegium Publishes Data From Xtampza(TM) ER Phase 3 Clinical Trial in the Journal PAIN collegiumpharma.com ↗
The study met its primary endpoint which showed a statistically significant difference in average pain intensity from Randomization Baseline to Week 12 between the Xtampza ER and placebo groups (p<0.0001). |
| 2015-08-07 | BioDelivery Sciences International | Regulatory Collegium Announces FDA Advisory Committee Meeting for Xtampza(TM) ER, an Abuse-Deterrent Analgesic for Chronic Pain collegiumpharma.com ↗
CANTON, Mass. , Aug. 7, 2015 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration ( FDA ) is scheduled to review the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone extended-release capsules) on September 11, 2015 . |
| 2015-06-25 | BioDelivery Sciences International | Results Collegium Announces Publication of "Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations With Abuse-Deterrent Properties," in Pain Medicine collegiumpharma.com ↗
Crushing Xtampza ER demonstrated no increase in Cmax, Tmax, or AUC and was bioequivalent to taking Xtampza ER intact capsules. |
| 2015-06-15 | BioDelivery Sciences International | Results Collegium to Present Xtampza ER(TM) Oral Human Abuse Potential Data at the College on Problems of Drug Dependence 77th Annual Meeting collegiumpharma.com ↗
The oral HAP study demonstrated that chewed Xtampza ER had significantly lower peak "Drug Liking" (E max ) when compared with crushed IR oxycodone (p < 0.0001). |
| 2015-02-12 | BioDelivery Sciences International | Regulatory Collegium Pharmaceutical Announces FDA Acceptance for Filing of NDA for Xtampza ER™ (oxycodone extended-release capsules), an Abuse-Deterrent Analgesic for Chronic Pain collegiumpharma.com ↗ |
| 2015-01-15 | BioDelivery Sciences International | Results “Evaluation of an Extended-Release, Abuse-Deterrent, Microsphere-in-Capsule Analgesic for the Management of Patients with Chronic Pain with Dysphagia (CPD),” Published in Pain Practice collegiumpharma.com ↗
The drug release profile of Xtampza ER microspheres sprinkled onto and mixed with various soft foods were similar to the control, intact Xtampza ER capsules. |
| 2014-12-15 | BioDelivery Sciences International | Regulatory Collegium Pharmaceutical Submits New Drug Application for Xtampza™ ER (oxycodone extended-release); Its Abuse-Deterrent, Extended-Release Analgesic for the Treatment of Chronic Pain collegiumpharma.com ↗
today announced that it has filed a New Drug Application ( NDA ) with the U.S. Food & Drug Administration ( FDA ) |
| 2014-11-17 | BioDelivery Sciences International | Results Collegium Pharmaceutical Releases Positive Top-Line Results of Oral Human Abuse Potential (HAP) Study with Oxycodone DETERx®, an Abuse-Deterrent, Extended-Release Product collegiumpharma.com ↗
The Oral HAP study, demonstrated that chewed Oxycodone DETERx ® , had significantly lower peak “drug liking” (Emax) when compared with crushed immediate release ( IR ) oxycodone (p < 0.0001). |
| 2014-08-20 | BioDelivery Sciences International | Results Collegium Pharmaceutical Announces Publication of Abuse-Deterrent Data on Oxycodone DETERx® in Journal of Opioid Management collegiumpharma.com ↗
Results from both studies, taken together, provide empirical data to show that manipulation by crushing or chewing did not alter the drug release or PK profile of Oxycodone DETERx. |
| 2014-08-06 | BioDelivery Sciences International | Results Collegium Pharmaceutical Announces Positive Top-Line Data from Phase III Study of Oxycodone DETERx®, its Abuse-Deterrent, Extended-Release Product for Chronic Pain collegiumpharma.com ↗
Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced positive top-line results from its pivotal Phase 3 study of the company’s investigational analgesic Oxycodone DETERx ® that studied the treatment of patients with moderate-to-severe chronic low back pain. |
| 2014-04-02 | BioDelivery Sciences International | Results Collegium Pharmaceutical Announces Positive Topline Results of Clinical Study Evaluating the Effect of Crushing Oxycodone DETERx® Compared with OxyContin® collegiumpharma.com ↗
today announced positive topline results from a clinical study evaluating the effect of physical manipulation by crushing on Oxycodone DETERx ® , it’s extended-release ( ER ), abuse-deterrent, oxycodone microsphere-in-capsule product, compared with reformulated OxyContin ® (OxyContin). |
| 2012-09-20 | Acura Pharmaceuticals Inc. | Regulatory Acura Pharmaceuticals Announces Paragraph IV ANDA Filing for OXECTA(R) acurapharm.com ↗
Acura Pharmaceuticals Announces Paragraph IV ANDA Filing for OXECTA(R) |
| 2011-04-11 | Impax Laboratories, LLC | Regulatory Impax Laboratories Confirms Patent Challenge Relating to OXYCONTIN(R) 10, 15, 20, 30, 40, 60, and 80 mg amneal.com ↗
Following receipt of the notice from FDA that Impax's ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owners of its paragraph IV certification. |
| 2009-04-13 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval to market generic Roxicodone® tablets. sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market generic Roxicodone ®, oxycodone hydrochloride tablets. |
| 2005-12-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval of Oxycodone ER Tablets, 10 Mg, 20 Mg and 40 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Oxycodone Extended Release Tablets, 10 mg, 20 mg and 40 mg. |
| 2005-12-06 | Impax Laboratories, LLC | Regulatory IMPAX Receives Final FDA Approval for Generic Version of OxyContin in 10mg, 20mg and 40mg Strengths; Sixth Approval in 2005 amneal.com ↗ |
| 2005-03-02 | Impax Laboratories, LLC | Regulatory IMPAX Receives Final FDA Approval for Generic Version of Dantrium; Global Division to Launch Immediately amneal.com ↗
The Company's revised RMP now is acceptable to the regulatory agency. |
| 2004-12-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Oxycodone Hydrochloride Er Tablets, 10 Mg, 20 Mg, And 40 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Oxycodone Hydrochloride Extended Release Tablets, 10 mg, 20 mg, and 40 mg. |
| 2004-09-24 | Impax Laboratories, LLC | Regulatory IMPAX Receives Final FDA Approval for Oxycodone Hydrochloride Controlled Release Tablets, 80mg; Tenth Approval in 2004 amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of OxyContin(R) (Oxycodone Hydrochloride) Controlled Release 80mg Tablets. |
| 2003-12-24 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Tentative Approval for Generic Versions Of OxyContin; Ninth ANDA Approval in 2003 amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for generic versions of OxyContin(R) (Oxycodone Hydrochloride) Controlled Release Tablets, 10, 20 and 40 mg. |
| 2003-11-05 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Tentative Approval for Generic Versions Of OxyContin; Ninth ANDA Approval in 2003 amneal.com ↗
the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Oxycontin®(Oxycodone Hydrochloride) Controlled Release Tablets, 80 mg. |
| 2003-09-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Oxycodone Hydrochloride ER Tablets, 80 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval to the company's ANDA for Oxycodone Hydrochloride Extended Release Tablets, 80 mg. |
| 2002-08-22 | Impax Laboratories, LLC | Regulatory IMPAX ANDA Filing for Generic Version of Oxycontin 40MG Accepted By FDA amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Oxycontin® (Oxycodone HCl) Extended Release 40 mg Tablets. |
| 2002-02-26 | Impax Laboratories, LLC | Regulatory IMPAX ANDA Filing for Generic Version of Oxycontin Accepted by FDA amneal.com ↗
The FDA's acceptance of the ANDA for filing means that the agency has determined that the application is sufficiently complete so as to permit a review. |
All press releases naming this drug 77 releases
Evidence & citations 37 cited values
Every value below carries the sentence it was read from. 487 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Oxycodone | “The objectives of this study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN) prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10...” NCT02880475 ↗461“A Double-blind, Randomized, Parallel Group Study to Compare the Efficacy and Safety, of Oxycodone Immediate-release Capsules Versus Morphine Immediate-release Tablets in...” NCT01675635 ↗ “Xtampza ER is a wax microsphere formulation of oxycodone that results in a nearly identical pharmacokinetic profile regardless of whether the capsule is intact when ingested or...” NCT03317730 ↗ “The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under...” NCT05485012 ↗ “If patient weight \<100 kg, oxycodone 5 mg tab PO q6h PRN for pain score 8-10 will be prescribed; disp-10, no refill. If patient weight \>100 kg, oxycodone 10 mg tab PO q6h PRN...” NCT07527039 ↗ “Opioid standard care pain medicine prescribed for an outpatient total knee arthroplasty is typically hydrocodone/acetaminophen (Norco), oxycodone (Oxycontin), or tramadol...” NCT07796152 ↗ “A Randomized, Repeated- Dose, Parallel-Group Comparison of Safety, Efficacy, and Quality of Life Measures With Dilaudid CR (Hydromorphone HCI) or Oxycontin (Oxycodone HCI) in...” NCT00399048 ↗ “OBJECTIVE: To evaluate the efficacy and safety of two dose strengths of oxycodone hydrochloride (HCl)/niacin tablets * for the treatment of moderate-to-severe postoperative...” PMID 21231862 ↗ Jan 2011 “This study aims to evaluate the safety and efficacy of 3D1002 alone or in combination with oxycodone hydrochloride sustained-release tablets (OxyContin) for the management of...” NCT05265052 ↗ “Participants who belong to the experimental arm will be given a single 'per os' dose of percocet (325mg acetaminophen + 7.5mg oxycodone) and lorazepam 1 mg, 30 minutes prior to...” NCT07017452 ↗ “ALO-02 capsules, intended to deter abuse, contain pellets of extended-release oxycodone hydrochloride (HCl), an opioid agonist, surrounding sequestered naltrexone HCl, an...” PMID 25724154 ↗ Apr 2015 |
| Known as | Apo-Oxycodone CR | “a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®” NCT02101840 ↗ |
| Known as | CR Oxycodone | “The common adverse event of Controlled-Release Oxycodone(CR Oxycodone ) are nausea (29.9%)、constipation （25.4%）、dizziness（22.4%） and vomit（11.9%）” NCT03639415 ↗ |
| Known as | GL2907 XL | “GL2907 XL 20mg (Oxycodone 20mg, fasted)” NCT01568450 ↗ |
| Known as | Ircodon | “Drug generic names: celecoxib (celebrex), Pregabalin (Lyrica), acetaminophen/tramadol (ultracet ER), oxycodone (Ircodon)” NCT02600247 ↗ |
| Known as | IRO-A | “An immediate-release oxycodone hydrochloride formulation (IRO-A) indicated for moderate to severe pain was designed (by adding functional excipients) to discourage tampering...” PMID 22717418 ↗ Jun 2012 |
| Known as | OC-CR | “OBJECTIVE: To compare cognitive and psychomotor effects of oxymorphone extended release (OM-ER) versus oxycodone controlled release (OC-CR).” PMID 21102969 ↗ Nov 2010 |
| Known as | ORF | “Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours” NCT01160614 ↗ |
| Known as | OXY PR | “Subjects with moderate to severe pain due to osteoarthritis (OA) will be randomised to oxycodone/naloxone prolonged release (OXN PR) or oxycodone prolonged release tablets...” NCT00902837 ↗3“compared with oxycodone prolonged-release tablets (OxyPR) in patients with moderate/severe cancer pain.” PMID 21937568 ↗ Sep 2011 “Oxycodone 10 or 20 mg Prolonged Release Tablets (OXY PR)” NCT01083485 ↗ “prolonged-release oxycodone (OXY PR, N = 115)” PMID 32020565 ↗ Feb 2020 |
| Known as | oxycodon | “If analgesia is inadequate oxycodon (OxyNorm®) (10 mg (less than 80 kg) - 15 mg (over 80 kg) po.” NCT02678897 ↗ |
| Known as | oxycodone controlled release | “OBJECTIVE: To compare cognitive and psychomotor effects of oxymorphone extended release (OM-ER) versus oxycodone controlled release (OC-CR).” PMID 21102969 ↗ Nov 2010 |
| Known as | Oxycodone CR | “The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).” NCT00955110 ↗1“Oxycodone CR One 5 mg to 40 mg capsule twice daily for 4 weeks.” NCT01165281 ↗ |
| Known as | Oxycodone HCI | “A Randomized, Repeated- Dose, Parallel-Group Comparison of Safety, Efficacy, and Quality of Life Measures With Dilaudid CR (Hydromorphone HCI) or Oxycontin (Oxycodone HCI) in...” NCT00399048 ↗ |
| Known as | oxycodone HCl | “A total of 606 patients aged ≥18 years with moderate-to-severe pain post-bunionectomy were screened, and 405 patients were randomized to receive placebo, 2 × 5/30 mg oxycodone...” PMID 21231862 ↗ Jan 201116“A Phase 4 Randomized Double-Blind Double-Dummy Placebo & Active-Controlled Single-Dose Six-Way Crossover Study Evaluating the Abuse Potential of Lyrica® Taken Orally With...” NCT05053126 ↗ “tapentadol ER (100-250 mg bid) has been shown to provide comparable pain relief to oxycodone HCl CR (20 - 50 mg bid) for chronic osteoarthritis knee pain and low back pain over...” PMID 23340531 ↗ Jan 2013 “Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.” NCT01192295 ↗ “Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin” NCT05319756 ↗ “Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours” NCT01427270 ↗ “Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours” NCT01427283 ↗ “Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).” NCT00313014 ↗ “Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.” NCT01825447 ↗ “oxycodone HCl and naltrexone HCl extended-release capsules” NCT01428583 ↗ “oxycodone HCl controlled release (CR; 20-50 mg)” PMID 24353047 ↗ Sep 2013 |
| Known as | oxycodone HCl CR | “Patients were randomized (1:1) to receive oral tapentadol ER (25-200 mg bid) or oral oxycodone HCl CR (5-40 mg bid) for 4 weeks of double-blind treatment.” PMID 23937387 ↗ Aug 2013 |
| Known as | Oxycodone HCL IR | “Oxycodone HCL IR Fixed Dose 10 mg BID for 3 days” NCT00364533 ↗ |
| Known as | Oxycodone Hydrochloride | “The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged...” NCT01369615 ↗26“The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16...” NCT01192295 ↗ “An immediate-release oxycodone hydrochloride formulation (IRO-A) indicated for moderate to severe pain was designed (by adding functional excipients) to discourage tampering...” PMID 22717418 ↗ Jun 2012 “Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two...” PMID 31456431 ↗ Sep 2019 “Oxycodone hydrochloride and naloxone hydrochloride dihydrate combined oral prolonged release tablets (OXN PR), is the investigational product to be used in this study.” NCT01439100 ↗ “Oxycodone hydrochloride, a newer opioid with established analgesic effects in adult surgery, has been less studied in pediatric contexts.” NCT06665048 ↗ “Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours” NCT01160614 ↗ “naloxone (naloxone hydrochloride) + oxycodone (oxycodone hydrochloride)” NCT06390046 ↗ “Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg” NCT04448457 ↗ “oxycodone hydrochloride (HCl) controlled release (CR; 20-50 mg)” PMID 24985410 ↗ Jul 2014 “Oxycodone Hydrochloride 50mg/mL Administered as an Infusion” NCT00626600 ↗ |
| Known as | oxycodone hydrochloride (HCl) | “ALO-02 capsules, intended to deter abuse, contain pellets of extended-release oxycodone hydrochloride (HCl), an opioid agonist, surrounding sequestered naltrexone HCl, an...” PMID 25724154 ↗ Apr 20153“patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100-250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20-50 mg).” PMID 24985410 ↗ Jul 2014 “Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.” NCT01825447 ↗ “Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users” NCT03996694 ↗ |
| Known as | Oxycodone hydrochloride (HCl) immediate-release (IR) tablets, 40 mg | “Oxycodone hydrochloride (HCl) immediate-release (IR) tablets, 40 mg” NCT05571345 ↗ |
| Known as | Oxycodone Hydrochloride Injection | “Oxycodone（Oxycodone Hydrochloride Injection，IV）” NCT07326683 ↗ |
| Known as | Oxycodone Immediate-Release | “Drug: Oxycodone Immediate-Release” NCT00313014 ↗ |
| Known as | Oxycodone IR | “Drug: Oxycodone IR” NCT06423703 ↗ |
| Known as | Oxycodone XL | “Oxycodone XL 20mg/day(20mg once a day, after high fat meal)” NCT01568450 ↗ |
| Known as | Oxycodone, Hameln (ATC code: N02A A05) | “Oxycodone, Hameln (ATC code: N02A A05)” NCT05639712 ↗ |
| Known as | Oxycodone, oxycontin | “Oxycodone, oxycontin” NCT01859715 ↗ |
| Known as | OxyContin | “This was a multicenter, open-label, randomized (patients are assigned different treatments based on chance), dose-titration, parallel-group study characterizing the...” NCT00399048 ↗15“The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet...” NCT00853268 ↗ “Intraoperative time: intravenous ketamine 0.5 mg kg-1, intravenous dexamethasone 8 mg Postoperative time: paracetamol 1 g every 6 hours a day, nefopam 20 every 8 hours a day,...” NCT06381063 ↗ “Opioid standard care pain medicine prescribed for an outpatient total knee arthroplasty is typically hydrocodone/acetaminophen (Norco), oxycodone (Oxycontin), or tramadol...” NCT07796152 ↗ “Patients will take either control-released oxycodone (OxyContin® 10mg and 20mg) or immediate-released oxycodone (OxyNorm® 5mg) or both for initial dose and used it to titrate...” NCT03176121 ↗ “OxyContin 10 mg® (oxycodone extended-release 10 mg): Administered by the patient as oral premedication 1 hour before scheduled start of surgery.” NCT03314792 ↗ “comprising of oxycodone immediate release (OXYNORM) and oxycodone sustained release (OXYCONTIN) in pre-defined doses and frequencies” NCT03024515 ↗ “commercially available controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.)” NCT00853892 ↗ “Oral Oxycodone 20mg (Oxycontin) controlled release formulation” NCT01127906 ↗ “Crushed OxyContin (oxycodone) extended-release 40 mg tablet” NCT03475862 ↗ “Every 12 hours for control-released oxycodone (OxyContin®)” NCT03176199 ↗ |
| Known as | Oxycontin CR | “Oxycontin CR 10mg (Oxycodone 10mg, fasted)” NCT01568450 ↗ |
| Known as | OxyIR | “Oxycodone (OxyContin®, OxyIR®, Roxicodone®)” NCT06240390 ↗ |
| Known as | OxyNEO | “a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®” NCT02101840 ↗ |
| Known as | OxyNorm | “Patients will take either control-released oxycodone (OxyContin® 10mg and 20mg) or immediate-released oxycodone (OxyNorm® 5mg) or both for initial dose and used it to titrate...” NCT03176121 ↗8“Patients will receive conservative treatment Acetaminophen (paracetamol) 1000 mg tid and pregabalin (lyrica) 75 mg bid; can be increased to 150 mg bid, oxycodone (oxynorm) 10mg IR PRN.” NCT07095569 ↗ “The efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus morphine immediate-release tablets in the treatment of cancer pain.” NCT01675622 ↗ “comprising of oxycodone immediate release (OXYNORM) and oxycodone sustained release (OXYCONTIN) in pre-defined doses and frequencies” NCT03024515 ↗ “If analgesia is inadequate oxycodon (OxyNorm®) (10 mg (less than 80 kg) - 15 mg (over 80 kg) po.” NCT02678897 ↗ “OxyNorm 10 mg® (oxycodone immediate-release 10 mg): Administered as oral rescue medicine.” NCT03314792 ↗ “Oxycodone immediate release (Oxynorm) 10mg as required every 4 to 6 hours.” NCT06864312 ↗ “additional OxyNorm (Oxycodone), if requested by the patients” NCT01816581 ↗ “Every 6 hours for immediate-released oxycodone (OxyNorm®)” NCT03176199 ↗ |
| Known as | PF 00345439 | “To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation...” NCT02117583 ↗ |
| Known as | PTI-821 | “PTI-821 (oxycodone) 40 mg extended release capsule” NCT03475862 ↗ |
| Known as | Roxicodone | “Roxicodone™ tablet 30 mg, single dose with food” NCT00853736 ↗1“Oxycodone (OxyContin®, OxyIR®, Roxicodone®)” NCT06240390 ↗ |
| Known as | Xtampza ER | “Xtampza ER (oxycodone)” NCT03588806 ↗ |
| Action | Activate | “opioid agonist” NCT01366014 ↗ |
| Modality | Other / unclassified | “Oxycodone is a semisynthetic strong opioid analgesic” NCT03024515 ↗ |
| Route | Oral | “15 mg/70 kg oxycodone administered once per day, orally.” NCT00158184 ↗ |