Drugs / Fentanyl
Fentanyl
also known as
fentanyl citrate · Duragesic · Fentanyl HCl · ACTIQ · KW-2246 · TTS fentanyl · DUROGESIC · FBT · +107 more
Other / unclassified targets OPRM1 via activation
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cancer 1 milestone | |||||
| Filed | Japan (PMDA) | — | cancer | 2010-02-24 | “An application for production and sale in Japan of KW-2246 as a treatment for breakthrough pain in cancer patients was made on February 24, 2010.” orexo.com ↗ |
| Filed chronic pain syndrome 1 milestone | |||||
| Filed | Japan (PMDA) | — | chronic pain syndrome | 2013-07-31 | “filed an application to Japan's Ministry of Health, Labour and Welfare (MHLW) seeking approval for additional indication of chronic pain* for Fentos® Tape” kyowakirin.com ↗ |
| Approved Indication not stated 10 milestones | |||||
| Label expansions (3) | US (FDA) | DURAGESIC-100 | — | 2003-05-20 – 2018-01-24 | fda.gov ↗ |
| Label expansion | US (FDA) | IONSYS | — | 2015-04-30 | fda.gov ↗ |
| Label expansion | US (FDA) | FENTORA | — | 2013-02-21 | fda.gov ↗ |
| Filed | Japan (PMDA) | Abstral | breakthrough cancer pain | 2012-11-13 | “submitted a New Drug Application (“NDA”) in Japan for KW-2246 (Abstral), a fentanyl sublingual tablet” orexo.com ↗ “平成 24 年 11 月 13 日にがん性疼痛に対する治 療剤として開発中の KW -2246(フェンタニルクエン 酸塩舌下錠)の製造販売承認申請 を行なったとの報告を受けました” hisamitsu.co.jp ↗ |
| Filed | US (FDA) | — | cancer pain | 2011-11-21 | “filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Fentora® with the U.S. Food & Drug Administration” amneal.com ↗ |
| Refused (EMA) | EU (EMA) | Ionsys | — | 2008-07-25 | europa.eu ↗ |
| Label expansion | US (FDA) | ACTIQ | — | 2007-02-07 | fda.gov ↗ |
| Approved | EU (EMA) | Ionsys | — | 2006-01-24 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | FENTANYL | — | 1995-10-30 – 1996-05-20 | fda.gov ↗ |
| Approved | US (FDA) | SUBLIMAZE PRESERVATIVE FREE | — | 1968-02-19 | fda.gov ↗ |
Trials 395 · started per year
today
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EU approved 2006
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 05 trials · 1 missed | ||||||
| Phase 0 | NCT06561672 | Sep 2024 → Mar 2025 overdue | — | Zagazig University | Enrolling by invitation | No outcome recorded |
| Phase 0 | NCT06435949 | Jul 2024 → Jun 2026 | — | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT05579509 | Oct 2022 → May 2024 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 0 | NCT02209610 | Jul 2015 → Jan 2017 | heart failure | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 0 | NCT01853449 | Jun 2013 → Aug 2014 | — | McGill University | Completed | Missed primary |
| Phase 125 trials · 1 met primary | ||||||
| Phase 1 | NCT06953453 | Sep 2025 → Jul 2026 overdue | cancer | Lee's Pharmaceutical Limited | Recruiting | No outcome recorded |
| Phase 1 | NCT06281951 | Apr 2024 → Jun 2027 expected | — | University Hospital, Rouen | Recruiting | No outcome recorded |
| Phase 1 | NCT05429567 | Mar 2021 → Feb 2022 | — | Egymedicalpedia | Completed | No outcome recorded |
| Phase 1 | NCT04062123 | Jul 2020 → Apr 2024 | — | Keith M Vogt | Completed | No outcome recorded |
| Phase 1 | NCT04823390 | Sep 2019 → Feb 2021 | — | Cairo University | Completed | No outcome recorded |
| Phase 1 | NCT04011098 | Jul 2019 → Nov 2020 | obstetric disorder | University of Saskatchewan | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03824314 | May 2019 → Jan 2020 | — | Mohamed Abdelrady Mohamed | Completed | No outcome recorded |
| Phase 1 | NCT03747341 | Mar 2018 → Jan 2019 | substance-related disorder | Indivior Inc. | Completed | Met primary |
| Phase 1 | NCT02641340 | Jan → Mar 2016 | — | INSYS Therapeutics Inc | Completed | No outcome recorded |
| Phase 1 | NCT02608320 | Nov 2015 → Apr 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02576353 | Oct → Nov 2015 | — | INSYS Therapeutics Inc | Completed | No outcome recorded |
| Phase 1 | NCT01756651 | Feb 2013 → May 2016 | — | Richard C Reznichek, MD | Completed | No outcome recorded |
| Phase 1 | NCT01750060 | Dec 2012 → Mar 2013 | — | Incline Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01717157 | Aug → Nov 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01593397 | Nov 2011 → Sep 2017 | obesity disorder | Stanford University | Completed | No outcome recorded |
| Phase 1 | NCT01497288 | Nov → Dec 2011 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT01780233 | Apr → May 2007 | — | INSYS Therapeutics Inc | Completed | No outcome recorded |
| Phase 1 | NCT00648414 | Oct 2006 | — | Mylan Pharmaceuticals Inc | Terminated | No outcome recorded |
| Phase 1 | NCT00857753 | Sep → Oct 2006 | — | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00402350 | Apr → Nov 2006 | — | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00886002 | Nov 2004 → Jan 2005 | — | Janssen-Cilag A.G., Switzerland | Completed | No outcome recorded |
| Phase 1 | NCT00864565 | Jun 2003 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00714558 | Apr → May 2003 | — | Alza Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00794209 | Mar → May 2003 | — | YM BioSciences | Completed | No outcome recorded |
| Phase 1 | NCT00708318 | Oct → Nov 2001 | — | YM BioSciences | Completed | No outcome recorded |
| Phase 1/29 trials · 2 met primary | ||||||
| Phase 1/2 | NCT07112430 | Sep 2026 → Mar 2028 expected | retinopathy of prematurity | Marsha Campbell-Yeo | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07672301 | Mar 2026 → Jun 2027 expected | — | University of Chicago | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06031883 | Feb 2023 → Dec 2024 | — | Minia University | Completed | No outcome recorded |
| Phase 1/2 | NCT05037539 | Jun → Dec 2021 | bone pain, periodic | Department of Medical Services Ministry of Public Health of Thailand | Completed | Met primary |
| Phase 1/2 | NCT04713189 | Mar → Dec 2021 | — | Lee's Pharmaceutical Limited | Unknown | Met primary |
| Phase 1/2 | NCT04136548 | Jun 2019 → Nov 2020 | — | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01515566 | Apr 2012 → Apr 2013 | — | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01248611 | Jan → May 2011 | cancer, chronic pain syndrome | St. Olavs Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT00685295 | Aug 2008 → Feb 2009 | — | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 230 trials · 1 met primary | ||||||
| Phase 2 | NCT07224620 | Nov 2025 → May 2026 | — | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT05057689 | Sep → Oct 2025 | acute stress disorder, anxiety | Nationwide Children's Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06531759 | Sep 2024 → Sep 2025 overdue | — | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05367336 | Aug 2022 → Feb 2025 | qualitative platelet defect | Corewell Health South | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05531422 | Oct 2021 → Mar 2023 | — | Lee's Pharmaceutical Limited | Completed | Met primary |
| Phase 2 | NCT04204967 | Feb 2021 → Apr 2024 | respiratory failure | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Completed | No outcome recorded |
| Phase 2 | NCT03809455 | Feb 2020 → Feb 2022 | — | UNICANCER | Withdrawn | No outcome recorded |
| Phase 2 | NCT03293927 | Apr 2018 → Jul 2019 | delirium | Duke University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03071744 | Mar 2017 → Mar 2018 | bone neoplasm | Joseph Ma | Terminated | No outcome recorded |
| Phase 2 | NCT02915978 | Dec 2016 → Feb 2017 | — | INSYS Therapeutics Inc | Completed | No outcome recorded |
| Phase 2 | NCT02514252 | Feb 2016 → Nov 2019 | — | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT02454751 | Oct 2015 → Jun 2017 | congestive heart failure | St. Boniface Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01856114 | May 2014 → Dec 2019 | cancer of unknown primary site | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01832402 | Jun 2013 → Nov 2019 | — | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02172014 | Jun 2013 → Jan 2015 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04635852 | Mar 2013 → Nov 2014 | cancer | University of Cologne | Completed | No outcome recorded |
| Phase 2 | NCT00807209 | Dec 2008 → Feb 2009 | — | Pacira Pharmaceuticals, Inc | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02430090 | Nov 2006 → Mar 2007 | — | Ankara City Hospital Bilkent | Completed | No outcome recorded |
| Phase 2 | NCT00236093 | Oct → Dec 2006 | cancer, sickle cell disease | Cephalon | Completed | No outcome recorded |
| Phase 2 | NCT00355628 | Jul 2006 → Jul 2007 | cancer | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00345735 | May 2006 → Oct 2007 | cancer | Nycomed | Completed | No outcome recorded |
| Phase 2 | NCT00478101 | Feb 2006 → Apr 2007 | — | Gachon University Gil Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00278824 | Jan → Aug 2006 | — | ZARS Pharma Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00216658 | Dec 2004 → Sep 2005 | neurological pain disorder | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT00236041 | Apr 2004 → Aug 2006 | cancer | Cephalon | Completed | No outcome recorded |
| Phase 2 | NCT00108771 | Apr 2004 → Sep 2006 | — | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00108446 | Oct 2003 → Mar 2006 | irritable bowel syndrome | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 2 | NCT00650182 | Jan → Jul 2003 | chronic pain syndrome | Alza Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00000273 | Aug 1995 → Nov 2005 | heroin dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT02137525 | ? → Jun 2017 | — | INSYS Therapeutics Inc | Withdrawn | No outcome recorded |
| Phase 2/312 trials · 1 missed | ||||||
| Phase 2/3 | NCT06799442 | Mar → Dec 2025 overdue | — | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05145543 | Dec 2021 → Mar 2022 | — | Assiut University | Unknown | No outcome recorded |
| Phase 2/3 | NCT04971759 | Dec 2019 → Dec 2020 | — | Assiut University | Completed | No outcome recorded |
| Phase 2/3 | NCT04004117 | Jul → Dec 2019 | chronic obstructive pulmonary disease | McGill University Health Centre/Research Institute of the McGill University Health Centre | Terminated | No outcome recorded |
| Phase 2/3 | NCT02489019 | Feb 2018 → Jul 2020 | hypotensive disorder | Loyola University | Unknown | No outcome recorded |
| Phase 2/3 | NCT03260283 | Aug 2017 → Nov 2018 | — | Saint Savvas Anticancer Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT03167905 | Jun 2017 → Jul 2021 overdue | postpartum depression | KK Women's and Children's Hospital | Active not recruiting | Missed primary |
| Phase 2/3 | NCT02597478 | Jan 2016 → Sep 2018 | cancer of unknown primary site | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2/3 | NCT02617199 | Nov 2015 → Dec 2016 | acute pancreatitis | Hospital General Naval de Alta Especialidad - Escuela Medico Naval | Unknown | No outcome recorded |
| Phase 2/3 | NCT02298582 | Dec 2014 → Oct 2017 | — | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 2/3 | NCT00286221 | Mar 2006 → Jul 2010 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2/3 | NCT01648595 | Jan → Aug 2006 | — | Mashhad University of Medical Sciences | Terminated | No outcome recorded |
| Phase 382 trials · 14 met primary · 4 missed | ||||||
| Phase 3 | NCT07076368 | Oct 2025 → Jul 2026 overdue | pregnancy disorder | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 3 | NCT06464146 | Feb 2025 → Feb 2028 expected | — | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT07019805 | Sep 2024 → Mar 2025 | acute hypotension | Indonesia University | Completed | No outcome recorded |
| Phase 3 | NCT06590870 | Aug 2024 → Feb 2025 | — | Mount Sinai Hospital, Canada | Completed | Mixed |
| Phase 3 | NCT06051227 | Jan 2024 → Aug 2026 | — | Academic Medical Center - University of Amsterdam | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05491187 | Sep 2022 → Apr 2023 | — | Tribhuvan University Teaching Hospital, Institute Of Medicine. | Completed | No outcome recorded |
| Phase 3 | NCT05137184 | Nov 2021 → Apr 2023 | — | Oslo University Hospital | Completed | Met primary |
| Phase 3 | NCT04621110 | Jun → Sep 2021 | childhood malignant neoplasm | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04188418 | Oct 2020 → Aug 2027 expected | cancer, hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Active not recruiting | Missed primary |
| Phase 3 | NCT04533243 | Sep 2020 → Aug 2022 | — | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04011150 | Aug 2020 → Dec 2025 overdue | — | KK Women's and Children's Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04128540 | Feb 2020 → Jul 2021 | aorta coarctation | Cairo University | Completed | No outcome recorded |
| Phase 3 | NCT03872700 | Aug 2019 → Dec 2022 | abscess | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT04026022 | Jun 2019 → Mar 2020 | — | Medical University of Graz | Completed | Missed primary |
| Phase 3 | NCT03639389 | Jan 2019 → Mar 2022 | — | Karolinska Institutet | Completed | No outcome recorded |
| Phase 3 | NCT02138409 | Dec 2017 → Jan 2018 | chronic pain syndrome | INSYS Therapeutics Inc | Withdrawn | No outcome recorded |
| Phase 3 | NCT03214510 | Oct 2017 → Jul 2027 expected | hepatobiliary disorder | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03063359 | May 2017 → Jul 2018 | — | University Hospital, Montpellier | Terminated | No outcome recorded |
| Phase 3 | NCT01906073 | Jan 2017 → Dec 2020 | cancer | Norwegian University of Science and Technology | Withdrawn | No outcome recorded |
| Phase 3 | NCT03005899 | Nov 2016 → Jul 2017 | — | SymBio Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT02395653 | Jun 2015 → Sep 2016 | — | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT02426697 | May 2015 → Apr 2020 | bone neoplasm | Centre Henri Becquerel | Completed | No outcome recorded |
| Phase 3 | NCT01980498 | Sep 2014 → Sep 2015 | — | L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02079090 | Jul 2014 → Jun 2017 | — | University of British Columbia | Completed | No outcome recorded |
| Phase 3 | NCT02084355 | Apr 2014 → Dec 2015 | cancer | Gyeongsang National University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02145975 | Jan → Apr 2014 | — | Universidad de Antioquia | Completed | No outcome recorded |
| Phase 3 | NCT02004899 | Dec 2013 → Oct 2014 | — | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase 3 | NCT02241486 | Sep 2013 → Sep 2014 | — | Loyola University | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01549002 | Jan 2012 → Apr 2013 | abscess | Columbia University | Completed | Met primary |
| Phase 3 | NCT01842893 | Nov 2011 → Jul 2012 | cancer | Ethypharm | Completed | Met primary |
| Phase 3 | NCT01493245 | Oct 2011 → Mar 2013 | chronic pain syndrome | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT01429051 | Aug 2011 → Jan 2013 | cancer | Takeda | Completed | Met primary |
| Phase 3 | NCT01270659 | May 2011 → Oct 2014 | — | University of Oklahoma | Completed | No outcome recorded |
| Phase 3 | NCT01326689 | Mar 2011 → Jun 2012 | — | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00959400 | Nov 2009 → Jun 2011 | — | Cristália Produtos Químicos Farmacêuticos Ltda. | Withdrawn | No outcome recorded |
| Phase 3 | NCT03713762 | Oct → Nov 2009 | — | Centro Medico Docente la Trinidad | Completed | No outcome recorded |
| Phase 3 | NCT00956254 | Oct 2009 → Oct 2010 | mucositis | INSYS Therapeutics Inc | 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 | NCT01008618 | Jan 2009 → Feb 2010 | chronic pain syndrome, osteoarthritis | Janssen Pharmaceutical K.K. | Completed | Missed primary |
| Phase 3 | NCT00813488 | Dec 2008 → Nov 2009 | chronic pain syndrome | Cephalon | Completed | Met primary |
| Phase 3 | NCT01008553 | Dec 2008 → Mar 2010 | complex regional pain syndrome, postherpetic neuralgia | Janssen Pharmaceutical K.K. | Completed | Met primary |
| Phase 3 | NCT00822614 | Dec 2008 → Dec 2009 | — | Akela Pharma, Inc. | Unknown | No outcome recorded |
| Phase 3 | NCT00788372 | Nov 2008 → Nov 2010 | chronic pain syndrome | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT00666393 | Oct 2008 → Dec 2010 | neuropathy, painful | Alza Corporation | Withdrawn | No outcome recorded |
| Phase 3 | NCT00696137 | Jun 2008 → Jul 2009 | respiratory underresponsiveness to hypoxia and hypercapnia | BioDelivery Sciences International | Completed | No outcome recorded |
| Phase 3 | NCT00684632 | Mar 2008 → Apr 2009 | — | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 3 | NCT00683995 | Mar 2008 → Jul 2009 | — | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00635063 | Feb 2008 → ? | cancer | Sosei | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00641667 | Jan → Jun 2008 | cancer | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT00538863 | Dec 2007 → Oct 2010 | cancer | INSYS Therapeutics Inc | Completed | No outcome recorded |
| Phase 3 | NCT00741351 | Dec 2007 → Mar 2009 | — | Azienda Ospedaliera San Gerardo di Monza | Completed | No outcome recorded |
| Phase 3 | NCT00538850 | Oct 2007 → Feb 2010 | cancer | INSYS Therapeutics Inc | Completed | Met primary |
| Phase 3 | NCT00463047 | Jul 2007 → Feb 2009 | chronic pain syndrome | Cephalon | Completed | Met primary |
| Phase 3 | NCT00458510 | Jan 2007 → Oct 2011 | — | Archimedes Development Ltd | Completed | No outcome recorded |
| Phase 3 | NCT00496392 | Jan 2007 → Aug 2008 | — | Nycomed | Completed | Met primary |
| Phase 3 | NCT00459277 | Dec 2006 → Jul 2008 | — | Archimedes Development Ltd | Completed | No outcome recorded |
| Phase 3 | NCT00387010 | Dec 2006 → Oct 2007 | chronic pain syndrome | Cephalon | Terminated | Missed primary |
| Phase 3 | NCT00405444 | Nov 2006 → Sep 2008 | — | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 3 | NCT00343733 | Aug 2006 → Jul 2007 | — | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00362583 | Jun 2006 → Oct 2007 | cancer | Nycomed | Completed | No outcome recorded |
| Phase 3 | NCT00293033 | Feb 2006 → Apr 2007 | cancer | BioDelivery Sciences International | Completed | Met primary |
| Phase 3 | NCT00293020 | Feb 2006 → Jun 2008 | cancer | BioDelivery Sciences International | Completed | No outcome recorded |
| Phase 3 | NCT00262678 | Dec 2005 → Dec 2008 | cancer | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 3 | NCT00263575 | Dec 2005 → Dec 2008 | cancer | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00241332 | Oct 2005 → Jul 2006 | — | Ullevaal University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00214942 | Sep 2005 → Mar 2006 | chronic pain syndrome | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00214955 | Sep 2005 → May 2006 | neuropathy, painful | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00126789 | Aug 2005 → Jul 2007 | cancer | ZARS Pharma Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00126763 | Jul 2005 → Dec 2006 | — | ZARS Pharma Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00216684 | May 2005 → Sep 2006 | chronic pain syndrome | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT00228605 | Mar 2005 → May 2007 | diabetic neuropathy, migraine disorder, osteoarthritis | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00105287 | Jan 2005 → Sep 2006 | cancer | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00279344 | Sep 2004 → Aug 2007 | — | Nycomed | Completed | No outcome recorded |
| Phase 3 | NCT00236145 | Jun 2004 → Aug 2005 | — | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00105937 | Apr 2004 → Nov 2006 | cancer | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00266539 | Apr 2004 → Apr 2005 | — | Alza Corporation | Completed | Met primary |
| Phase 3 | NCT00264485 | Mar 2004 → Apr 2005 | — | Alza Corporation | Completed | Met primary |
| Phase 3 | NCT00271466 | Feb 2000 → Apr 2002 | chronic pain syndrome | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00271414 | Mar 1999 → Mar 2001 | chronic pain syndrome | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 3 | NCT00271453 | Feb 1996 → Oct 1998 | chronic pain syndrome | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00269763 | Oct 1987 → Apr 1988 | cancer | Alza Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00269737 | May 1986 → Feb 1988 | cancer | Alza Corporation | Completed | No outcome recorded |
| Phase 4116 trials · 3 met primary · 6 missed | ||||||
| Phase 4 | NCT07684365 | Oct 2026 → Dec 2027 expected | — | Beth Israel Deaconess Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07670052 | Aug 2026 → Jun 2027 expected | — | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07556523 | Mar 2026 → Apr 2028 expected | aortic valve stenosis | David Lyubashevsky | Recruiting | No outcome recorded |
| Phase 4 | NCT07116564 | Aug 2025 → Aug 2026 overdue | — | Aga Khan University | Recruiting | No outcome recorded |
| Phase 4 | NCT06793358 | Jul 2025 → Feb 2026 | — | Indiana University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06696586 | Jul 2025 → Dec 2026 expected | — | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06763705 | Jun → Dec 2025 | — | Qassim Health Cluster | Completed | No outcome recorded |
| Phase 4 | NCT06752629 | Jan 2025 → Jan 2026 overdue | gallbladder disorder | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06720506 | Jan 2025 → Jan 2026 overdue | — | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06722963 | Jan 2025 → Jan 2026 overdue | — | Assiut University | Not yet recruiting | No outcome recorded |
| Show all 116 trials opens the full record — a long page | ||||||
| Phase not applicable116 trials · 4 met primary · 5 missed | ||||||
| — | NCT07435493 | Nov 2026 expected | adenoid hypertrophy, obstructive sleep apnea syndrome | Ain Shams University | Not yet recruiting | No outcome recorded |
| — | NCT07610408 | Jun → Sep 2026 | — | Ankara Etlik City Hospital | Completed | No outcome recorded |
| — | NCT07347886 | Jan → Jul 2026 overdue | cataract | Istanbul University - Cerrahpasa | Not yet recruiting | No outcome recorded |
| — | NCT07258628 | Oct 2025 → Jan 2026 | cardiac rhythm disease, hypertensive disorder | Ankara City Hospital Bilkent | Completed | No outcome recorded |
| — | NCT07310524 | Sep → Nov 2025 | — | Muhammad Rahman Efendi Nasution | Completed | No outcome recorded |
| — | NCT07166666 | Sep 2025 → Sep 2026 overdue | — | Oman Medical Speciality Board | Not yet recruiting | No outcome recorded |
| — | NCT07114263 | Aug 2025 → Feb 2026 overdue | — | Tanta University | Not yet recruiting | No outcome recorded |
| — | NCT07062601 | Jul → Nov 2025 overdue | tonsillitis | Anqing Municipal Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06779968 | Jan → May 2025 overdue | — | Xiaguang Duan | Not yet recruiting | No outcome recorded |
| — | NCT07141589 | Aug 2024 → Nov 2025 overdue | — | Cairo University | Recruiting | No outcome recorded |
| Show all 116 trials opens the full record — a long page | ||||||
| Comparator or background therapy731 trials | ||||||
| Phase 0 | NCT07711522 Background | Aug 2026 → Jul 2027 expected | — | Istanbul Medipol University Hospital | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT07211399 Comparator | Jul 2026 → Dec 2030 | substance-related disorder | Jacques E. Chelly | Withdrawn | No outcome recorded Stop: Business |
| Phase 0 | NCT07040163 Comparator | Mar 2025 → Feb 2026 overdue | — | CAMC Health System | Active not recruiting | No outcome recorded |
| Phase 0 | NCT05824338 Comparator | Aug 2024 → Jul 2025 overdue | — | Fraser Health | Recruiting | No outcome recorded |
| Phase 0 | NCT07190625 Comparator | Dec 2023 → Mar 2026 overdue | — | Ain Shams University | Recruiting | No outcome recorded |
| Show all 731 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 44
| Date | Issuer | Release |
|---|---|---|
| 2022-04-08 | Indivior Inc. | Results Indivior | Indivior Publishes Modeling Data Showing Buprenorphine May Mitigate Fentanyl-Induced Respiratory Depression in Chronic Opioid Users indivior.com ↗
Indivior PLC (LON: INDV) announces the publication of modeling data examining the competitive interaction between buprenorphine, a treatment for opioid use disorder (OUD), and fentanyl, a potent synthetic opioid, to better understand how buprenorphine can reduce fentanyl-induced respiratory depression. |
| 2022-01-27 | Indivior Inc. | Results Research Indicates Sustained High Plasma Concentrations of Buprenorphine Reduce Fentanyl lnduced Respiratory Depression in Opioid-Tolerant Participants indivior.com ↗ |
| 2021-11-08 | Indivior Inc. | Results Indivior | Indivior Presents Modelling Data on Interaction Between Buprenorphine and Fentanyl in Opioid-Naïve and Opioid-Tolerant Subjects at the 2021 American Conference of Pharmacometrics indivior.com ↗
This modelling suggested that clinically relevant exposures to buprenorphine has the potential to limit fentanyl binding to MORs and thereby possibly reduce the frequency and magnitude of respiratory depression induced by fentanyl in opioid-tolerant (OT) subjects. |
| 2020-09-10 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces a New Drug Application for Partial Change of Fentos® Tape in Japan kyowakirin.com ↗ |
| 2020-06-29 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces a Partial Change Approval of Fentos® Tape in Japan kyowakirin.com ↗
With this approval, the product is expected to be a new option for the treatment of cancer pain as the first strong opioid patch in Japan that can be used for opioid analgesic naïve cancer pain patients. |
| 2019-08-29 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces an Partial Change Approval Application of FENTOS®TAPE (Code: HFT-290) Submission by Hisamitsu Pharmaceutical in Japan kyowakirin.com ↗
Hisamitsu Pharmaceutical Co., Inc. (Hisamitsu Pharmaceutical, President and CEO: Kazuhide Nakatomi) has submitted a new drug application for the additional indications of opioid analgesic naïve cancer pain relief |
| 2019-04-08 | Indivior Inc. | Results Indivior | Indivior Announces New Study Data in Patients with Moderate to Severe Opioid Use Disorder (OUD) at the 50th ASAM Annual Conference indivior.com ↗
This study of eight opioid-tolerant patients showed that buprenorphine plasma concentrations of 2ng/mL and higher that were achieved following intravenous infusion reduced the extent of respiratory depression from fentanyl. |
| 2017-08-31 | Kyowa Kirin, Inc. | Regulatory Announcement of submission of supplemental new drug application (NDA) for the addition of a new 0.5mg dose of the transdermal, long-acting pain relief patch FENTOS® TAPE (development code: HFT-290) kyowakirin.com ↗
Hisamitsu Pharmaceutical has confirmed the efficacy and safety of the 0.5 mg dose of the product in the clinical study for patients with cancer pain and submitted the supplemental NDA. |
| 2016-09-08 | Assertio Holdings, Inc | Results Data from Depomed’s Highly-Differentiated Pain and CNS-Focused Product Portfolio Presented at PAINWeek 2016 assertiotx.com ↗ |
| 2016-07-20 | Lannett Company, Inc. | Regulatory Lannett Announces Receipt Of FDA Acceptable Filing Letter For Fentanyl Patch ANDA investorroom.com ↗
Sparsha Pharma USA, Inc., has received an Acceptable for Filing letter from the U.S. Food and Drug Administration (FDA) |
| 2015-01-15 | Orexo AB | Regulatory Orexo Receives Paragraph IV Notice Letter Concerning Abstral® in the US orexo.com ↗
Orexo AB, today announced that it has, together with its partner Galena Biopharma, Inc. (“Galena”), received a “Paragraph IV” patent certification notice from Actavis Laboratories FL, Inc. (“Actavis”). |
| 2014-06-20 | Kyowa Kirin, Inc. | Regulatory Hisamitsu Pharmaceutical is received Approval for Additional Indication of Chronic Pain for Fentos® Tape, a Transdermal Long-Acting Pain Relief Patch kyowakirin.com ↗ |
| 2013-09-20 | Kyowa Kirin, Inc. | Regulatory Announcement regarding the Marketing Approval of Abstral® sublingual tablets for Cancer Pain Treatment kyowakirin.com ↗
Since the efficacy and safety of this drug were confirmed in the Clinical trials, the application for marketing approval was made on November 13, 2012 and has been approved in Japan this time. |
| 2013-09-20 | Orexo AB | Regulatory Orexo announces the approval of Abstral® in Japan orexo.com ↗
Orexo AB today announced the approval of Abstral® (fentanyl) sublingual tablets in Japan, where the product has been registered and will be sold by Kyowa Hakko Kirin Co., Ltd. |
| 2013-07-31 | Kyowa Kirin, Inc. | Regulatory Hisamitsu Pharmaceutical Submits Application Seeking Approval for Additional Indication of Chronic Pain for Fentos® Tape, a Transdermal Long-Acting Cancer Pain Relief Patch kyowakirin.com ↗
Hisamitsu Pharmaceutical made the application seeking approval based on the results of domestic clinical trials of HFT-290, which demonstrated its efficacy and safety for patients with moderate-to-severe chronic pain. |
| 2013-03-08 | Kyowa Kirin, Inc. | Results Announcement of Results from a Japanese Phase 3 Clinical Trial on the Additional Indication of Chronic Pain for Fentos® Tape (Development Code: HFT-290), a Transdermal Long-Acting Cancer Pain Relief Patch kyowakirin.com ↗
The results showed that Fentos® Tape was effective for patients with moderate-to-severe chronic pain. |
| 2012-11-13 | Kyowa Kirin, Inc. | Regulatory Announcement regarding the Filing in Japan of an Application for Marketing Approval of KW-2246 for Cancer Pain Treatment kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced the application in Japan for the marketing approval of KW-2246 (fentanyl citrate sublingual tablet), which is currently undergoing development for the treatment of cancer pain. |
| 2012-11-13 | Hisamitsu Pharmaceutical Co., Inc. | Regulatory がん性疼痛治療剤KW-2246 の製造販売承認申請に関するお知らせ hisamitsu.co.jp ↗
久光製薬株式会社（本社：佐賀県鳥栖市、 代表取締役社長：中冨博隆 以下、 久光製薬）は、協和発酵キリン株式会社（ 本社：東京都千代田区、代表取締役社長： 花井陳雄 以下、協和発酵キリン）が平成 24 年 11 月 13 日にがん性疼痛に対する治 療剤として開発中の KW -2246(フェンタニルクエン 酸塩舌下錠)の製造販売承認申請 を行なったとの報告を受けましたので、お知らせ致します。 |
| 2012-11-13 | Orexo AB | Regulatory Orexo announces submission of a New Drug Application for KW‑2246 (Abstral®) in Japan orexo.com ↗
Swedish specialty pharmaceutical company Orexo today communicated that its partner Kyowa Hakko Kirin Co., Ltd has submitted a New Drug Application (“NDA”) in Japan for KW-2246 (Abstral), a fentanyl sublingual tablet developed for the treatment of breakthrough cancer pain. |
| 2011-11-21 | Impax Laboratories, LLC | Regulatory Impax Laboratories Confirms Patent Challenge Relating to Generic FENTORA® 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 owner of its paragraph IV certification. |
| 2011-07-04 | Daewoong Pharmaceutical Co. LTD. | Regulatory License obtained for patch-type narcotic analgesic, ""Matrifen"" daewoong.co.kr ↗
On May 31, Daewoong Pharmaceutical Co., Ltd (President Lee Jong Wook) obtained a sales license from KFDA for a patch type narcotic analgesic ""Matrifen"" (Fentanyl ingredient). |
| 2011-02-22 | Orexo AB | Regulatory Abstral® approved in Canada orexo.com ↗
Uppsala, Sweden– February 22, 2010 – Orexo AB (STO: ORX) today announces that ProStrakan’s partner, Paladin Labs Inc. has been informed by Health Canada, the Canadian Government Department with responsibility for public health, that it has approved Abstral®. |
| 2011-01-10 | Orexo AB | Regulatory FDA Approval for Abstral (Fentanyl) Sublingual Tablets - US launch planned for Q1 2011 orexo.com ↗
Uppsala, January 10, 2011 - Orexo AB (STO: ORX) announces today that its partner ProStrakan Group plc (LSE: PSK) has received approval from the US Food and Drug Administration (FDA) for Abstral® . |
| 2010-09-07 | Orexo AB | Regulatory Update on the FDA review for Abstral™ orexo.com ↗
However due to the ongoing nature of these discussions, the FDA has indicated to ProStrakan that it will not meet its previously expected PDUFA date for Abstral™ in early September. |
| 2010-08-27 | Orexo AB | Regulatory Orexo announces that partner Kyowa Hakko Kirin is to conduct additional clinical trials on KW-2246 for treatment of cancer pain in Japan orexo.com ↗
As a certain amount of time is required to conduct additional clinical trials, Kyowa Hakko Kirin has withdrawn the application for approval. |
| 2010-06-02 | Orexo AB | Regulatory Orexo confirms Abstral PDUFA date update orexo.com ↗
The FDA has issued the extension following its earlier request for additional information on the Abstral Risk Evaluation and Mitigation Strategy (“REMS”). |
| 2010-02-25 | Orexo AB | Regulatory Orexo announces Kyowa Hakko Kirin’s submission of KW-2246 (Abstral) for approval in Japan orexo.com ↗
Orexo AB (STO: ORX) today announces that its partner Kyowa Hakko Kirin Co., Ltd. has submitted the New Drug Application (NDA) in Japan for the cancer pain drug KW-2246 (Abstral). |
| 2010-02-04 | Orexo AB | Regulatory Orexo confirms Canadian Regulatory Filing of Abstral orexo.com ↗
The submission has been granted priority review status by Health Canada and review of the application is therefore expected to conclude in 180 days. |
| 2009-10-06 | Orexo AB | Regulatory Orexo confirms FDA acceptance of Abstral filing orexo.com ↗
Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK), has announced that the New Drug Application (NDA) filing for Abstral has been accepted for review by the US Food and Drug Administration (FDA). |
| 2009-08-06 | Orexo AB | Regulatory Abstral™ file submitted to the FDA for approval in the USA orexo.com ↗
Orexo AB (STO: ORX) today announces that its partner, UK-based international specialty pharmaceutical company ProStrakan Group plc (LSE: PSK), has submitted the New Drug Application (NDA) for Abstral™ (for the treatment of breakthrough cancer pain in opioid-tolerant patients) to the US Food and Drug Administration (FDA). |
| 2009-07-24 | Orexo AB | Results Orexo announces positive Phase III results for KW-2246 in Japan orexo.com ↗
The clinical study results revealed a statistically significant difference between KW-2246 and the placebo, and clinical effectiveness was confirmed. |
| 2009-03-02 | Orexo AB | Regulatory Orexo’s AbstralTM receives two further large EU market approvals in France and Spain orexo.com ↗
Orexo (NASDAQ-OMX:ORX), announces that AbstralTM has received Marketing Authorisation from the French and Spanish regulatory authorities for the treatment of breakthrough cancer pain. |
| 2008-12-11 | Orexo AB | Regulatory Abstral receives marketing approval in Germany orexo.com ↗
Orexo (OMX: ORX) confirms the announcement made by ProStrakan Group plc (LSE: PSK), Orexo’s partner for Abstral® in Europe and North America, that it has received a Marketing Authorisation from the German regulatory authority, BfArM for Abstral (for breakthrough cancer pain). |
| 2008-10-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval and Commercial Launch of Fentanyl Transdermal System tevapharm.com ↗
the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System |
| 2008-09-23 | Orexo AB | Regulatory UK Marketing Approval Issued for Abstral orexo.com ↗
As a result of the approval, Orexo will receive a milestone payment of USD 1 million. |
| 2008-06-26 | Orexo AB | Regulatory Orexo report Abstral (Rapinyl) approval in Europe orexo.com ↗
Abstral was referred to the CHMP for review in September 2007 and has now gained a positive opinion recommending approval of the product. |
| 2008-03-26 | Nxera Pharma UK Limited | Results Sosei Announces Temporary Halt to AD 923 CBP Phase III Studies in Europe nxera.life ↗
A detailed investigation is underway but, as a precautionary measure to ensure patient safety, a temporary halt to the study has been implemented and all affected clinical trial supplies will be recalled. |
| 2008-03-07 | Orexo AB | Regulatory Rapinyl™ has received Swedish Marketing Authorization orexo.com ↗
ProStrakan today announces that it has received Marketing Authorization in Sweden for Rapinyl™. |
| 2007-12-17 | Orexo AB | Results Orexo´s partner Endo announces positive results from interim analysis of Rapinyl ™ phase III clinical trial orexo.com ↗
The data from the analysis of 61 patients demonstrated that Rapinyl ™ met its primary endpoint, the Sum of Pain Intensity Difference from baseline to 30 minutes (SPID 0-30), and the results were highly statistically significant (p=0.0004). |
| 2007-12-07 | Nxera Pharma UK Limited | Regulatory Sosei Announces New Fundraising nxera.life ↗
Sosei is now in a position to commence its first phase III trials following the CTA (clinical trial authorisation) approval for 2 pivotal phase III studies for AD923 in Europe. |
| 2007-11-28 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2007-11-28 | Nxera Pharma UK Limited | Regulatory Sosei Announces Approval to Start AD 923 Phase III Studies in Europe nxera.life ↗ |
| 2007-05-22 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2007-05-22 | Nxera Pharma UK Limited | Results Sosei Announces Successful Completion of AD 923 Pharmacokinetic Study in the USA nxera.life ↗
The more rapid absorption of fentany l from AD 923 compared with Actiq ® was statistically significant, with substantial plasma exposure seen within 10 minutes. |
All press releases naming this drug 81 releases
Evidence & citations 120 cited values
Every value below carries the sentence it was read from. 1,134 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fentanyl | “The current double-blind, placebo-controlled in-patient study was designed to compare the effects of intravenously delivered fentanyl (0, 0.0625, 0.125, 0.187, and 0.250 mg/70...” PMID 17581533 ↗ Jun 20071107“patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0...” NCT03553576 ↗ “After the surgery: 10 ml 0.25% bupivacaine through epidural catheters before extubation and continuous infusion of 0,1% bupivacaine and 1 µg/ml fentanyl 5 ml/h with...” NCT02622893 ↗ “Participants will be induced using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, followed by 0.6 mg/kg IV rocuronium, and IV propofol with dosage at the...” NCT06029049 ↗ “The parturients were randomly assigned to groups receiving either spinal sufentanil (5 µg), epidural sufentanil (20 µg), spinal fentanyl (20 µg) or epidural fentanyl (100 µg),...” PMID 31286476 ↗ Jul 2019 “Preservative free 0.5% Hyperbaric bupivacaine (AstraZeneca) 5mg + 25mcg fentanyl for the initial dose will be followed by top up doses of 2.5 mg boluses of 0.5% Hyperbaric...” NCT05897151 ↗ “Maintenance of anesthesia will be achieved by isoflurane at an end tidal concentration of 1-1.5% in FiO2 of 0.5, intravenous fentanyl at a dose of 1 µg/kg in incremental...” NCT06873906 ↗ “Intraoperative analgesia will be ensured by administering fentanyl 0.5-1 µg/kg as needed, based on clinical signs of inadequate analgesia (e.g., an increase in blood pressure...” NCT07207304 ↗ “Intraoperatively, fentanyl in fractional doses of 1-3 µg∙kg-1 were applied if the heart rate (HR; Heart Rate) or mean blood pressure (MBP; Mean Blood Pressure) increased by...” NCT04355468 ↗ “The administered anesthetic mixture will include a fixed dose of fentanyl (15 μg), a variable dose of ropivacaine based on the parturient's somatometric characteristics, and a...” NCT07023497 ↗ “The patient will be sedated with a combination of midazolam, fentanyl administered intravenously in small boluses until the desired level of sedation is achieved as expressed...” NCT03546088 ↗ |
| Known as | Abstral | “Ten minutes before the procedure fentanyl sublingual tablet (Abstral ® 100 µg, ProStrakan) will be given to the patient.” NCT01604187 ↗1“Abstral” NCT03080324 ↗ |
| Known as | ACTIQ | “Actiq® 400 µg is a solid formulation of fentanyl citrate on a plastic stick that dissolves slowly in the mouth for absorption across the buccal mucosa.” NCT01780233 ↗3“Fentanyl (Actiq®, Duragesic®, Fentora®, Lazanda®, Subsys®, and others)” NCT06240390 ↗ “ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])” NCT00236093 ↗ “ACTIQ (Oral transmucosal fentanyl citrate)” NCT00236145 ↗ |
| Known as | AD 923 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00635063 ↗ |
| Known as | AeroLEF | “Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects” NCT00708318 ↗1“one dose (5mL) of inhaled AeroLEF (500 mcg/mL as fentanyl base)” NCT00794209 ↗ |
| Known as | BEMA Fentanyl | “Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy” NCT00293020 ↗ |
| Known as | Breakyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Duragesic | “This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan)...” NCT02486016 ↗8“For patients who were using transdermal fentanyl (ie,Duragesic®), the initial dose of ZR-02-01 was the same as their current Duragesic dose.” NCT00126763 ↗ “In addition, fentanyl is currently marketed for transdermal use (Duragesic fentanyl transdermal patch) for the management of chronic pain.” NCT00714558 ↗ “Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr” NCT00648414 ↗ “Fentanyl (Actiq®, Duragesic®, Fentora®, Lazanda®, Subsys®, and others)” NCT06240390 ↗ “Duragesic® (fentanyl) Transdermal Therapeutic System (TTS)” NCT00271414 ↗ “then wore a Duragesic® fentanyl TDDS (25 µg/h) for 72 h” NCT02531971 ↗ “Duragesic® (Fentanyl Transdermal System)” NCT00237341 ↗ “Duragesic (fentanyl transdermal system)” NCT00650182 ↗ |
| Known as | Duragesic fentanyl skin patch | “Duragesic® fentanyl skin patch” NCT02531971 ↗ |
| Known as | Duragesic-100 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Duragesic-12 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Duragesic-25 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Duragesic-37 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Duragesic-50 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Duragesic-75 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Duragesic | “Duragesic® (fentanyl) Therapeutic Transdermal System (TTS)” NCT00271466 ↗ |
| Known as | DUROGESIC | “Open-Label Study To Assess The Effect On Pain Control Of Durogesic (Fentanyl Transdermic Therapeutic System) Treatment In Subjects With Rheumatoid Arthritis Or Osteoarthritis...” NCT00524160 ↗2“One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.” NCT01717157 ↗ “Durogesic® (fentanyl transdermal drug delivery system)” NCT00271453 ↗ |
| Known as | Durogesic d-trans | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Effentora | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | EN3267 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00263575 ↗ |
| Known as | FBT | “Previous single-dose studies found that prophylactic administration of fentanyl buccal tablet (FBT) improved exertional dyspnoea.” PMID 41115797 ↗ Mar 20262“Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.” NCT00387010 ↗ “A Preliminary Study of Prophylactic Fentanyl Buccal Tablets (FBT) for Exercise Induced Breakthrough Dyspnea” NCT01856114 ↗ |
| Known as | FCIV | “Fentanyl Citrate IV (FCIV)” NCT02576353 ↗ |
| Known as | FEN | “Drug: Fentanyl (FEN)” NCT07556133 ↗1“Drug: Fentanyl (FEN)” NCT07794852 ↗ |
| Known as | Fencino | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fendrop | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentalis reservoir | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanest | “Fentanest® 25 mcg/h. Each patch delivers 25 mcg of fentanyl per hour continuously for 72 hours.” NCT00959400 ↗ |
| Known as | FENTANILE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02909049 ↗ |
| Known as | FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764 | “FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764” NCT02909049 ↗ |
| Known as | Fentanilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl "Hameln" ATC-code: N01AH01 | “Fentanyl, Hameln (ATC code: N01A H01)” NCT05639712 ↗1“Fentanyl "Hameln" ATC-code: N01AH01” NCT01934088 ↗ |
| Known as | Fentanyl (Fentanyl Citrate) | “Fentanyl (Fentanyl Citrate)” NCT07267377 ↗ |
| Known as | Fentanyl buccal | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl Buccal Tablets | “A Preliminary Study of Prophylactic Fentanyl Buccal Tablets (FBT) for Exercise Induced Breakthrough Dyspnea” NCT01856114 ↗ |
| Known as | Fentanyl cii | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | fentanyl citrate | “Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA (Perfusor space pump,Germany)with...” NCT03242668 ↗38“Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related...” NCT00343733 ↗ “Fentanyl citrate is an opioid strong analgesic that is particularly well suited for use in anesthesia because of its high potency, rapid onset and short duration of action” NCT07425444 ↗ “during which patients received sublingual fentanyl citrate orally disintegrating tablet (sublingual fentanyl ODT) or placebo, in a random order.” PMID 19814586 ↗ Dec 2009 “Fentanyl citrate (0.05 mg/ml) (Fentanyl Hameln pharmaceutical, Germany) (Low Dose) low dose fentanyl iv 1 microgram per kg before induction” NCT07533643 ↗ “Treatment A: Fentanyl citrate (equivalent to 80 mcg fentanyl) administered over 20 minutes by IV infusion every hour through 23.33 hours.” NCT01750060 ↗ “a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer.” PMID 24508417 ↗ Feb 2014 “Solution of fentanyl citrate (DIN : 02384124 / 02240434 / 02385406) will be administered sublingually by syringe.” NCT04004117 ↗ “to characterize the pharmacokinetics profile of ACTIQ (fentanyl citrate) in these children” NCT00236041 ↗ “Volunteers received a single-dose of 100 µg fentanyl citrate infusion” NCT02531971 ↗ “100 mcg fentanyl citrate will be inhaled via nebulizer.” NCT03018756 ↗ |
| Known as | Fentanyl citrate cii | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl citrate component of innovar | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl Citrate Injection, USP (Fentanyl) | “Fentanyl Citrate Injection, USP (Fentanyl)” NCT01050699 ↗ |
| Known as | Fentanyl Citrate Nasal Spray | “Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)” NCT00459277 ↗2“Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)” NCT00458510 ↗ “Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)” NCT07120763 ↗ |
| Known as | Fentanyl citrate preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl Citrate USP | “single dose of intravenous Fentanyl Citrate USP (200 mcg)” NCT00794209 ↗ |
| Known as | Fentanyl component of tranq | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | fentanyl ethypharm | “a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer.” PMID 24508417 ↗ Feb 2014 |
| Known as | Fentanyl Hameln | “will be given 0.5 ml of one ampoule (2ml) of 100µg fentanyl (Fentanyl Hameln® 0.1mg/2ml - Sunny pharm) equivalent to 25 µg fentanyl as an adjuvant to 2.2ml hyperbaric...” NCT06318546 ↗1“Fentanyl (Fentanyl Hameln® 0.1mg/2ml) 25 mcg will be given intrathecally added to 4 ml (20 mg) of 0.5% hyperbaric bupivacaine” NCT06834841 ↗ |
| Known as | Fentanyl HCI | “Double-Blind, Placebo-Controlled Comparative Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain” NCT03005899 ↗ |
| Known as | Fentanyl HCl | “The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients.” NCT00666393 ↗4“Fentanyl HCl Patient-Controlled Transdermal System (E-TRANS fentanyl)” NCT00266539 ↗ “Fentanyl HCl and morphine are narcotic pain relievers.” NCT00264485 ↗ “IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem” NCT00996177 ↗ “Drug: Fentanyl HCl” NCT05550597 ↗ |
| Known as | fentanyl hydrochloride | “One patch of SyB P-1501 contains 10.8 mg of fentanyl hydrochloride (fentanyl 9.7 mg) and produces an electric current to deliver the drug iontophoretically after the system is...” NCT03005899 ↗2“E-TRANS Fentanyl hydrochloride; Morphine” NCT00266539 ↗ “Drug: Fentanyl Hydrochloride” NCT02953210 ↗ |
| Known as | fentanyl ITS | “The fentanyl iontophoretic transdermal system (fentanyl ITS) enables needle-free, patient-controlled analgesia for postoperative pain management.” PMID 17519263 ↗ Jun 2007 |
| Known as | Fentanyl SL Spray | “Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain” NCT00538863 ↗ |
| Known as | Fentanyl Sublingual Spray | “Fentanyl Sublingual Spray (FSS)” NCT02576353 ↗1“Drug: Fentanyl Sublingual Spray” NCT02597478 ↗ |
| Known as | Fentanyl Transdermal System | “Duragesic® (Fentanyl Transdermal System)” NCT00237341 ↗1“Drug: Fentanyl Transdermal System” NCT04204967 ↗ |
| Known as | Fentanyl WZF | “intraoperative rescue opioid analgesia using 1mcg/kg of fentanyl (Fentanyl WZF, POlfa Warsawa, Poland)” NCT06609993 ↗ |
| Known as | Fentanyl, 50μg/ml, Janssen-Cilag, Belgium | “Fentanyl, 50μg/ml (Janssen-Cilag, Belgium)” NCT01558713 ↗1“Fentanyl, 50μg/ml, Janssen-Cilag, Belgium” NCT01582607 ↗ |
| Known as | Fentanyl-100 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl-12 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl-25 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl-37 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl-50 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl-62 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl-75 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentanyl-87 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Fentora | “Fentanyl (Actiq®, Duragesic®, Fentora®, Lazanda®, Subsys®, and others)” NCT06240390 ↗ |
| Known as | FITpatch | “Transdermal Fentanyl (FITpatch)” NCT00279344 ↗ |
| Known as | FNT | “Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia.” NCT02619032 ↗ |
| Known as | FPNS | “Fentanyl pectin nasal spray (FPNS)” NCT01980498 ↗ |
| Known as | FSS | “Fentanyl sublingual spray (FSS) packaged to deliver 100 µg/spray, 200 µg/spray or 400 µg/spray” NCT02138409 ↗ |
| Known as | IDS-NF-001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | INF | “OBJECTIVE: Intranasal fentanyl (INF) quickly and noninvasively relieves severe
pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires...” PMID 32649717 ↗ Jul 20201“intranasal fentanyl (INF) is effective for rapidly decreasing MSK-I related pain in children” NCT02985177 ↗ |
| Known as | INFS | “intranasal fentanyl spray* (INFS) 400 μg” PMID 25641199 ↗ Jan 20151“Intranasal Fentanyl Spray (INFS)” NCT01497288 ↗ |
| Known as | Innovar | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Instanyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | IONSYS | “An Open-Label Evaluation of Safety of the IONSYS System [Fentanyl Iontophoretic Transdermal System (40ug) for Management of Acute Post-Operative Pain in Pediatric Patients” NCT00666393 ↗1“IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem” NCT00996177 ↗ |
| Known as | JNS020QD | “One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to...” NCT01008553 ↗ |
| Known as | KW-2246 | “KW-2246 (fentanyl citrate)” NCT00684632 ↗ |
| Known as | Lazanda | “Fentanyl (Actiq®, Duragesic®, Fentora®, Lazanda®, Subsys®, and others)” NCT06240390 ↗ |
| Known as | Leptanal | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Martindale pharma Fentanyl | “20 mcg of "Fentanyl," "Martindale pharma Fentanyl®," 50mcg/ml (0.4ml)” NCT06769737 ↗ |
| Known as | Matrifen | “Fentanyl (Matrifen)” NCT00279344 ↗ |
| Known as | MCN-JR-4263-49 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Mezolar matrix | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Mylafent | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Mylan Fentanyl Transdermal System | “Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr” NCT00648414 ↗ |
| Known as | Mylan generic fentanyl | “Mylan generic fentanyl” NCT02531971 ↗ |
| Known as | Mylan generic fentanyl skin patch | “Mylan generic fentanyl skin patch” NCT02531971 ↗ |
| Known as | N02AB03 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Narco | “subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.” NCT05053308 ↗ |
| Known as | Nasalfent | “Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)” NCT00459277 ↗2“Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)” NCT00458510 ↗ “Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)” NCT07120763 ↗ |
| Known as | Onsolis | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Onsolis (fentanyl buccal soluble film) | “Onsolis (fentanyl buccal soluble film)” NCT00293033 ↗ |
| Known as | Opiodur | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Oral Transmucosal Fentanyl Citrate | “ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])” NCT00236093 ↗ |
| Known as | Oralet | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | OraVescent | “ORAVESCENT Fentanyl Citrate” NCT00214942 ↗ |
| Known as | OraVescent Fentanyl | “Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related...” NCT00343733 ↗ |
| Known as | Osmach | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Osmanil | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | OTFC | “ACTIQ® (Oral Transmucosal Fentanyl Citrate [OTFC®]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain” NCT00236041 ↗1“ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])” NCT00236093 ↗ |
| Known as | OVF | “OraVescent fentanyl (OVF)” NCT00105287 ↗ |
| Known as | Painkyl, fentanyl buccal soluble film (FBSF) | “Painkyl, fentanyl buccal soluble film (FBSF)” NCT03669263 ↗ |
| Known as | PecFent | “PecFent will be supplied by Archimedes Pharma as two strengths of nasal spray solution at 1000 or 4000 mcg/mL fentanyl (as citrate).” NCT02009306 ↗2“Medication Commercial name Formulation Administration route Dose Fentanyl citrate Pecfent® Nasal spray Intranasal 100 µg” NCT03809455 ↗ “Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly” NCT02298582 ↗ |
| Known as | Phentanyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | R 4263 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Recivit | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Recuvyra | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Staccato Fentanyl | “Inhaled Staccato Fentanyl, 25 mcg x 1 dose” NCT00402350 ↗ |
| Known as | Sublimase | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Sublimaze | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Sublimaze preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Subsys | “Fentanyl (Actiq®, Duragesic®, Fentora®, Lazanda®, Subsys®, and others)” NCT06240390 ↗1“sublingual fentanyl spray (Subsys)” NCT02241486 ↗ |
| Known as | Thalamonal | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Tilofyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | TTS fentanyl | “This is an open label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time) study conducted to assess the...” NCT01774903 ↗3“TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl)” NCT00269737 ↗ “TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days.” NCT01774929 ↗ “therapeutic transdermal fentanyl system (TTS-fentanyl)” PMID 11591092 ↗ Sep 2001 |
| Known as | Victanyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | Yemex | ChEMBL registry synonym — accepted as the source's own label CHEMBL596 ↗ |
| Known as | ZR-02-01 | “ZR-02-01 Fentanyl Transdermal Matrix Patch” NCT00108771 ↗ |
| Action | Activate | “Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.” NCT00523887 ↗1“Mu opioid receptor agonist” CHEMBL596 ↗ |
| Modality | Other / unclassified | “Fentanyl HCl and morphine are narcotic pain relievers.” NCT00264485 ↗ |
| Route | Intravenous | “The current double-blind, placebo-controlled in-patient study was designed to compare the effects of intravenously delivered fentanyl (0, 0.0625, 0.125, 0.187, and 0.250 mg/70...” PMID 17581533 ↗ Jun 2007 |
| Target | OPRM1 | “Mu opioid receptor agonist” CHEMBL596 ↗ |