Duloxetine
Small molecule targets CYP2D6, SLC6A2, SLC6A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic pain syndrome 1 milestone | |||||
| Filed | US (FDA) | Cymbalta | chronic pain syndrome | 2009-06-03 | “has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration (FDA).” lilly.com ↗ |
| Filed depressive disorder 1 milestone | |||||
| Filed | US (FDA) | — | depressive disorder | 2002-01-24 | “Lilly submitted an NDA to the FDA for duloxetine” lilly.com ↗ |
| Filed fibromyalgia 1 milestone | |||||
| Filed | US (FDA) | Cymbalta | fibromyalgia | 2007-08-21 | “recently submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for Cymbalta for the management of fibromyalgia.” lilly.com ↗ “The company submitted a supplemental new drug application to the U.S. Food and Drug Administration for Cymbalta for the management of fibromyalgia.” lilly.com ↗ |
| Filed generalized anxiety disorder 1 milestone | |||||
| Filed | US (FDA) | Cymbalta | generalized anxiety disorder | 2006-05-09 | “submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the treatment of generalized...” lilly.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | DRIZALMA SPRINKLE | — | 2021-07-23 | fda.gov ↗ |
| Label expansions (6) | US (FDA) | CYMBALTA | — | 2007-02-23 – 2020-04-20 | fda.gov ↗ |
| Approved | EU (EMA) | Yentreve | — | 2004-08-11 | europa.eu ↗ |
| Approved | US (FDA) | CYMBALTA | — | 2004-08-03 | fda.gov ↗ |
Trials 251 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT05292066 | Oct → Dec 2022 | neuropathy, painful | Aga Khan University | Unknown | No outcome recorded |
| Phase 0 | NCT03623711 | Aug 2018 → Dec 2022 | major depressive disorder | Yuqi Cheng | Unknown | No outcome recorded |
| Phase 0 | NCT00763178 | Feb 2007 → Apr 2009 | post-traumatic stress disorder | Yale University | Completed | No outcome recorded |
| Phase 115 trials | ||||||
| Phase 1 | NCT04836533 | Jan 2023 | depressive disorder | Queens College, The City University of New York | Withdrawn | No outcome recorded |
| Phase 1 | NCT05065671 | Feb 2022 → Sep 2025 | — | Rutgers, The State University of New Jersey | Completed | No outcome recorded |
| Phase 1 | NCT04751318 | Feb 2021 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT04723238 | Jan → Feb 2021 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT03575403 | Sep 2018 → Mar 2023 | alcohol-related disorders | Craig Rush | Completed | No outcome recorded |
| Phase 1 | NCT02869035 | Aug 2016 → Jul 2019 | major depressive disorder | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 1 | NCT02700711 | Feb 2016 → Jun 2018 | substance-related disorder | University of Kentucky | Completed | No outcome recorded |
| Phase 1 | NCT02174822 | Jan → Mar 2014 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00990067 | Nov 2009 → May 2010 | mood disorder, substance-related disorder | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 1 | NCT00933452 | Jul → Nov 2009 | — | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 1 | NCT02291367 | May 2008 | — | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 1 | NCT02291341 | May 2008 | — | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 1 | NCT00414323 | Nov 2006 → May 2007 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00387413 | Oct 2006 → May 2007 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02232542 | Jun → Aug 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05949229 | Aug 2023 → Aug 2026 overdue | delirium | Amira Hassan Ahmed Ali | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05814640 | Feb 2023 → Dec 2026 expected | major depressive disorder, splenic sequestration | First Affiliated Hospital of Chongqing Medical University | Recruiting | No outcome recorded |
| Phase 224 trials · 3 missed | ||||||
| Phase 2 | NCT07431606 | May 2026 → Mar 2027 expected | inflammatory bowel disease | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2 | NCT06614322 | Feb 2026 → Jun 2028 expected | chemotherapy-induced neuropathy, diabetic polyneuropathy, neuropathy, painful | University of Rochester | Recruiting | No outcome recorded |
| Phase 2 | NCT06551051 | Aug 2024 → Dec 2025 overdue | cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05611749 | May 2023 → Mar 2024 | chronic pain syndrome, opiate dependence | Scripps Health | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05120934 | Nov 2021 → Oct 2026 expected | interstitial lung disease | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT05110144 | Nov 2021 → Dec 2026 expected | — | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT04111627 | Oct 2021 → Aug 2025 | depressive disorder, osteoarthritis, knee | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 2 | NCT04970121 | Aug 2021 → Jul 2027 expected | cancer, chemotherapy-induced neuropathy | Yan Yang, MD, Ph.D | Recruiting | No outcome recorded |
| Phase 2 | NCT04437485 | Oct 2020 → Aug 2022 | dysthymic disorder, major depressive disorder, prediabetes syndrome, type 2 diabetes mellitus | Indiana University | Completed | Missed primary |
| Phase 2 | NCT04560673 | Jul 2020 → Dec 2026 expected | cancer, chemotherapy-induced neuropathy, hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03315533 | Jan 2018 → Mar 2019 | musculoskeletal system disorder | Rhode Island Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03038867 | Dec 2016 → Aug 2018 | depressive disorder, male infertility | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 2 | NCT02857244 | Nov 2016 → Nov 2017 | Parkinson disease | University of Chicago | Withdrawn | No outcome recorded |
| Phase 2 | NCT02458690 | Jul 2015 → Aug 2019 | coronary artery disorder, dysthymic disorder, major depressive disorder, stroke disorder | Indiana University | Completed | Missed primary |
| Phase 2 | NCT02307305 | Aug 2014 → Dec 2016 | neuropathy, painful | Hanyang University Seoul Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01912612 | Oct 2013 → Jun 2019 | — | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00929344 | Jul 2009 → Oct 2014 | alcohol dependence | The Scripps Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT00863057 | May 2009 → Dec 2010 | HIV infectious disease, peripheral neuropathy | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT00837941 | Apr → Aug 2009 | diabetic polyneuropathy | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT00742573 | Aug 2008 → Jan 2014 | major depressive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT00529789 | Aug 2007 → Sep 2008 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00475696 | Nov 2002 → Mar 2005 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00190606 | Jan 2002 → Apr 2006 | urinary system disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00190567 | Oct 2001 → Apr 2006 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2/37 trials · 1 met primary · 1 missed | ||||||
| Phase 2/3 | NCT04747314 | Mar 2021 → Nov 2024 | anxiety, chronic pain syndrome | Ajay Wasan, MD, Msc | Completed | No outcome recorded |
| Phase 2/3 | NCT04137107 | Jun 2020 → Feb 2026 overdue | digestive system carcinoma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT00370656 | Feb 2007 → May 2009 | diabetes mellitus, peripheral neuropathy | University of Surrey | Completed | No outcome recorded |
| Phase 2/3 | NCT00457730 | Jan 2007 → Aug 2012 | multiple sclerosis | Brown, Theodore R., M.D., MPH | Completed | Met primary |
| Phase 2/3 | NCT00375973 | Sep 2006 → Jun 2012 | myalgic encephalomeyelitis/chronic fatigue syndrome | University of Cincinnati | Completed | Missed primary |
| Phase 2/3 | NCT00215228 | Jul 2005 → Aug 2007 | major depressive disorder | Duke University | Completed | No outcome recorded |
| Phase 2/3 | NCT00136383 | Mar 2005 → Jun 2007 | depressive disorder | Duke University | Completed | No outcome recorded |
| Phase 380 trials · 27 met primary · 9 missed | ||||||
| Phase 3 | NCT06407401 | Dec 2024 → Apr 2028 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, musculoskeletal system disorder | European Organisation for Research and Treatment of Cancer - EORTC | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06606067 | Sep 2024 → Jul 2026 overdue | chronic pain syndrome | Parc de Salut Mar | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05677295 | Apr 2023 → Dec 2024 | female stress incontinence | Far Eastern Memorial Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03068247 | Nov 2021 → May 2023 | major depressive disorder | University of Utah | Withdrawn | No outcome recorded |
| Phase 3 | NCT04364997 | Jun 2020 → Sep 2021 | major depressive disorder | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04412876 | May 2020 | female stress incontinence | Far Eastern Memorial Hospital | Withdrawn | No outcome recorded |
| Phase 3 | NCT03395353 | Jan 2018 → Jul 2020 | depressive disorder | Shionogi | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03315793 | Dec 2017 → Nov 2019 | depressive disorder | Shionogi | Completed | Missed primary |
| Phase 3 | NCT03249168 | Oct 2017 → Nov 2018 | — | Assiut University | Completed | No outcome recorded |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT02335346 | Jan 2015 → Mar 2016 | osteoarthritis, knee | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02248480 | Oct 2014 → Jun 2015 | osteoarthritis, knee | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01914666 | Sep 2013 → Dec 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01931475 | Sep 2013 → Mar 2015 | osteoarthritis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01598298 | May 2013 → Dec 2016 | breast cancer, musculoskeletal system disorder | SWOG Cancer Research Network | Completed | Met primary |
| Phase 3 | NCT01855919 | May 2013 → Jul 2014 | — | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01621191 | Jun 2012 → Feb 2014 | fibromyalgia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01552057 | Mar 2012 → Dec 2013 | fibromyalgia | Eli Lilly and Company | Completed | Mixed |
| Phase 3 | NCT01226511 | Jun 2011 → Feb 2013 | anxiety disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01504178 | May 2011 → Dec 2015 | Parkinson disease | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 3 | NCT01179672 | Apr 2011 → Aug 2013 | diabetic polyneuropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01237587 | Mar 2011 → May 2017 | fibromyalgia | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT01140906 | May 2010 → Sep 2011 | major depressive disorder | H. Lundbeck A/S | Completed | Met primary |
| Phase 3 | NCT01089556 | Mar 2010 → Nov 2011 | diabetic neuropathy | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT01018680 | Nov 2009 → Apr 2011 | osteoarthritis, knee | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00989157 | Sep 2009 → Oct 2012 | — | Neuropsychiatric Research Institute, Fargo, North Dakota | Completed | No outcome recorded |
| Phase 3 | NCT00945945 | Jul 2009 → May 2010 | osteoarthritis, knee | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00849901 | Mar 2009 → Mar 2011 | major depressive disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00849693 | Mar 2009 → Feb 2011 | major depressive disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00811252 | Jan 2009 → Feb 2010 | major depressive disorder | H. Lundbeck A/S | Completed | Met primary |
| Phase 3 | NCT00803361 | Dec 2008 → Jan 2010 | generalized anxiety disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00755807 | Oct 2008 → Aug 2010 | multiple sclerosis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00767806 | Sep 2008 → Jul 2009 | chronic pain syndrome | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00489411 | Apr 2008 → Jan 2012 | cancer of unknown primary site, chemotherapy-induced toxicity, peripheral neuropathy | Alliance for Clinical Trials in Oncology | Completed | Met primary |
| Phase 3 | NCT00641719 | Mar 2008 → Mar 2010 | diabetic neuropathy | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00635219 | Feb 2008 → Apr 2009 | major depressive disorder | H. Lundbeck A/S | Completed | Missed primary |
| Phase 3 | NCT00552175 | Nov 2007 → Mar 2009 | diabetic neuropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00433290 | Feb 2007 → May 2008 | osteoarthritis, knee | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00552682 | Jan 2007 → Jul 2009 | HIV infectious disease, fibromyalgia | Germans Trias i Pujol Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00424593 | Jan → Dec 2007 | — | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00408876 | Dec 2006 → Nov 2007 | — | Eli Lilly and Company | Completed | Mixed |
| Phase 3 | NCT00408993 | Dec 2006 → Feb 2008 | diabetic neuropathy | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00408421 | Nov 2006 → Oct 2007 | osteoarthritis, knee | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00384033 | Sep 2006 → Sep 2007 | major depressive disorder | Pfizer | Completed | Missed primary |
| Phase 3 | NCT00366652 | Sep 2006 | major depressive disorder | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00321490 | Apr 2006 → May 2007 | major depressive disorder | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00583193 | Dec 2005 → Jun 2008 | post-traumatic stress disorder | Canive, Jose M., M.D. | Unknown | No outcome recorded |
| Phase 3 | NCT00233025 | Sep 2005 → Jun 2007 | fibromyalgia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00125892 | Jul 2005 → Mar 2007 | fibromyalgia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00190866 | Jun 2005 → Jun 2007 | fibromyalgia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02232555 | May 2005 → May 2006 | major depressive disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00191919 | May 2005 → May 2006 | major depressive disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00122837 | Apr 2005 → Jan 2007 | anxiety disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00105989 | Mar 2005 → Jan 2008 | major depressive disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00191594 | Mar 2005 → Aug 2006 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00122863 | Jan 2005 → Mar 2007 | anxiety disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00190853 | Jan 2005 → Sep 2006 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00122850 | Oct 2004 → Nov 2005 | anxiety disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00475969 | Aug 2004 → Jun 2005 | generalized anxiety disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00122824 | Jun 2004 → Sep 2005 | generalized anxiety disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00191685 | May 2004 → Sep 2005 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00489775 | Jan 2004 → Jun 2005 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00475397 | Dec 2003 → Oct 2004 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00073411 | Nov 2003 → May 2005 | depressive disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00190827 | Sep 2003 → May 2006 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00190814 | Sep 2003 → May 2006 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00475358 | Apr 2003 → Feb 2005 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00062673 | Mar 2003 → Jul 2004 | depressive disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00190996 | Jan 2003 → Jun 2006 | female stress incontinence | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00042562 | Dec 2002 → Dec 2003 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00489073 | Nov 2002 → Dec 2003 | fibromyalgia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00058968 | Oct 2002 → Mar 2005 | diabetic polyneuropathy | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00042575 | Jun → Aug 2002 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00036309 | May 2002 → Jul 2003 | depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00036335 | Mar 2002 → Jan 2003 | depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00191204 | Sep 2001 → May 2006 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00190619 | May 2001 → May 2006 | urinary bladder disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00191087 | Apr 2001 → May 2006 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00190632 | Mar 2001 → Apr 2006 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00190645 | Feb 2001 → May 2006 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 487 trials · 12 met primary · 8 missed | ||||||
| Phase 4 | NCT07795593 | Oct 2026 → May 2031 expected | diabetic kidney disease, diabetic neuropathy | University of Michigan | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05976347 | Jun 2025 → May 2027 expected | depressive disorder | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT06807866 | Mar 2025 → Dec 2026 expected | — | University of Miami | Recruiting | No outcome recorded |
| Phase 4 | NCT06423716 | Nov 2024 → Jul 2026 overdue | osteoarthritis, knee | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 4 | NCT05851898 | Apr 2024 → Dec 2028 expected | osteoporosis | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT06232473 | Jan 2024 → Nov 2027 expected | — | Aarhus University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05851976 | Oct 2023 → May 2027 expected | — | Montefiore Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT04639011 | Oct 2022 → Dec 2023 | — | Boston Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT05086393 | Nov 2021 → Jun 2025 | neuropathy, painful | Rush University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT04870957 | Jun 2021 → Oct 2024 | chronic pain syndrome | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT04782310 | Mar → Aug 2021 | — | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT04697693 | Mar → May 2021 | major depressive disorder, post-traumatic stress disorder | New York State Psychiatric Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04395001 | Feb 2021 → Jul 2024 | chronic pain syndrome | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT04388189 | Oct 2020 → May 2023 | major depressive disorder | Alto Neuroscience | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03729284 | Mar → Jun 2020 | — | Pfizer | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03794154 | Mar → Jun 2020 | — | Pfizer | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04246619 | Nov 2019 → Dec 2021 | diabetic polyneuropathy | KRKA | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04117893 | Oct 2019 → Jun 2021 | chronic pain syndrome, osteoarthritis, knee | Beijing Tiantan Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03792828 | Jan → Oct 2019 | osteoarthritis, knee | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03548454 | Sep 2018 → Dec 2023 | chronic pain syndrome | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT03271151 | Sep 2017 → Dec 2020 | arthropathy, chronic pain syndrome | Hospital for Special Surgery, New York | Completed | No outcome recorded |
| Phase 4 | NCT02846701 | Nov 2016 → Jun 2017 | neuropathy, painful | University Hospital, Strasbourg, France | Completed | No outcome recorded |
| Phase 4 | NCT02351440 | Apr 2016 → Aug 2017 | — | Northwestern University | Withdrawn | No outcome recorded |
| Phase 4 | NCT02590874 | Jan 2016 → Jul 2017 | cognitive impairment with or without cerebellar ataxia, depressive disorder | University of North Texas Health Science Center | Completed | No outcome recorded |
| Phase 4 | NCT02711215 | May 2015 → Jan 2020 | major depressive disorder | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 4 | NCT02417935 | Apr 2015 → May 2017 | diabetic polyneuropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT02208778 | Dec 2014 → Jun 2016 | chronic pain syndrome, osteoarthritis | University of Nottingham | Completed | No outcome recorded |
| Phase 4 | NCT02260388 | Oct 2014 → Sep 2017 | idiopathic progressive polyneuropathy | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01973283 | Feb 2014 → Dec 2019 | dysthymic disorder, major depressive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT02005601 | Nov 2013 → May 2015 | — | Hospital for Special Surgery, New York | Completed | No outcome recorded |
| Phase 4 | NCT01916824 | Aug 2013 → Dec 2015 | major depressive disorder | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT01796132 | Aug 2012 → Dec 2016 | depressive disorder, lactation disease | Centre Hospitalier Universitaire Vaudois | Unknown | No outcome recorded |
| Phase 4 | NCT01619566 | Jun 2012 → Jan 2015 | fibromyalgia | University of California, San Diego | Withdrawn | No outcome recorded |
| Phase 4 | NCT01558700 | Mar 2012 → Apr 2014 | osteoarthritis | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT01391221 | Jul 2011 → Aug 2013 | major depressive disorder | Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal | Unknown | No outcome recorded |
| Phase 4 | NCT01118780 | Oct 2010 → Jul 2012 | generalized anxiety disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT01166048 | May 2010 → Jun 2014 | chronic pain syndrome | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT01070329 | Mar 2010 → Mar 2011 | major depressive disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT01089621 | Mar → Aug 2010 | fibromyalgia | Eli Lilly and Company | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01078870 | Feb 2010 → Jan 2011 | schizophrenia | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01051466 | Jan 2010 → Mar 2013 | major depressive disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT01000805 | Nov 2009 → Oct 2010 | major depressive disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00961298 | Sep 2009 → Dec 2011 | generalized anxiety disorder, irritable bowel syndrome | West Penn Allegheny Health System | Completed | No outcome recorded |
| Phase 4 | NCT00965081 | Sep 2009 → Nov 2010 | fibromyalgia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00985504 | Sep 2009 → Dec 2010 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00960986 | Aug 2009 → Feb 2011 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT01117857 | Aug 2009 → Jun 2011 | depressive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00889369 | May 2009 → Feb 2012 | major depressive disorder | Hamilton Health Sciences Corporation | Unknown | No outcome recorded |
| Phase 4 | NCT00844194 | Feb 2009 → Jun 2010 | diabetic polyneuropathy, major depressive disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT01754493 | Dec 2008 → Dec 2014 | irritable bowel syndrome, major depressive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT00810069 | Nov 2008 → Feb 2010 | major depressive disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00673452 | Jun 2008 → Apr 2009 | fibromyalgia | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00696774 | Jun 2008 → Jul 2009 | major depressive disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00666757 | May 2008 → Feb 2009 | depressive disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00658931 | Apr 2008 → Apr 2010 | major depressive disorder | Jefferson Clinic, P.C. | Unknown | No outcome recorded |
| Phase 4 | NCT00532480 | Sep 2007 → Apr 2009 | major depressive disorder | Indiana University | Completed | No outcome recorded |
| Phase 4 | NCT00536471 | Sep 2007 → May 2008 | major depressive disorder | Eli Lilly and Company | Completed | Mixed |
| Phase 4 | NCT00443352 | Aug 2007 → Nov 2012 | migraine disorder | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT00696293 | May 2007 → Mar 2010 | major depressive disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 4 | NCT00437125 | Mar 2007 → Jul 2009 | Parkinson disease, major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT02229825 | Feb 2007 → Aug 2008 | major depressive disorder | Boehringer Ingelheim | Completed | Missed primary |
| Phase 4 | NCT00422162 | Feb 2007 → Aug 2008 | major depressive disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00517985 | Feb 2007 → Jun 2008 | major depressive disorder | University of Arizona | Completed | No outcome recorded |
| Phase 4 | NCT00398632 | Nov 2006 → Apr 2009 | depressive disorder | Stanford University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00401258 | Nov 2006 → Feb 2008 | irritable bowel syndrome | Mclean Hospital | Completed | Met primary |
| Phase 4 | NCT00406848 | Nov 2006 → Jul 2009 | major depressive disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00607789 | Oct 2006 → Oct 2009 | binge eating disorder, depressive disorder | University of Cincinnati | Completed | Missed primary |
| Phase 4 | NCT00385671 | Sep 2006 → Aug 2009 | diabetic polyneuropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00360724 | Aug 2006 → Dec 2011 | depressive disorder, dysthymic disorder | New York State Psychiatric Institute | Completed | Met primary |
| Phase 4 | NCT00438971 | Aug 2006 → Jan 2009 | panic disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00531895 | Apr 2006 → Mar 2007 | headache disorder, major depressive disorder | Kraepelin Psiquiatria Clinica | Completed | No outcome recorded |
| Phase 4 | NCT00322621 | Apr 2006 → Oct 2007 | diabetic neuropathy | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT01035073 | Apr 2006 → May 2009 | major depressive disorder, myofascial pain syndrome | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT01852383 | Jan 2006 → Sep 2010 | depressive disorder, dysthymic disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT00464698 | Dec 2005 → Dec 2013 | obsessive-compulsive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00266643 | Dec 2005 → Apr 2007 | diabetic polyneuropathy | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00244296 | Oct 2005 → Jan 2007 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00224302 | Aug 2005 → Nov 2007 | psychotic disorder | Central Institute of Mental Health, Mannheim | Completed | No outcome recorded |
| Phase 4 | NCT00296699 | Mar 2005 → Jun 2007 | atypical depressive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT00191061 | Oct 2004 → Jan 2006 | major depressive disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00118430 | Sep 2004 → Jul 2008 | depressive disorder | Indiana University | Completed | Met primary |
| Phase 4 | NCT00609557 | Sep 2004 → Feb 2007 | osteoarthritis | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT00479726 | Aug 2004 → Jan 2005 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00191932 | Aug 2004 → Mar 2006 | major depressive disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00190905 | Feb 2004 → Jul 2005 | female stress incontinence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00071695 | Jul 2003 → May 2004 | depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00067912 | Apr 2003 → Mar 2004 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase not applicable32 trials · 1 met primary · 1 missed | ||||||
| — | NCT07731750 | Jul 2026 → Feb 2030 expected | chronic pain syndrome | University of Michigan | Recruiting | No outcome recorded |
| — | NCT07654179 | Jun 2026 → Jun 2027 expected | depressive disorder, obesity disorder | Riphah International University | Recruiting | No outcome recorded |
| — | NCT07421427 | Feb 2026 → Jan 2027 expected | chronic pain syndrome | Cairo University | Recruiting | No outcome recorded |
| — | NCT06711978 | Dec 2024 → May 2025 overdue | chemotherapy-induced neuropathy | Pusan National University Yangsan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06429605 | May → Dec 2024 | — | Erzincan Military Hospital | Completed | No outcome recorded |
| — | NCT05311774 | Apr 2022 → Oct 2025 | — | Assiut University | Completed | No outcome recorded |
| — | NCT04313335 | Mar 2021 → May 2023 | postherpetic neuralgia | Beijing Tiantan Hospital | Completed | Missed primary |
| — | NCT04732455 | Jan 2021 → Jun 2022 | breast cancer, chemotherapy-induced neuropathy | Gamal Mohamed Taha Abouelmagd | Completed | No outcome recorded |
| — | NCT04719585 | Jan 2021 → Dec 2022 | osteoarthritis, knee | The Catholic University of Korea | Unknown | No outcome recorded |
| — | NCT04478526 | Apr 2020 → May 2021 | generalized anxiety disorder | Dr. Nazanin Alavi | Completed | No outcome recorded |
| — | NCT03880916 | Mar 2019 → Mar 2020 | osteoarthritis, knee | The Catholic University of Korea | Unknown | No outcome recorded |
| — | NCT03560427 | Sep 2018 → Mar 2020 | — | Assiut University | Completed | No outcome recorded |
| — | NCT03549026 | Jan 2018 → Dec 2019 | — | Assiut University | Unknown | No outcome recorded |
| — | NCT03276689 | Oct 2017 → Dec 2020 | neuropathy, painful | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT03148522 | Jun 2017 → Dec 2021 | — | Peking University | Unknown | No outcome recorded |
| — | NCT03054220 | Jul 2016 → Dec 2018 | — | Jules Desmeules | Completed | No outcome recorded |
| — | NCT02600247 | Nov 2015 → Nov 2016 | osteoarthritis | The Catholic University of Korea | Unknown | No outcome recorded |
| — | NCT03121573 | Dec 2014 → Sep 2016 | major depressive disorder | Taichung Veterans General Hospital | Completed | No outcome recorded |
| — | NCT01650740 | Aug 2012 → Aug 2014 | major depressive disorder | Sunnybrook Health Sciences Centre | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01269866 | Dec 2010 → May 2012 | systemic lupus erythematosus | Dr. Jesus Gutierrez Stone | Completed | No outcome recorded |
| — | NCT01425827 | Nov 2010 → Jun 2011 | — | University of Alexandria | Completed | Met primary |
| — | NCT01363284 | Jun 2010 → Aug 2012 | diabetes mellitus, neuropathy, painful | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT01127490 | May 2010 → Sep 2015 | fibromyalgia | Albany Medical College | Completed | No outcome recorded |
| — | NCT00981149 | May 2009 → Nov 2011 | temporomandibular joint disorder | University of Maryland, Baltimore | Completed | No outcome recorded |
| — | NCT01028352 | Oct 2008 → Nov 2010 | breast cancer | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| — | NCT00617045 | Jul 2007 → Dec 2012 | major depressive disorder, postpartum depression | Yale University | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00491348 | Apr 2007 → Nov 2008 | anxiety | National Taiwan University Hospital | Terminated | No outcome recorded |
| — | NCT00425230 | Jan → Jun 2007 | — | Baylor College of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00388414 | Sep 2006 → Jan 2010 | — | Stanford University | Completed | No outcome recorded |
| — | NCT00933439 | Feb 2005 → Sep 2007 | major depressive disorder | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| — | NCT00185575 | Sep 2004 → Apr 2006 | depressive disorder | Stanford University | Completed | No outcome recorded |
| — | NCT00399022 | — | obsessive-compulsive disorder | Sheba Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase not stated1 trial | ||||||
| — | NCT00071708 | — | diabetic polyneuropathy, fibromyalgia, generalized anxiety disorder, major depressive disorder | Eli Lilly and Company | Approved for marketing | No outcome recorded |
| Comparator or background therapy138 trials | ||||||
| Phase 0 | NCT07400471 Comparator | Feb 2026 → Mar 2027 expected | — | Chattogram International Dental College | Recruiting | No outcome recorded |
| Phase 0 | NCT05508516 Comparator | Sep 2022 → Oct 2024 | fibromyalgia | China-Japan Friendship Hospital | Completed | No outcome recorded |
| Phase 0 | NCT01688570 Comparator | Aug 2011 → May 2015 | stroke disorder | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 1 | NCT06965569 Background | Apr → Dec 2025 | — | Alar Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04862845 Comparator | Jul 2021 → Dec 2025 | — | Cairo University | Completed | No outcome recorded |
| Show all 138 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 51
| Date | Issuer | Release |
|---|---|---|
| 2021-02-15 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for Eight Generic Drugs with 20 Strengths upsher-smith.com ↗
Osaka, Japan – February 15, 2021 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for eight generic drugs with 20 strengths. |
| 2020-07-27 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - "DULOXETINE HYDROCHLORIDE ENTERIC CAPSULES" OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗
The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries, the “Group”) is pleased to announce that the “Duloxetine Hydrochloride Enteric Capsules (20mg, 30mg, 60mg)” (the “ Product ”) developed by CSPC Ouyi Pharmaceutical Co., Ltd.*ʮ̡, a subsidiary of the Company, has obtained drug registration approval granted by the National Medical Products Administration of the People’s Republic of China, being the second generic drug of this type passing the consistency of quality and efficacy evaluation in China. |
| 2013-12-12 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces US FDA approval for generic Cymbalta® sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) today announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta ®, Duloxetine Delayed-Release Capsules USP, 20 mg, 30 mg and 60 mg. |
| 2012-07-06 | Eli Lilly and Company | Regulatory Lilly Obtains Six Months U.S. Pediatric Exclusivity for Cymbalta® (duloxetine HCl) lilly.com ↗
Based on this decision by the FDA, Lilly has gained an additional six months of U.S. market exclusivity for Cymbalta, which now will expire in December 2013. |
| 2011-07-08 | Wockhardt | Regulatory WOCKHARDT RECEIVES TENTATIVE US FDA APPROVAL FOR GENERIC VERSION OF DEPRESSION DRUG CYMBALTA® wockhardt.com ↗
Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for marketing 20mg, 30mg and 60mg delayed release capsules of Duloxetine hydrochloride which is used in treatment of depression. |
| 2010-11-24 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA tentative approval for generic Cymbalta® sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary a tentative approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta®, duloxetine hydrochloride delayed-release capsules. |
| 2010-11-22 | Impax Laboratories, LLC | Regulatory Impax Laboratories Receives Tentative FDA Approval for Generic Cymbalta(R) Delayed-Release 20, 30 and 60 mg Capsules amneal.com ↗
Impax Laboratories, Inc.(NASDAQ: IPXL ) today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Cymbalta(R) delayed-release (duloxetine hydrochloride) 20, 30 and 60 mg capsules. |
| 2010-11-04 | Eli Lilly and Company | Regulatory FDA Approves Cymbalta® for the Management of Chronic Musculoskeletal Pain lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the management of chronic musculoskeletal pain. |
| 2010-08-19 | Eli Lilly and Company | Regulatory Statement from Eli Lilly and Company Regarding Approval Recommendation from FDA Advisory Committee for Expanding the Pain Indications for Cymbalta(R) to a Broader Pain Population lilly.com ↗
In addition, the committee voted positively regarding the overall safety profile of Cymbalta, including potential liver toxicity, with the majority agreeing that the benefit-risk profile warrants an expanded indication. |
| 2010-02-03 | Eli Lilly and Company | Results Cymbalta(R) Significantly Reduced Chronic Low Back Pain in New Study lilly.com ↗
In a new study, 60 mg of Cymbalta(R) (duloxetine HCl) taken once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) average pain rating, compared with placebo.(1) |
| 2009-11-30 | Eli Lilly and Company | Regulatory FDA Approves Cymbalta(R) for Maintenance Treatment of Generalized Anxiety Disorder lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2009-09-11 | Eli Lilly and Company | Results New Data Show Patients With Chronic Low Back Pain Maintained Pain Reduction on Cymbalta® lilly.com ↗
New data show patients with chronic low back pain on Cymbalta(R) (duloxetine HCl) maintained reductions in pain for 41 weeks.(1) |
| 2009-06-03 | Eli Lilly and Company | Regulatory Lilly Resubmits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration lilly.com ↗
As projected, Eli Lilly and Company (NYSE: LLY) has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration (FDA). |
| 2009-01-30 | Eli Lilly and Company | Results Cymbalta(R) Significantly Reduced Osteoarthritis Knee Pain in New Study lilly.com ↗
In a new study, Cymbalta (duloxetine HCl) 60-120 mg, taken once daily, reduced pain severity significantly, compared with placebo, in patients with osteoarthritis pain of the knee. |
| 2008-12-10 | Eli Lilly and Company | Results Study Showed New Episodes of Depression Delayed in People Taking Cymbalta(R) lilly.com ↗
Additionally, patients who were treated with duloxetine were less likely (p < .001) to experience a new episode of depression than those who received placebo (recurrence rates were 14.4 percent vs. 33.1 percent, respectively). |
| 2008-12-10 | Eli Lilly and Company | Results Study Showed New Episodes of Depression Delayed in People Taking Cymbalta(R) lilly.com ↗
Additionally, patients who were treated with duloxetine were less likely (p < .001) to experience a new episode of depression than those who received placebo (recurrence rates were 14.4 percent vs. 33.1 percent, respectively). |
| 2008-11-28 | Eli Lilly and Company | Regulatory Lilly Withdraws Application for Additional U.S. Indication for Cymbalta(R) for Chronic Pain lilly.com ↗
Eli Lilly and Company (NYSE: LLY) has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain. |
| 2008-08-25 | Eli Lilly and Company | Results Patients Taking Cymbalta(R) Experienced Reduced Chronic Low Back Pain in New Study lilly.com ↗
Data from a new study suggest that Cymbalta (duloxetine HCl) 60-120 mg once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) 24-hour average pain score, compared with placebo.(1) |
| 2008-08-22 | Eli Lilly and Company | Regulatory Cymbalta Receives European Approval for the Treatment of Generalised Anxiety Disorder lilly.com ↗
Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim have announced that the European Commission has approved the use of Cymbalta(R) (duloxetine) for the treatment of Generalised Anxiety Disorder (GAD). |
| 2008-06-27 | Eli Lilly and Company | Regulatory European CHMP Issues Positive Opinion on Cymbalta for the Treatment of Generalised Anxiety Disorder lilly.com ↗
The positive opinion is based upon the results of five clinical studies -- four double-blind placebo-controlled studies and a relapse prevention study -- involving more than 2,000 non-depressed adults with GAD. |
| 2008-06-16 | Eli Lilly and Company | Regulatory FDA Approves Cymbalta(R) for the Management of Fibromyalgia lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2008-06-13 | Eli Lilly and Company | Results Patients Taking Cymbalta(R) Reported Reduced Pain Severity of Osteoarthritis of the Knee in New Study lilly.com ↗
New data suggest that patients with osteoarthritis pain of the knee treated with 60 mg and 120 mg Cymbalta (duloxetine HCl) once daily experienced significant pain reduction. |
| 2008-05-29 | Eli Lilly and Company | Regulatory Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration lilly.com ↗
Eli Lilly and Company (NYSE: LLY) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a new indication for Cymbalta(R) (duloxetine HCl) for the management of chronic pain, the company announced today. |
| 2007-11-30 | Eli Lilly and Company | Regulatory FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults. |
| 2007-08-21 | Eli Lilly and Company | Results New Data Suggest Cymbalta® Reduced Pain in Fibromyalgia Patients With and Without Depression lilly.com ↗
At three months, patients treated with 60mg per day or 120mg per day of duloxetine showed significantly greater reduction in pain and improvement in PGI-I scores compared with patients taking placebo. |
| 2007-05-23 | Eli Lilly and Company | Results In New Study, Duloxetine Was Equally Effective, Regardless of Switch Method, In Reducing Painful Symptoms in SSRI Non- or Partial-responders with Depression lilly.com ↗
These results demonstrate that a switch to duloxetine results in a significant decrease in the painful symptoms in patients with depression and was well tolerated regardless of the switch method used. |
| 2007-05-21 | Eli Lilly and Company | Results Data Suggest Cymbalta(R) Improved Functioning in Patients With Generalized Anxiety Disorder lilly.com ↗
In the second study, patients treated with 60-120 mg once daily of Cymbalta experienced statistically significant improvements compared to those treated with a sugar pill (defined by mean change on SDS 5.78 vs. 3.11). |
| 2007-05-03 | Eli Lilly and Company | Results Data Suggest Cymbalta(R) Reduced Severity of Night Pain in Patients with Diabetic Nerve Pain lilly.com ↗
Results from the analysis of more than 1,000 patients were presented today at the annual meeting of the American Pain Society in Washington D.C. |
| 2007-02-26 | Eli Lilly and Company | Regulatory FDA Approves Cymbalta® for Treatment of Generalized Anxiety Disorder lilly.com ↗
With this approval, physicians and patients will be happy to know that there is another medication now available to treat this debilitating condition. |
| 2006-05-22 | Eli Lilly and Company | Results New Data Presented on the Effect of Cymbalta(R) on Sexual Function in Depressed Patients lilly.com ↗ |
| 2006-05-09 | Eli Lilly and Company | Regulatory Lilly Submits Cymbalta(R) Supplemental New Drug Application for Generalized Anxiety Disorder lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced the recent submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the treatment of generalized anxiety disorder. |
| 2006-03-24 | Eli Lilly and Company | Results Study Suggests Cymbalta(R) Significantly Reduces Core Anxiety Symptoms of Generalized Anxiety Disorder lilly.com ↗
Patients taking both 60mg/day and 120mg/day had significantly greater response and remission rates compared to patients taking sugar pill. |
| 2006-02-14 | Eli Lilly and Company | Results Study Finds Cymbalta(R) Was As Safe And Well-Tolerated As Routine Drug Treatments For Diabetic Nerve Pain lilly.com ↗
A long-term study of more than 200 patients found that Cymbalta (duloxetine HCl) is as safe and well- tolerated as current routine care that uses one or more medications for the management of pain caused by diabetic nerve damage. |
| 2005-12-13 | Eli Lilly and Company | Results New Study Suggests Cymbalta(R) Reduced Depression Symptoms At Least As Fast As a Leading Competitor lilly.com ↗
Cymbalta(R) (duloxetine hydrochloride) reduced symptoms of depression at least as fast as Lexapro(R) (escitalopram) by the end of two weeks, according to results from the first head-to-head study comparing the two antidepressants. |
| 2005-06-11 | Eli Lilly and Company | Results New Data Show Cymbalta Improved Physical, Social and Emotional Functioning and Overall Health of Patients With Painful Diabetic Neuropathy lilly.com ↗
That means Cymbalta patients reported significantly less interference from pain on key measures of physical functioning, including their ability to walk, work and sleep. |
| 2005-05-24 | Eli Lilly and Company | Results New Analysis Shows Duloxetine Reduced Anxiety Symptoms in Elderly Patients with Depression lilly.com ↗
Duloxetine significantly reduced anxiety symptoms in elderly patients with depression, compared with those treated with a sugar pill, according to new research presented today at the annual meeting of the American Psychiatric Association. |
| 2005-05-24 | Eli Lilly and Company | Results New Analysis Shows Cymbalta Reduced Anxiety Symptoms in Elderly Patients with Depression lilly.com ↗
Cymbalta(TM) (duloxetine HCL) significantly reduced anxiety symptoms in elderly patients with depression, compared with those treated with a sugar pill, according to new research presented today at the annual meeting of the American Psychiatric Association. |
| 2005-03-07 | Eli Lilly and Company | Results New Study Data Show Improved Cognitive Function in Elderly Patients Treated with Cymbalta for Depression lilly.com ↗
Elderly patients with depression treated with Cymbalta(R) (duloxetine hydrochloride, pronounced sim- BAWL'-tuh), 60 mg once daily, had twice as much improvement in verbal learning and recalling information than those given a sugar pill, according to new research presented Saturday at the annual meeting of the American Association for Geriatric Psychiatry. |
| 2005-02-18 | Eli Lilly and Company | Regulatory EU Scientific Committee Recommends Approval of Cymbalta(R) For the Treatment of Diabetic Peripheral Neuropathic Pain lilly.com ↗
The medical advisory board of the European Medicines Agency (EMEA), which regulates pharmaceuticals in Europe, has recommended the approval of duloxetine hydrochloride (sold in the United States as Cymbalta) as safe and effective for the management of diabetic peripheral neuropathic pain (DPNP) in adults, Eli Lilly and Company announced today. |
| 2005-01-28 | Eli Lilly and Company | Regulatory Lilly and Boehringer Ingelheim Jointly Announce the Recision of U.S. FDA Application for Duloxetine for Treatment of Stress Urinary Incontinence lilly.com ↗ |
| 2005-01-05 | Eli Lilly and Company | Regulatory New Treatment for Depression Approved in Europe lilly.com ↗
Eli Lilly and Company and Boehringer Ingelheim announced today that Cymbalta®/Xeristar® (duloxetine hydrochloride)(+) has been granted marketing authorization by the European Commission for the treatment of major depressive episodes. |
| 2004-10-18 | Eli Lilly and Company | Results Cymbalta Provided Sustained Pain Relief for Women with Fibromyalgia lilly.com ↗
In the study, Cymbalta's effect on pain was independent of any effect on mood, and there was no significant difference in response rates between patients in the study with and without major depression. |
| 2004-09-24 | Eli Lilly and Company | Results New Study Shows Women with Severe Stress Urinary Incontinence May Reconsider Surgery After Experiencing the Benefits of Yentreve lilly.com ↗
All women enrolled in the study were awaiting continence surgery however, after eight weeks on Yentreve®, 20 percent of these patients reconsidered their willingness to undergo surgery. |
| 2004-09-17 | Eli Lilly and Company | Regulatory EU Scientific Committee Recommends Approval of Cymbalta lilly.com ↗
September 17, 2004 Eli Lilly and Company and Boehringer Ingelheim today announced that the Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of duloxetine for the treatment of major depressive episodes. |
| 2004-09-07 | Eli Lilly and Company | Regulatory FDA Approves Antidepressant Cymbalta for Treatment of Pain Caused by Diabetic Peripheral Neuropathy, Which Affects Up to 5 Million Americans lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved the antidepressant Cymbalta® (duloxetine HCl; pronounced SIM-BALL-TA), judging it safe and effective for the management of diabetic peripheral neuropathic pain, a symptom of nerve damage that affects up to 5 million Americans, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2004-08-13 | Eli Lilly and Company | Regulatory Yentreve Receives Approval Across the European Union for the Treatment of Stress Urinary Incontinence in Women lilly.com ↗
August 13, 2004 Eli Lilly and Company and Boehringer Ingelheim announced today that Yentreve™* (duloxetine hydrochloride) has been granted marketing authorization across the European Union (EU) for the treatment of moderate to severe stress urinary incontinence (SUI) in women. |
| 2004-08-04 | Eli Lilly and Company | Regulatory FDA Approves Lilly's Cymbalta for the Treatment of Depression lilly.com ↗
The U.S. Food and Drug Administration has approved Cymbalta® (duloxetine HCl; pronounced SIM-BALL-TA), judging it a safe and effective treatment for major depressive disorder, Eli Lilly and Company announced today. |
| 2004-07-29 | Eli Lilly and Company | Results Duloxetine Clinical Study Results Show Improvement in Stress Urinary Incontinence in Women lilly.com ↗
A study presented today shows that women who transitioned from placebo to duloxetine in an open-label study reported similar improvement to that of women who took duloxetine during the preceding 12 weeks in a double-blind study. |
| 2004-06-29 | Eli Lilly and Company | Results Multiple Clinical Trial Analysis Shows Duloxetine Reduces Stress Urinary Incontinence Episodes and Improves Quality of Life for Women lilly.com ↗
Results from a worldwide, four-study meta-analysis, comparing the efficacy of duloxetine and placebo in more than 1,900 women, demonstrated a statistically significant improvement after 12 weeks, compared to placebo (p<0.001). |
| 2004-06-24 | Eli Lilly and Company | Regulatory FDA Extends Action Data for Cymbalta for Continued Analysis of Already-Submitted Data lilly.com ↗
The U.S. Food and Drug Administration has extended the action date for completion of its review of the investigational antidepressant Cymbalta® (duloxetine hydrochloride), Eli Lilly and Company (NYSE: LLY) announced today. |
| 2001-11-19 | Eli Lilly and Company | Results Eli Lilly and Company's Duloxetine Shown to Significantly Reduce Symptoms of Depression, Including Physical Symptoms lilly.com ↗
Data on duloxetine, an investigational balanced serotonin and norepinephrine reuptake inhibitor, suggest superiority over placebo and paroxetine in reducing depressive symptoms. |
All press releases naming this drug 59 releases
Evidence & citations 33 cited values
Every value below carries the sentence it was read from. 392 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | duloxetine | “we have restricted the IMPACT list of antidepressants to SSRIs (sertraline, escitalopram, paroxetine, fluoxetine, citalopram), duloxetine, bupropion, and mirtazapine. These...” NCT02458690 ↗379“Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR),...” NCT00564278 ↗ “ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its...” NCT01838876 ↗ “Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine,...” NCT02400346 ↗ “Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week...” NCT00854100 ↗ “SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine...” NCT01436175 ↗ “This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report...” NCT02700711 ↗ “If never taken SSRI or SNRI, commence primary medication arm (SSRI: sertraline, escitalopram or Pregabalin/SNRI: duloxetine, venlafaxine) will be described to patient and will...” NCT04478526 ↗ “Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.” NCT00742573 ↗ “quantifying the range of concentration to citalopram, escitalopram, sertraline, fluoxetine, paroxetine, fluvoxamine, duloxetine and venlafaxine in mother plasma and breast milk” NCT01796132 ↗ “The drugs included in the treatment plan are morphine (60 mg/day), pregabalin (150 mg/day) and duloxetine (60 mg/day), available free of charge to the participating patients.” NCT05558397 ↗ |
| Known as | Ariclaim | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Cymbalta | “Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR),...” NCT00564278 ↗23“Experimental: Duloxetine group 1. Phase I (preemptive): 1day before operation (30mg for 1 day) 2. Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus...” NCT02600247 ↗ “Duloxetine(Cymbalta) for Fibromyalgia: An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic...” NCT01127490 ↗ “The purpose of this study is to test the hypothesis that duloxetine (Cymbalta), in doses of 60 or 120 mg/day, is an effective and tolerable treatment for adult outpatients...” NCT00185575 ↗ “Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy.” NCT03271151 ↗ “Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.” NCT03794154 ↗ “Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.” NCT03729284 ↗ “35 patients will receive duloxetine (Cymbalta; Eli Lilly \& Company, Indiana, USA) 30 mg orally with sips of water, 2 h before induction of anesthesia.” NCT03037073 ↗ “Duloxetine (Cymbalta) is one of the newer antidepressants approved for the treatment of Major Depressive Disorder (MDD).” NCT00517985 ↗ “pain relievers such as acetaminophen and antidepressants such as Duloxetine (Cymbalta) and milnacipran” NCT07533487 ↗ “impact of duloxetine ("Cymbalta"), a serotonin and norepinephrine reuptake inhibitor” NCT02005601 ↗ |
| Known as | Cymbalta (duloxetine) | “Cymbalta (duloxetine)” NCT00889369 ↗ |
| Known as | Cymbatex | “one capsule of Duloxetine 30 mg (Cymbatex 30 mg, EVA Pharma)” NCT07421427 ↗ |
| Known as | DLX | “Duloxetine (DLX)” NCT00945945 ↗ |
| Known as | Drizalma sprinkle | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Duciltia | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | DUL | “45 patients will be assigned into each group, by order of their recruitment. Third of the patients in each group will be randomized to Duloxetine (DUL), third to Pregabalin...” NCT02672202 ↗ |
| Known as | Duloxetina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Duloxetine (as hydrochloride) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Duloxetine boehringer ingelheim | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Duloxetine HCl | “In the duloxetine group, one capsule of Duloxetine HCl 30mg (Duroceptol) is taken orally and daily from the day before the first operation to seven days after the second operation.” NCT03792828 ↗1“Totally, 144 received 60 mg/day of duloxetine HCL and 144 received placebo for 16 weeks.” PMID 22743149 ↗ Jun 2012 |
| Known as | Duloxetine Hydrochloride | “To determine the dosage of duloxetine hydrochloride (duloxetine) (30 mg or 60 mg daily) that appears most promising in preventing oxaliplatin-induced peripheral neuropathy (OIPN).” NCT04137107 ↗19“Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.” NCT03794154 ↗ “Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.” NCT03729284 ↗ “Desvenlafaxine Succinate Sustained-Release Tablet 50 mg+Duloxetine Hydrochloride Enteric-coated Capsule Placebo 60 mg orally once daily for 8 weeks.” NCT04364997 ↗ “Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain” NCT00036335 ↗ “Generic Duloxetine Hydrochloride (Germed) will be purchased and sent for fractioning and placebo preparation.” NCT07203339 ↗ “Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.” NCT05508516 ↗ “Cymbalta® (duloxetine hydrochloride 60 mg, delayed-release capsule)” NCT06715462 ↗ “Drug: Duloxetine hydrochloride” NCT00583193 ↗ “Drug: duloxetine hydrochloride” NCT00385671 ↗ “Drug: duloxetine hydrochloride” NCT00673452 ↗ |
| Known as | Duloxetine Hydrochloride Enteric Capsules | “Duloxetine Hydrochloride Enteric Capsules 60mg/day is to be given orally, once daily, for 8 weeks.” NCT07253207 ↗ |
| Known as | Duloxetine lilly | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Duloxetine mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Duloxetine zentiva | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Duloxetine, Cymbalta | “Duloxetine, Cymbalta” NCT01916824 ↗ |
| Known as | Dulsevia | “Dulsevia® (duloxetine) hard gastro-resistant capsules of different strenghts: 30 mg and 60 mg.” NCT04246619 ↗ |
| Known as | Duroceptol | “In the duloxetine group, one capsule of Duloxetine HCl 30mg (Duroceptol) is taken orally and daily from the day before the first operation to seven days after the second operation.” NCT03792828 ↗ |
| Known as | LY-248686 HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | LY248686 | “Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain” NCT00036335 ↗ |
| Known as | Nodetrip (previously xeristar) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | NSC-759112 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Xeristar | ChEMBL registry synonym — accepted as the source's own label CHEMBL1175 ↗ |
| Known as | Yentreve | “duloxetine_Cymbalta, Yentreve” NCT00817011 ↗ |
| Action | Inhibit | “The purpose of this non-inferiority study was to compare the speed of onset of antidepressant efficacy for duloxetine (a dual serotonin and norepinephrine reuptake inhibitor)...” PMID 17288694 ↗ Feb 2007 |
| Modality | Small molecule | “Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI)” NCT00438971 ↗ |
| Route | Oral | “duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks” NCT00105989 ↗ |
| Target | CYP2D6 | “Duloxetine is known to inhibit CYP2D6.” NCT01443520 ↗ |
| Target | SLC6A2 | “Norepinephrine transporter inhibitor” CHEMBL1175 ↗ |
| Target | SLC6A4 | “Serotonin transporter inhibitor” CHEMBL1175 ↗ |