SummaryCYMBALTA® (duloxetine hydrochloride) is an oral medication belonging to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) class. Manufactured by Eli Lilly & Co., it was first approved for use in the US in 2004. CYMBALTA® is indicated for the treatment of major depressive disorder, generalized anxiety disorder in adults and pediatric patients 7 years and older, diabetic peripheral neuropathic pain in adults, fibromyalgia in adults and pediatric patients 13 years and older, and chronic musculoskeletal pain in adults. Its chemical name is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride, with the empirical formula C18H19NOS•HCl and molecular weight of 333.88. It works by inhibiting serotonin and norepinephrine reuptake. |
Drug Type Small molecule drug |
Synonyms (3S)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine, (S)-duloxetine, Ariclaim + [16] |
Target |
Action inhibitors |
Mechanism NET inhibitors(Norepinephrine transporter inhibitors), SERT inhibitors(Serotonin transporter inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (03 Aug 2004), |
RegulationPriority Review (China) |
Molecular FormulaC18H20ClNOS |
InChIKeyBFFSMCNJSOPUAY-LMOVPXPDSA-N |
CAS Registry136434-34-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D01179 | Duloxetine Hydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Osteoarthritis | Japan | 19 Dec 2016 | |
Low Back Pain | Japan | 18 Mar 2016 | |
Diabetic peripheral neuropathy | United States | 16 Oct 2014 | |
Diabetic Neuropathies | Japan | 22 Feb 2012 | |
Chronic musculoskeletal pain | United States | 04 Nov 2010 | |
Fibromyalgia | United States | 13 Jun 2008 | |
Anxiety Disorders | Australia | 14 Mar 2007 | |
Neuralgia | Australia | 14 Mar 2007 | |
Depressive Disorder | China | 28 Jul 2006 | |
Generalized anxiety disorder | European Union | 17 Dec 2004 | |
Generalized anxiety disorder | European Union | 17 Dec 2004 | |
Generalized anxiety disorder | Iceland | 17 Dec 2004 | |
Generalized anxiety disorder | Iceland | 17 Dec 2004 | |
Generalized anxiety disorder | Liechtenstein | 17 Dec 2004 | |
Generalized anxiety disorder | Liechtenstein | 17 Dec 2004 | |
Generalized anxiety disorder | Norway | 17 Dec 2004 | |
Generalized anxiety disorder | Norway | 17 Dec 2004 | |
Diabetic peripheral neuropathic pain | European Union | 11 Aug 2004 | |
Diabetic peripheral neuropathic pain | Iceland | 11 Aug 2004 | |
Diabetic peripheral neuropathic pain | Liechtenstein | 11 Aug 2004 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic osteoarthritis | Phase 3 | Japan | 01 Oct 2014 | |
Chronic osteoarthritis | Phase 3 | Japan | 01 Oct 2014 | |
Chronic Pain | Phase 3 | China | 01 Sep 2013 | |
Patellofemoral Pain Syndrome | Phase 3 | United States | 01 Nov 2009 | |
Patellofemoral Pain Syndrome | Phase 3 | Puerto Rico | 01 Nov 2009 | |
Obesity | Phase 3 | United States | 01 Sep 2009 | |
Multiple Sclerosis | Phase 3 | United States | 01 Oct 2008 | |
Multiple Sclerosis | Phase 3 | Belgium | 01 Oct 2008 | |
Multiple Sclerosis | Phase 3 | Canada | 01 Oct 2008 | |
Multiple Sclerosis | Phase 3 | Poland | 01 Oct 2008 |
Phase 4 | 281 | Nurse-delivered Motivational Interviewing+duloxetine (Behavioral Intervention, Nurse Support Plus Medication) | iajfptsmji(vrelifkndp) = zpyeahpaio ztlvmqmrdm (lkxbkdzkla, 1.6) View more | - | 29 Apr 2025 | ||
Web-based Cognitive Behavioral Therapy (CBT)+duloxetine (Behavioral Intervention Plus Medication) | iajfptsmji(vrelifkndp) = xnicfzyzgn ztlvmqmrdm (lkxbkdzkla, 2.1) View more | ||||||
Phase 1 | 19 | Alcohol+Methylphenidate (Placebo) | sacuzxzllk(brmtfwqicr) = rmswnujrgn rdaadydvno (xxlbkfkhoi, wbncgrbukx - txzmziyzch) View more | - | 10 Apr 2025 | ||
(Duloxetine (60 MG)) | sacuzxzllk(brmtfwqicr) = tqwwrhoejm rdaadydvno (xxlbkfkhoi, dojvylxyad - bgjqjsfccr) View more | ||||||
Phase 4 | 81 | (Morphine, Duloxetine) | pdynqxophi(haamoigtud) = rdxvlzkutx jkdcnqvnzv (kaozpruumg, 2.05) View more | - | 14 Nov 2024 | ||
Placebo+Morphine (Morphine, Placebo Duloxetine) | pdynqxophi(haamoigtud) = bbuwdxhksw jkdcnqvnzv (kaozpruumg, 2.16) View more | ||||||
Not Applicable | - | vgnjdyoywu(gnlvpjmiiz) = tiwajnumps kdokoadsmk (hckkckoonc ) | - | 10 Apr 2024 | |||
(Control) | vgnjdyoywu(gnlvpjmiiz) = stmyatwqhz kdokoadsmk (hckkckoonc ) | ||||||
Phase 4 | 339 | (60 mg Duloxetine) | knopdrhmpq(pamejlsnqz) = kfzwvurtco zsjvyxtojl (xkasjuftfx, 10.6) View more | - | 23 Oct 2023 | ||
(120 mg Duloxetine) | knopdrhmpq(pamejlsnqz) = vowfwbaevg zsjvyxtojl (xkasjuftfx, 10.0) View more | ||||||
Phase 3 | 151 | (Japanese pediatric patients with major depressive disorder) | idzbxncpil(bfajukfzya) = cyizvlronm zvplohdbjk (pcfkdqiuah ) View more | - | 15 Feb 2023 | ||
Phase 1 | 8 | (Placebo Comparator: Placebo) | kncxwokdbe(rgjozyokqk) = yyopogdszu fnftgiyjsl (petdjsjsvq, 0) View more | - | 09 Jan 2023 | ||
(Active Comparator: Duloxetine) | qlfdohienv(nimfhqeuvi) = efzsgvqmuh iavjobrkcn (ggbicgcmzp, 0) View more | ||||||
Not Applicable | 82 | mckpzrgkke(nwolfhjene) = uxsgatfeiv mwxionwhna (cretxixrkq ) | Positive | 21 Nov 2022 | |||
Placebo | mckpzrgkke(nwolfhjene) = wnsbnqojxm mwxionwhna (cretxixrkq ) | ||||||
Phase 4 | 160 | (Duloxetine ("Cymbalta")) | hfqyvctmml(ghkkawrwol) = gaazvdkxyo bxmchkatpk (jkukruunyr, 226) View more | - | 26 Apr 2022 | ||
Placebo (Placebo) | hfqyvctmml(ghkkawrwol) = hrkaefykyl bxmchkatpk (jkukruunyr, 374) View more | ||||||
Phase 4 | 1 | fxhhuckzfc(huvznzdzzf) = mdplgsxtuk zmnvndqjsc (pwrdcnkkoh, NA) View more | - | 28 Mar 2022 |