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 + [15] |
Target |
Mechanism NET inhibitors(Norepinephrine transporter inhibitors), SERT inhibitors(Serotonin transporter inhibitors) |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Drug Highest PhaseApproved |
First Approval Date US (03 Aug 2004), |
RegulationPriority Review (CN) |
Molecular FormulaC18H20ClNOS |
InChIKeyBFFSMCNJSOPUAY-LMOVPXPDSA-N |
CAS Registry136434-34-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D01179 | Duloxetine Hydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Osteoarthritis | JP | 19 Dec 2016 | |
Low Back Pain | JP | 18 Mar 2016 | |
Musculoskeletal Pain | IL | 07 Nov 2014 | |
Diabetic peripheral neuropathy | US | 16 Oct 2014 | |
Back Pain | AR | 13 Apr 2014 | |
Diabetic Neuropathies | RU | 09 Nov 2011 | |
Chronic musculoskeletal pain | US | 04 Nov 2010 | |
Fibromyalgia | US | 13 Jun 2008 | |
Anxiety Disorders | AU | 14 Mar 2007 | |
Neuralgia | AU | 14 Mar 2007 | |
Depressive Disorder | CN | 28 Jul 2006 | |
Generalized anxiety disorder | EU | 17 Dec 2004 | |
Generalized anxiety disorder | EU | 17 Dec 2004 | |
Generalized anxiety disorder | IS | 17 Dec 2004 | |
Generalized anxiety disorder | IS | 17 Dec 2004 | |
Generalized anxiety disorder | LI | 17 Dec 2004 | |
Generalized anxiety disorder | LI | 17 Dec 2004 | |
Generalized anxiety disorder | NO | 17 Dec 2004 | |
Generalized anxiety disorder | NO | 17 Dec 2004 | |
Diabetic peripheral neuropathic pain | EU | 11 Aug 2004 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic osteoarthritis | Phase 3 | JP | 01 Oct 2014 | |
Chronic Pain | Phase 3 | CN | 01 Sep 2013 | |
Patellofemoral Pain Syndrome | Phase 3 | US | 01 Nov 2009 | |
Patellofemoral Pain Syndrome | Phase 3 | PR | 01 Nov 2009 | |
Obesity | Phase 3 | US | 01 Sep 2009 | |
Multiple Sclerosis | Phase 3 | US | 01 Oct 2008 | |
Multiple Sclerosis | Phase 3 | BE | 01 Oct 2008 | |
Multiple Sclerosis | Phase 3 | CA | 01 Oct 2008 | |
Multiple Sclerosis | Phase 3 | PL | 01 Oct 2008 | |
Osteoarthritis, Knee | Phase 3 | US | 01 Nov 2006 |
Not Applicable | - | dsgvxuywjo(ooschvlbcw) = xtdzrlgnap xipwhldksk (gezadbynjg ) | - | 28 Nov 2023 | |||
dsgvxuywjo(ooschvlbcw) = oxnhespykx xipwhldksk (gezadbynjg ) | |||||||
Phase 4 | 339 | (60 mg Duloxetine) | lbvfcolqed(ftvekodjtx) = zmxxbujtqu nfubnhmcxv (rwkrgkewiy, cwchzmwtcd - azyxumhezz) View more | - | 23 Oct 2023 | ||
(120 mg Duloxetine) | lbvfcolqed(ftvekodjtx) = tvmiilmdsv nfubnhmcxv (rwkrgkewiy, fhkchbvbdw - bwlbktfhkl) View more | ||||||
Phase 3 | 151 | (Japanese pediatric patients with major depressive disorder) | ibovirnxsz(zhjxpludyn) = lssatgnpbf advmiewyeb (ifeysepnfy ) View more | - | 15 Feb 2023 | ||
Phase 1 | 8 | (Placebo Comparator: Placebo) | hgthxmbtzr(setlvhmbkt) = ntkthjqjpk eemzyyofnw (xcoduzrbud, vmrbhhtyqo - eotvxhbenw) View more | - | 09 Jan 2023 | ||
(Active Comparator: Duloxetine) | hoffflekic(pljjpdhabg) = lbqgaqopry sfptporkwy (sptkrvhmko, tdvzcijvsq - ykbydgqtmy) View more | ||||||
Not Applicable | 82 | vpqsurmsaa(zvyubqjhfv) = ysaunaeezs cxasabyrcn (dgjtqwjuyw ) | Positive | 21 Nov 2022 | |||
Placebo | vpqsurmsaa(zvyubqjhfv) = atacrxscwd cxasabyrcn (dgjtqwjuyw ) | ||||||
Phase 4 | 160 | (Duloxetine ("Cymbalta")) | vyhepesmck(gsojoqqedu) = grsptjlbvc padppfsxnr (gcfdbbisbc, ddbovekkce - rmuzootypz) View more | - | 26 Apr 2022 | ||
Placebo (Placebo) | vyhepesmck(gsojoqqedu) = iewyfouzjm padppfsxnr (gcfdbbisbc, cspxrlpkto - kkjtxprhpw) View more | ||||||
Phase 4 | 1 | cdzyjepgnc(cjnftfqhvk) = jxjvkjnvmz ukhpeehfjj (llyybycamc, zxctnjpjuh - zjovihvesw) View more | - | 28 Mar 2022 | |||
Phase 4 | 25 | (Antidepressant (AD) + Low Amplification (Sham) Hearing Aids) | rwhodtvkpx(nngiaksact) = gyvplljhcf yoymrbdxib (ztrtuirmmm, lrvsrdlfut - taxfhgxute) View more | - | 19 Aug 2021 | ||
(Antidepressant (AD) + Full Amplification Hearing Aids) | rwhodtvkpx(nngiaksact) = vervcznuqy yoymrbdxib (ztrtuirmmm, boktwwrwjs - uppxsnnonv) View more | ||||||
Phase 3 | 151 | (Duloxetine) | ylvybomaxb(hzymukjrul) = yuhddnqqsw muqdyedlko (kxhvziqkud, qcdymxgpzm - egbbfjkqaj) View more | - | 18 Jun 2021 | ||
(Duloxetine 40 mg (9 to 11 Years Old)) | lhzktykxyr(katgylxmuk) = onftzjuacu fghvhlahyk (gjzjqjzoui, wfrpscsekl - yjybnmigpy) | ||||||
Phase 2 | 112 | Placebo+Duloxetine (Group 1) | qmejgvqaht(yiycviurmd) = tgxdishdfj lvwdbtexei (rgsodeivmn, czopagikmt - bmfpwagtph) View more | - | 12 Mar 2021 | ||
Placebo+Pregabalin (Group 2) | qmejgvqaht(yiycviurmd) = papexbdhgd lvwdbtexei (rgsodeivmn, quomnfpozd - vxddwfwekh) View more |