Milnacipran

also known as Savella · Dalcipran · Impulsor · Ixel · Ixel (outside of United States) · Milnacipran hcl · Milnacipran hydrochloride · Milnacipran pierre fabre medicament · +4 more

Other / unclassified targets SLC6A2, SLC6A4 via inhibition

Developed for: fibromyalgia · depressive disorder · osteoarthritis · rheumatoid arthritis · autism spectrum disorder · chronic pain syndrome · cognitive disorder · lumbar disk disease
+11 more
· migraine with aura · migraine without aura · osteoarthritis, knee · peripheral neuropathy · sleep disorder · systemic lupus erythematosus · vulvodynia · irritable bowel syndrome · major depressive disorder · migraine disorder · neuropathy, painful
Investigated by: Forest Laboratories · Cypress Bioscience, Inc. · Duke University · Pierre Fabre Laboratories · Brigham and Women's Hospital · Samsung Medical Center
+17 more
· Analgesic Solutions · Banner Health · Best Practice · California Medical Clinic for Headache · Chang Gung Memorial Hospital · Columbia University · Dr. Norman Harden · Loma Linda University · Mansoor Ahmed M.D. · Montefiore Medical Center · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Northwestern University · Shirley Ryan AbilityLab · University of California, Los Angeles · University of Michigan · University of Tennessee · Wyeth is now a wholly owned subsidiary of Pfizer

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Refused (EMA)	EU (EMA)	Milnacipran Pierre Fabre Medicament	—	2010-04-08	europa.eu ↗
Approved	US (FDA)	SAVELLA	—	2009-01-14	fda.gov ↗

Trials 33

today

US approved 2009

NCT01359826 · Ph 4 NCT01329406 · Ph 4 NCT01829243 · Ph 3 NCT01328002 · Ph 2 NCT01331109 · Ph 2 NCT01319825 · Ph 4 NCT01288937 · Ph 3 NCT01418651 · Ph 3 NCT01337700 · Ph 4 NCT01207453 · Ph 4 NCT01225991 · Ph 4 NCT01510457 · Ph 4 NCT01234675 · Ph 4 NCT01304589 · Ph 3 NCT01225068 · Ph 2 NCT01780389 · Ph 4 NCT01221740 · Ph 3 NCT01173055 · Ph 4 NCT01777581 · Ph 4 NCT01077375 · Ph 4 NCT01014585 · Ph 4 NCT00797797 · Ph 3 NCT00793520 · Ph 3 NCT00618956 · Ph 3 NCT00606203 · not/applicable NCT00757731 · Ph 3 NCT00757679 · Ph 2 NCT00314249 · Ph 3 NCT00436033 · Ph 3 NCT00098124 · Ph 3 NCT00225511 · Ph 3 NCT01352572 · not/applicable NCT01352559 · not/applicable

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 24 trials
Phase 2	NCT01328002	Apr 2011 → Aug 2012	fibromyalgia	Forest Laboratories	Terminated	No outcome recorded
Phase 2	NCT01331109	Apr 2011 → Aug 2012	fibromyalgia	Forest Laboratories	Terminated	No outcome recorded
Phase 2	NCT01225068	Oct 2010 → Jan 2012	—	Northwestern University	Completed	No outcome recorded
Phase 2	NCT00757679	Sep 2006 → Sep 2009	fibromyalgia	Pierre Fabre Laboratories	Completed	No outcome recorded
Phase 313 trials · 4 met primary
Phase 3	NCT01829243	Jul 2011 → May 2013	cognitive disorder, fibromyalgia	Duke University	Completed	No outcome recorded
Phase 3	NCT01288937	Apr 2011 → Oct 2014	peripheral neuropathy	Columbia University	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01418651	Mar → Aug 2011	fibromyalgia	Banner Health	Terminated	No outcome recorded
Phase 3	NCT01304589	Oct 2010 → Sep 2012	vulvodynia	University of Tennessee	Completed	No outcome recorded
Phase 3	NCT01221740	Aug 2010 → Aug 2011	—	Brigham and Women's Hospital	Withdrawn	No outcome recorded
Phase 3	NCT00797797	Nov 2008 → Nov 2009	fibromyalgia	Forest Laboratories	Completed	Met primary
Phase 3	NCT00793520	Nov 2008 → Apr 2009	fibromyalgia	Forest Laboratories	Terminated	No outcome recorded
Phase 3	NCT00618956	Oct 2007 → Jul 2008	fibromyalgia	Forest Laboratories	Completed	No outcome recorded
Phase 3	NCT00757731	Sep 2006 → Oct 2008	fibromyalgia	Pierre Fabre Laboratories	Completed	No outcome recorded
Phase 3	NCT00314249	Apr 2006 → Jun 2008	fibromyalgia	Forest Laboratories	Completed	Met primary
Phase 3	NCT00436033	Feb 2006 → Sep 2007	fibromyalgia	Pierre Fabre Laboratories	Completed	Met primary
Phase 3	NCT00098124	Nov 2004 → Dec 2006	fibromyalgia	Forest Laboratories	Completed	Met primary
Phase 3	NCT00225511	Jun 2004 → ?	depressive disorder	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded

Phase 413 trials · 2 met primary · 2 missed
Phase 4	NCT01359826	Oct 2011 → Jun 2013	fibromyalgia, systemic lupus erythematosus	Loma Linda University	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT01329406	Jul 2011 → Feb 2012	osteoarthritis	Analgesic Solutions	Unknown	No outcome recorded
Phase 4	NCT01319825	Apr 2011 → May 2012	migraine with aura, migraine without aura	California Medical Clinic for Headache	Unknown	No outcome recorded
Phase 4	NCT01337700	Feb 2011 → Jul 2014	autism spectrum disorder	Montefiore Medical Center	Completed	No outcome recorded
Phase 4	NCT01207453	Jan 2011 → Nov 2013	rheumatoid arthritis	Brigham and Women's Hospital	Completed	Missed primary
Phase 4	NCT01225991	Nov 2010 → May 2013	rheumatoid arthritis	University of California, Los Angeles	Completed	No outcome recorded
Phase 4	NCT01510457	Nov 2010 → Oct 2013	chronic pain syndrome, osteoarthritis, knee	Dr. Norman Harden	Completed	No outcome recorded
Phase 4	NCT01234675	Nov 2010 → Feb 2014	fibromyalgia, sleep disorder	Mansoor Ahmed M.D.	Completed	Missed primary
Phase 4	NCT01780389	Oct 2010 → Jul 2011	osteoarthritis	Duke University	Completed	No outcome recorded
Phase 4	NCT01173055	Jun 2010 → Jun 2012	fibromyalgia	University of Michigan	Completed	No outcome recorded
Phase 4	NCT01777581	Mar 2010 → Oct 2011	lumbar disk disease	Duke University	Completed	Met primary
Phase 4	NCT01077375	Feb → Dec 2010	fibromyalgia	Forest Laboratories	Completed	No outcome recorded
Phase 4	NCT01014585	Nov 2009 → May 2010	fibromyalgia	Forest Laboratories	Completed	Met primary

Phase not applicable3 trials
—	NCT00606203	Sep 2007 → Sep 2010	depressive disorder, ischemic stroke	Chang Gung Memorial Hospital	Unknown	No outcome recorded
—	NCT01352572	Jan 2002 → Dec 2018	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT01352559	Nov 2001 → Mar 2007	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
Comparator or background therapy18 trials
Phase 1	NCT01294059 Comparator	Nov 2009 → Apr 2014	fibromyalgia	University of Florida	Completed	No outcome recorded
Phase 2	NCT03321526 Background	Dec 2017 → Jun 2019	major depressive disorder	Janssen Research & Development, LLC	Completed	Missed primary
Phase 2	NCT01914042 Comparator	Jul 2013 → Jul 2019	neuropathy, painful	Rambam Health Care Campus	Unknown	No outcome recorded
Phase 2	NCT01747044 Comparator	Apr 2013 → Nov 2014	fibromyalgia	University Hospital, Clermont-Ferrand	Unknown	No outcome recorded
Phase 2	NCT01471379 Comparator	Apr 2012 → Feb 2013	irritable bowel syndrome	Spencer Dorn, MD, MPH	Terminated	No outcome recorded Stop: Enrollment
Phase 2/3	NCT02783430 Background	Sep 2016 → Mar 2024	depressive disorder	University Hospital, Lille	Completed	No outcome recorded
Phase 2/3	NCT01108731 Comparator	Mar 2010 → Jan 2014	fibromyalgia	Beth Israel Medical Center	Completed	No outcome recorded
Phase 4	NCT01125423 Comparator	May 2010 → Jan 2013	fibromyalgia	Albany Medical College	Completed	No outcome recorded
Phase 4	NCT01038323 Comparator	Dec 2009 → Sep 2012	fibromyalgia	Indiana University	Completed	No outcome recorded
Phase 4	NCT01289236 Comparator	Oct 2009 → Jun 2011	chronic pain syndrome	Valera Bussell	Completed	No outcome recorded
—	NCT07533487 Background	Sep 2022 → Jan 2025	fibromyalgia	Cairo University	Completed	No outcome recorded
—	NCT05384210 Comparator	Jun 2022 → Oct 2023	fibromyalgia	Mansoura University	Unknown	No outcome recorded
—	NCT03905486 Comparator	Apr → Nov 2019	fibromyalgia	Yousra Hisham Abdel Fattah	Completed	No outcome recorded
—	NCT02687165 Comparator	Jan 2016 → Jan 2017	chronic pain syndrome, post-treatment Lyme disease syndrome	New York State Psychiatric Institute	Terminated	No outcome recorded Stop: Enrollment
—	NCT01488266 Comparator	Nov 2011 → Jan 2013	major depressive disorder	Korea University	Unknown	No outcome recorded
—	NCT01393522 Comparator	Jun 2011 → Dec 2013	migraine disorder	Timothy Smith	Completed	No outcome recorded
—	NCT00817375 Comparator	Feb 2003 → Dec 2018	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT01228357 Comparator	Feb 2003 → Dec 2018	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded

Press releases naming this drug 1 release

Date	Issuer	Release
2026-03-19	Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals Inc., USA launches Authorized Generic to Milnacipran Hydrochloride Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg glenmarkpharma.com ↗

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 53 sources stand behind the page.

Field	Value	Cited text
Known as	milnacipran	“Aim of the work: To compare the efficacy of pregabalin agent (averopreg) alone versus combined pregabalin and serotonin norepinephrine reuptake inhibitor (milnacipran) in the...” NCT03905486 ↗ 48 “Participants will receive SNRI antidepressant (such as duloxetine, milnacipran, levomilnacipran, venlafaxine, desvenlafaxine) as a part of background therapy” NCT03321526 ↗ “non-SSRI treated group is depressive patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine” NCT00817375 ↗ “pain relievers such as acetaminophen and antidepressants such as Duloxetine (Cymbalta) and milnacipran” NCT07533487 ↗ “milnacipran” NCT01352559 ↗ “milnacipran” NCT01488266 ↗ “milnacipran” NCT01352572 ↗ “milnacipran” NCT01228357 ↗ NCT01319825 ↗ NCT00797797 ↗ NCT01207453 ↗ Show 38 more sources
Known as	Dalcipran	ChEMBL registry synonym — accepted as the source's own label CHEMBL259209 ↗
Known as	Impulsor	ChEMBL registry synonym — accepted as the source's own label CHEMBL259209 ↗
Known as	Ixel	“Milnacipran (Ixel)- a serotonin-norepinephrine reuptake inhibitor (SNRI)” NCT01914042 ↗
Known as	Ixel (outside of United States)	“Ixel (outside of United States)” NCT00618956 ↗
Known as	Milnacipran hcl	ChEMBL registry synonym — accepted as the source's own label CHEMBL259209 ↗
Known as	Milnacipran hydrochloride	“Drug: Milnacipran hydrochloride” NCT00618956 ↗
Known as	Milnacipran pierre fabre medicament	ChEMBL registry synonym — accepted as the source's own label CHEMBL259209 ↗
Known as	MLN	“Gabapentin and milnacipran (MLN) show strong evidence of reduced pain, increased sleep, and improvement in the quality of life in fibromyalgia (FM) patients.” NCT05384210 ↗
Known as	NSC-759806	ChEMBL registry synonym — accepted as the source's own label CHEMBL259209 ↗
Known as	Savella	“This medicine is known as Milnacipran (the trade name is "Savella"); this medicine is not addictive and it has been shown to reduce chronic pain by its multiple actions on pain...” NCT02687165 ↗ 4 “Savella ®, (milnacipran) is an FDA approved drug for fibromyalgia.” NCT01038323 ↗ “Savella” NCT01393522 ↗ NCT01418651 ↗ NCT01221740 ↗
Known as	Savella (milnacipran HCL) Tablets	“Savella (milnacipran HCL) Tablets” NCT01510457 ↗
Known as	Toledomin	ChEMBL registry synonym — accepted as the source's own label CHEMBL259209 ↗
Action	Inhibit	“milnacipran, a dual norepinephrine-serotonin reuptake inhibitor” PMID 19108787 ↗ Nov 2008 2 “Norepinephrine transporter inhibitor” CHEMBL259209 ↗ “Serotonin transporter inhibitor” CHEMBL259209 ↗
Modality	Other / unclassified	“serotonin-norepinephrine reuptake inhibitor (SNRI)” NCT01329406 ↗
Route	Oral	“oral administration” NCT00618956 ↗
Target	SLC6A2	“Norepinephrine transporter inhibitor” CHEMBL259209 ↗
Target	SLC6A4	“Serotonin transporter inhibitor” CHEMBL259209 ↗