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milnacipran

Trade name: savella

Small moleculeapproved

Approved

Jan 14, 2009

Milnacipran is the only marketed serotonin/norepinephrine (5-HT/NE) reuptake inhibitor (SNRI) reported to have greater relative potency at NET than SERT in vitro and is the first SNRI to report equal occupancy of both transporters at clinical doses. Milnacipran is a racemic mixture of the 1S, 2R (F2695/levomilnacipran) and 1R, 2S (F2696/dextromilnacipran) enantiomers. Savella® (Milnacipran) is indicated for the management of fibromyalgia. — NCATS

Clinical trial activity

50 trials · 40 clinical orgs · 16 marketing orgs

Phase 1
2
Phase 2
22
Phase 3
17
Phase 4
17

Earliest trial started Jan 1, 2002 (NCT01352572)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

  4. Jan 14, 2009

    Forest Laboratories — Earliest FDA Approval

  5. Jan 14, 2009

    Allergan — NDA Secondary Org

  6. Jan 14, 2009

    Forest Laboratories — NDA Organization

  7. Jan 14, 2009

    Allergan — Marketing Organization

  8. Jan 14, 2009

    AbbVie — Marketing Organization

  9. Jan 14, 2009

    AbbVie — NDA Secondary Org

2010s

  1. Oct 9, 2015

    Par Pharmaceuticals — Marketing Organization

  2. Oct 9, 2015

    Bristol-Myers Squibb — Marketing Organization

  3. Oct 20, 2015

    Lupin — Marketing Organization

  4. Jan 27, 2016

    US Pharma — Marketing Organization

  5. Jan 27, 2016

    ANDA Repository — Marketing Organization

  6. Jan 27, 2016

    Oryza — Marketing Organization

  7. Jan 27, 2016

    Esteve Labs — Marketing Organization

  8. Apr 22, 2016

    Amneal Pharmaceuticals — Marketing Organization

  9. Jul 26, 2016

    Mylan — Marketing Organization

  10. Mar 30, 2017

    Glenmark Pharmaceuticals — Marketing Organization

  11. Nov 2, 2018

    Macleods Pharmaceuticals, Ltd — Marketing Organization

2020s

  1. Jan 5, 2022

    Neogen — Marketing Organization

  2. Oct 3, 2024

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 14, 2009

Chemistry & pharmacology

Loading structure…

SMILES

CCN(CC)C(=O)[C@@]1(C[C@@H]1CN)C2=CC=CC=C2
Mol. weight
246.348 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 1-phenyl-1-diethylaminocarbonyl-2-aminomethylcyclopropane hcl
  • cyclopropanecarboxamide, 2-(aminomethyl)-n,n-diethyl-1-phenyl-, cis-(+-)-
  • f 2207
  • f-2207
  • ixel
  • midalcipran
  • midalcipran
  • midalcipran
  • midalcipran
  • midalcipran
  • milnacipran
  • milnacipran
  • milnacipran
  • milnacipran
  • milnacipran
  • milnacipran
  • milnacipran
  • milnacipran
  • milnacipran
  • milnacipran
  • milnacipran
  • milnacipran
  • (-)-milnacipran
  • (-)-milnacipran
  • (+/-)-milnacipran
  • milnacipran hcl
  • milnacipran hcl
  • milnacipran hcl
  • milnacipran hydrochloride
  • milnacipran hydrochloride
  • milnacipran hydrochloride
  • milnacipran hydrochloride
  • milnacipran hydrochloride
  • milnacipranum
  • milnacipranum
  • savella
  • savella
  • savella
  • savella

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05384210N/AJun 30, 2022Mansoura University
NCT03905486N/AApr 30, 2019Alexandria University
NCT02783430Phase 2/Phase 3 (Phase 3)Sep 8, 2016University of Lille, Valenciennes Hospital Centre
NCT02687165N/AJan 1, 2016Columbia University
NCT02266966Phase 1Apr 1, 2014Pierre Fabre
NCT01914042Phase 2Jul 1, 2013Technion University
NCT01747044Phase 2Apr 1, 2013University Clermont Auvergne
NCT01639014Phase 3Jul 1, 2012Pierre Fabre
NCT01471379Phase 2Apr 1, 2012Forest Laboratories, University of North Carolina at Chapel Hill
NCT01359826Phase 4Oct 1, 2011Forest Laboratories, Loma Linda University
NCT01829243Phase 3Jul 1, 2011Duke University, Forest Laboratories
NCT01329406Phase 4Jul 1, 2011Analgesic Solutions, Forest Laboratories
NCT01393522N/AJun 1, 2011Government of Canada, Mercy Health Research
NCT01331109Phase 2Apr 1, 2011Cypress Bioscience, Inc., Forest Laboratories
NCT01328002Phase 2Apr 1, 2011Cypress Bioscience, Inc., Forest Laboratories
NCT01319825Phase 4Apr 1, 2011California Medical Clinic for Headache
NCT01418651Phase 3Mar 1, 2011Forest Laboratories, University of Arizona
NCT01337700Phase 4Feb 1, 2011Forest Laboratories, Yeshiva University
NCT01288807Phase 4Feb 1, 2011Department of Veteran Affairs, Forest Laboratories, University of California, San Diego
NCT01207453Phase 4Jan 1, 2011Forest Laboratories, Harvard University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Showing 20 of 50 trials
Page 1 / 3

Organizations

Research & Development (40)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Forest LaboratoriesFor profit311152004
Cypress Bioscience, Inc.For profit6032006
Pierre FabreFor profit5532006
Duke UniversityAcademic/Hospital3322010
Harvard UniversityAcademic/Hospital3322010
Columbia UniversityAcademic/Hospital2212010
Hospital Egas MonizAcademic/Hospital2012006
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government2012009
Northwestern UniversityAcademic/Hospital2122010
Albany Medical CollegeAcademic/Hospital1112010
Alexandria UniversityAcademic/Hospital1112019
Analgesic SolutionsFor profit1112011
California Medical Clinic for HeadacheAcademic/Hospital1112011
Chang Gung UniversityAcademic/Hospital1112007
Cleveland Sleep Research CenterAcademic/Hospital1112010
Delray Research AssociatesFor profit1112009
Department of Veteran AffairsGovernment1012011
Government of CanadaGovernment1112011
Icahn School of Medicine at Mount SinaiAcademic/Hospital1012010
Indiana UniversityAcademic/Hospital1112009
40 organizations
Page 1 / 2

Marketing (19)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGJan 27, 2016
AbbVieFor profitMKTGJan 14, 2009
AbbVieFor profitNDA2Jan 14, 2009
AllerganFor profitNDA2Jan 14, 2009
AllerganFor profitMKTGJan 14, 2009
Amneal PharmaceuticalsFor profitMKTGApr 22, 2016
Bristol-Myers SquibbFor profitMKTGOct 9, 2015
Esteve LabsFor profitMKTGJan 27, 2016
Forest LaboratoriesFor profitNDAJan 14, 2009
Glenmark PharmaceuticalsFor profitMKTGMar 30, 2017
Hetero Labs LtdFor profitMKTGOct 3, 2024
LupinFor profitMKTGOct 20, 2015
Macleods Pharmaceuticals, LtdFor profitMKTGNov 2, 2018
MylanFor profitMKTGJul 26, 2016
NeogenFor profitMKTGJan 5, 2022
OryzaFor profitMKTGJan 27, 2016
Par PharmaceuticalsFor profitMKTGOct 9, 2015
US PharmaFor profitMKTGJan 27, 2016
US PharmaFor profitSYNJan 27, 2016