CDEK
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ropivacaine

Trade name: naropin

Small moleculeapproved

Approved

Sep 24, 1996

Ropivacaine is a member of the amino amide class of local anesthetics and is supplied as the pure S-(-)-enantiomer. It produces effects similar to other local anesthetics via reversible inhibition of sodium ion influx in nerve fibers. Ropivacaine is less lipophilic than bupivacaine and is less likely to penetrate large myelinated motor fibers, resulting in a relatively reduced motor blockade. Thus, ropivacaine has a greater degree of motor-sensory differentiation, which could be useful when the motor blockade is undesirable. The reduced lipophilicity is also associated with decreased potential for central nervous system toxicity and cardiotoxicity. Ropivacaine is indicated for the production of local or regional anesthesia for surgery and for acute pain management. — NCATS

Clinical trial activity

1,051 trials · 538 clinical orgs · 17 marketing orgs

Phase 1
46
Phase 2
192
Phase 3
142
Phase 4
397

Earliest trial started Aug 1, 2000 (NCT00042510)

Timeline

1990s

  1. Sep 24, 1996

    Fresenius — Earliest FDA Approval

  2. Sep 24, 1996

    Fresenius — NDA Organization

  3. Sep 24, 1996

    Fresenius — NDA Secondary Org

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jul 17, 2014

    Navinta — Marketing Organization

  2. Sep 23, 2014

    Rising Pharmaceuticals — Marketing Organization

  3. Sep 23, 2014

    Hospira — Marketing Organization

  4. Sep 23, 2014

    Mylan — Marketing Organization

  5. Jul 13, 2016

    Aurobindo Pharma — Marketing Organization

  6. Jul 13, 2016

    Eugia Pharma — Marketing Organization

  7. Mar 16, 2018

    Akorn, Inc. — Marketing Organization

  8. Jun 11, 2018

    Inforlife — Marketing Organization

  9. Jun 15, 2018

    Somerset Pharmaceuticals — Marketing Organization

2020s

  1. Apr 9, 2020

    Caplin Point Laboratories — Marketing Organization

  2. Jul 20, 2020

    Hikma — Marketing Organization

  3. Aug 18, 2022

    Gland Pharma Ltd — Marketing Organization

  4. Aug 18, 2022

    Fosun — Marketing Organization

  5. Mar 8, 2023

    Amneal Pharmaceuticals — Marketing Organization

  6. Jul 30, 2024

    KINDOS — Marketing Organization

  7. Mar 21, 2025

    ANTHEA PHARMA — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedSep 24, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Mol. weight
274.41 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 1-propyl-2',6'-pipecoloxylidide
  • al 381
  • al-381
  • anapeine
  • lea 103
  • lea-103
  • l-n-n-propylpipecolic acid-2,6-xylidide
  • l-n-n-propylpipecolic acid-2,6-xylidide
  • narapin
  • narapin
  • naropeine
  • naropeine
  • naropin
  • naropin
  • naropin
  • naropin
  • naropin
  • naropine
  • naropine
  • naropine
  • noropin
  • prf-108
  • prf-108
  • prf-110
  • ropivacaina
  • ropivacaina
  • ropivacaina
  • ropivacaine
  • ropivacaine
  • ropivacaine
  • ropivacaine
  • ropivacaine
  • ropivacaine
  • ropivacaine
  • ropivacaine
  • ropivacaine
  • ropivacaine
  • (-)-ropivacaine
  • ropivacaine hcl
  • ropivacaine hcl
  • ropivacaine hcl
  • ropivacaine hydrochloride
  • ropivacaine hydrochloride
  • ropivacaine hydrochloride
  • ropivacaine hydrochloride
  • ropivacaine hydrochloride
  • ropivacaine hydrochloride
  • ropivacaine hydrochloride monohydrate
  • ropivacaine monohydrochloride
  • ropivacaine monohydrochloride, (s)-isomer
  • ropivacainum
  • ropivacainum
  • ropivicaine
  • (s)-(−)-1-propyl-2',6'-pipecoloxylidide
  • (s)-(−)-1-propyl-2',6'-pipecoloxylidide
  • (s)-ropivacaine
  • (s)-ropivacaine
  • s-ropivacaine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07216586Phase 4Jan 31, 2026University of Miami
NCT06964347N/ADec 31, 2025Stanford University
NCT07271979N/ADec 31, 2025Shandong University
NCT07294755N/ADec 20, 2025People's Liberation Army of China
NCT07222748Phase 3Nov 30, 2025Taiwan Liposome Company
NCT07092566Phase 3Nov 14, 2025University of North Carolina at Chapel Hill, Wake Forest University
NCT07087015N/AOct 31, 2025Stanford University
NCT07176065Phase 4Oct 31, 2025University of Malaya
NCT07209345N/AOct 15, 2025Capital Medical University
NCT06953661N/AOct 13, 2025Stanford University
NCT07061678Phase 4Oct 1, 2025Poznan University
NCT07180979Phase 4Oct 1, 2025Poznan University
NCT07131657Phase 2Sep 30, 2025PHARMAFINA
NCT07109388N/ASep 30, 2025University of Lausanne
NCT07116343Phase 4Sep 25, 2025Saint-Petersburg State Medical University
NCT07196631Phase 4Sep 20, 2025Huazhong University of Science and Technology
NCT07171125Phase 4Sep 20, 2025Peking University
NCT07174440N/ASep 15, 2025Case Western Reserve University
NCT07076368Phase 3Aug 31, 2025University of California, San Francisco
NCT07145775Phase 4Aug 31, 2025Peking University
Showing 20 of 1,051 trials
Page 1 / 53

Organizations

Research & Development (538)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of CopenhagenAcademic/Hospital514952007
Capital Medical UniversityAcademic/Hospital222022014
Poznan UniversityAcademic/Hospital191922020
University of California, San DiegoAcademic/Hospital181722008
University of PittsburghAcademic/Hospital141432008
Duke UniversityAcademic/Hospital131232007
Mayo ClinicAcademic/Hospital131342005
Harvard UniversityAcademic/Hospital12852014
People's Liberation Army of ChinaGovernment121032013
University of Western OntarioAcademic/Hospital121032011
Huazhong University of Science and TechnologyAcademic/Hospital111042013
Northwestern UniversityAcademic/Hospital11732010
Peking UniversityAcademic/Hospital111122014
University of TorontoAcademic/Hospital111142009
Yonsei UniversityAcademic/Hospital111132008
Orebro UniversityAcademic/Hospital10732004
Jiao Tong UniversityAcademic/Hospital9732014
Seoul National UniversityAcademic/Hospital9842008
Thomas Jefferson UniversityAcademic/Hospital8832012
University of FloridaAcademic/Hospital8742016
538 organizations
Page 1 / 27

Marketing (23)

OrganizationOrg typeRelationshipDate
ANTHEA PHARMAFor profitMKTGMar 21, 2025
Akorn, Inc.For profitMKTGMar 16, 2018
Akorn, Inc.For profitSYNApr 11, 2016
Amneal PharmaceuticalsFor profitMKTGMar 8, 2023
Aurobindo PharmaFor profitMKTGJul 13, 2016
Caplin Point LaboratoriesFor profitMKTGApr 9, 2020
Eugia PharmaFor profitMKTGJul 13, 2016
FosunFor profitMKTGAug 18, 2022
FreseniusFor profitNDASep 24, 1996
FreseniusFor profitNDA2Sep 24, 1996
Gland Pharma LtdFor profitMKTGAug 18, 2022
Gland Pharma LtdFor profitSYNAug 18, 2022
HikmaFor profitMKTGJul 20, 2020
HikmaFor profitSYNJul 20, 2020
HospiraFor profitMKTGSep 23, 2014
InforlifeFor profitMKTGJun 11, 2018
KINDOSFor profitMKTGJul 30, 2024
MylanFor profitMKTGSep 23, 2014
MylanFor profitSYNOct 26, 2023
NavintaFor profitMKTGJul 17, 2014
Rising PharmaceuticalsFor profitMKTGSep 23, 2014
Rising PharmaceuticalsFor profitSYNSep 23, 2014
Somerset PharmaceuticalsFor profitMKTGJun 15, 2018