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remifentanil

Trade name: ultiva

Small moleculeapproved

Approved

Jan 1, 1996

Remifentanil (marketed by Abbott as Ultiva) is a potent ultra short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anaesthetic. ULTIVA is a µ-opioid agonist with rapid onset and peak effect, and short duration of action. The µ-opioid activity of ULTIVA is antagonized by opioid antagonists such as naloxone. ULTIVA is indicated for IV administration: 1. As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. 2. For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. 3. As an analgesic component of monitored anesthesia care in adult patients. — NCATS

Clinical trial activity

490 trials · 332 clinical orgs · 6 marketing orgs

Phase 1
23
Phase 2
60
Phase 3
33
Phase 4
177

Earliest trial started Jan 1, 2001 (NCT01720615)

Timeline

1990s

  1. Jan 1, 1996

    Earliest FDA Approval

  2. Jul 12, 1996

    Glaxo Wellcome — First NDA Organization

  3. Jul 12, 1996

    Mylan — NDA Secondary Org

  4. Jul 12, 1996

    Glaxo Wellcome — NDA Organization

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 16, 2018

    Fresenius — Marketing Organization

2020s

  1. Oct 13, 2020

    Hikma — Marketing Organization

  2. Oct 13, 2020

    Navinta — Marketing Organization

  3. Jun 28, 2024

    Nivagen Pharmaceuticals Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 1, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Mol. weight
376.45 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 1-piperidinepropanoic acid, 4-(methoxy-carbonyl)-4-((1-oxopropyl)phenylamino)-, methyl ester
  • 3-(4-methoxycarbonyl-4-((1-oxopropyl)phenylamino)-1-piperidine)propanoic acid methyl ester
  • gi87084b
  • gi 87084b
  • gi-87084b
  • gi-87084b
  • gi-87084b
  • ramifentanyl
  • remifantanil
  • remifentamil
  • remifentani
  • remifentanil
  • remifentanil
  • remifentanil
  • remifentanil
  • remifentanil
  • remifentanil
  • remifentanil
  • remifentanil
  • remifentanil
  • remifentanil
  • remifentanil hcl
  • remifentanil hcl
  • remifentanil hcl
  • remifentanil hydrochloride
  • remifentanil hydrochloride
  • remifentanil hydrochloride
  • remifentanil hydrochloride
  • remifentanil hydrochloride
  • remifentanil monohydrochloride
  • remifentanyl
  • remifentanyl
  • remifentanyl
  • ultiva
  • ultiva
  • ultiva
  • ultiva

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06810843N/ADec 31, 2025Shandong first medical University, Shandong Province Qianfoshan Hospital
NCT07271472N/ADec 1, 2025Ataturk University
NCT07182097N/ASep 19, 2025Konya City Hospital
NCT07181564N/ASep 11, 2025University of Patras
NCT07092384N/AJul 30, 2025Huazhong University of Science and Technology
NCT07059429N/AJul 1, 2025Pirogov Russian National Research Medical University
NCT07034963Phase 1/Phase 2 (Phase 2)Jun 26, 2025Xiamen University
NCT06564857Phase 4Jun 1, 2025University of Copenhagen
NCT06788743N/AJun 1, 2025Xijing Hospital
NCT06958393Phase 4May 20, 2025Shandong Province Qianfoshan Hospital
NCT06897696Phase 4Apr 10, 2025Firat University
NCT07035301N/AMar 17, 2025Harbin Medical University
NCT07002801N/AMar 14, 2025Harbin Medical University
NCT06810336Early Phase 1 (Phase 1)Mar 10, 2025University of Virginia
NCT06732427N/AMar 1, 2025Nantong University
NCT07307625N/ADec 15, 2024Dr. Lutfi Kirdar Kartal Training and Research Hospital
NCT06617039N/AOct 31, 2024Nanjing Medical University
NCT06658132N/AOct 29, 2024Jiao Tong University
NCT06581731N/ASep 19, 2024Nanjing Medical University
NCT06531837N/AAug 25, 2024Capital Medical University
Showing 20 of 490 trials
Page 1 / 25

Organizations

Research & Development (332)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Yonsei UniversityAcademic/Hospital363532009
Ajou UniversityAcademic/Hospital171432011
Seoul National UniversityAcademic/Hospital171732009
Huazhong University of Science and TechnologyAcademic/Hospital12842017
Jiao Tong UniversityAcademic/Hospital11722011
Capital Medical UniversityAcademic/Hospital8632014
University of ParisAcademic/Hospital8532004
University of GroningenAcademic/Hospital7542009
Yeungnam UniversityAcademic/Hospital7712012
Erasmus University RotterdamAcademic/Hospital6432013
Fudan UniversityAcademic/Hospital6222018
GlaxoSmithKlineFor profit6432004
Harvard UniversityAcademic/Hospital6442015
University of RochesterAcademic/Hospital6332006
University of TorontoAcademic/Hospital6432005
University of VersaillesAcademic/Hospital6622008
Changhai HospitalAcademic/Hospital5522012
Nanjing Medical UniversityAcademic/Hospital5522008
Peking UniversityAcademic/Hospital5522011
University of MontrealAcademic/Hospital5522005
332 organizations
Page 1 / 17

Marketing (6)

OrganizationOrg typeRelationshipDate
FreseniusFor profitMKTGJan 16, 2018
Glaxo WellcomeFor profitNDAJul 12, 1996
HikmaFor profitMKTGOct 13, 2020
MylanFor profitNDA2Jul 12, 1996
NavintaFor profitMKTGOct 13, 2020
Nivagen Pharmaceuticals Inc.For profitMKTGJun 28, 2024