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terlipressin

Trade name: Terlivaz

PeptideapprovedOrphan Drug FDAFast Track FDA

Approved

Sep 14, 2022

Terlipressin, sold under the brand name Terlivaz among others, is an analogue of vasopressin used as a vasoactive drug in the management of low blood pressure. It has been found to be effective when norepinephrine does not help. Terlipressin is a vasopressin receptor agonist. — Wikipedia

Clinical trial activity

81 trials · 77 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
31
Phase 3
23
Phase 4
18

Earliest trial started Feb 1, 2002 (NCT00287664)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  3. Oct 29, 2004

    Orphan Drug Designation

  4. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Sep 14, 2022

    International Minerals and Chemical Corporation — Earliest FDA Approval

  2. Sep 14, 2022

    Mallinckrodt — Marketing Organization

  3. Sep 14, 2022

    International Minerals and Chemical Corporation — NDA Secondary Org

  4. Sep 14, 2022

    International Minerals and Chemical Corporation — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackSep 14, 2022

Chemistry & pharmacology

Loading structure…

SMILES

NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSC[C@H](NC(=O)CNC(=O)CNC(=O)CN)C(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Mol. weight
1227.4 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in classProdrug

Sources

Also known as

  • glipressin
  • glycylpressin
  • glycylpressin
  • gly-gly-gly-8-lys-vasopressin
  • glypressin
  • glypressin
  • n-(alpha)-glycyl-glycyl-glycyl-8-lysine vasopressin
  • n-(n- (n-glycylglycyl)glycyl)-8-l-lysinevasopressin
  • remestyp
  • remestyp
  • terlipressin
  • terlipressin
  • terlipressin
  • terlipressin
  • terlipressin
  • terlipressin
  • terlipressin
  • terlipressin
  • terlipressin
  • terlipressina
  • terlipressina
  • terlipressin acetate
  • terlipressin acetate
  • terlipressine
  • terlipressine
  • terlipressinum
  • terlipressinum
  • terlypressin
  • tglvp
  • triglycyl-(8-lysine)vasopressin
  • triglycyl-8-lysine-vasopressin
  • triglycyl lysine vasopressin
  • triglycylvasopressin
  • variquel
  • vasopressin, tri-gly-8-lys-

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07304466N/ADec 29, 2025Istanbul Medipol University
NCT07252401N/ADec 25, 2025People's Liberation Army of China
NCT06855758N/AMar 1, 2025Capital Medical University
NCT06815770Phase 2/Phase 3 (Phase 3)Feb 10, 2025Institute of Liver and Biliary Sciences, India
NCT06556472N/AAug 15, 2024Institute of Liver and Biliary Sciences, India
NCT06256432Phase 2Apr 17, 2024Noorik Biopharmaceuticals AG
NCT06027970Phase 3Sep 30, 2023Postgraduate Institute of Medical Education and Research
NCT06108362Phase 4Aug 18, 2023Tsinghua University
NCT05875948Phase 2Jun 30, 2023River 3 Renal Corp.
NCT05207280Phase 3May 31, 2022Fundación Pública Andaluza, Hospital Universitario Virgen Macarena
NCT05315557N/AApr 5, 2022Institute of Liver and Biliary Sciences, India
NCT05170230N/AFeb 27, 2022Wael El-Banna Clinic Cairo Egypt
NCT05242783N/AFeb 1, 2022Wael El-Banna Clinic Cairo Egypt
NCT05266534N/ADec 30, 2021Wael El-Banna Clinic Cairo Egypt
NCT05154279N/ADec 27, 2021Wael El-Banna Clinic Cairo Egypt
NCT04961528Phase 3Nov 1, 2021Assistance Publique - Hôpitaux de Paris, Government of France, Hôpital Européen Georges-Pompidou
NCT05080543Phase 1Oct 31, 2021Cairo University
NCT04819568N/AJun 25, 2021Institute of Liver and Biliary Sciences, India
NCT04460560Phase 3Dec 11, 2020University of Pennsylvania
NCT04353193Phase 4Jun 30, 2020University of Barcelona
Showing 20 of 81 trials
Page 1 / 5

Organizations

Research & Development (77)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Institute of Liver and Biliary Sciences, IndiaAcademic/Hospital121222012
University of BarcelonaAcademic/Hospital5432002
People's Liberation Army of ChinaGovernment4222013
Postgraduate Institute of Medical Education and ResearchAcademic/Hospital4422009
Wael El-Banna Clinic Cairo EgyptAcademic/Hospital4412021
Aga Khan UniversityAcademic/Hospital3322004
Assiut UniversityAcademic/Hospital3312015
Fudan UniversityAcademic/Hospital3332014
MallinckrodtFor profit3212010
Sun Yat-Sen UniversityAcademic/Hospital3322013
Anhui Medical UniversityAcademic/Hospital2022013
BioVie Inc.For profit2222017
Cairo UniversityAcademic/Hospital2222018
Government of TaiwanGovernment2212006
I-Shou UniversityAcademic/Hospital2112006
Jiao Tong UniversityAcademic/Hospital2022013
Mahidol UniversityAcademic/Hospital2222016
Southeast UniversityAcademic/Hospital2122019
Southern Medical UniversityAcademic/Hospital2122013
University of PadovaAcademic/Hospital2212005
77 organizations
Page 1 / 4

Marketing (3)

OrganizationOrg typeRelationshipDate
International Minerals and Chemical CorporationFor profitNDA2Sep 14, 2022
International Minerals and Chemical CorporationFor profitNDASep 14, 2022
MallinckrodtFor profitMKTGSep 14, 2022