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rabies immune globulin (human)

Trade name: HyperRAB

Biologicalapproved

Approved

Jun 12, 1974

Clinical trial activity

17 trials · 20 clinical orgs · 3 marketing orgs

Phase 1
2
Phase 2
12
Phase 3
8
Phase 4
0

Earliest trial started Mar 1, 2008 (NCT00656097)

Timeline

1970s

  1. Jun 12, 1974

    Grifols — Earliest FDA Approval

  2. Jun 12, 1974

    Grifols — NDA Secondary Org

  3. Jun 12, 1974

    Grifols — NDA Organization

2000s

  1. Mar 6, 2001

    Sanofi-Aventis — NDA Secondary Org

  2. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2014

    Grifols — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

  3. Aug 23, 2017

    Kamada, Ltd. — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 12, 1974

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • bayrab
  • bayrab
  • human polyclonal rabies immune globulin
  • human rabies immune globulin
  • human rabies immunoglobin
  • human rabies virus immune globulin
  • imogam
  • rabies immune globulin
  • rabies immune globulin
  • rabies immune globulin
  • rabies immune globulin human
  • rabies immune globulin (human)
  • rabies immune globulin (human)
  • rabies immune globulin,human
  • rabies immune globulin, human
  • rabies immunoglobulin
  • rabies immunoglobulin
  • rabies immunoglobulins

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06548139Phase 2Jul 31, 2024Anning City First People's Hospital, Changchun BCHT Biotechnology Co., Government of China, Yunnan University of Traditional Chinese Medicine
NCT05832073Early Phase 1 (Phase 1)Apr 30, 2023Anning City First People's Hospital, Changchun BCHT Biotechnology Co., Government of China, Yunnan University of Traditional Chinese Medicine
NCT05846568Phase 3Oct 21, 2022Government of China
NCT04594551Phase 3Oct 31, 2020Sanofi, Sanofi-Aventis
NCT04644484Phase 3Sep 23, 2020Clinchoice Inc, Government of China, Synermore Biologics Co., Ltd.
NCT03961555Phase 2Aug 31, 2019Synermore Biologics Co., Ltd.
NCT03965962Phase 3Jul 1, 2019Sanofi-Aventis
NCT03264157Phase 2/Phase 3 (Phase 3)Dec 8, 2017Bio Products Laboratory
NCT02912845Phase 3Jan 1, 2017Kamada, Ltd., Kedrion SpA
NCT02559921Phase 2Dec 1, 2014Capital Medical University
NCT02177032Phase 3Jun 1, 2014Novartis
NCT02139657Phase 1Mar 1, 2014Grifols
NCT02040090Phase 2/Phase 3 (Phase 3)Apr 1, 2013Kamada, Ltd., Prism Research
NCT01610362N/AJun 1, 2012Chulalongkorn University
NCT01228383Phase 2Dec 1, 2011Crucell, Lotus Labs
NCT00708084Phase 2May 1, 2008Crucell, Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines
NCT00656097Phase 2Mar 1, 2008Crucell, MDS Pharma
Showing 17 of 17 trials
Page 1 / 1

Organizations

Research & Development (20)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Government of ChinaGovernment4132020
CrucellFor profit3312008
Anning City First People's HospitalAcademic/Hospital2022023
Changchun BCHT Biotechnology Co.For profit2222023
Kamada, Ltd.For profit2212013
Sanofi-AventisFor profit2112019
Synermore Biologics Co., Ltd.For profit2222019
Yunnan University of Traditional Chinese MedicineAcademic/Hospital2022023
Bio Products LaboratoryFor profit1112017
Capital Medical UniversityAcademic/Hospital1112014
Chulalongkorn UniversityAcademic/Hospital1112012
Clinchoice IncAcademic/Hospital1012020
GrifolsFor profit1112014
Kedrion SpAFor profit1012017
Lotus LabsFor profit1012011
MDS PharmaFor profit1012008
NovartisFor profit1112014
Prism ResearchFor profit1012013
Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, PhilippinesAcademic/Hospital1012008
SanofiFor profit1112020
20 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
GrifolsFor profitNDA2Jun 12, 1974
GrifolsFor profitNDAJun 12, 1974
Kamada, Ltd.For profitNDA2Aug 23, 2017
Sanofi-AventisFor profitNDA2Mar 6, 2001