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Ibalizumab

Monoclonal antibody

Monoclonal antibody

FieldValue
Verifiedfieldschanged
verifiedrevid458273983
typemab
mab_typemab
sourcezu/o
targetCD4
tradenameTrogarzo
Drugs.com{{drugs.commonographibalizumab-uiyk
ChEMBL_IDCHEMBL1743029
MedlinePlusa618020
DailyMedIDIbalizumab
pregnancy_AU
routes_of_administrationIntravenous (IV)
ATC_prefixJ05
ATC_suffixAX23
legal_AU
legal_BR
legal_CA
legal_DE
legal_NZ
legal_UK
legal_USRx-only
legal_US_comment
legal_EURx-only
legal_UN
legal_status
CAS_number_Ref
CAS_number680188-33-4
DrugBank_Ref
DrugBankDB12698
ChemSpiderID_Ref
ChemSpiderIDnone
UNII_Ref
UNIILT369U66CE
KEGG_Ref
KEGGD09575
ChEMBL1743029
NIAID_ChemDB209859
synonymsIbalizumab-uiyk; TMB-355, TNX-355
CH=Ag=Al=As=Au=B=Bi=Br=Ca=Cl=Co=F=Fe=Gd=I=
KLi=Mg=Mn=N=Na=O=P=Pt=S=Sb=Se=Sr=Tc=Zn=charge=

| Drugs.com = {{drugs.com|monograph|ibalizumab-uiyk

| elimination_half-life =

Ibalizumab, sold under the brand name Trogarzo, is a non-immunosuppressive humanised monoclonal antibody that binds CD4, the primary receptor for HIV, and inhibits HIV from entering cells. It is a post-attachment inhibitor, blocking HIV from binding to the CCR5 and CXCR4 co-receptors after HIV binds to the CD4 receptor on the surface of a CD4 cell. Post-attachment inhibitors are a subclass of HIV drugs called entry inhibitors.

On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved ibalizumab for multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.

Medical uses

Ibalizumab, in combination with other antiretrovirals, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Development

Ibalizumab is being developed by TaiMed Biologics but was originally developed by Tanox, now part of Genentech. As part of Genentech's takeover of Tanox, the patent for ibalizumab was sold to TaiMed Biologics, a biotech company formed in 2007 with support from the Taiwanese Government through a $20 million investment by the state-owned National Development Fund.

Milestones for the intravenous (i.v.) infusion dosage form:

  • 2003: completed a phase-1a clinical trial for i.v. infusion dosage form.
  • 2003: granted fast track status by U.S. FDA.
  • 2003: completed a phase-1b clinical trial for i.v. infusion dosage form.
  • 2006: completed a phase-2a clinical trial for i.v. infusion dosage form.
  • 2011: completed a phase-2b clinical trial for i.v. infusion dosage form.
  • 2012: completed a phase-1 clinical trial for s.c. injection dosage form.
  • 2013: initiated a phase-1/2 clinical trial for s.c. and i.m. injection dosage forms (on-going).
  • 2014: granted orphan drug designation for HIV MDR patients by U.S. FDA.
  • 2015: granted breakthrough therapy designation for i.v. infusion dosage form by U.S. FDA.
  • 2015: initiated a phase-3 clinical trial for i.v. infusion dosage form (on-going).
  • 2016: initiated and intended to complete a rolling BLA submission for i.v. infusion dosage form to U.S. FDA.
  • 2016: completion of a phase-3 clinical trial for i.v. infusion dosage form
  • 2017: completion of BLA submission and pre-approval inspection for i.v. infusion dosage form to U.S. FDA
  • 2018: U.S. market approval (trade name: Trogarzo)

In a Phase III trial with 48 weeks of follow-up, HIV patients with multi-drug resistance tolerated ibalizumab well in combination with other treatments, and 59% of patients achieved viral suppression.

References

References

  1. (29 September 2021). "Trogarzo- ibalizumab injection, solution".
  2. (2009-09-09). "Ibalizumab (TMB-355)". TaiMed Biologics.
  3. (February 2009). "Safety, pharmacokinetics, and antiretroviral activity of multiple doses of ibalizumab (formerly TNX-355), an anti-CD4 monoclonal antibody, in human immunodeficiency virus type 1-infected adults". Antimicrobial Agents and Chemotherapy.
  4. (2006-08-25). "TNX-355 fact sheet". AIDSmeds.com.
  5. (24 March 2020). "FDA approves new HIV treatment for patients who have limited treatment options".
  6. (6 March 2018). "Drug Approval Package: Trogarzo injection (ibalizumab-uiyk)".
  7. (January 2019). "New Drug Therapy Approvals 2018".
  8. (2007-09-18). "Genentech Partners with Taiwan Company on AIDS Drug". Seeking Alpha.
  9. (2007-09-15). "Government pushes biotech industry". Taipei Times.
  10. (2008-04-11). "Tanox's AIDS Drug Survives". BioHouston.
  11. "Ibalizumab (TMB-355) Intravenous Infusion". TaiMed.
  12. "Ibalizumab Orphan Drug Designations and Approvals".
  13. (October 2017). "Forty-eight-week Safety and Efficacy On-treatment Analysis of Ibalizumab in Patients with Multi-drug Resistant HIV-1.". Open Forum Infectious Diseases.
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