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UB 421

Drug Profile

UB 421

Alternative Names: dB4; dB4C7 mAb; mAb B4; UB421

Latest Information Update: 06 Aug 2019

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At a glance

  • Originator United Biomedical
  • Developer United Biomedical; United BioPharma
  • Class Antiretrovirals; Monoclonal antibodies
  • Mechanism of Action HIV fusion inhibitors; Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II HIV-1 infections

Most Recent Events

  • 02 Aug 2019 United BioPharma plans a phase II trial for HIV-1 infections (Adjunctive treatment, Combination therapy) (IV) in April 2020 (NCT04041362)
  • 21 May 2019 The US FDA approves IND application for a phase IIb/III trial in HIV-1 infection (Adjunctive therapy, Treatment-experienced) in USA
  • 13 May 2019 The China National Medical Products Administration and Thailand regulatory agency approve an IND application for a phase III trial for HIV-1 infections (Monotherapy, Adjunctive treatment) in China and Thailand
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