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Budigalimab - AbbVie

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Drug Profile

Budigalimab - AbbVie

Alternative Names: ABBV-181

Latest Information Update: 01 Dec 2025

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At a glance

  • Originator AbbVie
  • Developer AbbVie; Aceragen
  • Class Antineoplastics; Antiretrovirals; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants
  • 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/III Liver cancer; Non-small cell lung cancer
  • Phase II HIV-1 infections
  • Phase I/II Pancreatic cancer
  • Phase I Solid tumours
  • No development reported Colorectal cancer; Endometrial cancer; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer; Small cell lung cancer; Squamous cell cancer

Most Recent Events

  • 01 Dec 2025 AbbVie plans a phase I trial in Solid tumours ( Combination therapy, Late-stage diseases) (IV, infusion) (EUCT2025-521607-48-00) (NCT07241039)
  • 27 Oct 2025 AbbVie terminates a phase I trial in Solid tumours (Combination therapy, Late-stage disease, Second-line therapy or greater) in Israel, Japan and USA (IV) due to strategic considerations (NCT06158958)
  • 20 Sep 2025 AbbVie terminates the Phase-II clinical trials in HIV-1 infections (Combination therapy, Treatment-experienced) in USA, Belgium, Brazil, Canada, France, Germany, Japan, Poland, Puerto Rico, Puerto Rico, Spain, United Kingdom, Italy, South Africa (IV, SC) due to company's decision (NCT06032546)

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