Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 193 |
| INN | Budigalimab |
| Status | Clinical |
| Drug code(s) | ABBV-181 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | NSCLC, Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, Hepatocellular Carcinoma, Head and neck cancer, Solid tumors, ovarian cancer, colorectal cancer, HIV |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2016 |
| Start of Phase 2 | May 15, 2021 |
| Start of Phase 3 | January 15, 2024 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | AbbVie |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06236438 Phase 2/3 in NSCLC to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab started in April 2024. NCT06109272 Phase 2/3 in Hepatocellular Carcinoma in combination with budigalimab started in January 2024. NCT06032546 Phase 2 in HIV due to start in Oct 2023. NCT05822752 Phase 2 in hepatocellular carcinoma started in Aug 2023. NCT04807972 Phase 1/2 in pancreatic cancer started in May 2021 active not recruiting as of last update in Aug 2023. NCT04799353 Phase 1 in HIV started in March 2021. NCT04223804 Phase 1 in HIV started in Jan 2020 completed in Feb 2023. NCT03893955 Phase 1 study started in May 2019 recruiting as of Aug 2019; NCT03818542 in Head and Neck cancer started in Jan 2020 terminated in Sep 2020 for strategic considerations April 2019: AbbVie terminates a phase I studies in colorectal and ovarian cancers in USA due to strategic considerations (NCT03035279 and NCT03138408). Five Phase 1 studies recruiting as of July 2018. |
| Full address of company | North Chicago, Illinois, United States North America United States of America https://www.abbvie.com/ |
Immune checkpoint target. ABBV-181 is a humanized, recombinant, IgG1 monoclonal antibody targeting programmed cell death 1 (PD-1). L234A L235A mutations reduce effector functions https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6220479/. ABBV-1882 is a combination of ABBV-181 (anti-PD1) and ABBV-382 (anti-a4b7 mAb)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |