Drug name
Last update: Aug 2026Budigalimab
Developer(s)
Drug information
budigalimab
investigational
Biotherapeutic
mAb anti-PD1
Budigalimab (ABBV-181) is an investigational anti-PD-1 monoclonal antibody developed for treating solid tumors and hematological malignancies. It binds to the PD-1 receptor on activated T cells, blocking interactions with its ligands, PD-L1 and PD-L2, thereby restoring T-cell activity and promoting anti-tumor immune responses. This mechanism is similar to that of approved checkpoint inhibitors like nivolumab and pembrolizumab. Budigalimab exhibits linear pharmacokinetics, with a half-life of approximately 14–17 days, clearance of 0.22–0.29 L/day, and a volume of distribution of 4–6 L. It reaches steady-state levels after repeated intravenous dosing. Studies show that it also delays HIV rebound or sustained low viral load in a majority of people who interrupted antiretroviral therapy (ART)
Not yet approved
Not approved by any regulatory authorities yet (investigational)
Therapeutic area(s)
- HIV
- Oncology
- Treatment
Administration route
Intravenous
Associated long-acting platforms
Solution
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Monthly
- Every 2 weeks
Dosage
250mg and 500mg
Not available
Budigalimab 250 mg intravenously Q2W Budigalimab 500 mg intravenously Q4W
Not provided
Not provided
Associated compounds, formulations and regimens
Not provided
Associated technologies
Not provided
Additional information
Developer(s)
AbbVie
AbbVie Inc. is an American pharmaceutical company headquartered in North Chicago, Illinois. It is a global biopharmaceutical company known for its focus on developing treatments in several therapeutic areas, including immunology, oncology, neuroscience, and virology. It was founded in 2013 as a spin-off from Abbott Laboratories to focus specifically on pharmaceuticals.
Drug structure
Scale-up and manufacturing prospects
Not provided
Not provided
• Cell Line Development using CHO (Chinese Hamster Ovary) cell line. • Upstream Processing (USP): Cell Culture & Fermentation in bioreactors • Downstream Processing (DSP): Purification using Ion-Exchange Chromatography • Size exclusion chromatography (SEC) to remove aggregates and fragments
• SEC-HPLC, SDS-PAGE, Mass spectrometry, peptide mapping
Excipients & delivery device(s)
Not provided
Not provided
Not provided
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided
Method of treatment of HIV using budigalimab and/or ABBV-382
The present disclosure is directed to methods of treating Human Immunodeficiency Virus (HIV) disease, and in particular, to methods of treating HIV disease using anti-PD-1 antibodies and/or anti-α4β7 antibodies, in patients living with HIV who are virologically suppressed on anti-retroviral therapy (ART) undergoing analytical treatment interruption.
WO2025038861
Method of treatment
ABBVIE INC.
Not provided
August 15, 2044
Not yet in national phase , deadline for entry 15 February 2026
Budigalimab compound, including sequences of heavy chain
The present application pertains to, among other things, novel anti-PD-1 antibodies, compositions including the new antibodies, nucleic acids encoding the antibodies, and methods of making and using the same.
WO2018053106
Compound
ABBVIE BIOTHERAPEUTICS INC.
Not provided
September 14, 2037
Granted: CN, CO, EP, HK, JP, KR, MX, ZA, US Pending: AU, BR, CA, VN Withdrawn: CL, CR, DO, EC, ID, GT, MY, PA, PE, PH, RU, UA, TH