Budigalimab

Phase 3Monoclonal antibody

AbbVie

Budigalimab is one of 181 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

180

Competitors

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerRecruiting

Metastatic Gastric AdenocarcinomaActive, not recruiting

Hepatocellular Carcinoma (HCC)Active, not recruiting

Advanced Squamous TumorsRecruiting

Locally Advanced or Metastatic Solid TumorsActive, not recruiting

Advanced Solid TumorsTerminated

Hepatocellular CarcinomaRecruiting

Urothelial CarcinomaActive, not recruiting

Non-Small Cell Lung CancerPhase 1

Recruiting

Metastatic Gastric AdenocarcinomaPhase 2

Active, not recruiting

Hepatocellular Carcinoma (HCC)Phase 1

Active, not recruiting

Advanced Squamous TumorsPhase 1

Recruiting

Locally Advanced or Metastatic Solid TumorsPhase 1

Active, not recruiting

Advanced Solid TumorsPhase 1

Terminated

Hepatocellular CarcinomaPhase 3

Recruiting

Urothelial CarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Alunbrig

Takeda

Phase 3

13 2

Zykadia

Novartis

Phase 3

8 3

Opdualag

Bristol-Myers Squibb

Phase 3

3 4

Budigalimab

AbbVie

Phase 3

3 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Hepatocellular Carcinoma

NCT05822752

Q1 2027

Phase 1Active, not recruiting

Hepatocellular Carcinoma (HCC)

NCT06487559

Q2 2027

Phase 1Active, not recruiting

Locally Advanced or Metastatic Solid Tumors

NCT03821935

Q3 2027

Phase 1Recruiting

Non-Small Cell Lung Cancer

NCT05005403

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Recruiting· AbbVie logo

AbbVie·Preclinical·NCT06236438·840 enrolled

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Recruiting· AbbVie logo

AbbVie·Preclinical·NCT06772623·252 enrolled

A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors With Azirkitug as a Single Agent and in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

Recruiting· AbbVie logo

AbbVie·Phase 1·NCT05005403·694 enrolled

Immunodeficiency2 trials

Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)

Completed· AbbVie logo

AbbVie·Phase 1·NCT04799353·33 enrolled

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382

Terminated· AbbVie logo

AbbVie·Phase 2·NCT06032546·163 enrolled

Advanced Solid Tumors2 trials

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT05599984·288 enrolled

A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors

Terminated· AbbVie logo

AbbVie·Phase 1·NCT06158958·27 enrolled

Hepatocellular Carcinoma2 trials

A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC)

Recruiting· AbbVie logo

AbbVie·Phase 2/3·NCT06109272·660 enrolled

Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC)

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT05822752·130 enrolled

Urothelial Carcinoma1 trial

Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC)

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT06632951·150 enrolled

5 more indications

Locally Advanced or Metastatic Solid Tumors1 trial

Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT03821935·364 enrolled

Small Cell Lung Cancer1 trial

A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer

Completed· AbbVie logo

AbbVie·Phase 1·NCT03639194·132 enrolled

Advanced Squamous Tumors1 trial

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors

Recruiting· AbbVie logo

AbbVie·Phase 1·NCT07241039·220 enrolled

Hepatocellular Carcinoma (HCC)1 trial

A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Livmoniplimab in Combination With Budigalimab in Chinese Subjects With Locally Advanced or Metastatic Child-Pugh A Hepatocellular Carcinoma Who Have Progressed After a First-Line Regimen That Includes an Immune Checkpoint Inhibitor

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT06487559·3 enrolled

Metastatic Gastric Adenocarcinoma1 trial

A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977)

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT06628310·185 enrolled

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Budigalimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Budigalimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Budigalimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AbbVie

Budigalimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

Immunodeficiency2 trials

Advanced Solid Tumors2 trials

Hepatocellular Carcinoma2 trials

Urothelial Carcinoma1 trial

Locally Advanced or Metastatic Solid Tumors1 trial

Small Cell Lung Cancer1 trial

Advanced Squamous Tumors1 trial

Hepatocellular Carcinoma (HCC)1 trial

Metastatic Gastric Adenocarcinoma1 trial

References

Drug Info

Quick Facts

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