Monoclonal Antibodies — Pipeline, Approvals, Sponsors

Monoclonal antibody therapeutics — engineered antibodies that bind a single target. Dominant class in oncology IO (PD-1/L1), immunology (anti-TNF, anti-IL), and increasingly cardiometabolic (anti-PCSK9).

Marketed leaders

• Not specified — [89Zr]Zr-crefmirlimab berdoxam · Pfizer · Radiolabeled Monoclonal Antibody · Oncology
• N/A — Venetoclax; Rituximab · Pfizer · BCL-2 inhibitor (venetoclax); Monoclonal antibody (rituximab) · Oncology
• 2025-01-01 — Penpulimab kcqx · Akeso Biopharma · Oncology
• 2025-01-01 — Bizengri · Merus N.V. · Oncology
• 2025-01-01 — Tevimbra · Beigene · Programmed Death Receptor-1 Blocking Antibody [EPC] · Oncology
• 2025-01-01 — Imaavy · Janssen Biotech · Immunology
• 2025-01-01 — Lynozyfic · Rengeneron Pharmaceuticals, Inc. · Bispecific B Cell Maturation Antigen-directed CD3 T Cell Engager [EPC] · Oncology
• 2025-01-01 — Yartemlea · Omeros Corp · Immunology
• 2025-01-01 — Piasky · Genentech Inc · Complement C5 Inhibitor [EPC] · Immunology
• 2025-01-01 — Emrelis · Abbvie Inc · Oncology
• 2025-01-01 — Exdensur · Glaxosmithkline Llc · Respiratory
• 2025-01-01 — Hympavzi · Pfizer Inc · Monoclonal Antibody · Rare Disease

Recent approvals (last 30 days)

No approvals in the last 30 days.

Upcoming PDUFA (next 180 days)

No upcoming PDUFA in next 180 days.

Top sponsors in this modality

1. · 56 monoclonal antibodies
2. Pfizer Inc. · 46 monoclonal antibodies
3. Pfizer · 20 monoclonal antibodies
4. Roche · 19 monoclonal antibodies
5. AstraZeneca · 10 monoclonal antibodies
6. Johnson & Johnson · 8 monoclonal antibodies
7. Regeneron · 6 monoclonal antibodies
8. Novartis · 5 monoclonal antibodies
9. Eli Lilly · 4 monoclonal antibodies
10. Amgen · 3 monoclonal antibodies

Drug classes within Monoclonal Antibodies

• Programmed Death Receptor-1 Blocking Antibody [EPC] · 7
• Monoclonal antibody · 6
• Programmed Death Ligand-1 Blocker [EPC] · 5
• CD20-directed Cytolytic Antibody [EPC] · 5
• Interleukin-23 Antagonist [EPC] · 4
• Tumor Necrosis Factor Blocker [EPC] · 4
• Complement Inhibitor [EPC] · 3
• TNF blocker · 3
• Interleukin-6 Receptor Antagonist [EPC] · 3
• Epidermal Growth Factor Receptor Antagonist [EPC] · 3
• CD33-directed Immunoconjugate [EPC] · 3
• Bispecific CD20-directed CD3 T Cell Engager [EPC] · 3

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Other modalities

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing