Friday, July 10, 2026

Drug profile · INN

inotuzumab ozogamicin

inotuzumab ozogamicin (BESPONSA) is a cd22 binding agent. Associated with Pfizer Australia Pty Ltd. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L01) L01FB01
US status approved
Patents linked 0
Pipeline programs 7
News articles 0
Drug details — inotuzumab ozogamicin
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
Patents
0
Programs
7
Data quality
0.83

Quick answer

inotuzumab ozogamicin (BESPONSA) is a cd22 binding agent. Associated with Pfizer Australia Pty Ltd. Current US regulatory status: approved.

Key facts

INN inotuzumab ozogamicin
Brand BESPONSA
Mechanism CD22 binding agent
Target B-cell receptor CD22
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Formulation POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
ATC code L01FB01

Mechanism of action

CD22 binding agent

Primary target: B-cell receptor CD22

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. inotuzumab ozogamicin Phase 3 · Pfizer · Lymphoma, Follicular
  2. ALL2418 Phase 2 · Telethon Foundation · Acute B-cell Lymphoblastic Leukemia with minimal residual po
  3. B1931036 Phase 2 · First Biotech (Australia) · Acute Lymphoblastic Leukemia (ALL)
  4. Inotuzumab Ozogamicin±Donor Lymphocyte Infusion Phase 2 · First People's Hospital · Leukemia, Lymphocytic, Acute
  5. Inotuzumab ozogamicin Phase 2 · Chinese Academy of · Acute Lymphocytic Leukemia
  6. inotuzumab ozogamicin-dose level 2 Approved · Pfizer · Leukemia
  7. the usage of Olverembatinib combined with Inotuzumab Ozogamicin Unknown · Chinese Academy of · Ph+ ALL

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is inotuzumab ozogamicin?

inotuzumab ozogamicin (BESPONSA) is a cd22 binding agent. Associated with Pfizer Australia Pty Ltd. Current US regulatory status: approved.

What is the brand name for inotuzumab ozogamicin?

BESPONSA is a marketed brand name for inotuzumab ozogamicin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of inotuzumab ozogamicin?

inotuzumab ozogamicin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.