Wednesday, July 8, 2026

Drug profile · INN

ofatumumab

ofatumumab (KESIMPTA) is a b-lymphocyte antigen cd20 binding agent. Associated with Novartis Pharmaceuticals. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L04) L04AA52
US status approved
Patents linked 0
Pipeline programs 8
News articles 0
Drug details — ofatumumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
INJECTION
Patents
0
Programs
8
Data quality
0.84

Quick answer

ofatumumab (KESIMPTA) is a b-lymphocyte antigen cd20 binding agent. Associated with Novartis Pharmaceuticals. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN ofatumumab
Brand KESIMPTA
Mechanism B-lymphocyte antigen CD20 binding agent
Target B-lymphocyte antigen CD20
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route INJECTION
Formulation INJECTABLE
ATC code L04AA52

Mechanism of action

B-lymphocyte antigen CD20 binding agent

Primary target: B-lymphocyte antigen CD20

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. CBAF312D2301 Phase 3 · Novartis India · Multiple Sclerosis in pediatric patients
  2. COMB157G23101 Phase 3 · Novartis India · relapsing multiple sclerosis (RMS)
  3. COMB157G3301 Phase 3 · Novartis India · relapsing multiple sclerosis (RMS)
  4. Ofatumumab Phase 3 · Novartis India · Leukaemia, Lymphocytic, Chronic
  5. KYV101-007 Phase 2 · Kyverna Therapeutics · Primary or Secondary Progressive Multiple Sclerosis
  6. NET-MS Phase 2 · Telethon Foundation · Relapsing Remitting Multiple Sclerosis
  7. Kesimpta 20 mg solution for injection in pre-filled syringe Approved · Novartis India · Relapsing forms of Multiple Sclerosis (RMS)
  8. Ofatumumab Approved · Novartis India · Relapsing Multiple Sclerosis

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 ofatumumab?

ofatumumab (KESIMPTA) is a b-lymphocyte antigen cd20 binding agent. Associated with Novartis Pharmaceuticals. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for ofatumumab?

KESIMPTA is a marketed brand name for ofatumumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ofatumumab?

ofatumumab 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.