Wednesday, July 8, 2026

Drug profile · INN

ocrelizumab

ocrelizumab (OCREVUS) is a b-lymphocyte antigen cd20 binding agent. Associated with Hoffmann-La Roche. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AG08
US status approved
Patents linked 0
Pipeline programs 24
News articles 0
Drug details — ocrelizumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
INJECTION
Patents
0
Programs
24
Data quality
0.84

Quick answer

ocrelizumab (OCREVUS) is a b-lymphocyte antigen cd20 binding agent. Associated with Hoffmann-La Roche. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN ocrelizumab
Brand OCREVUS
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 L04AG08

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

Pipeline programs

  1. 20230309 Phase 3 · Amgen · Relapsing-remitting Multiple Sclerosis
  2. BN42082 Phase 3 · HOFFMANN-LA ROCHE · Relapsing Multiple Sclerosis (MS)
  3. BN42083 Phase 3 · HOFFMANN-LA ROCHE · Primary Progressive Multiple Sclerosis (PPMS)
  4. CLOU064C12306 Phase 3 · Novartis India · Relapsing multiple sclerosis
  5. CN42097 Phase 3 · HOFFMANN-LA ROCHE · Multiple Sclerosis (MS)
  6. GN41791 Phase 3 · HOFFMANN-LA ROCHE · Primary Progressive Multiple Sclerosis (PPMS)
  7. MN39158 Phase 3 · HOFFMANN-LA ROCHE · Multiple sclerosis (MS)
  8. MN39159 Phase 3 · HOFFMANN-LA ROCHE · Progressive multiple sclerosis (PMS)

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 ocrelizumab?

ocrelizumab (OCREVUS) is a b-lymphocyte antigen cd20 binding agent. Associated with Hoffmann-La Roche. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for ocrelizumab?

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

What is the US approval status of ocrelizumab?

ocrelizumab 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.