TheraRadar
Data updated: May 26, 2026

OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq)

CD20-directed Antibody Interactions Genetic Support
CNS Approved 2024-09-13

OCREVUS ZUNOVO is indicated for the treatment of Multiple Sclerosis.

Source: FDA Label • Roche • Endoglycosidase

How OCREVUS ZUNOVO Works

Ocrelizumab is a cytolytic antibody that targets CD20, an antigen found on the surface of pre-B and mature B lymphocytes. Upon binding, it induces B cell depletion through antibody-dependent cellular cytolysis and complement-mediated lysis. The hyaluronidase component functions by depolymerizing hyaluronan to transiently increase the permeability of the subcutaneous tissue at the injection site. This local effect is reversible, with tissue permeability typically restored within 24 to 48 hours.

1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-09-13
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

OCREVUS ZUNOVO Approval History

2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2024 to 2025
Aug 2025 SUPPL
Label · Labeling
Sep 2024 ORIGINAL
New Form · Type 3 - New Dosage Form

What OCREVUS ZUNOVO Treats

1 indications

OCREVUS ZUNOVO is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Multiple Sclerosis
Source: FDA Label

OCREVUS ZUNOVO Target & Pathway

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Target

CD20 (B-Lymphocyte Antigen CD20) Cell Surface Marker

A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.

OCREVUS ZUNOVO Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in OCREVUS ZUNOVO's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OCREVUS ZUNOVO treats. First-in-class if their pivotal trials read out positive.

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OCREVUS ZUNOVO FDA Label Details

Indications & Usage

FDA Label (PDF)

OCREVUS ZUNOVO is indicated for the treatment of Multiple Sclerosis.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.