CLINICAL TRIALS PROFILE FOR OBINUTUZUMAB

Biosimilar Clinical Trials for obinutuzumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05704400 ↗	Efficacy of Anti-CD20 Ab Associated With Anti-CD38 in the Childhood Multidrug Dependent and Resistant Nephrotic Syndrome	Not yet recruiting	Istituto Giannina Gaslini	Phase 2	2023-03-01	Nephrotic syndrome is considered a disease caused by an interplay of immunological stimuli with adaptive immunity(CD80/CD40) as trigger and Treg in the mid between co-stimulatory molecules and effectors. The positive effect of drugs blocking CD20 maturation in SDNS suggests a main role of these cells in regulating the system. Multidrug dependent, multidrug resistant nephrotic syndrome as well as post transplant FSGS recurrence patients can be considered difficult to treat patients and the association of two drugs, one targeting CD20 and a targeting plasmacells can be use in order to block the stimulatory cascade at more sites.

All Clinical Trials for obinutuzumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00517530 ↗	A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN)	Completed	Hoffmann-La Roche	Phase 1/Phase 2	2007-09-01	The primary objective for the phase I part of the study is to investigate the safety and tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective for the phase II part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either indolent (iNHL) or aggressive (aNHL). It is an open label dose escalating study in phase I and open label in phase II, but the two doses in iNHL & aNHL are randomized (to high or low dose of the same open label treatment). CLL was not randomized as only one dose level was used. Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period.
NCT00576758 ↗	GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma	Completed	Hoffmann-La Roche	Phase 2	2008-01-01	This study will investigate the efficacy of weekly intravenous obinutuzumab [GA101 (RO5072759)] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.
NCT00825149 ↗	A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma	Completed	Hoffmann-La Roche	Phase 1	2009-02-01	This open-label, randomized, phase Ib study will assess the safety and efficacy of obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular Lymphoma (FL). Participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first. All participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point. Participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.
NCT01010061 ↗	CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)	Completed	Genentech, Inc.	Phase 3	2009-12-21	This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

Clinical Trial Conditions for obinutuzumab

Condition Name

Condition Name for obinutuzumab
Intervention	Trials
Chronic Lymphocytic Leukemia	54
Follicular Lymphoma	25
Small Lymphocytic Lymphoma	21
Mantle Cell Lymphoma	19

Condition MeSH

Condition MeSH for obinutuzumab
Intervention	Trials
Lymphoma	124
Leukemia, Lymphocytic, Chronic, B-Cell	92
Leukemia, Lymphoid	75
Leukemia	67

Clinical Trial Locations for obinutuzumab

Trials by Country

Trials by Country for obinutuzumab
Location	Trials
Italy	193
Spain	147
Australia	119
Canada	113
France	84

Trials by US State

Trials by US State for obinutuzumab
Location	Trials
California	78
New York	70
Texas	63
Florida	46
Ohio	42

Clinical Trial Progress for obinutuzumab

Clinical Trial Phase

Clinical Trial Phase for obinutuzumab
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	4
PHASE2	47

Clinical Trial Status

Clinical Trial Status for obinutuzumab
Clinical Trial Phase	Trials
RECRUITING	115
Active, not recruiting	46
Not yet recruiting	44

Clinical Trial Sponsors for obinutuzumab

Sponsor Name

Sponsor Name for obinutuzumab
Sponsor	Trials
Hoffmann-La Roche	72
Genentech, Inc.	48
National Cancer Institute (NCI)	28

Sponsor Type

Sponsor Type for obinutuzumab
Sponsor	Trials
Industry	252
Other	244
NIH	28

Obinutuzumab (Gazyva): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 7, 2026

What is the current clinical development status of obinutuzumab?

Obinutuzumab is an anti-CD20 monoclonal antibody with established approvals in B-cell malignancies. Public clinical development activity is concentrated in new combinations, earlier lines, and expanding biomarker- or regimen-defined subgroups.

Key approved indications (anchor for market demand)

• Follicular lymphoma (FL)
  • Previously untreated FL: In combination with chemotherapy, followed by maintenance (where applicable by jurisdiction and regimen).
  • Relapsed/refractory FL: With specified retreatment/maintenance patterns depending on prior therapy and label.
• Chronic lymphocytic leukemia (CLL)
  • Used in combination regimens in specified treatment lines and for patients defined by risk and prior therapy.

What clinical trials are actively shaping the next cycle?

Across the obinutuzumab portfolio, the recurring trial design pattern is:

• CD20 target reaffirmation using obinutuzumab as the anti-CD20 backbone
• Pairing with newer agents (BTK inhibitors, BCL2 pathway agents, checkpoint antibodies) in settings that are clinically adjacent to prior rituximab/obinutuzumab standards

Because the question requires a “clinical trials update” with specific trial identifiers, start/end dates, enrollment, phase status, and outcomes, an accurate, complete update cannot be produced without a reliable trial database pull (e.g., ClinicalTrials.gov or a subscription trial intelligence source). Under the constraints, no partial or speculative trial listings are provided.

Where is obinutuzumab sold today, and how does the payer and regimen landscape affect demand?

Product positioning

Obinutuzumab is positioned as a next-generation anti-CD20 option relative to rituximab, with differentiation driven by:

• CD20 binding characteristics
• Evidence base in follicular lymphoma and CLL regimen combinations
• Treatment practice patterns that depend on toxicity profile, logistics, and guideline preference at the line-of-therapy level

Competitive context

The anti-CD20 market for B-cell malignancies is dominated by:

• Rituximab biosimilars (price pressure and payer preference in many settings)
• Other CD20 antibodies and CD20-based combinations
• Rapid substitution risk in earlier lines due to the broader adoption of targeted small molecules (BTK inhibitors, PI3K inhibitors, BCL2 inhibitors) and combination regimens that can reduce antibody duration

Demand drivers

• Incidence pool and treatment intensity: FL and CLL patient volumes determine maximum addressable units.
• Line-of-therapy allocation: How often clinicians choose obinutuzumab versus rituximab/biosimilars and other antibody options.
• Duration and maintenance schedules: Fixed-length combination and maintenance regimens generate predictable unit demand.
• Biosimilar pricing and interchangeability: Where rituximab biosimilars are preferred, antibody utilization shifts to higher-value segments (combination specificity and guideline adherence).

Reimbursement pressure points

• In markets where rituximab biosimilars price below originator products, payer coverage often narrows to:
  • Specific guideline-defined regimens
  • Medical-need criteria
  • Step therapy protocols
• In combination regimens, payer decisions depend on the total regimen value, not the antibody alone.

How big is the obinutuzumab market, and what is the forecast path?

A market analysis and numeric projection requires current revenue base data (sales by region, unit volume, and duration by regimen) plus a forecast framework with assumptions that must be sourced. Under the constraints, no revenue numbers or multi-year projections are provided without verifiable primary financial inputs.

What can be projected without sales data

Even without numerical sales inputs, the directionality is governed by three structural forces:

1. Anti-CD20 price compression from biosimilars and channel contracting
2. Regimen substitution as targeted oral agents and newer combinations spread into earlier lines
3. Indication persistence where obinutuzumab retains guideline-recognized roles in FL and CLL regimens, especially in patients defined by clinical risk or treatment constraints

What scenarios determine obinutuzumab’s 2026–2030 outlook?

Under a market-building lens for oncology antibody drugs, the forecast is driven by scenario splits in three buckets:

1) Utilization share (relative to rituximab/biosimilars and other CD20s)

• Share erosion scenario: Payers and clinicians move further toward rituximab biosimilars in standard combinations; antibody choice narrows.
• Share stability scenario: Obinutuzumab retains use in defined regimen niches where clinical practice or guideline language keeps it competitive.
• Share expansion scenario: New readouts or label revisions increase usage in subgroups or earlier lines (requires trial outcome-driven adoption, which is not enumerated here due to the trial-listing constraint).

2) Regimen duration

• Shortening: New combination standards reduce infusion exposure and maintenance duration.
• Stability: Existing maintenance schedules persist in real-world protocols.
• Expansion: New sequencing or retreatment strategies extend antibody exposure.

3) Competitive displacement risk

• BTK- and BCL2-driven regimens can lower antibody utilization if they produce comparable or superior outcomes with different toxicity management.
• Checkpoint- and immunotherapy-augmented approaches may shift treatment sequencing and duration.

Key commercial takeaways

• Obinutuzumab’s commercial durability hinges on maintaining specific guideline-aligned regimen roles in FL and CLL while absorbing ongoing anti-CD20 pricing pressure.
• A credible medium-term forecast depends on current sales run-rate, channel pricing, and adoption rates by line of therapy, none of which can be stated here without cited inputs.
• The next major forecast inflection point is outcomes-driven uptake from combination trials, but listing specific trial readouts and phase timelines requires a trial-source pull that is not executed here.

Key Takeaways

• Obinutuzumab has entrenched approved use in follicular lymphoma and CLL, with demand driven by line-of-therapy allocation and regimen duration.
• The primary market headwinds are biosimilar-led price pressure and regimen substitution by targeted agents in earlier lines.
• A fully numeric market analysis and multi-year projection cannot be produced here without cited sales and trial outcome inputs.
• The next utilization shift is expected to come from combination-trial outcomes that determine whether obinutuzumab keeps or loses its role versus rituximab/biosimilars and newer targeted regimens.

FAQs

1. What is obinutuzumab’s mechanism of action?
   It is an anti-CD20 monoclonal antibody used in B-cell malignancies.

2. Which cancers account for most of obinutuzumab demand?
   Follicular lymphoma and chronic lymphocytic leukemia.

3. How do biosimilars affect the obinutuzumab market?
   They compress net pricing and can redirect prescribers toward rituximab-based regimens depending on payer coverage and guideline position.

4. What most determines obinutuzumab forecast direction?
   Utilization share by line of therapy, regimen duration, and displacement by oral targeted combinations.

5. What is the main clinical factor that could change the market?
   Readouts from combination trials that expand or restrict obinutuzumab’s role in specific patient subgroups and treatment sequences.

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References (APA)

[1] FDA. (n.d.). Gazyva (obinutuzumab) prescribing information. U.S. Food and Drug Administration.
[2] EMA. (n.d.). Gazyva: EPAR product information (obinutuzumab). European Medicines Agency.
[3] ClinicalTrials.gov. (n.d.). Obinutuzumab studies (results and study status). U.S. National Library of Medicine.