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Gazyvaro
Gazyvaro is a Small molecule drug developed by Incyte Corporation. It is currently in Phase 1 development for CD20-positive follicular lymphoma, Chronic lymphoid leukemia, disease. Also known as: Gazyva®, Obinutuzumab.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Gazyvaro |
|---|---|
| Also known as | Gazyva®, Obinutuzumab |
| Sponsor | Incyte Corporation |
| Target | B-lymphocyte antigen CD20 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 1 |
Approved indications
- CD20-positive follicular lymphoma
- Chronic lymphoid leukemia, disease
Common side effects
Key clinical trials
- A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma (PHASE1)
- Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) (PHASE2)
- Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia (PHASE3)
- Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma (PHASE1, PHASE2)
- Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (PHASE2)
- Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study (PHASE3)
- Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma (PHASE2)
- Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Gazyvaro CI brief — competitive landscape report
- Gazyvaro updates RSS · CI watch RSS
- Incyte Corporation portfolio CI
Frequently asked questions about Gazyvaro
What is Gazyvaro?
What is Gazyvaro used for?
Who makes Gazyvaro?
Is Gazyvaro also known as anything else?
What development phase is Gazyvaro in?
What does Gazyvaro target?
Related
- Target: All drugs targeting B-lymphocyte antigen CD20
- Manufacturer: Incyte Corporation — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for CD20-positive follicular lymphoma
- Indication: Drugs for Chronic lymphoid leukemia, disease
- Also known as: Gazyva®, Obinutuzumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing