Ozmosi | PF-05280586 Drug Profile
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PF-05280586

Alternative Names: pf-05280586, pf05280586, pf 05280586
Clinical Status: Inactive
Latest Update: 2025-12-22
Latest Update Note: Clinical Trial Update

Product Description

PF-05280586 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Rituxan/MabThera. Rituxan/MabThera is indicated for the treatment of patients with certain types of CD20-positive non-Hodgkin lymphoma; CD20-positive chronic lymphocytic leukemia; rheumatoid arthritis; granulomatosis with polyangiitis and microscopic polyangiitis; and other region-specific indications. (Sourced from: https://www.pfizer.com/news/press-release/press-release-detail/pfizer_presents_positive_26_week_data_for_pf_05280586_a_potential_biosimilar_to_rituximab_at_the_american_society_of_hematology_annual_meeting)

Mechanisms of Action: TNF Inhibitor

Novel Mechanism: No

Modality: Antibody

Route of Administration: Intravenous

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Pfizer
Company Location: Eastern America
Company CEO: Albert Bourla
Additional Commercial Interests: None

Clinical Description

Countries in Clinic:

Active Clinical Trial Count:

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Follicular Lymphoma|Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Myelodysplastic Syndrome|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Preleukemia

Phase 2: Arthritis, Rheumatoid|Lymphocytic Chronic B-Cell Leukemia|Histiocytosis, Langerhans-Cell|Hodgkin Lymphoma|Lymphoma, Non-Hodgkin|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Chronic Lymphoid Leukemia|Lymphoma, B-Cell|Anemia, Refractory, with Excess of Blasts|Myeloid, Accelerated Leukemia|Acute Lymphoid Leukemia|Biphenotypic Acute Leukemia|Chronic Myelomonocytic Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Acute Myelomonocytic Leukemia|Preleukemia|Chronic Myeloid Leukemia|Acute Monocytic Leukemia|Myelodysplastic Syndrome|Acute Myeloid Leukemia|Juvenile Myelomonocytic Leukemia,|T-Cell Cutaneous Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Myelodysplastic-Myeloproliferative Diseases|Inflammation|Follicular Lymphoma|B-Cell Leukemia|Myeloproliferative Disorders|Diffuse Large B-Cell Lymphoma|Leukemia, Plasma Cell|Multiple Myeloma

Phase 1: Acute Myelomonocytic Leukemia|Leukemia, Plasma Cell|Chronic Myelomonocytic Leukemia|Myeloproliferative Disorders|Juvenile Myelomonocytic Leukemia,|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Lymphoma, B-Cell|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, Non-Hodgkin|Acute Myeloid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Anemia, Aplastic|Acute Lymphoid Leukemia|Multiple Myeloma|Preleukemia|Blast Crisis|Myelodysplastic Syndrome|Acute Monocytic Leukemia|Adenocarcinoma|B-Cell Marginal Zone Lymphoma|Myeloid, Accelerated Leukemia|T-Cell Cutaneous Lymphoma|Breast Cancer|Mycosis Fungoides|Diffuse Large B-Cell Lymphoma|Biphenotypic Acute Leukemia

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

ACTRN12622000306718p

2006-7041-83/hah

N/A

Not yet recruiting

Dental Caries|Intestinal Diseases

2022-02-28

NCT01643928

REFLECTIONS B328-04

N/A

Completed

Arthritis, Rheumatoid

2016-03-14

2019-03-19

Primary Completion Date|Start Date

NCT05052528

UCDCC#299

P1

Recruiting

Diffuse Large B-Cell Lymphoma

2025-05-15

2024-05-14

NCT02960646

NCI-2016-01915

P1

Completed

Myelodysplastic Syndrome|Acute Myelomonocytic Leukemia|Acute Myeloid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Chronic Myelomonocytic Leukemia|Lymphoma, B-Cell|Acute Monocytic Leukemia|Multiple Myeloma|Chronic Myeloid Leukemia|Lymphoma, Non-Hodgkin|Preleukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Myeloproliferative Disorders|Leukemia, Plasma Cell|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Chronic Lymphoid Leukemia|Anemia, Aplastic|Juvenile Myelomonocytic Leukemia,|Acute Lymphoid Leukemia|Blast Crisis

2023-02-13

2023-02-18

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

NCT03432741

MC1689

P1

Terminated

Breast Cancer|T-Cell Cutaneous Lymphoma|Lymphoma, Non-Hodgkin|B-Cell Marginal Zone Lymphoma|Adenocarcinoma|Mycosis Fungoides

2022-08-26

2025-05-28

Primary Completion Date|Primary Endpoints|Treatments

NCT01619761

NCI-2012-02071

P1

Unknown status

Chronic Myeloid Leukemia|Myeloid, Accelerated Leukemia|Leukemia, Plasma Cell|Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia|Lymphoma, B-Cell|Acute Myeloid Leukemia|Acute Lymphoid Leukemia|Lymphoma, Non-Hodgkin|Multiple Myeloma|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Biphenotypic Acute Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Myelodysplastic Syndrome|Preleukemia

2021-11-01

2022-02-02

Primary Endpoints|Treatments|Trial Status

NCT02779283

IRB00011766

P1

Completed

Acute Myeloid Leukemia|Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

2018-04-19

2025-02-07

Primary Endpoints|Treatments

NCT02727803

NCI-2016-00584

P2

Recruiting

Preleukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Myeloproliferative Disorders|B-Cell Leukemia|Acute Lymphoid Leukemia|Myelodysplastic-Myeloproliferative Diseases|Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Myeloid, Accelerated Leukemia|Acute Myeloid Leukemia|Juvenile Myelomonocytic Leukemia,|Chronic Myelomonocytic Leukemia|Multiple Myeloma|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, B-Cell|Myelodysplastic Syndrome|Anemia, Refractory, with Excess of Blasts|Leukemia, Plasma Cell|Chronic Myeloid Leukemia|Biphenotypic Acute Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Lymphoma, Non-Hodgkin|Chronic Lymphoid Leukemia

2027-05-31

2025-05-10

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

NCT06834373

MC230813

P2

Recruiting

Follicular Lymphoma|Diffuse Large B-Cell Lymphoma|Inflammation|T-Cell Cutaneous Lymphoma|Lymphoma, Non-Hodgkin

2027-03-03

2025-04-05

Primary Endpoints|Start Date|Treatments|Trial Status

NCT03096782

NCI-2018-01236

P2

Completed

Acute Lymphoid Leukemia|Juvenile Myelomonocytic Leukemia,|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloid, Accelerated Leukemia|Myelodysplastic Syndrome|Chronic Myelomonocytic Leukemia|Acute Myeloid Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Acute Monocytic Leukemia|Lymphocytic Chronic B-Cell Leukemia|Chronic Myeloid Leukemia|Preleukemia|Biphenotypic Acute Leukemia|Hodgkin Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Histiocytosis, Langerhans-Cell|Anemia, Refractory, with Excess of Blasts|Chronic Lymphoid Leukemia|Acute Myelomonocytic Leukemia|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin

2022-09-20

2023-06-30

Primary Endpoints

2012-003223-38

REFLECTIONS B328-04

P2

Completed

Arthritis, Rheumatoid

2016-03-14

2022-03-13

Treatments

2011-002896-40

2011-002896-40

P2

Completed

Arthritis, Rheumatoid

2014-05-07

2022-03-13

Treatments

NCT01526057

REFLECTIONS

P2

Completed

Arthritis, Rheumatoid

2013-08-13

2019-03-19

Treatments

NCT05457556

ASCT2031

P3

Active, not recruiting

Acute Myeloid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Myelodysplastic Syndrome|Preleukemia

2026-06-30

2025-05-06

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

NCT02003222

NCI-2013-02229

P3

Active, not recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia

2023-06-23

2025-02-07

Primary Endpoints|Treatments

2014-000132-41

2014-000132-41

P3

Completed

Follicular Lymphoma

2018-04-19

2022-03-13

Treatments

JapicCTI-152823

JapicCTI-152823

P3

Unknown

Follicular Lymphoma

2018-04-19

NCT02213263

REFLECTIONS B328-06

P3

Completed

Follicular Lymphoma

2017-10-23

2019-03-20