Ozmosi | IBI-301 Drug Profile

Product Description

Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (Sourced from: https://clinicaltrials.gov/ct2/show/NCT02945215)

Mechanisms of Action: CD20 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: M.D. Anderson Cancer Center
Company Location: Western America
Company Founding Year: 1941
Additional Commercial Interests: None

Clinical Description

Countries in Clinic:

Active Clinical Trial Count:

Recent & Upcoming Milestones

Highest Development Phases

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Latest Trial Update Date	Data Updated
ACTRN12622000306718p	2006-7041-83/hah	N/A	Not yet recruiting	Intestinal Diseases\|Dental Caries	2022-02-28
NCT05052528	UCDCC#299	P1	Recruiting	Diffuse Large B-Cell Lymphoma	2025-05-15	2024-05-14
NCT02960646	NCI-2016-01915	P1	Completed	Acute Myelomonocytic Leukemia\|Chronic Lymphoid Leukemia\|Myelodysplastic Syndrome\|Chronic Myelomonocytic Leukemia\|Leukemia, Plasma Cell\|Myelogenous, Chronic, BCR-ABL Positive Leukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Acute Lymphoid Leukemia\|Blast Crisis\|Lymphoma, B-Cell\|Lymphocytic Chronic B-Cell Leukemia\|Chronic Myeloid Leukemia\|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma\|Preleukemia\|Acute Monocytic Leukemia\|Myeloproliferative Disorders\|Anemia, Aplastic\|Lymphoma, Non-Hodgkin\|Multiple Myeloma\|Juvenile Myelomonocytic Leukemia,\|Acute Myeloid Leukemia	2023-02-13	2023-02-18	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT03432741	MC1689	P1	Terminated	Lymphoma, Non-Hodgkin\|Adenocarcinoma\|B-Cell Marginal Zone Lymphoma\|T-Cell Cutaneous Lymphoma\|Breast Cancer\|Mycosis Fungoides	2022-08-26	2025-05-28	Primary Completion Date\|Primary Endpoints\|Treatments
NCT01619761	NCI-2012-02071	P1	Unknown status	Acute Lymphoid Leukemia\|Multiple Myeloma\|Lymphocytic Chronic B-Cell Leukemia\|Myeloid, Accelerated Leukemia\|Chronic Lymphoid Leukemia\|Acute Myeloid Leukemia\|Myelogenous, Chronic, BCR-ABL Positive Leukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Lymphoma, Non-Hodgkin\|Preleukemia\|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma\|Lymphoma, B-Cell\|Chronic Myeloid Leukemia\|Leukemia, Plasma Cell\|Myelodysplastic Syndrome\|Biphenotypic Acute Leukemia	2021-11-01	2022-02-02	Primary Endpoints\|Treatments\|Trial Status
CTR20160770	CTR20160770	P1	Completed	Lymphoma, B-Cell	2019-10-15	2025-04-29	Patient Enrollment\|Treatments
NCT02945215	CIBI301A201	P1	Completed	Lymphoma, B-Cell	2019-03-21	2020-09-03
NCT02779283	IRB00011766	P1	Completed	Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Acute Myeloid Leukemia\|Acute Lymphoid Leukemia	2018-04-19	2025-02-07	Primary Endpoints\|Treatments
CTR20140762	CTR20140762	P1	Completed	Lymphoma, Non-Hodgkin	2016-10-06	2025-04-29	Treatments
NCT02727803	NCI-2016-00584	P2	Recruiting	Myelogenous, Chronic, BCR-ABL Positive Leukemia\|Chronic Myeloid Leukemia\|Myeloid, Accelerated Leukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Leukemia, Plasma Cell\|Acute Myeloid Leukemia\|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma\|Acute Lymphoid Leukemia\|Biphenotypic Acute Leukemia\|Juvenile Myelomonocytic Leukemia,\|Myelodysplastic Syndrome\|Chronic Myelomonocytic Leukemia\|Myelodysplastic-Myeloproliferative Diseases\|Multiple Myeloma\|Anemia, Refractory, with Excess of Blasts\|Chronic Lymphoid Leukemia\|Lymphoma, Non-Hodgkin\|Acute Monocytic Leukemia\|Acute Myelomonocytic Leukemia\|Preleukemia\|B-Cell Leukemia\|Myeloproliferative Disorders\|Lymphoma, B-Cell	2027-05-31	2025-05-10	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT06834373	MC230813	P2	Recruiting	T-Cell Cutaneous Lymphoma\|Follicular Lymphoma\|Inflammation\|Diffuse Large B-Cell Lymphoma\|Lymphoma, Non-Hodgkin	2027-03-03	2025-04-05	Primary Endpoints\|Start Date\|Treatments\|Trial Status
NCT03096782	NCI-2018-01236	P2	Completed	Lymphoma, Non-Hodgkin\|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma\|Myelogenous, Chronic, BCR-ABL Positive Leukemia\|Preleukemia\|Acute Myeloid Leukemia\|Chronic Myeloid Leukemia\|Lymphoma, B-Cell\|Lymphocytic Chronic B-Cell Leukemia\|Myelodysplastic Syndrome\|Hodgkin Lymphoma\|Histiocytosis, Langerhans-Cell\|Chronic Lymphoid Leukemia\|Acute Monocytic Leukemia\|Acute Lymphoid Leukemia\|Anemia, Refractory, with Excess of Blasts\|Chronic Myelomonocytic Leukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Myeloid, Accelerated Leukemia\|Juvenile Myelomonocytic Leukemia,\|Acute Myelomonocytic Leukemia\|Biphenotypic Acute Leukemia	2022-09-20	2023-06-30	Primary Endpoints
NCT05457556	ASCT2031	P3	Active, not recruiting	Acute Myeloid Leukemia\|Acute Lymphoid Leukemia\|Myelodysplastic Syndrome\|Preleukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma	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	Acute Lymphoid Leukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma	2023-06-23	2025-02-07	Primary Endpoints\|Treatments
CTR20160493	CTR20160493	P3	Completed	Diffuse Large B-Cell Lymphoma	2019-09-05	2025-04-29	Patient Enrollment\|Treatments
NCT02867566	CIBI301A301	P3	Completed	Diffuse Large B-Cell Lymphoma	2019-09-05	2020-08-14	Patient Enrollment\|Primary Completion Date\|Primary Endpoints\|Start Date\|Study Completion Date

Recent News Events

Date	Type	Title
01/18/2023	News Article	Innovent Announces Inclusion in the China National Reimbursement Drug List (NRDL) of TYVYT in Two New Indications, Olverembatinib for the First Listing, BYVASDA, HALPRYZA and SULINNO in Multiple New Indications
04/01/2021	PubMed	Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial.
09/08/2020	News Article	Rituximab Biosimilars Landscape Report 2020 Featuring 34 Key Players & 30 Key Products - ResearchAndMarkets.com
07/15/2020	PubMed	Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20(+) B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study.
01/13/2020	News Article	Innovent Out-Licenses Commercial Rights for Avastin® Biosimilar to Coherus BioSciences in the United States and Canada
09/20/2019	News Article	Innovent Provides Update on Two Studies of IBI301 (Rituximab Biosimilar) in the Treatment of CD20-positive Lymphoma at Annual Meeting of CSCO

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IBI-301

Alternative Names: ibi-301, ibi301, ibi 301 Clinical Status: Inactive Latest Update: 2026-03-03 Latest Update Note: Clinical Trial Update