Mantle Cell Lymphoma Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, NICE Approvals, Mechanism of Action, ROA, IND, NDA Approval and Companies by DelveInsight

Mantle Cell Lymphoma Clinical Trials

(Albany, USA) DelveInsight’s, “Mantle Cell Lymphoma Pipeline Insight, 2025,” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in Mantle Cell Lymphoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

The report provides a detailed description of the Mantle Cell Lymphoma drugs, including the mechanism of action, type, stage, route of administration, molecule type, clinical studies, inactive pipeline products, and NDA approvals (if any). The Mantle Cell Lymphoma pipeline report also covers commercial and clinical activities of the pipeline products from the pre-clinical developmental phase to the marketed stage. Additionally, it presents the ongoing developments in the therapeutics segment, including collaborations, licensing, mergers & acquisitions (M&A), funding, designations, and other product-related details.

Discover the latest drugs and treatment options in the Mantle Cell Lymphoma Pipeline. Dive into DelveInsight’s comprehensive report today! @ Mantle Cell Lymphoma Pipeline Outlook

Key Takeaways from the Mantle Cell Lymphoma Pipeline Report

• DelveInsight’s Mantle Cell Lymphoma pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for Mantle Cell Lymphoma treatment.
• In April 2025, BeiGene announced results of a Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma
• In April 2025, Loxo Oncology announced results of a Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)
• In January 2025, AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.
• In October 2024:- Hoffmann-La Roche- The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator’s choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
• In October 2024:- Loxo Oncology, Inc announced a Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL). This study includes 3 parts: Phase 1 (pirtobrutinib monotherapy dose escalation and dose expansion), Phase 1b (pirtobrutinib combination therapy dose expansion), and Phase 2 (pirtobrutinib monotherapy dose expansion).
• Key mantle cell lymphoma companies such as AbbVie, Adicet Bio, InnoCare Pharma Inc., Guangzhou Lupeng Pharmaceutical Company LTD., BeiGene, Nurix, LegoChem Biosciences, Xynomic Pharmaceuticals, Merck & Co, Incyte Corporation, TG Therapeutics, Janssen/Pharmacyclics, Eternity Bioscience, Traws Pharm, Advenchen Laboratories, and others are evaluating new mantle cell lymphoma drugs to improve the treatment landscape.
• Promising mantle cell lymphoma pipeline therapies such as Venetoclax, ADI-001, Orelabrutinib, LP-168, BGB-11417, NX 2127, LCB 71, NX 5948, Abexinostat, Pembrolizumab, Parsaclisib, Umbralisib, Ibrutinib, Edralbrutinib, Narazaciclib, Lucitanib, and others are under different phases of mantle cell lymphoma clinical trials.

Stay ahead with the most recent pipeline outlook for Mantle Cell Lymphoma. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Mantle Cell Lymphoma Treatment Drugs

Mantle Cell Lymphoma Emerging Drugs Profile

• Venetoclax: AbbVie

Venetoclax is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

• Ixazomib: Takeda

Ixazomib belongs to a class of drugs called proteasome inhibitors, which work by blocking the action of proteasomes, cellular structures responsible for breaking down proteins. By inhibiting proteasomes, ixazomib helps to disrupt the growth and survival of cancer cells. Currently, the product is in the Phase II stage of its development for the treatment of mantle cell lymphoma.

• ADI-001: Adicet Bio

ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy being developed as a potential treatment for relapsed or refractory B-cell NHL. ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent antitumor activity in preclinical models, leading to long-term control of tumor growth. ADI-001 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed or refractory B-cell NHL. Currently, the drug is in the Phase I stage of its development for the treatment of mantle cell lymphoma.

Explore groundbreaking therapies and clinical trials in the Mantle Cell Lymphoma Pipeline. Access DelveInsight’s detailed report now! @ New Mantle Cell Lymphoma Drugs

Mantle Cell Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Mantle Cell Lymphoma Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Unveil the future of Mantle Cell Lymphoma Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Mantle Cell Lymphoma Market Drivers and Barriers

Scope of the Mantle Cell Lymphoma Pipeline Report

• Coverage- Global
• Key Mantle cell lymphoma companies: AbbVie Inc. (NYSE: ABBV), Adicet Bio, Inc. (NASDAQ: ACET), InnoCare Pharma Ltd. (HKEX: 9969), BeiGene, Ltd. (NASDAQ: BGNE), Nurix Therapeutics, Inc. (NASDAQ: NRIX), LegoChem Biosciences, Inc. (KOSDAQ: 141080), Xynomic Pharmaceuticals Holdings, Inc. (NASDAQ: XYN), Merck & Co., Inc. (NYSE: MRK), Incyte Corporation (NASDAQ: INCY), TG Therapeutics, Inc. (NASDAQ: TGTX), Janssen/Pharmacyclics (acquired by Johnson & Johnson and AbbVie respectively, not independently listed), Advenchen Laboratories, Eternity Bioscience, Traws Pharm, Guangzhou Lupeng Pharmaceutical Company LTD, and others.
• Mantle cell lymphoma therapies: Venetoclax, ADI-001, Orelabrutinib, LP-168, BGB-11417, NX 2127, LCB 71, NX 5948, Abexinostat, Pembrolizumab, Parsaclisib, Umbralisib, Ibrutinib, Edralbrutinib, Narazaciclib, Lucitanib, and others.
• Mantle Cell Lymphoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Mantle Cell Lymphoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Mantle Cell Lymphoma Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ Mantle Cell Lymphoma Companies, Key Products and Unmet Needs

Table of Content

1. Introduction
2. Executive Summary
3. Mantle Cell Lymphoma: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Mantle Cell Lymphoma– DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. Venetoclax: AbbVie
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. Ixazomib: Takeda
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. ADI-001: Adicet Bio
15. Drug profiles in the detailed report…..
16. Preclinical Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Mantle Cell Lymphoma Key Companies
21. Mantle Cell Lymphoma Key Products
22. Mantle Cell Lymphoma- Unmet Needs
23. Mantle Cell Lymphoma- Market Drivers and Barriers
24. Mantle Cell Lymphoma- Future Perspectives and Conclusion
25. Mantle Cell Lymphoma Analyst Views
26. Mantle Cell Lymphoma Key Companies
27. Appendix

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