Marginal Zone Lymphoma Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight | Beigene, InnoCare Pharma, Hutchmed, Incyte, Innovent, MorphoSys, Beijing Mabworks Biotech
(Las Vegas, Nevada, United States) As per DelveInsight’s evaluation, globally, the Marginal Zone Lymphoma (MZL) pipeline consists of 50+ leading companies actively working to develop 50+ MZL treatment therapies, covering clinical trials, therapeutic approaches, mechanisms of action, routes of administration, and ongoing developments.
The “Marginal Zone Lymphoma Pipeline Insight, 2025” report by DelveInsight delivers comprehensive insights into the current clinical development landscape and future growth opportunities within the Marginal Zone Lymphoma market.
The report provides an in-depth commercial and clinical evaluation of pipeline products from preclinical to marketed stages. It also includes detailed drug information, mechanisms of action, clinical trial data, NDA approvals (if any), and development activities including technology platforms, collaborations, M&A, funding, designations, and other product-specific insights.
Some Key Highlights from the Marginal Zone Lymphoma Pipeline Report
- Companies worldwide are actively developing innovative therapies for Marginal Zone Lymphoma and have achieved significant milestones in recent years.
- Key MZL companies include Carna Biosciences, Hutchmed, Incyte, Innovent, MorphoSys, Beigene, InnoCare Pharma, Beijing Mabworks Biotech, MEI Pharma, Kyowa Kirin, ADC Therapeutics, Loxo Oncology, Adicet Bio, Celldex Therapeutics, and others.
- Emerging MZL therapies across clinical trial phases include AS-1763, Amdizalisib (HMPL689), Parsaclisib (IBI376), Tafasitamab, Zanubrutinib, Orelabrutinib, MIL62, Zandelisib, Loncastuximab, LOXO-305, ADI-001, CDX-1140, and more, expected to significantly shape the MZL market.
- August 2025: FDA granted priority review to lisocabtagene maraleucel (Liso-cel; Breyanzi) for adult patients with relapsed/refractory MZL after at least two prior therapies, supported by Phase 2 TRANSCEND FL data demonstrating a 95.5% ORR and 62.1% CR.
- June 2025: ADC Therapeutics announced updated Phase 2 IIT data for ZYNLONTA® in relapsed/refractory MZL at the 18th ICML.
- June 2025: Combination therapy of rituximab and ibrutinib shows potential in MZL treatment; Phase II IELSG47/MALIBU trial highlights positive clinical outcomes.
- February 2025: Breyanzi demonstrated statistically significant ORR in relapsed/refractory MZL patients in the Phase 2 TRANSCEND FL trial.
- January 2025: Verismo Therapeutics dosed the first patient in the CELESTIAL-301 Phase 1 trial evaluating SynKIR™-310 in relapsed/refractory B-cell NHL, including MZL.
Marginal Zone Lymphoma Overview
Marginal Zone Lymphoma is a slow-growing B-cell non-Hodgkin lymphoma affecting lymph nodes, spleen, or MALT tissue. It often presents as painless swelling and may be linked to chronic infections or autoimmune conditions. Treatments vary by subtype and disease stage, ranging from watchful waiting to chemotherapy or targeted therapies.
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Emerging Marginal Zone Lymphoma Drugs Under Clinical Development
- AS-1763 – Carna Biosciences
- Amdizalisib (HMPL689) – Hutchmed
- Parsaclisib (IBI376) – Incyte/Innovent
- Tafasitamab – MorphoSys/Incyte
- Zanubrutinib – Beigene
- Orelabrutinib – InnoCare Pharma
- MIL62 – Beijing Mabworks Biotech
- Zandelisib – MEI Pharma/Kyowa Kirin
- Loncastuximab – ADC Therapeutics
- LOXO-305 – Loxo Oncology
- ADI-001 – Adicet Bio
- CDX-1140 – Celldex Therapeutics Inc
Marginal Zone Lymphoma – Route of Administration
Therapies in the MZL pipeline include:
- Inhalation
- Inhalation/Intravenous/Oral
- Intranasal
- Intravenous
- Intravenous/Subcutaneous
- Oral
- Oral/Intranasal/Subcutaneous
- Parenteral
- Subcutaneous
- NA
Marginal Zone Lymphoma – Molecule Type
Pipeline products are categorized as:
- Antibody
- Antisense oligonucleotides
- Immunotherapy
- Monoclonal antibody
- Peptides
- Protein
- Recombinant protein
- Small molecule
- Stem Cell
- Vaccine
Marginal Zone Lymphoma Pipeline Therapeutics Assessment
- Assessment by Product Type
- Assessment by Stage and Product Type
- Assessment by Route of Administration
- Assessment by Stage and Route of Administration
- Assessment by Molecule Type
- Assessment by Stage and Molecule Type
The report evaluates 50+ MZL drug candidates across:
- Late-stage products (Phase III)
- Mid-stage products (Phase II)
- Early-stage products (Phase I)
- Preclinical/Discovery stage candidates
- Discontinued/Inactive candidates
Download the full pipeline report to explore @ Marginal Zone Lymphoma emerging therapies
Key Companies in the Marginal Zone Lymphoma Therapeutics Market
Prominent developers include Incyte, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech, ADC Therapeutics, MEI Pharma, Genentech, Novartis, AstraZeneca, Kite Pharma, Roche, Oncternal Therapeutics, Celgene, IGM Biosciences, Loxo Oncology, Genmab, ArQule, and others.
Marginal Zone Lymphoma Pipeline Analysis
- Detailed insights on companies developing MZL therapies and total pipeline products
- Segmentation by clinical development stage
- Active and inactive pipeline programs
- Drugs categorized by route of administration, mechanism, molecular type, and monotherapy/combination therapy
- Analysis of collaborations, licensing deals, and financing to advance MZL treatment
- Data sourced from proprietary databases, trial registries, SEC filings, investor presentations, conferences, and verified third-party industry sources
Marginal Zone Lymphoma Pipeline Market Drivers
- Rising prevalence of MZL
- Increased R&D activities and therapeutic innovations
Marginal Zone Lymphoma Pipeline Market Barriers
- Moderately favorable patient outcomes
- Extended treatment durations
- Other clinical and operational challenges
Scope of Marginal Zone Lymphoma Pipeline Drug Insight
- Coverage: Global
- Key Companies: Carna Biosciences, Hutchmed, Incyte, Innovent, MorphoSys, Beigene, InnoCare Pharma, Beijing Mabworks Biotech, MEI Pharma, Kyowa Kirin, ADC Therapeutics, Loxo Oncology, Adicet Bio, Celldex Therapeutics, and others
- Key Therapies: AS-1763, Amdizalisib, Parsaclisib, Tafasitamab, Zanubrutinib, Orelabrutinib, MIL62, Zandelisib, Loncastuximab, LOXO-305, ADI-001, CDX-1140
- Therapeutic Assessment: Current marketed and emerging therapies
- Market Dynamics: Key drivers and barriers
Download the report to explore detailed therapy pipelines, clinical trial updates, and emerging innovations in @ MZL treatment
Table of Contents
- Marginal Zone Lymphoma Report Introduction
- Marginal Zone Lymphoma Executive Summary
- Marginal Zone Lymphoma Overview
- Analytical Perspective – In-depth Commercial Assessment
- Marginal Zone Lymphoma Pipeline Therapeutics
- Late-Stage Products (Phase II/III)
- Mid-Stage Products (Phase II)
- Early-Stage Products (Phase I)
- Preclinical Stage Products
- Therapeutics Assessment
- Inactive Products
- Company–University Collaborations (Licensing/Partnering)
- Key Companies
- Key Products
- Unmet Needs
- Market Drivers and Barriers
- Future Perspectives and Conclusion
- Analyst Views
- Appendix
- About DelveInsight
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
