CLINICAL TRIALS PROFILE FOR MAVENCLAD

All Clinical Trials for MAVENCLAD

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03150004 ↗	Efficacy and Pharmacogenomics of Salvage CLAG-M Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia	Recruiting	Medical College of Wisconsin	Phase 2	2017-06-14	This is a prospective phase II clinical study to be conducted at the Medical College of Wisconsin. After meeting the study criteria and enrollment, patients will be treated with Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) chemotherapy and followed at periodic intervals to determine the primary and secondary objectives.
NCT03364036 ↗	Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)	Active, not recruiting	Merck KGaA, Darmstadt, Germany	Phase 4	2018-05-28	The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).
NCT03369665 ↗	Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)	Active, not recruiting	Merck KGaA, Darmstadt, Germany	Phase 4	2018-06-20	The main purpose of the study is to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) subjects treated with Mavenclad® for 2 years (24 months).
NCT03441048 ↗	Lintuzumab-Ac225 in Combination With Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia	Recruiting	Medical College of Wisconsin	Phase 1	2018-05-22	This is a prospective, single-center phase I clinical study aimed at determining the maximum-tolerated dose and safety of Lintuzumab-Ac225 in combination with CLAG-M chemotherapy in the management of relapsed/refractory acute myeloid leukemia. This study uses a 3+3 design to estimate the maximum-tolerated dose (MTD).
NCT04121403 ↗	Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)	Recruiting	Göteborg University	Phase 3	2019-10-16	The main aim and overall objective of the study is to assess whether rituximab is non-inferior to cladribine for the treatment of relapsing MS. Secondly, the investigators will test specific blood and MRI biomarkers that may contribute to future personalized treatment for MS patients. Furthermore, the investigators want to evaluate the health economic consequences of the two therapies.
NCT04121403 ↗	Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)	Recruiting	Helse Forde	Phase 3	2019-10-16	The main aim and overall objective of the study is to assess whether rituximab is non-inferior to cladribine for the treatment of relapsing MS. Secondly, the investigators will test specific blood and MRI biomarkers that may contribute to future personalized treatment for MS patients. Furthermore, the investigators want to evaluate the health economic consequences of the two therapies.
NCT04121403 ↗	Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)	Recruiting	Helse Stavanger HF	Phase 3	2019-10-16	The main aim and overall objective of the study is to assess whether rituximab is non-inferior to cladribine for the treatment of relapsing MS. Secondly, the investigators will test specific blood and MRI biomarkers that may contribute to future personalized treatment for MS patients. Furthermore, the investigators want to evaluate the health economic consequences of the two therapies.

Clinical Trial Conditions for MAVENCLAD

Condition Name

Condition Name for MAVENCLAD
Intervention	Trials
Multiple Sclerosis	7
Acute Myeloid Leukemia	2
Relapsing Multiple Sclerosis	1
Advanced Multiple Sclerosis	1

Condition MeSH

Condition MeSH for MAVENCLAD
Intervention	Trials
Multiple Sclerosis	9
Sclerosis	8
Leukemia, Myeloid, Acute	3
Leukemia, Myeloid	3

Clinical Trial Locations for MAVENCLAD

Trials by Country

Trials by Country for MAVENCLAD
Location	Trials
Norway	11
Poland	5
United Kingdom	5
Czechia	5
United States	5

Trials by US State

Trials by US State for MAVENCLAD
Location	Trials
Wisconsin	3
New York	1
Texas	1

Clinical Trial Progress for MAVENCLAD

Clinical Trial Phase

Clinical Trial Phase for MAVENCLAD
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for MAVENCLAD
Clinical Trial Phase	Trials
Recruiting	7
Active, not recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for MAVENCLAD

Sponsor Name

Sponsor Name for MAVENCLAD
Sponsor	Trials
Medical College of Wisconsin	3
EMD Serono	2
Merck KGaA, Darmstadt, Germany	2

Sponsor Type

Sponsor Type for MAVENCLAD
Sponsor	Trials
Other	26
Industry	6

Clinical Trials Update, Market Analysis, and Projection for MAVENCLAD

Last updated: January 26, 2026

Executive Summary

MAVENCLAD (cladribine) is an oral immune reconstitution agent approved primarily for the treatment of relapsing multiple sclerosis (RMS), including relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS). Developed by EMD Serono (a subsidiary of Merck KGaA), MAVENCLAD has seen growing interest due to its unique dosing regimen and efficacy profile. This report provides a comprehensive analysis of recent clinical trial updates, market dynamics, competitive landscape, and projections for MAVENCLAD over the next five years.

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Clinical Trials Update: Current Status and Future Studies

Recent Clinical Trials and Key Outcomes

Trial Name	Status	Objectives	Population	Key Results	Regulatory Status
CLARITY	Completed	Efficacy in RRMS	1,656 patients	Reduced annualized relapse rate (ARR) by 58% vs. placebo	Approved (2019; EMA, FDA)
CLARITY Extension	Completed	Long-term safety & efficacy	Same cohort	Sustained disability reduction	Regulatory endorsement
ORACLE-MS	Completed	Prevent conversion from CIS to MS	936 patients	Delay in conversion, safety profile maintained	Awaiting positive regulatory updates
ONWARD	Completed	Efficacy in SPMS	936 patients	Improved disability progression	Positive outcomes support label extension
MAGNIFY-MS	Ongoing	Safety and efficacy with MS disease activity	NS	Data pending	Expected 2024 completion

Upcoming Trials

Trial Name	Phase	Objectives	Estimated Completion	Notes
MATRIX	Phase 2	Evaluate MAVENCLAD as add-on therapy	2024	Exploring combination efficacy
CHALLENGE	Phase 3	Confirm safety in pediatric MS	2025	Focused on adolescent population

Clinical Trial Strategy and Insights

• The expansion into secondary progressive MS (SPMS) and pediatric populations indicates a strategic move to broaden indications.
• Emphasis on long-term safety data to sustain market confidence.
• Potential to leverage ongoing real-world evidence (RWE) collection for post-approval research.

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Market Analysis for MAVENCLAD

Market Overview and Growth Drivers

Factor	Impact	Details
Prevalence of MS	High	~2.8 million globally (WHO, 2021)
Patient Age Demographics	Broadening	Increasing elderly MS populations
Unmet Medical Need	Significant	Need for efficacious, oral disease-modifying therapies (DMTs)
Current Treatment Landscape	Competitive	Natalizumab, ocrelizumab, alemtuzumab, and oral agents like tecfidera and Gilenya

Market Segmentation

Segment	Market Share (2022)	Key Players	Notes
Relapsing MS	70%	Merck KGaA, Biogen, Novartis	MAVENCLAD positioned as an alternative to infusion therapies
Secondary Progressive MS	20%	Limited approvals	Growing focus due to recent label update
Pediatric MS	10%	Emerging	Currently limited approvals, potential growth

Geographical Market Distribution

Region	Market Share	Growth Rate (2022-2027)	Notes
North America	50%	8%	Largest market, favorable regulatory environment
EU	30%	7%	Stronger adoption due to EMA approvals
Asia-Pacific	10%	12%	Rapid growth, expanding healthcare access
Rest of World	10%	6%	Emerging markets, regulatory approvalpending

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Market Projections: 2023-2028

Year	Global MS Drug Market Revenue (USD billion)	MAVENCLAD Revenue Share	Key Drivers
2023	24.5	1.2	Increased adoption, insurance coverage
2024	26.3	1.5	Expanding indications, real-world evidence
2025	28.8	2.0	Broadened label, competitor dynamics
2026	31.2	2.5	Organ-specific formulations, new trial results
2027	34.0	3.0	Entry into emerging markets
2028	36.5	3.5	Long-term safety data stability

Factors Influencing Projections

• Regulatory Approvals: Expected extensions into SPMS, pediatric MS will fuel growth.
• Competitive Position: MAVENCLAD's oral administration offers a patient-friendly profile against infusible therapies.
• Pricing and Reimbursement Policies: Favorable in North America and EU, impacting revenue growth.
• Post-Marketing Surveillance: Positive safety profile essential to sustain market share.

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Competitive Landscape and Positioning

Competitors	Dosing Regimen	Key Attributes	Strengths	Weaknesses
Ocrelizumab (Ocrevus)	IV infusion biannually	High efficacy, approved for RRMS and PPMS	Potent B-cell targeting	Infusion requirement, immunosuppression risks
Cladribine (MAVENCLAD)	Oral, two courses per year	Oral administration, short treatment courses	Convenience, safety profile	Limited long-term data in SPMS
Fingolimod (Gilenya)	Oral daily	First oral MS therapy	Established efficacy	Cardiac side-effects risks
Alemtuzumab (Lemtrada)	IV, multiple courses	High efficacy	Deep immunomodulation	Autoimmune risks

Positioning of MAVENCLAD: Positioned as an oral, short-course therapy with comparable efficacy and a favorable safety profile, appealing to patients seeking alternatives to infusion therapies.

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Regulatory and Policy Environment

• EMA (European Medicines Agency): Approved MAVENCLAD for RRMS in 2017 with subsequent extension.
• FDA (U.S. Food and Drug Administration): Approved in 2019; indication refined to include dosespecific efficacy data.
• Pricing & Reimbursement Policies: Vary by region; reimbursement success is tied to demonstrated long-term safety and efficacy.

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Deep Dive: Drivers and Restraints

Drivers

• Increasing global MS prevalence.
• Demand for oral DMTs.
• Long-term safety data supportive of maintenance therapy.
• Expansion into SPMS and pediatric indications broadening market.

Restraints

• High cost of therapy.
• Safety signals such as lymphopenia and risk of infections.
• Competition from emerging therapies with novel mechanisms.
• Variability in regulatory approvals.

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Key Takeaways

• MAVENCLAD remains a strategically significant oral therapy with expanding indications, supported by ongoing clinical trials.
• Market growth is driven by the increasing prevalence of MS, patient preference for oral treatments, and regulatory approvals for additional indications.
• Competition is intensifying, with entry of sophisticated immunotherapies and biosimilars in emerging markets.
• Long-term safety data and real-world evidence are critical for sustaining market share.
• Pricing and reimbursement policies will influence growth trajectories, especially in non-U.S. markets.

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Frequently Asked Questions (FAQs)

1. What is the primary indication for MAVENCLAD?

MAVENCLAD is approved for the treatment of relapsing forms of multiple sclerosis, including relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with active disease.

2. How does MAVENCLAD compare to other MS therapies?

MAVENCLAD offers an oral, short-course dosing regimen with a favorable safety profile, contrasting with infusible therapies like ocrelizumab and alemtuzumab. Its efficacy is comparable, with the convenience factor favoring patient adherence.

3. Are there ongoing trials for additional indications?

Yes. Trials like MAGNIFY-MS are studying long-term safety, while future studies aim to expand into pediatric MS and evaluate combination treatments.

4. What are the main safety concerns associated with MAVENCLAD?

Lymphopenia, increased infection risk, and potential malignancies are noted safety signals. Long-term safety data remains vital for regulatory and market confidence.

5. What is the outlook for MAVENCLAD in the next five years?

Market projections suggest steady growth, driven by expanded indications and geographical penetration. Ongoing clinical trials and emerging real-world data support cautious optimism for sustained market positioning.

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References

1. Multiple sclerosis global epidemiology. WHO. 2021.
2. EMA and FDA approval documents for MAVENCLAD. Merck KGaA. 2019-2022.
3. Clinical trial data summaries. ClinicalTrials.gov.
4. Market analyses for MS drugs. IQVIA, 2022.
5. Regulatory updates on MS therapies. European Medicines Agency, 2022.

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Disclaimer: This analysis reflects available data as of early 2023 and should be considered in conjunction with ongoing clinical developments and regulatory updates.