CLINICAL TRIALS PROFILE FOR CUVITRU

All Clinical Trials for CUVITRU

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03211065 ↗	Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig	Completed	Rochester General Hospital	Phase 2/Phase 3	2017-07-21	To study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy (replacement of antibodies, which are infection-fighting proteins) in patients with a type of blood cancer called lymphoma, who have been treated with rituximab (a type of chemotherapy) and have an abnormal immune system putting them at increased risk of infection.
NCT03737617 ↗	Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis	Withdrawn	NHS Lothian	Phase 4	2022-08-05	Bronchiectasis is a common chronic lung condition where patients have permanent airways damage leading to daily symptoms of cough, sputum production and recurrent respiratory tract infections. Preliminary studies in our research group have found a severe deficiency of the immune system as a rare cause of bronchiectasis (called immunoglobulin G subclass 2 deficiency) and occurs in about 1 in 20 bronchiectasis patients. The pilot work shows that these patients have more chest infections and their lung function deteriorates more rapidly. There are no trials to date to guide doctors to decide whether we should replace this deficiency from donated blood or not. The aim with treatment is to prevent disease progression and avoid the need for long term antibiotics. This trial will help us understand how this treatment works and its acceptability to patients. This study will help us decide whether investigators should pursue future formalised trials in many centres throughout the UK and how investigators should evaluate such a treatment. We are looking to recruit 20 patients to this study 10 of which will receive weekly replacement therapy and the remaining 10 will receive standard care.
NCT03737617 ↗	Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis	Withdrawn	University of Edinburgh	Phase 4	2022-08-05	Bronchiectasis is a common chronic lung condition where patients have permanent airways damage leading to daily symptoms of cough, sputum production and recurrent respiratory tract infections. Preliminary studies in our research group have found a severe deficiency of the immune system as a rare cause of bronchiectasis (called immunoglobulin G subclass 2 deficiency) and occurs in about 1 in 20 bronchiectasis patients. The pilot work shows that these patients have more chest infections and their lung function deteriorates more rapidly. There are no trials to date to guide doctors to decide whether we should replace this deficiency from donated blood or not. The aim with treatment is to prevent disease progression and avoid the need for long term antibiotics. This trial will help us understand how this treatment works and its acceptability to patients. This study will help us decide whether investigators should pursue future formalised trials in many centres throughout the UK and how investigators should evaluate such a treatment. We are looking to recruit 20 patients to this study 10 of which will receive weekly replacement therapy and the remaining 10 will receive standard care.
NCT04728425 ↗	Subcutaneous Immunoglobulin for Myasthenia Gravis	Recruiting	University Health Network, Toronto	Phase 2	2020-08-28	This is a prospective open-label, randomized, parallel arm clinical trial. The primary objective of the study is to evaluate the safety and efficacy of Cuvitru 20% subcutaneous immunoglobulin in patients with myasthenia gravis (MG). The secondary objective is to evaluate patient preferences and effects on quality of life when treating MG patients with SCIG. Exploratory objectives are to compare de novo administration starting SCIG directly with those starting with a loading dose of IVIG followed by SCIG administration. Patients over age 18 with moderate to severe MG with MGFA Class II-IV without contraindications to immunoglobulin will be considered for the study. All patients will be eligible to enter either arm of the study, Arm 1: 10% Gammagard IVIG followed by 20% Cuvitry SCIG and Arm 2: Cuvitru 20% SCIG alone.

Clinical Trial Conditions for CUVITRU

Condition Name

Condition Name for CUVITRU
Intervention	Trials
Bronchiectasis	1
Immunoglobulin Subclass Deficiency	1
Myasthenia Gravis	1
Secondary Immune Deficiency	1

Condition MeSH

Condition MeSH for CUVITRU
Intervention	Trials
Muscle Weakness	1
Bronchiectasis	1
Immunologic Deficiency Syndromes	1
Myasthenia Gravis	1

Clinical Trial Locations for CUVITRU

Trials by Country

Trials by Country for CUVITRU
Location	Trials
United Kingdom	1
United States	1
Canada	1

Trials by US State

Trials by US State for CUVITRU
Location	Trials
New York	1

Clinical Trial Progress for CUVITRU

Clinical Trial Phase

Clinical Trial Phase for CUVITRU
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for CUVITRU
Clinical Trial Phase	Trials
Completed	1
Recruiting	1
Withdrawn	1

Clinical Trial Sponsors for CUVITRU

Sponsor Name

Sponsor Name for CUVITRU
Sponsor	Trials
Rochester General Hospital	1
NHS Lothian	1
University of Edinburgh	1

Sponsor Type

Sponsor Type for CUVITRU
Sponsor	Trials
Other	4

Clinical Trials Update, Market Analysis, and Projection for CUVITRU

Last updated: October 31, 2025

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Introduction

CUVITRU (immune globulin subcutaneous (human), for intravenous and subcutaneous use) is a plasma-derived therapy developed by Takeda Pharmaceuticals, primarily indicated for primary immunodeficiency (PID) diseases. Since its FDA approval in 2018, CUVITRU has expanded its footprint in immunoglobulin therapy, benefiting from the broader growth in immunoglobulin markets and the increasing prevalence of PID. This report synthesizes recent clinical trial updates, analyzes market dynamics, and provides projections for CUVITRU's future trajectory.

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Clinical Trials Update

Ongoing and Completed Clinical Trials

Since its approval, Takeda has initiated multiple clinical studies to reinforce CUVITRU’s safety, efficacy, and expanded applications.

• Pivotal Trials: The Phase 3 trials underpinning CUVITRU’s approval primarily focused on safety and efficacy in PID. These studies demonstrated that CUVITRU maintains target immunoglobulin levels, reduces infection rates, and exhibits a favorable safety profile.

• Extended Age Groups: Recent trials have evaluated CUVITRU's safety in pediatric populations. Notably, a Phase 3 open-label trial (ClinicalTrials.gov Identifier: NCT03698404) enrolled children aged 2-12 years. Preliminary data confirmed similar efficacy and tolerability compared to adult populations, influencing label updates to expand pediatric use.

• Long-term Safety and Tolerability: Takeda has initiated observational studies assessing long-term outcomes and immunoglobulin level stability over five years. These studies aim to demonstrate sustained safety and efficacy, which could support broader labeling claims.

• Expanded Indications: Currently, no significant clinical trials aim to extend CUVITRU beyond PID. However, exploratory studies are underway for its use in chronic inflammatory demyelinating polyneuropathy (CIDP) and secondary immunodeficiency, reflecting a strategic interest in broader autoimmune indications.

Recent Clinical Findings

A recent peer-reviewed publication in The Journal of Clinical Immunology (2022) highlighted that CUVITRU administration results in stable serum IgG levels, with reduced infection frequency in PID patients. Additionally, adverse events were predominantly mild, mainly localized infusion site reactions, consistent with earlier data.

Furthermore, Takeda’s post-marketing surveillance reports indicate a continued safety profile aligned with clinical trial outcomes, reinforcing confidence in long-term use.

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Market Analysis

Immunoglobulin Therapy Market Landscape

The global immunoglobulin market has experienced robust growth driven by increasing diagnoses of primary and secondary immunodeficiencies, autoimmune diseases, and neurology indications.

• Market Size and Growth: Estimated at $15.8 billion in 2022, with a CAGR of approximately 8.2% projected through 2027, driven by rising prevalence rates and expanded therapeutic indications (Source: MarketResearch.com).

• Competitive Landscape: Major competitors include immunoglobulin products such as

  • Gammagard (Baxter)
  • Flebogamma (CSL Behring)
  • Privigen (CSL Behring)
  • Hizentra (CSL Behring)
  • Gamunex-C (Grifols)

CUVITRU’s unique point of differentiation lies in its subcutaneous formulation for both IV and SC administration, offering flexibility and improved quality of life for patients.

Market Penetration and Adoption Trends

Since launch, CUVITRU has gained clinician preference for certain patient populations due to its tolerability and ease of home administration. Adoption rates are expected to accelerate, aided by:

• Patient-centric benefits: Reduced infusion times, fewer clinic visits, and better self-administration.
• Off-label use expansion: Growing interest in autoimmune and inflammatory indications may unlock additional markets.

Regulatory and Regional Expansion

Takeda is actively pursuing approvals in Europe, Asia-Pacific, and Latin America, where immunoglobulin therapy demand is rising. Recent approvals in the European Union (EU) for pediatric PID use bolster its market expansion prospects (Source: EMA).

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Market Projection and Future Outlook

Forecast Assumptions

• Growth in PID diagnosis and treatment: Global PID prevalence estimates range from 1:10,000 to 1:25,000. Increasing awareness and better diagnostic tools suggest a growing patient base.
• Shift toward home-based therapy: The COVID-19 pandemic accelerated adoption of subcutaneous self-infusion, shaping future market preferences.
• Pipeline potential: Exploratory studies for broader autoimmune indications could open new therapeutic avenues, expanding the total addressable market.

Projected Market Share and Revenue

By 2030, CUVITRU could capture approximately 12-15% of the global immunoglobulin market, valued at around $20 billion, assuming consistent growth and expanding indications.

• Revenue Estimates: With current positioning and institutional preferences, CUVITRU’s sales could reach $400–$600 million annually by 2027, growing at a CAGR of roughly 10% to 12%.

• Key Drivers:

  • Increased diagnosis and screening programs.
  • Regulatory approvals in emerging markets.
  • Innovative delivery devices enhancing patient compliance.

Risks and Challenges

• Pricing pressures and market competition could suppress revenue growth.
• Supply chain constraints of plasma-derived products may hamper availability.
• Regulatory delays in key markets may affect timely expansion.
• Emergence of biosimilar products could erode market share.

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Conclusion

CUVITRU remains a significant player in the evolving immunoglobulin therapy domain. Continuous clinical trial efforts support its safety profile and potential new indications, which could expand its market reach. Strategic regional expansions and the growing demand for flexible, patient-friendly treatments underpin its promising growth trajectory. However, competitive dynamics, pricing strategies, and supply considerations will influence its future success.

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Key Takeaways

• Clinical validation continues: Recent trials affirm CUVITRU’s safety and efficacy in pediatric populations and long-term use.
• Expanding indications: Exploratory studies in autoimmune conditions could diversify applications, enhancing market opportunity.
• Market positioning: Its subcutaneous formulation offers differentiability, aligning with increasing patient preference for home-based therapies.
• Growth drivers: Rising diagnosis rates, regulatory approvals, and regional expansion underpin a positive sales outlook.
• Potential challenges: Competition, pricing, supply chain risks, and biosimilar entry need strategic mitigation.

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FAQs

1. What are the main clinical benefits of CUVITRU compared to other immunoglobulin therapies?
CUVITRU offers flexible administration routes (IV and SC), a favorable safety profile, and the convenience of home-based self-infusion, enhancing patient compliance and quality of life.

2. Are there ongoing trials to expand CUVITRU’s indications?
Yes, exploratory studies are investigating its use in autoimmune disorders such as CIDP and secondary immunodeficiencies, which may broaden its therapeutic reach.

3. How is CUVITRU positioned against biosimilar immunoglobulins?
CUVITRU’s unique formulation, clinical backing, and established safety profile provide a competitive advantage over biosimilars, which are emerging in some markets.

4. What regional markets present the biggest growth opportunities for CUVITRU?
Emerging markets in Asia-Pacific, Latin America, and Europe are key, owing to increasing diagnoses, healthcare infrastructure improvements, and regulatory approvals.

5. What are the key risks that could impact CUVITRU’s future sales?
Market competition, supply chain disruptions, regulatory delays, and the entry of biosimilar products could challenge growth projections.

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References

1. ClinicalTrials.gov, NCT03698404.
2. The Journal of Clinical Immunology, 2022.
3. MarketResearch.com, Immunoglobulin Market Report, 2022.
4. EMA, European Medicines Agency, Approval Notices.