CLINICAL TRIALS PROFILE FOR IMMUNE GLOBULIN (HUMAN)

Biosimilar Clinical Trials for immune globulin (human)

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01624805 ↗	Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome	Recruiting	National Cancer Institute (NCI)	Phase 2	2012-06-25	This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.
NCT01624805 ↗	Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome	Recruiting	M.D. Anderson Cancer Center	Phase 2	2012-06-25	This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.

All Clinical Trials for immune globulin (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000580 ↗	Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1975-11-01	To evaluate whether hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis B virus, the single most important route of hepatitis spread in the entire Third World.
NCT00000584 ↗	Transfusion-Transmitted Cytomegalovirus Prevention in Neonates	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1983-07-01	To evaluate the capacity of intravenously administered cytomegalovirus (CMV)-immune globin (CMVIG) to immunize high risk premature infants against CMV infections.
NCT00000751 ↗	A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during pregnancy for medical indications. Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary.
NCT00000751 ↗	A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1969-12-31	To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during pregnancy for medical indications. Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary.
NCT00000827 ↗	A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children	Completed	North American Biologicals Inc	Phase 1	1969-12-31	To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children. Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.

Clinical Trial Conditions for immune globulin (human)

Condition Name

Condition Name for immune globulin (human)
Intervention	Trials
Leukemia	54
Lymphoma	36
Myelodysplastic Syndromes	31
Multiple Myeloma and Plasma Cell Neoplasm	21

Condition MeSH

Condition MeSH for immune globulin (human)
Intervention	Trials
Leukemia	73
Myelodysplastic Syndromes	54
Preleukemia	52
Syndrome	47

Clinical Trial Locations for immune globulin (human)

Trials by Country

Trials by Country for immune globulin (human)
Location	Trials
United States	641
Canada	44
China	26
Germany	21
Italy	12

Trials by US State

Trials by US State for immune globulin (human)
Location	Trials
California	49
Texas	47
New York	45
Ohio	37
Maryland	35

Clinical Trial Progress for immune globulin (human)

Clinical Trial Phase

Clinical Trial Phase for immune globulin (human)
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	5

Clinical Trial Status

Clinical Trial Status for immune globulin (human)
Clinical Trial Phase	Trials
Completed	151
Recruiting	46
Terminated	35

Clinical Trial Sponsors for immune globulin (human)

Sponsor Name

Sponsor Name for immune globulin (human)
Sponsor	Trials
National Cancer Institute (NCI)	60
M.D. Anderson Cancer Center	23
National Heart, Lung, and Blood Institute (NHLBI)	20

Sponsor Type

Sponsor Type for immune globulin (human)
Sponsor	Trials
Other	319
NIH	113
Industry	87

Last updated: May 11, 2026

Immune Globulin (Human) Clinical Trials Update, Market Analysis, and Market Projections

Immune globulin (human) is a mature biologic category rather than a single, discrete “drug product” in the way small molecules are. Market and clinical-trial reporting varies by branded product, IgG concentration, indication set (primary immunodeficiency vs neurologic and infectious diseases), and country. This update is constrained to public information that is available at a product-class level and to sources that explicitly support clinical status and market sizing.

No complete, citation-backed dossier for “immune globulin (human)” as a single identifiable drug asset can be generated from the information in scope here.

What clinical trials exist for immune globulin (human) and what stage are they in?

Featured snippet answer: Current clinical activity for immune globulin products is generally indication-led (primary immunodeficiency, immune thrombocytopenia, Kawasaki disease, chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy, and secondary immunodeficiencies). Trial registers show intermittent updates by sponsor and product, not by the generic phrase “immune globulin (human)” alone.

Which trial registries publish immune globulin (human) updates?

• ClinicalTrials.gov
• EU Clinical Trials Register
• WHO ICTRP
• Company press releases and congress abstracts

Why do trial updates look inconsistent for this class?

• Multiple IgG preparations (IVIG vs SCIG) are counted under similar generic wording.
• Sponsors frequently register trials by branded product name.
• Indication entry criteria differ by disease subtype and age group.

What to expect in trial reads (high-level)

• Primary endpoints are typically efficacy (response rate, relapse prevention), safety (AE/SAE, hypersensitivity), and immunologic endpoints (IgG trough, functional antibody responses).
• Neurologic indications and infectious prophylaxis programs tend to run with longer follow-up.
• Manufacturing changes can trigger bridging studies rather than new efficacy trials.

Which immune globulin (human) products are commercial leaders and what are their indications?

Featured snippet answer: Commercial positioning is typically built around:

• IVIG for primary immunodeficiency and selected inflammatory/neurologic indications
• SCIG for chronic replacement therapy and some convenience-focused switching
• Geographic coverage tied to supply contracts, national reimbursement, and plasma collection networks

Product segmentation that drives market outcomes

• Route: IVIG vs SCIG
• IgG concentration and formulation: stabilizers, osmolarity, sugar alcohol content, infusion tolerability
• Indications: overlap between replacement therapy and immunomodulatory use
• Patient segment: adult vs pediatric; chronic vs episodic use

Key inclusion patterns in reimbursement

• Primary immunodeficiency is usually tightly defined and often supports stable demand.
• Off-label use varies by country and payer policy.
• Neurologic and pediatric inflammatory uses can be more reimbursement-contingent.

How big is the immune globulin (human) market and what growth rates are projected?

Featured snippet answer: Public market reports generally size the global immunoglobulin market (IVIG + SCIG) rather than “immune globulin (human)” as a standalone single line item. Reported growth typically reflects:

• aging populations and expanding diagnosis
• increased use of immunomodulatory indications
• supply constraints and pricing normalization after biosupply shocks
• shifts from IVIG to SCIG in chronic replacement therapy settings

Market sizing approaches used in industry reports

• Epidemiology-driven demand (PID prevalence and immunomodulatory utilization)
• Unit demand based on grams of IgG dispensed
• Pricing and reimbursement modeling by region

What moves projections up or down

• Plasma supply variability and collection capacity
• Regulatory safety updates (e.g., thrombotic risk, renal risk monitoring)
• Formulation switching (IV to SC)
• Tendering and reimbursement negotiations
• Competitive entry of additional IVIG/SCIG brands and biosimilar-like alternatives where applicable by jurisdiction

When does immune globulin (human) lose exclusivity and what patent cliffs matter?

Featured snippet answer: For IgG products, exclusivity and patent cliffs are product-specific and depend on:

• formulation improvements
• manufacturing process claims
• specific indication and method-of-use patents
• pediatric exclusivity and orphan exclusivity (where applicable)
• country-by-country status in patent and data exclusivity registries

Why “class exclusivity” is not a clean concept for IgG

• Multiple manufacturers can sell IgG under different reference products, with distinct patents and data packages.
• “Immune globulin (human)” is often a generic description for a family of plasma-derived biologics and follow-on products rather than a single originator trackable by one exclusivity date.

What patents protect immune globulin (human) formulations and manufacturing?

Featured snippet answer: Patent coverage for IgG products typically clusters around:

• formulation composition and stabilizers
• solvent or virus inactivation steps (low pH, solvent-detergent)
• chromatography or purification process
• container closure systems and fill-finish methods
• methods of treatment for named indications

Patent estate patterns that affect freedom-to-operate

• Strong process claims can block “manufacturing design-around” even if composition is broadly similar.
• Indication method claims can block competing labels.

What generic entry risks exist for immune globulin (human)?

Featured snippet answer: For plasma-derived IgG, direct “generic” pathways are usually not the same as for small molecules. Competition risks come from:

• additional licensed plasma-derived products
• label expansion by competitors
• process bridging and comparability studies
• interchangeability or reimbursement switching

Regulatory pathways that shape competitive entry

• Biologics licensure under jurisdictional frameworks
• Comparability to an existing reference and demonstration of quality, safety, and efficacy
• Post-approval manufacturing changes handled via regulatory supplements and comparability protocols

What is the FDA regulatory status of immune globulin (human) products?

Featured snippet answer: In the US, immune globulin products are licensed biologics. The regulatory status depends on the specific product and application (BLA), not the generic class name.

Orange Book vs biologics reality

• Small-molecule “Orange Book” listing does not directly map to biologic products.
• For biologics, patent linkage exists through different systems (and disputes are handled under different statutes than classic Hatch-Waxman “Orange Book” small-molecule paradigms).

How do clinical endpoints and safety profiles differ across immune globulin (human) indications?

Featured snippet answer: Safety monitoring is broadly shared across IgG products (infusion reactions, thromboembolic events, renal dysfunction risk). Efficacy endpoints are indication-specific:

• PID replacement: trough IgG maintenance and infection rate reduction
• ITP: platelet response and durability
• Kawasaki: IVIG response and fever resolution metrics
• CIDP/MMN: functional scales, relapse prevention, and nerve conduction measures
• Infectious prevention: incidence endpoints and breakthrough infection rates

Common trial safety endpoints

• rate of treatment-emergent adverse events
• hypersensitivity reactions and infusion-related AEs
• serious adverse events and discontinuation rates
• lab monitoring linked to renal and thrombotic risk mitigation

What recent market drivers affect pricing and utilization of immune globulin (human)?

Featured snippet answer: The dominant near-term drivers are:

• reimbursement policy and contracting dynamics by country and hospital system
• plasma supply constraints impacting allocation and lead times
• switching from IVIG to SCIG for maintenance regimens
• guideline and payer alignment on which indications are reimbursed

Which companies are competing most actively in immune globulin (human) and where?

Featured snippet answer: Competitive activity generally tracks:

• plasma collection footprint
• manufacturing scale for IVIG and SCIG
• label breadth and claims that support reimbursement
• tender wins and long-term supply agreements

Where competition concentrates commercially

• US and EU represent major demand pools
• High-growth markets expand where PID and neurology recognition increases
• Tender-based procurement can create rapid share shifts

Key Takeaways

• “Immune globulin (human)” is a class-level description; actionable clinical and exclusivity timelines depend on the specific IVIG or SCIG product and labeled indication.
• Clinical trials are generally indication-led and product-named in registries, so class-level “update” needs product mapping to be defensible.
• Market projections are usually built on immunoglobulin (IVIG + SCIG) demand models with drivers tied to diagnosis rates, dosing patterns, route switching, and supply.
• Exclusivity, patent cliffs, and generic entry risk are product-specific (formulation, process, and method-of-use patents), not class-based.

FAQs

1. How do IVIG and SCIG clinical trial endpoints differ for primary immunodeficiency?
2. What safety monitoring protocols are most common for immune globulin infusion-related adverse events?
3. Which reimbursement policies most strongly influence immune globulin utilization by indication?
4. How do patent estates differ for immune globulin formulations versus methods of treatment claims?
5. What factors determine whether a competitor product is positioned as interchangeable or routinely switchable in practice?

References

1. [No cited sources are available in the prompt context to support a clinical-trials status table, market sizing figures, or product-specific patent/exclusivity dates for “immune globulin (human)”.]