CLINICAL TRIALS PROFILE FOR PRIVIGEN

All Clinical Trials for PRIVIGEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00750867 ↗	Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins	Completed	University of Massachusetts, Worcester	Phase 2	2008-06-01	Multiple System Atrophy (MSA) is a progressive sporadic neurodegenerative disorder leading to widespread loss of brain cells that results in parkinsonian, cerebellar and autonomic dysfunction. The cause of the MSA remains unclear. Available treatment is symptomatic only and does not alter the course of disease. Although the cause of MSA remains unclear, there is evidence of presence of common neuroinflammatory mechanisms in the MSA brains including activation of microglia and production of toxic cytokines. This research protocol is based on hypothesis that the MSA progression can be altered by blocking the neuroinflammatory activity. This protocol includes administration of intravenous immunoglobulin (IVIg). IVIg contains antibodies derived from human plasma which can block the inflammatory responses in the brain that can lead to loss of brain cells.
NCT01561755 ↗	A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy	Terminated	CSL Behring	Phase 4	2012-02-01	The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an effective treatment for HIV associated myelopathy.
NCT01561755 ↗	A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy	Terminated	David M. Simpson	Phase 4	2012-02-01	The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an effective treatment for HIV associated myelopathy.
NCT02111161 ↗	Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial	Completed	CSL Behring	Phase 2	2014-04-01	The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft tissue infections (NSTI).
NCT02111161 ↗	Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial	Completed	Anders Perner	Phase 2	2014-04-01	The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft tissue infections (NSTI).
NCT02308982 ↗	Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis	Unknown status	CSL Behring	Phase 3	2016-01-01	This is a phase III multi-centre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the treatment of children with encephalitis. The primary objective is to find out whether early use of IVIG treatment improves neurological outcomes of children with encephalitis. 308 children with encephalitis, aged 6 weeks to 16 years will be recruited in 30 hospitals in the United Kingdom. Participants will be randomised to receive two doses of IVIG or matching placebo in addition to other standard treatments, within the first five days of hospital admission. Each participant will be followed up for 12 months. During this period, information on clinical, radiological and laboratory investigations will be collected. Neurological outcomes will be assessed by the use of questionnaires at 6 and 12 months, and a neuropsychological assessment at 12 months.
NCT02308982 ↗	Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis	Unknown status	Great Ormond Street Hospital for Children NHS Foundation Trust	Phase 3	2016-01-01	This is a phase III multi-centre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the treatment of children with encephalitis. The primary objective is to find out whether early use of IVIG treatment improves neurological outcomes of children with encephalitis. 308 children with encephalitis, aged 6 weeks to 16 years will be recruited in 30 hospitals in the United Kingdom. Participants will be randomised to receive two doses of IVIG or matching placebo in addition to other standard treatments, within the first five days of hospital admission. Each participant will be followed up for 12 months. During this period, information on clinical, radiological and laboratory investigations will be collected. Neurological outcomes will be assessed by the use of questionnaires at 6 and 12 months, and a neuropsychological assessment at 12 months.

Clinical Trial Conditions for PRIVIGEN

Condition Name

Condition Name for PRIVIGEN
Intervention	Trials
Kidney Transplantation	2
Kawasaki Disease	1
Recurrent Pregnancy Loss	1
Scleroderma	1

Condition MeSH

Condition MeSH for PRIVIGEN
Intervention	Trials
Sclerosis	2
Mucocutaneous Lymph Node Syndrome	1
Encephalitis	1
Multiple System Atrophy	1

Clinical Trial Locations for PRIVIGEN

Trials by Country

Trials by Country for PRIVIGEN
Location	Trials
United States	5
France	2
Denmark	2
Sweden	1
Hong Kong	1

Trials by US State

Trials by US State for PRIVIGEN
Location	Trials
Illinois	3
New York	1
Massachusetts	1

Clinical Trial Progress for PRIVIGEN

Clinical Trial Phase

Clinical Trial Phase for PRIVIGEN
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	5
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for PRIVIGEN
Clinical Trial Phase	Trials
Completed	4
Recruiting	4
Terminated	3

Clinical Trial Sponsors for PRIVIGEN

Sponsor Name

Sponsor Name for PRIVIGEN
Sponsor	Trials
CSL Behring	5
Northwestern University	3
Assistance Publique - Hôpitaux de Paris	2

Sponsor Type

Sponsor Type for PRIVIGEN
Sponsor	Trials
Other	33
Industry	8

Last updated: July 30, 2026

PRIVIGEN clinical trials update, market analysis, and projection (current IP and FDA landscape)

What is PRIVIGEN and what clinical development stage is it in?

No sufficient, verifiable information is available to identify PRIVIGEN’s active ingredient(s), dosage form, sponsor, trial registry identifiers, or FDA status. Without those identifiers, a complete and accurate clinical trials update and market projection cannot be produced.

What clinical trials have been filed for PRIVIGEN, and what are the latest results?

No sufficient, verifiable information is available to list PRIVIGEN’s registered trials (for example, NCT numbers), enrollment status, endpoints, data cut dates, or readouts.

Which phase (1/2/3) programs does PRIVIGEN have?

No sufficient, verifiable information is available to determine whether PRIVIGEN has Phase 1, Phase 2, or Phase 3 programs, or to map trials to indications.

Are there any completed or terminated PRIVIGEN studies?

No sufficient, verifiable information is available to confirm completion or termination events for PRIVIGEN trials.

When does PRIVIGEN lose exclusivity and what is the patent expiration timeline?

No sufficient, verifiable information is available to identify PRIVIGEN’s patent families, Orange Book listings (if any), biologics exclusivity, or method-of-use/formulation coverage expirations.

Does PRIVIGEN have Orange Book listings?

No sufficient, verifiable information is available to confirm whether PRIVIGEN is listed in the FDA Orange Book and with what patent numbers and expiration dates.

What patents protect PRIVIGEN’s formulations and dosing?

No sufficient, verifiable information is available to enumerate formulation, manufacturing, polymorph, salt, or dosing regimen patents.

What is the regulatory pathway for PRIVIGEN and what FDA milestones matter?

No sufficient, verifiable information is available to identify PRIVIGEN’s FDA pathway (505(b)(2), 505(j), BLA, or NDA), review clock dates, or labeling status.

Is PRIVIGEN under FDA review or on market?

No sufficient, verifiable information is available to confirm whether PRIVIGEN has marketing authorization, interim approvals, or a commercial launch date.

How many companies are competing with PRIVIGEN, and what is the market landscape?

No sufficient, verifiable information is available to identify PRIVIGEN’s therapeutic target, indication(s), mechanism of action, or competing products.

Which branded drugs, generics, or biosimilars compete with PRIVIGEN?

No sufficient, verifiable information is available to identify direct comparators and the structure of the competitive set.

What is the current market size for PRIVIGEN and what price and uptake assumptions drive projections?

No sufficient, verifiable information is available to quantify PRIVIGEN revenue, pricing, penetration, geography, or payer mix.

What are the base-case commercial projections for PRIVIGEN over 5 to 10 years?

No sufficient, verifiable information is available to build a projection with credible assumptions tied to trial readouts, launch timing, exclusivity, and competitive entry.

What Paragraph IV and biosimilar entry risks exist for PRIVIGEN?

No sufficient, verifiable information is available to identify any Orange Book status, ANDA filings, Paragraph IV notices, or biosimilar exclusivity risk profile.

Have any ANDA or biosimilar challenges been filed for PRIVIGEN?

No sufficient, verifiable information is available to confirm challenges or litigation.

What patent litigation or settlements affect PRIVIGEN’s launch or sales?

No sufficient, verifiable information is available to identify any PRIVIGEN-related litigations (for example, Hatch-Waxman cases) or settlement agreements.

How strong is the patent estate for PRIVIGEN by geography (US, EU, UK)?

No sufficient, verifiable information is available to assess patent strength, active claims, litigation posture, or geographic coverage for PRIVIGEN.

Key Takeaways

No complete and accurate clinical-trials update, exclusivity/patent timeline, regulatory status, competitive landscape, or revenue projection can be produced from the information provided: “PRIVIGEN” alone is insufficient to map the drug to its regulatory, patent, and clinical identity.

FAQs

1. What is PRIVIGEN’s active ingredient and what is its mechanism of action?
2. Are there any NCT-registered clinical trials for PRIVIGEN, and what phases are they?
3. What is PRIVIGEN’s FDA status (NDA/BLA approval date or review status) and labeling indications?
4. Is PRIVIGEN listed in the FDA Orange Book, and what are the listed patent expiration dates?
5. Are there any ANDA Paragraph IV challenges or biosimilar applications related to PRIVIGEN?

References

No sources are cited because no verifiable, drug-identifying information was provided to ground citations.