CLINICAL TRIALS PROFILE FOR BERINERT

All Clinical Trials for BERINERT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00748202 ↗	Berinert P Study of Subcutaneous Versus Intravenous Administration	Completed	Clinical trial center Rhine-Main	Phase 3	2008-09-01	The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not suitable. The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study. Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.
NCT00748202 ↗	Berinert P Study of Subcutaneous Versus Intravenous Administration	Completed	CSL Behring	Phase 3	2008-09-01	The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not suitable. The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study. Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.
NCT00748202 ↗	Berinert P Study of Subcutaneous Versus Intravenous Administration	Completed	Institut für Medizinische Virologie JWG-University hospital	Phase 3	2008-09-01	The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not suitable. The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study. Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.
NCT00748202 ↗	Berinert P Study of Subcutaneous Versus Intravenous Administration	Completed	PharmaPart	Phase 3	2008-09-01	The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not suitable. The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study. Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.
NCT00748202 ↗	Berinert P Study of Subcutaneous Versus Intravenous Administration	Completed	University of Milan	Phase 3	2008-09-01	The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not suitable. The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study. Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.
NCT00748202 ↗	Berinert P Study of Subcutaneous Versus Intravenous Administration	Completed	ZKI Kindergerinnungslabor	Phase 3	2008-09-01	The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not suitable. The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study. Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.
NCT00748202 ↗	Berinert P Study of Subcutaneous Versus Intravenous Administration	Completed	Johann Wolfgang Goethe University Hospital	Phase 3	2008-09-01	The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not suitable. The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study. Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.

Clinical Trial Conditions for BERINERT

Condition Name

Condition Name for BERINERT
Intervention	Trials
Hereditary Angioedema	3
End Stage Renal Disease	2
Kidney Failure	1
Kidney Transplantation	1

Condition MeSH

Condition MeSH for BERINERT
Intervention	Trials
Angioedemas, Hereditary	4
Angioedema	4
Kidney Failure, Chronic	2
Kidney Diseases	2

Clinical Trial Locations for BERINERT

Trials by Country

Trials by Country for BERINERT
Location	Trials
United States	4
Germany	2
Russian Federation	1

Trials by US State

Trials by US State for BERINERT
Location	Trials
California	3
New York	1

Clinical Trial Progress for BERINERT

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for BERINERT
Clinical Trial Phase	Trials
Completed	5
Withdrawn	1
Not yet recruiting	1

Clinical Trial Sponsors for BERINERT

Sponsor Name

Sponsor Name for BERINERT
Sponsor	Trials
CSL Behring	3
Cedars-Sinai Medical Center	2
Stanley Jordan, MD	1

Sponsor Type

Sponsor Type for BERINERT
Sponsor	Trials
Other	13
Industry	5

BERINERT Market Analysis and Financial Projection

Last updated: May 1, 2026

BERINERT: Clinical Trials Update, Market Analysis, and Projection

BERINERT (C1 esterase inhibitor, human) is marketed for hereditary angioedema (HAE) with C1-INH deficiency. Clinical development activity is dominated by ongoing life-cycle work, manufacturing/registry evidence, and label support across jurisdictions rather than large new pivotal trials.

What is BERINERT’s clinical-trial status and evidence base?

Core approved indications

BERINERT is used for:

• On-demand treatment of acute attacks of HAE in patients with C1-INH deficiency
• Perioperative prophylaxis and other label-specific prophylaxis strategies in certain markets

Recent clinical activity pattern (what actually moves the label)

For mature biologics like BERINERT, “updates” typically come from:

• Long-term extension follow-up for safety (immunogenicity, thromboembolic events, systemic reactions)
• Pharmacovigilance and registry data that refresh benefit-risk language
• Manufacturing changes validated via comparability studies rather than new efficacy endpoints

What is missing in this request set: no specific trial identifiers, dates, or endpoints were provided. Without those, a complete, accurate “trial-by-trial” update cannot be produced.

Where is BERINERT sold, and how is it positioned competitively?

Competitive set

BERINERT competes in HAE acute and prophylaxis segments against:

• Plasma-derived and recombinant C1-INH therapies (acute and prophylaxis use-cases vary by product)
• Kallikrein inhibitors (oral and injectable options in some markets)
• Bradykinin receptor antagonists
• Evolving prophylaxis sequencing driven by route of administration and clinician preference

Positioning economics

Key drivers for BERINERT uptake:

• Fit for on-demand acute management in settings where rapid access and established workflow matter
• Clinician familiarity and historic use
• Reimbursement and formulary access by country and payer

Key constraints:

• Market share pressure from self-administration and newer prophylaxis agents in HAE maintenance settings
• Substitution risk when payers favor lower administration burden or broader prophylaxis coverage

What does the market look like for BERINERT, and how should it be projected?

Market sizing logic (segment-first, payer-driven)

A practical projection for BERINERT depends on:

1. HAE diagnosed population in each geography
2. Treatment penetration (acute on-demand use vs prophylaxis use)
3. Share of prescriptions by mechanism (C1-INH products vs kallikrein inhibitors vs bradykinin pathway drugs)
4. Route adoption and reimbursement rules (home infusion vs clinic/hospital administration)
5. Price and rebate dynamics (especially post-launch competition)

Projection framework (quantitative, but requires inputs not provided here)

To generate a numeric forecast (revenue, units, or share) with defensible assumptions, the analysis must anchor on:

• Current net sales (by geography and channel)
• Patient and utilization estimates (treating patients, attack frequency assumptions, dosing per attack or per prophylactic regimen)
• Competitor traction trends by mechanism
• Competitive switching and guideline-driven prophylaxis adoption

No financial figures, country coverage, or time series were supplied in the prompt. Without those inputs, any numeric market projection would be speculative rather than “actionable.”

Decision-grade summary: what can be concluded from the available information

• BERINERT’s clinical development emphasis is consistent with a mature biologic lifecycle: safety follow-up, comparability, and label support.
• Competitive dynamics in HAE increasingly depend on route of administration and payer-favored prophylaxis models, which can reduce incremental share for plasma-derived C1-INH if newer prophylaxis expands.
• A defensible market projection requires current net sales and treatment-segment utilization assumptions; these are not present in the request.

Key Takeaways

• BERINERT is a mature HAE C1-INH product where “clinical trial updates” typically reflect long-term safety and lifecycle evidence rather than major new efficacy pivots.
• The competitive threat in HAE is structural: shifting prescribing from on-demand-only care toward prophylaxis models and self-administered agents.
• A numeric market forecast for BERINERT cannot be produced accurately without current sales baselines, utilization data, and geography-specific assumptions.

FAQs

1. What is BERINERT used for in hereditary angioedema?
   On-demand treatment of acute HAE attacks and other prophylaxis uses as defined by regional labeling for patients with C1-INH deficiency.

2. What kind of clinical updates typically appear for established C1-INH therapies?
   Long-term extension follow-up, safety updates, immunogenicity monitoring, and comparability studies after manufacturing changes.

3. How does competition affect BERINERT share?
   Uptake shifts toward prophylaxis and therapies that reduce administration burden or align better with payer and guideline preferences.

4. What drives BERINERT market uptake at the payer level?
   Reimbursement coverage, formulary placement, treatment pathway alignment (acute vs prophylaxis), and negotiated pricing.

5. What is required to build a credible revenue projection?
   Current net sales baseline, treated population estimates, dosing/utilization assumptions by indication, and competitor adoption rates by mechanism.

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References

[1] FDA Label, BERINERT (C1-Esterase Inhibitor, Human). U.S. Food and Drug Administration.
[2] EMA Product Information, BERINERT. European Medicines Agency.
[3] ClinicalTrials.gov. Search results for “berinert” and “C1 esterase inhibitor human” (accessed current date).