CLINICAL TRIALS PROFILE FOR PALIVIZUMAB

Biosimilar Clinical Trials for palivizumab

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05121246 ↗	Pharmacokinetic Study Comparing MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.	Not yet recruiting	mAbxience S.A	Phase 1	2022-01-01	Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety, immunogenicity and tolerability of MB05 with US and EU Synagis® in healthy subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

All Clinical Trials for palivizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00014391 ↗	Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation	Completed	National Cancer Institute (NCI)	Phase 3	1999-02-01	RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is not yet known if ribavirin is more effective with or without monoclonal antibody therapy in treating patients who develop RSV pneumonia following peripheral stem cell transplantation. PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with or without monoclonal antibody in treating patients who develop RSV pneumonia following peripheral stem cell transplantation.
NCT00014391 ↗	Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation	Completed	Fred Hutchinson Cancer Research Center	Phase 3	1999-02-01	RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is not yet known if ribavirin is more effective with or without monoclonal antibody therapy in treating patients who develop RSV pneumonia following peripheral stem cell transplantation. PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with or without monoclonal antibody in treating patients who develop RSV pneumonia following peripheral stem cell transplantation.
NCT00240929 ↗	A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)	Completed	MedImmune LLC	Phase 2	2002-09-01	A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.
NCT00484393 ↗	Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study	Completed	Fraser Health	Phase 4	2007-11-01	This is a small study known as a pilot study. This pilot study is being done to see if a difference in pain from intramuscular palivizumab injection can be detected if tetracaine a topical numbing gel is used compared to no medication (placebo). If a difference is found in this pilot study, then a larger study may be done to confirm that there is a difference in pain experience.
NCT01466062 ↗	Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions	Completed	AbbVie (prior sponsor, Abbott)	Phase 3	2011-08-01	To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.

Clinical Trial Conditions for palivizumab

Condition Name

Condition Name for palivizumab
Intervention	Trials
Respiratory Syncytial Virus (RSV)	3
Respiratory Syncytial Virus Infections	3
Acute Respiratory Tract Infections	2
Pain	1

Condition MeSH

Condition MeSH for palivizumab
Intervention	Trials
Respiratory Syncytial Virus Infections	5
Infections	5
Virus Diseases	5
Communicable Diseases	3

Clinical Trial Locations for palivizumab

Trials by Country

Trials by Country for palivizumab
Location	Trials
United States	82
United Kingdom	9
Canada	8
Ukraine	7
South Africa	5

Trials by US State

Trials by US State for palivizumab
Location	Trials
California	5
South Carolina	4
New York	4
Florida	3
Wisconsin	3

Clinical Trial Progress for palivizumab

Clinical Trial Phase

Clinical Trial Phase for palivizumab
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for palivizumab
Clinical Trial Phase	Trials
Completed	10
Not yet recruiting	2
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for palivizumab

Sponsor Name

Sponsor Name for palivizumab
Sponsor	Trials
MedImmune LLC	4
AstraZeneca	3
mAbxience S.A	2

Sponsor Type

Sponsor Type for palivizumab
Sponsor	Trials
Industry	16
Other	5
NIH	1

Palivizumab: Clinical Trials Update, Market Analysis and Projection

Last updated: April 26, 2026

What is palivizumab and what is the commercial use case?

Palivizumab (Synagis) is a monoclonal antibody targeting respiratory syncytial virus (RSV). It is indicated for prevention of RSV lower respiratory tract disease in high-risk pediatric populations, which is the core commercial use case for dosing-based revenues. Current commercial patterns remain constrained by:

• Seasonal demand (winter peaks by geography)
• High-cost, antibody-based prophylaxis under payer control
• Competition from newer RSV preventive products for infants (including long-acting mAbs and vaccines, depending on geography and eligibility rules)

Where does the clinical development landscape sit today?

A full “active global trials” view requires real-time registry pulls. With the information available here, the clinical-trials update that can be stated as fact is limited to the established product, its regulatory status as a marketed RSV prophylaxis antibody, and the general competitive shift toward newer preventive modalities. No incremental, high-confidence late-stage trial dataset (phase, endpoints, timelines, enrollment status, or readout dates) can be populated from the provided material with sufficient precision.

What has changed competitively in the RSV prevention market?

The RSV prevention space has shifted from short-acting, seasonal mAb prophylaxis toward longer-acting antibodies and maternal or infant vaccines (depending on country approvals). The commercial impact is that palivizumab’s addressable population narrows as payers and providers move to lower-frequency dosing options where reimbursement and guideline adoption support them. This reduces:

• The volume of patients qualifying for prophylaxis
• The probability of line-item substitution at the same season’s prescribing decision

What are the known regulatory and labeling constraints that shape use?

Palivizumab is designed for RSV prevention, and its use follows guideline-driven high-risk eligibility rather than general prophylaxis for all infants. That structure creates direct dependence on:

• Guideline definitions of “high risk” by age, prematurity status, bronchopulmonary dysplasia, and congenital heart disease
• Payer policy thresholds and prior authorization practices
• Seasonal ordering behavior by distributors and hospitals

(Those structural drivers are the primary determinants of revenue cadence for this product class.)

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Market Analysis

What drives palivizumab demand?

Demand is governed by a small set of variables that compound into season-by-season utilization:

• Eligibility rate: fraction of infants meeting high-risk criteria by guideline and payer policy
• Dosing schedule: the number of administered doses per eligible patient per season
• Site of care: hospital infusion or clinic delivery patterns that influence adherence and switching behavior
• Budget impact management: payer and hospital formulary restrictions when competing prevention options exist

How does competition affect palivizumab pricing power?

Competition changes negotiating dynamics. When longer-acting prophylaxis and/or vaccines gain guideline support, palivizumab pricing power weakens through:

• Formulary substitution: payers steer eligible cohorts to alternative products
• Volume displacement: fewer patients qualify or choose palivizumab even if clinically eligible
• Contract pressure: manufacturers face rebates and net price erosion to maintain share

What is the realistic market trajectory?

For a short-acting prophylactic mAb exposed to substitution by longer-acting antibodies and preventive vaccines, the base case market trajectory is typically:

• Declining unit volume in geographies with broad adoption of competing modalities
• Stabilization in geographies where guideline and payer rules still prioritize palivizumab for specific high-risk subsets
• Seasonal volatility but an overall long-run downtrend in share

Because the prompt does not supply numerical sales baselines, market share, or geography-specific adoption curves, no hard quantitative forecast can be generated without inventing figures.

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Projection Framework (Non-numeric)

What would a decision-grade projection model need to include?

A projection-grade model for palivizumab should be built on three layers:

1) Addressable eligible cohort

• Birth cohort size by geography
• Proportion of high-risk infants by guideline (prematurity strata, chronic lung disease, congenital heart disease)
• Payer policy thresholds and prior authorization approval rates

2) Product selection behavior

• Share of prophylaxis among eligible patients allocated to palivizumab vs alternatives
• Seasonal switching rules and contracting timing
• Provider prescribing patterns by site of care

3) Net revenue mechanics

• Net price after rebates and discounts
• Mix of private vs public payer
• Dosing adherence and wastage effects

This structure yields directional and scenario-based projections without requiring assumptions that could distort results.

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Clinical Trials Update (Actionable Summary)

What is the current development posture for palivizumab?

From a business perspective, palivizumab is treated as an established prophylactic product with the clinical strategy focused on maintaining market access and line extensions rather than transformative late-stage development in the way newer RSV preventive assets are positioned. The key “clinical” outcome today is not a new phase readout, but whether guideline and reimbursement decisions keep palivizumab within the eligible prevention pathway for high-risk infants.

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Key Takeaways

• Palivizumab remains an RSV prophylaxis monoclonal antibody used for high-risk infant prevention, with seasonal demand and eligibility-driven utilization.
• Competitive substitution by longer-acting RSV preventives and vaccines is the primary force shaping palivizumab’s revenue trajectory.
• A decision-grade market projection must model eligible cohort size, payer guideline interpretation, product selection share, and net price mechanics; without numeric inputs, only a non-numeric directional projection is supportable.
• The “clinical trials update” for palivizumab today is primarily about maintaining its place in the guideline-driven prophylaxis pathway rather than new late-stage development momentum.

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FAQs

Is palivizumab still used in clinical practice?

Yes. It is an approved RSV prevention mAb with ongoing use in high-risk pediatric populations that meet guideline and payer criteria.

What is the main risk to palivizumab’s market growth?

Clinical and economic substitution by longer-acting RSV antibodies and preventive vaccines that reduce dosing frequency and expand preventive coverage under payer programs.

Does palivizumab sales depend on seasonality?

Yes. Utilization is seasonal, driven by RSV activity windows in each geography and by ordering and administration cycles.

What determines patient eligibility for palivizumab use?

Guideline-defined high-risk criteria (such as prematurity and certain comorbidities) and payer authorization rules that determine which infants receive prophylaxis.

How should a forecast for palivizumab be built?

Use a model that combines the eligible cohort, product selection share versus competing preventives, dosing adherence, and net revenue calculations (rebates, discounts, payer mix).

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References

[1] Food and Drug Administration. Synagis (palivizumab) prescribing information. FDA. https://www.accessdata.fda.gov/