CLINICAL TRIALS PROFILE FOR EPIPEN JR.

All Clinical Trials for EPIPEN JR.

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00434421 ↗	Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma	Completed	Inner-City Asthma Consortium	Phase 1	2007-02-01	Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given sublingually to people with perennial (year-round) allergic rhinitis, with or without asthma.
NCT00434421 ↗	Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2007-02-01	Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given sublingually to people with perennial (year-round) allergic rhinitis, with or without asthma.
NCT00809146 ↗	Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications	Completed	Medical University of South Carolina	Phase 3	2009-06-01	The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.

Clinical Trial Conditions for EPIPEN JR.

Condition Name

Condition Name for EPIPEN JR.
Intervention	Trials
Anaphylaxis	5
Allergy	2
Anaphylactic Reaction	2

Condition MeSH

Condition MeSH for EPIPEN JR.
Intervention	Trials
Anaphylaxis	6
Rhinitis, Allergic	2
Rhinitis	2

Clinical Trial Locations for EPIPEN JR.

Trials by Country

Trials by Country for EPIPEN JR.
Location	Trials
United States	41
Israel	2
Canada	2
Sweden	1
Serbia	1

Trials by US State

Trials by US State for EPIPEN JR.
Location	Trials
Maryland	4
New York	3
Missouri	2
Wisconsin	2
Virginia	2

Clinical Trial Progress for EPIPEN JR.

Clinical Trial Phase

Clinical Trial Phase for EPIPEN JR.
Clinical Trial Phase	Trials
PHASE1	4
Phase 4	3
Phase 3	3

Clinical Trial Status

Clinical Trial Status for EPIPEN JR.
Clinical Trial Phase	Trials
COMPLETED	10
RECRUITING	1
Unknown status	1

Clinical Trial Sponsors for EPIPEN JR.

Sponsor Name

Sponsor Name for EPIPEN JR.
Sponsor	Trials
Nasus Pharma	3
National Institute of Allergy and Infectious Diseases (NIAID)	2
National Institute of Neurological Disorders and Stroke (NINDS)	1

Sponsor Type

Sponsor Type for EPIPEN JR.
Sponsor	Trials
Industry	12
Other	12
NIH	3

Last updated: July 28, 2026

Epipen Jr. clinical trials update, market analysis and launch projection

No complete, reliable dataset is available here to produce a factual clinical-trials update and market projection for Epipen Jr. (epinephrine) that can be tied to specific ongoing studies, sponsor sites, trial identifiers, FDA regulatory milestones, and current commercial metrics.

What clinical trials are ongoing for Epipen Jr. and what are their key endpoints?

Which trial IDs and sponsors are driving Epipen Jr. studies?

No citable trial registry identifiers, sponsor names, or endpoint summaries are available in the provided information to compile an update tied to Epipen Jr.

What efficacy and safety endpoints do Epipen Jr. studies use?

No citable protocol details (primary endpoints, inclusion criteria, dosing, comparative arms, or safety characterization) are available.

What is the FDA approval and Orange Book status of Epipen Jr.?

Is Epipen Jr. listed in the Orange Book with listed patents?

No Orange Book listing identifiers, applicant/holder information, or listed patent numbers are available.

What exclusivity protections apply to Epipen Jr.?

No FDA exclusivity dates (NCE, 505(b)(2), orphan, or patent-term-related exclusivities) are available.

How big is the Epipen Jr. market and what growth drivers matter?

Current addressable market by patient type and setting

No current market sizing, utilization volumes, or payer channel mix are available.

Key growth drivers: prescribing, guideline adherence, and switching between devices

No citable prescribing trend data, guideline timing, or device switching metrics are available.

What competitors does Epipen Jr. face and how do products compare?

Which epinephrine auto-injectors compete directly?

No competitor list, product equivalence, price points, rebate structure, or formulary placement data is available.

How does Epipen Jr. compare on device mechanics, dosing, and usability?

No citable technical comparison (needle length, injection force, activation mechanism, storage constraints, or training outcomes) is available.

When can generic or authorized alternatives enter and what are the IP barriers?

What patents protect Epipen Jr. auto-injector formulations and devices?

No patent estate details, key expiration dates, or device-specific IP are available.

What Paragraph IV or device-challenge pathways could matter?

No filing history, notice dates, or litigation posture is available.

What is the near-term sales and revenue projection for Epipen Jr.?

Base case, downside case, and upside case assumptions

No sales history, ASP trends, distribution changes, or budget-impact data is available to ground projections.

Scenario plan for payer reimbursement changes and tendering

No reimbursement/tender data is available to support scenario-driven forecasts.

Key Takeaways

• A factual clinical-trials update and market projection for Epipen Jr. cannot be produced without citable trial registry details, FDA regulatory and Orange Book patent/exclusivity records, and current commercial metrics tied to the product.

FAQs

1. What is the latest ClinicalTrials.gov status for studies involving Epipen Jr.?
2. What FDA labeling or RLD references govern Epipen Jr.’s approval pathway and scope?
3. How do Epipen Jr. pricing and formulary placement compare with competing epinephrine auto-injectors?
4. What patent expirations or litigation events could affect Epipen Jr. launch timing for alternatives?
5. What dosing regimen and age weight indications define Epipen Jr.’s target patient population?

References (APA)

No sources were provided or can be cited from the information available in this chat.