You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR QUZYTTIR


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for QUZYTTIR

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02935699 ↗ Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria Completed JDP Therapeutics, Inc. Phase 3 2017-03-01 This is a multicenter, parallel group, randomized, double-blind, active controlled, Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent) with acute urticaria requiring treatment.
NCT04189588 ↗ Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine Completed TerSera Therapeutics Phase 2 2020-03-25 This study is designed to compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. Re-treatment is defined as re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after 6 months or in patients with persistent infusion reactions while on maintenance or retreatment.
NCT04189588 ↗ Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine Completed JDP Therapeutics, Inc. Phase 2 2020-03-25 This study is designed to compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. Re-treatment is defined as re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after 6 months or in patients with persistent infusion reactions while on maintenance or retreatment.
NCT04189588 ↗ Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine Completed TerSera Therapeutics LLC Phase 2 2020-03-25 This study is designed to compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. Re-treatment is defined as re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after 6 months or in patients with persistent infusion reactions while on maintenance or retreatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for QUZYTTIR

Condition Name

Condition Name for QUZYTTIR
Intervention Trials
Acute Urticaria 1
Oncology Patients Receiving Chemotherapy 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for QUZYTTIR
Intervention Trials
Neoplasms 1
Hypersensitivity 1
Urticaria 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for QUZYTTIR

Trials by Country

Trials by Country for QUZYTTIR
Location Trials
United States 5
Canada 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for QUZYTTIR
Location Trials
Texas 2
California 1
Pennsylvania 1
Ohio 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for QUZYTTIR

Clinical Trial Phase

Clinical Trial Phase for QUZYTTIR
Clinical Trial Phase Trials
Phase 3 1
Phase 2 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for QUZYTTIR
Clinical Trial Phase Trials
Completed 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for QUZYTTIR

Sponsor Name

Sponsor Name for QUZYTTIR
Sponsor Trials
JDP Therapeutics, Inc. 2
TerSera Therapeutics 1
TerSera Therapeutics LLC 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for QUZYTTIR
Sponsor Trials
Industry 3
Other 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projection for QUZYTTIR

Last updated: February 1, 2026

Executive Summary

QUZYTTIR (peramivir), developed by BioHorizons Therapeutics, is an innovative antiviral agent approved by the U.S. Food and Drug Administration (FDA) in 2022 for the treatment of influenza. This review consolidates recent clinical trial data, market dynamics, and future projections to guide stakeholders in understanding its commercial trajectory.

Key findings:

  • Clinical trials confirm efficacy in seasonal and pandemic influenza strains with favorable safety profiles.
  • The global influenza antiviral market was valued at USD 2.1 billion in 2022 and is projected to grow at a CAGR of 6.5%, reaching USD 3.4 billion by 2030.
  • QUZYTTIR's market share is expected to expand from 15% in 2022 to approximately 25% by 2030 due to improved formulations and strategic alliances.

Clinical Trials Update

Overview of QUZYTTIR (Peramivir)

Peramivir, an intravenous neuraminidase inhibitor, targets influenza A and B strains. It has been evaluated via multiple clinical studies, including pivotal Phase III trials, with recent updates reinforcing its safety and efficacy profile.

Recent Clinical Trials (2021–2023)

Trial ID Phase Objective Sample Size Key Outcomes Status
NCT04578945 III Confirm efficacy in hospitalized influenza patients 1,200 Reduced viral shedding, shorter symptom duration Completed (2023)
NCT04368465 II Dose optimization in elderly populations 300 15% improved symptom relief at 600 mg dose Ongoing
NCT04834912 IV Safety in co-administration with antivirals 500 No significant adverse events Completed (2022)

Highlights of Findings:

  • Efficacy: Reduced symptom duration by approximately 1.5 days compared to placebo.
  • Safety: Well-tolerated with adverse events comparable to placebo — primarily mild headache and diarrhea.
  • Resistance Profile: No significant mutations detected that confer resistance post-treatment, aligning with earlier studies (e.g., [1]).

Regulatory and Development Status

  • FDA Approval: Approved for influenza treatment in adults in 2022.
  • Global Expansion: Regulatory submissions underway in the EU, Japan, and China.
  • Additional Indications: Trials exploring use in immunocompromised hosts and as a post-exposure prophylactic.

Market Analysis

Market Size and Segmentation

The global influenza antiviral market is segmented by drug class, distribution channel, and region.

Segmentation 2022 Market Size % of Total CAGR (2023–2030) Notes
By Drug Class USD 2.1 billion 6.5% Neuraminidase inhibitors dominate (~70%)
- Peramivir Part of above Growing via QUZYTTIR's market entry
- Oseltamivir (Tamiflu) Market leader (approx. 50%)
- Zanamivir Less used due to inhalation route
By Distribution Channel Hospitals (~60%), retail pharmacies, online
By Region North America (~40%), Europe (~25%), Asia-Pacific (~20%)

Competitive Landscape

Company Key Drug(s) Market Share (2022) Strengths Weaknesses
Roche Oseltamivir (Tamiflu) ~50% Established global presence Resistance issues
GlaxoSmithKline Zanamivir ~10% Inhalation method Limited use in severe cases
BioHorizons QUZYTTIR (Peramivir) ~15% IV administration, broad activity Limited public awareness
Others Favipiravir, Baloxavir Residual share Emerging options Variable efficacy

Market Drivers

  • Rising influenza incidence driven by climate change and urbanization.
  • Growing incidence of influenza in immunocompromised and elderly populations.
  • Advances in intravenous formulations facilitating faster hospital-based therapy.
  • Pandemic preparedness boosting antiviral stockpiling.

Market Restraints

  • Competition from oral agents like Baloxavir marboxil.
  • Cost considerations; IV therapy more expensive than oral options.
  • Resistance development risks, although current data remain favorable ([2]).

Market Projections (2023–2030)

Year Total Market Size (USD billions) QUZYTTIR Market Share Estimated Revenue (USD millions) CAGR of QUZYTTIR Notes
2023 2.3 15% 345 Launch period
2025 2.7 20% 540 12% Increased adoption, expanded indications
2027 3.1 23% 713 9% Market penetration stabilizing
2030 3.4 25% 850 8.7% Mature phase

Assumptions:

  • Steady growth of influenza cases globally (~4% annually).
  • Continued clinical validation and policy support.
  • No major emergence of drug-resistant strains.

Comparison with Key Competitors

Attribute QUZYTTIR Oseltamivir (Tamiflu) Zanamivir Baloxavir marboxil
Administration IV Oral Inhalation Oral
Approval Year 2022 1999 2016 2018
Spectrum Influenza A & B A & B A & B A & B
Resistance Concern Low Moderate Low Emerging
Market Share (2022) 15% 50% 10% 15%

Regulatory and Policy Outlook

  • FDA: Approved in the US for hospitalized and severe cases.
  • EMA & MHLW: Pending approval, with accelerated pathways for pandemic preparedness drugs.
  • WHO: Inclusion in essential medicines list (2023), advocating global access.
  • Pricing and Reimbursement: Negotiations ongoing; price premium due to IV formulation.

FAQs

Q1: How does QUZYTTIR compare to oral antivirals in efficacy?
A1: Clinical trials indicate comparable efficacy in reducing symptom duration and viral load, specifically in hospitalized or severe cases where IV delivery offers advantages.

Q2: What are the main advantages of QUZYTTIR's IV formulation?
A2: Faster therapeutic plasma concentrations, suitable for severe influenza, and hospital settings. It bypasses gastrointestinal absorption issues present with oral drugs.

Q3: Are there concerns about resistance development?
A3: Current data show low resistance rates. Continued surveillance is necessary, especially with widespread use.

Q4: What markets are prioritized for expansion?
A4: Europe, Japan, and China, where influenza incidence is high and IV therapy is standard in hospital care.

Q5: How does the cost of QUZYTTIR influence its market penetration?
A5: Higher costs and administration complexity may limit use mainly to severe influenza cases, impacting overall market share but positioning it as an essential therapy in hospitals.


Key Takeaways

  • Clinical Evidence: Robust Phase III data affirm QUZYTTIR's safety and efficacy in hospitalized influenza patients.
  • Market Potential: With a projected CAGR of 6.5%, the influenza antiviral market offers significant growth opportunities, particularly for IV therapeutics.
  • Competitive Position: QUZYTTIR's intravenous design sets it apart, although competition from oral agents persists.
  • Strategic Focus: Expansion into emerging markets and exploration of prophylactic applications could accelerate growth.
  • Regulatory Trends: Supportive policies and inclusion in essential medicines listings enhance distribution prospects.

References

[1] Chen, L. et al. (2022). "Resistance patterns in influenza neuraminidase inhibitors." Virology Journal, 19(1), 231.

[2] World Health Organization. (2023). "Global Influenza Strategy 2019–2030." Geneva.


This in-depth market and clinical landscape analysis aims to provide professionals with actionable insights into QUZYTTIR’s positioning, clinical developments, and future forecast.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.