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Last Updated: March 30, 2025

CLINICAL TRIALS PROFILE FOR DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE


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All Clinical Trials for dexamethasone sodium phosphate; lidocaine hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT03299452 ↗ Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor Unknown status Alphacait, LLC Phase 2 2017-01-01 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT02266433 ↗ Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders Terminated New York University School of Medicine Phase 3 2012-08-01 The primary objective of this study is to compare local corticosteroid hand and elbow injections to placebo or ketorolac to determine if there is an equal or better reduction of symptoms for common orthopaedic upper extremity disorders including: De Quervain's tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators will enroll 780 subjects, divided equally into three arms for each disease process, and compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 month followup periods, prospectively over time.
NCT02266433 ↗ Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders Terminated NYU Langone Health Phase 3 2012-08-01 The primary objective of this study is to compare local corticosteroid hand and elbow injections to placebo or ketorolac to determine if there is an equal or better reduction of symptoms for common orthopaedic upper extremity disorders including: De Quervain's tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators will enroll 780 subjects, divided equally into three arms for each disease process, and compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 month followup periods, prospectively over time.
NCT01372904 ↗ Prevention of Cisplatin-Induced Hearing Loss by Intratympanic Dexamethasone Treatment Completed Meir Medical Center Phase 4 2011-06-01 Cisplatin is a widely used chemotherapeutic agent for the treatment of various malignant neoplasms, including testicular, ovarian, bladder, cervix uteri, head and neck and lung cancers. One of the common side-effects of this drug is bilateral, symmetric, progressive and usually irreversible sensorineural hearing loss. Cisplatin induces cochlear toxicity by the production of reactive oxygen species (ROS). Dexamethasone treatment is currently practiced for various pathologies afflicting the inner ear. The positive effect of Dexamethasone is attributed to it's anti ROS activity and it's capability to up-regulate cochlear anti ROS enzymes. In order to reach higher inner ear concentration of the drug while avoiding it's undesirable systemic side-effects, Intratympanic (IT) delivery of Dexamethasone became vastly used in the last decades for the treatment of sudden sensorineural hearing loss and Meniere's disease. Dexamethasone inserted IT, diffuse across the round window into the inner ear perilymph where it exerts its therapeutic effects. The investigators review of the literature yielded three animal studies which examined the protective effect of IT dexamethasone in the prevention of cisplatin-induced hearing loss. These studies demonstrated promising results pointing to the potential for IT dexamethasone in the prevention of cisplatin ototoxicity in humans. The purpose of this study is to examine possible protective effect of IT dexamethasone on cisplatin-induced hearing loss, in humans. The study hypothesis is that IT dexamethasone treatment would prevent cisplatin-induced hearing loss.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for dexamethasone sodium phosphate; lidocaine hydrochloride

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1Lateral EpicondylitisMetastatic CancerTennis ElbowTenosynovitis[disabled in preview]
Condition Name for dexamethasone sodium phosphate; lidocaine hydrochloride
Intervention Trials
Lateral Epicondylitis 1
Metastatic Cancer 1
Tennis Elbow 1
Tenosynovitis 1
[disabled in preview] 0
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1Hearing LossDeafnessNeoplasm MetastasisTrigger Finger Disorder[disabled in preview]
Condition MeSH for dexamethasone sodium phosphate; lidocaine hydrochloride
Intervention Trials
Hearing Loss 1
Deafness 1
Neoplasm Metastasis 1
Trigger Finger Disorder 1
[disabled in preview] 0
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Clinical Trial Locations for dexamethasone sodium phosphate; lidocaine hydrochloride

Trials by Country

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Trials by Country for dexamethasone sodium phosphate; lidocaine hydrochloride
Location Trials
Israel 1
China 1
United States 1
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Trials by US State

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Trials by US State for dexamethasone sodium phosphate; lidocaine hydrochloride
Location Trials
New York 1
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Clinical Trial Progress for dexamethasone sodium phosphate; lidocaine hydrochloride

Clinical Trial Phase

33.3%33.3%33.3%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for dexamethasone sodium phosphate; lidocaine hydrochloride
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 1
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Clinical Trial Status

33.3%33.3%33.3%0-0.100.10.20.30.40.50.60.70.80.911.1TerminatedUnknown statusCompleted[disabled in preview]
Clinical Trial Status for dexamethasone sodium phosphate; lidocaine hydrochloride
Clinical Trial Phase Trials
Terminated 1
Unknown status 1
Completed 1
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Clinical Trial Sponsors for dexamethasone sodium phosphate; lidocaine hydrochloride

Sponsor Name

trials000001111111Meir Medical CenterNew York University School of MedicineNYU Langone Health[disabled in preview]
Sponsor Name for dexamethasone sodium phosphate; lidocaine hydrochloride
Sponsor Trials
Meir Medical Center 1
New York University School of Medicine 1
NYU Langone Health 1
[disabled in preview] 1
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Sponsor Type

100.0%0-0.500.511.522.533.544.555.5Other[disabled in preview]
Sponsor Type for dexamethasone sodium phosphate; lidocaine hydrochloride
Sponsor Trials
Other 5
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Dexamethasone Sodium Phosphate and Lidocaine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Dexamethasone Sodium Phosphate and Lidocaine Hydrochloride

Dexamethasone sodium phosphate and lidocaine hydrochloride are two pharmaceutical agents with diverse therapeutic applications. Dexamethasone sodium phosphate is a corticosteroid used to treat various inflammatory and autoimmune conditions, while lidocaine hydrochloride is a local anesthetic and antiarrhythmic drug. Here, we will delve into the current clinical trials, market analysis, and projections for these drugs.

Dexamethasone Sodium Phosphate

Clinical Trials Update

Dexamethasone sodium phosphate is currently under various clinical investigations for its therapeutic potential in different conditions.

EryDex for Ataxia

One notable development is the EryDex system by Quince Therapeutics, which involves encapsulating dexamethasone sodium phosphate into red blood cells for a controlled, slow release. This therapy has gained orphan drug designation for the treatment of Ataxia-Telangiectasia (A-T) from both the FDA and the European Medicines Agency. After the FDA lifted its clinical hold, Quince Therapeutics is set to begin patient enrollment for the Phase 3 NEAT study in the second quarter of 2024[1].

Taiwan Liposome's SR Formulation

Taiwan Liposome is developing a sustained-release (SR) formulation of dexamethasone sodium phosphate, currently in Phase III clinical trials for the treatment of osteoarthritis pain. According to GlobalData, Phase III drugs for osteoarthritis pain have a 37% phase transition success rate, indicating the potential for this drug to progress to pre-registration[5].

Market Analysis

Market Size and Forecast

The dexamethasone sodium phosphate injection market is projected to grow significantly. As of 2023, the market size was valued at USD 121.21 million and is expected to reach USD 200.21 million by 2031, growing at a CAGR of 5.8% from 2024 to 2031[2].

End-User Segmentation

The market is primarily segmented into hospitals and clinics. Hospitals represent a significant segment due to their advanced facilities for administering injectable medications, catering to patients in emergency care, surgical recovery, and intensive care units. The increasing prevalence of chronic diseases drives the demand for dexamethasone sodium phosphate injections in hospitals[2].

Application Segmentation

The primary application segments include inflammatory diseases, allergic reactions, and autoimmune disorders. Inflammatory diseases, such as rheumatoid arthritis and lupus, drive a significant portion of the market due to the widespread use of dexamethasone as an anti-inflammatory agent. Allergic reactions and autoimmune disorders also contribute substantially to the market demand[2].

Geographical Segmentation

The market is segmented geographically into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America and Europe are characterized by advanced healthcare infrastructure and a high prevalence of chronic diseases, driving the demand for dexamethasone sodium phosphate injections. The Asia-Pacific region is witnessing a surge in demand due to rising health expenditures and increasing incidences of respiratory diseases[2].

Lidocaine Hydrochloride

Clinical Trials Update

Lidocaine hydrochloride, particularly in the form of ZTlido®, is undergoing several clinical trials and studies.

ZTlido® for Chronic Pain

Scilex Holding Company's ZTlido®, a lidocaine patch, has been studied for its efficacy in treating chronic neck pain. A recent study showed that 27.7% of patients experienced a positive outcome on ZTlido®, compared to 14.9% on placebo. Although the study had limitations due to early termination, it provided valuable insights for planning a potential Phase 3 development trial for a triple-strength formulation of ZTlido®, known as SP-103[4].

SP-103 Phase 2 Trial

The SP-103 Phase 2 trial, which involves a triple-strength formulation of ZTlido®, has achieved its objectives in characterizing safety, tolerability, and preliminary efficacy in acute low back pain associated with muscle spasms. The trial showed that SP-103 was safe and well-tolerated, with no signs of systemic toxicity or increased application site reactions[4].

Market Analysis

Market Performance of ZTlido®

ZTlido® has seen significant growth in prescriptions. New prescriptions (NRxs) grew by 34% and total prescriptions (TRxs) grew by 27% in the second quarter of 2023 compared to the same period in 2022. This growth is attributed to increased awareness and the effective promotion of ZTlido® among healthcare providers[3].

Future Projections

Based on independent market research, ZTlido® is projected to have peak sales potential of over $500 million in the next six years. The vast majority of this growth is expected to occur in the first three years, driven by current promotion efforts and increased utilization by healthcare providers[3].

Key Takeaways

  • Dexamethasone Sodium Phosphate: The market is expected to grow at a CAGR of 5.8% from 2024 to 2031, driven by its applications in inflammatory diseases, allergic reactions, and autoimmune disorders. Clinical trials, such as the EryDex system and Taiwan Liposome's SR formulation, are advancing the therapeutic potential of this drug.
  • Lidocaine Hydrochloride (ZTlido®): ZTlido® is showing promising results in treating chronic pain, with significant growth in prescriptions and a projected peak sales potential of over $500 million in the next six years. The SP-103 Phase 2 trial has demonstrated safety and efficacy, paving the way for further development.

FAQs

What is the current status of the EryDex clinical trial for Ataxia-Telangiectasia?

The FDA has lifted its clinical hold on the IND for the EryDex trial, and patient enrollment for the Phase 3 NEAT study is set to begin in the second quarter of 2024[1].

How is the market for dexamethasone sodium phosphate injections segmented?

The market is segmented by end-user (hospitals and clinics), application (inflammatory diseases, allergic reactions, and autoimmune disorders), and geography (North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa)[2].

What are the key findings from the ZTlido® clinical trials for chronic pain?

ZTlido® has shown a clinical benefit trend in treating chronic neck pain, with 27.7% of patients experiencing a positive outcome. The SP-103 Phase 2 trial demonstrated safety and efficacy for acute low back pain associated with muscle spasms[4].

What is the projected market size for dexamethasone sodium phosphate injections by 2031?

The market size is projected to reach USD 200.21 million by 2031, growing at a CAGR of 5.8% from 2024 to 2031[2].

What is the peak sales potential projected for ZTlido® in the next six years?

ZTlido® is projected to have peak sales potential of over $500 million in the next six years, driven by increased awareness and utilization among healthcare providers[3].

Sources

  1. FDA Lifts Hold on IND for Phase 3 Trial of Ataxia Agent EryDex. Neurology Live.
  2. Dexamethasone Sodium Phosphate Injection Market Size. Verified Market Research.
  3. Scilex Holding Company Announces Results From Independent Market Research Study. GlobeNewswire.
  4. Scilex Holding Company Announces Publication in Anesthesiology Journal. GlobeNewswire.
  5. Dexamethasone sodium phosphate SR by Taiwan Liposome for Osteoarthritis Pain. Pharmaceutical Technology.

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